Skip to main content
2010 Links Archive
[ Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov ]
Links Archive: 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014

These links take users to additional information, announcements, and government documents mentioned in BioCentury's publications.

Cell/Gene therapy (December 20, 2010)
FDA transcript of the Nov. 2 public workshop on clinical trials of gene and cell therapies in pediatric populations.

Combination therapies (PDF file) (December 20, 2010)
FDA draft guidance for the co-development of two or more investigational drugs for use in combination (see BioCentury Extra, Tuesday, Dec. 14).

Orphan drugs (PDF file) (December 20, 2010)
Summary of actions taken at the Dec. 7-8 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Patents (PDF file) (December 20, 2010)
U.S. Court of Appeals for the Federal Circuit decision that again upheld the validity of two patents from Prometheus Laboratories Inc. after reconsidering Prometheus Laboratories Inc. v. Mayo Collaborative Services on remand from the U.S. Supreme Court (see BioCentury Extra, Friday, Dec. 17).

PDUFA (PDF file) (December 20, 2010)
FDA minutes of a Nov. 18 meeting with industry to discuss reauthorization of PDUFA in which the agency proposed to add two months to the review period for new molecular entity (NME) NDAs and original BLAs (see BioCentury Extra, Monday, Dec. 13).

Synthetic Biology (PDF files) (December 20, 2010)
Presidential Commission for the Study of Bioethical Issues report and FAQ on its examination of the implications synthetic biology (see BioCentury Extra, Thursday, Dec. 16).
 
Product documentation (December 20, 2010)
—Avastin: FDA documentation on its proposal to withdraw approval of Avastin bevacizumab for first-line treatment of HER2-negative metastatic breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY); plus a link to a healthcare professionals website for Avastin that contains a presentation "The Question for Angiogenesis Biomarkers" describing efforts to identify biomarkers predictive of response to the drug; and a link (PDF file) to NICE final guidance recommending against Avastin in combination with chemotherapy to treat metastatic colorectal cancer (mCRC) (see Cover Story).
Herceptin: NICE preliminary appraisal recommending against Herceptin trastuzumab in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, Dec. 14).
PegIntron: CHMP revised EPAR updating SPC to include information related to growth inhibition and psychiatric side effects in children receiving PegIntron peginterferon alfa-2b to treat HCV; from Enzon Pharmaceuticals Inc. (NASDAQ:ENZN) and Merck & Co. Inc. (NYSE:MRK).
Prezista: CHMP revised EPAR updating SPC to include contraindication with sildenafil for pulmonary arterial hypertension (PAH) and warning about concomitant use of cholchicine for Prezista darunavir to treat HIV-1 infection; from Johnson & Johnson (NYSE:JNJ).
Resolor: NICE final guidance recommending Resolor prucalopride to treat constipation in women in whom treatment with at least two laxatives from different classes for at least six months has failed to provide adequate relief, and in whom invasive treatment for constipation is being considered; from Shire plc (LSE:SHP; NASDAQ:SHPGY) (see BioCentury Extra, Tuesday, Dec. 15). (PDF file)
Tysabri: CHMP revised EPAR updating SPC to include data indicating that prior use of immunosuppressants increases the risk for progressive multifocal leukoencephalopathy (PML) independent of the duration of therapy with Tysabri natalizumab to treat relapsing-remitting multiple sclerosis (RRMS), from Biogen Idec Inc. (NASDAQ:BIIB) and Elan Corp. plc (NYSE:ELN).
Tyverb: NICE preliminary appraisal recommending against Tyverb lapatinib as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Tuesday, Dec. 14).

Biosimilars (PDF file) (December 13, 2010)
FDA notice requesting stakeholders notify the agency of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act).

Cardiovascular (PDF file) (December 13, 2010)
European Medicines Agency (EMA) Cardiovascular Working Party 2011 work plan.

Diabetes (PDF file) (December 13, 2010)
Text of the Medicare and Medicaid Extenders Act of 2010 (H.R. 4994) which would renew the Special Diabetes Program for Type I diabetes (see BioCentury Extra, Thursday, Dec. 9).

Drug surveillance (PDF file) (December 13, 2010)
FDA notice of the Jan. 12 Third Annual Sentinel Initiative Public Workshop to discuss topics in active medical product surveillance.

FDA guidances (PDF file) (December 13, 2010)
FDA annual agenda on possible topics for future guidance document development or revisions of existing ones.

Gene patents (PDF files) (December 13, 2010)
Patent Amendment (Human Genes and Biological Materials) Bill 2010 proposed by Australian senators to amend the Patent Acts of 1990 to prevent patenting of human genes and biological materials, including DNA, RNA, proteins, cell and fluids, which are identical or substantially identical to materials as they exist in nature (see BioCentury Extra, Monday, Dec. 6).
Australian Senate committee report recommending increased requirements for patenting genes but recommending against amending existing legislation to prohibit such patents

Immunoglobulin (PDF files) (December 13, 2010)
European Medicines Agency (EMA) guideline on the information to be included in the summary of product characteristics (SmPC) for human IV immunoglobulin (IVIg) and overview of comments received.

Orphan Drugs (PDF file) (December 13, 2010)
Report from the joint European Biopharmaceutical Enterprises-EuropaBio Task Force on Rare Diseases and Orphan Medicinal Products evaluating the impact of the legislation on research for rare diseases and the availability of new drugs to treat rare diseases over the last 10 years.

Personalized medicine (PDF file) (December 13, 2010)
Personalized Medicine Coalition report on the opportunities and challenges that might affect the pace of adoption of personalized medicine.

Stem Cells (PDF file) (December 13, 2010)
External Advisory Panel (EAP) report on the strategy, policies and procedures at the California Institute for Regenerative Medicine (CIRM).

Translational research (PDF file) (December 13, 2010)
NIH's Scientific Management Review Board report outlining recommendations to create the National Center for Advancing Translational Sciences to provide tools and expertise to help academic researchers develop therapeutics and collaborate with biotech and pharmaceutical companies (see BioCentury Extra, Wednesday, Dec. 8).

Transparency (PDF file) (December 13, 2010)
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) recommendations on the release of information for new medicinal product applications before and after an opinion or decision on granting of a marketing authorization (see BioCentury, Dec. 6).

Product documentation (December 13, 2010)
Avastin: NICE final appraisal determination (FAD) recommending against Avastin bevacizumab in combination with a taxane for first-line treatment of metastatic breast cancer; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, Dec. 7). (PDF file)

Advanced therapies (PDF file) (December 6, 2010)
Summary of actions taken at the Nov. 11-12 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

ANDAs (PDF file) (December 6, 2010)
FDA guidance on impurities in drug products submitted under an ANDA.

Antibacterial drugs (PDF files) (December 6, 2010)
—FDA draft guidance on developing drugs to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
—FDA guidance on the use of non-inferiority trials to support approval of antibacterial drug.

Antipsychotics (PDF file) (December 6, 2010)
HHS's Agency for Healthcare Research and Quality (AHRQ) draft review of the comparative effectiveness of antipsychotic drugs for pediatric and young adult populations (see BioCentury Extra, Wednesday, Nov. 24).

CHMP (PDF file) (December 6, 2010)
Detailed report of actions taken at the Nov. 15-19 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

EMA (PDF files) (December 6, 2010)
European Medicines Agency (EMA) report on annual accounts and budgetary and financial management.

Enantiomers (PDF file) (December 6, 2010)
European Medicines Agency (EMA) draft reflection paper on considerations given to designation of a single stereoisomeric form (enantiomer) as a new active substance in relation to a reference active substance.

ESAs (December 6, 2010)
CMS questions posted for the Jan. 19 meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss the use of erythropoiesis stimulating agents in patients with chronic kidney disease (CKD) (see BioCentury Extra, Monday, Nov. 29).

Gene therapy (PDF file) (December 6, 2010)
European Medicines Agency's Gene Therapy Working Party (GTWP) work plan for 2011.

Healthcare reform (PDF file) (December 6, 2010)
The National Commission on Fiscal Responsibility and Reform final proposal on reducing the national debt and spending, including healthcare costs (see BioCentury Extra, Wednesday, Dec. 1).

Influenza (PDF files) (December 6, 2010)
European Medicines Agency (EMA) procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralized procedure, and an overview of comments received.

mAbs (PDF files) (December 6, 2010)
—European Medicines Agency (EMA) draft guidelines for the development of biosimilar mAbs (see BioCentury Extra, Monday, Nov. 29).
—EMA draft guideline on assessing the immunogenicity of mAbs intended for clinical use (see BioCentury Extra, Monday, Nov. 29).

Manufacturing (PDF files) (December 6, 2010)
—European Medicines Agency (EMA) draft concept paper on the revision of a chapter on quality control in the EU good manufacturing practice (GMP) guide.
—EMA draft concept paper on storage conditions during transport of medicinal products.

Patents (PDF file) (December 6, 2010)
U.K. consultation document outlining plans for a "patent box" to lower the corporation tax rate on income stemming from patents in the U.K (see BioCentury Extra, Tuesday, Nov. 30).

Patient, consumer groups (PDF files) (December 6, 2010)
Minutes of the Sept. 8 meeting of the European Medicines Agency (EMA) Scientific Committees' Working Party with Patients' and Consumers' Organizations (PCWP).
—EMA third report on the progress of the interaction with patient and consumer organizations during 2009.

PDUFA (PDF file) (December 6, 2010)
Minutes from FDA's Nov. 17 stakeholder meeting on PDUFA V reauthorization.

Pediatric drugs (PDF file) (December 6, 2010)
European Medicines Agency (EMA) revised priority list for studies into off-patent pediatric medicinal products for 2011. 

Pharmacovigilance (December 6, 2010)
Summary of actions taken at the Nov. 15-17 plenary meeting of CHMP's Pharmacovigilance Working Party (PhVWP). (PDF file)
ENCePP E-Register of Studies, a public register launched by the European Medicines Agency (EMA) and the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) that consists of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centers and other research organizations (see BioCentury Extra, Monday, Nov. 29).

Transparency (PDF files) (December 6, 2010)
European Medicines Agency (EMA) policy that will make all agency documents available upon request, including marketing authorization dossiers submitted by companies, plus a guidance on the types of documents that will be available (see "Expanded Transparency").

Product documentation (December 6, 2010)
Afinitor: NICE second final appraisal determination (FAD) recommending against the use of Afinitor everolimus for second-line treatment of advanced renal cell carcinoma (RCC); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, Nov. 29). (PDF file)
Contrave: Briefing documents for the Dec. 7 meeting of FDA's Metabolic and Endocrine Drug Products Advisory Committee to discuss Contrave to treat obesity; from Orexigen Therapeutics Inc. (NASDAQ:OREX) (see BioCentury Extra, Friday, Dec. 3).
Glivec (Gleevec): NICE guidance recommending against the use of 600 or 800 mg/day Glivec imatinib to treat unresectable and/or metastatic gastrointestinal stromal tumors (GIST) in patients whose disease has progressed after treatment with a 400 mg/day dose; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Wednesday, Nov. 24). (PDF file)
Herceptin: NICE guidance recommending Herceptin trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-positive, metastatic adenocarcinoma of the stomach or gastro-esophageal junction in patients who have not received prior treatment and whose tumors express high levels of HER2, as defined by a positive immunohistochemistry score of 3 (IHC3 positive); from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, Nov. 24). (PDF file)
Hycamtin: CHMP revised EPAR updating SPC to include information on risk or severe bleeding, pancytopenia, potential fatal outcome of sepsis and interstitial lung disease, and dehydration as a result of severe diarrhea experienced with use of Hycamin topotecan to treat ovarian and small cell lung cancers; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Javlor: NICE preliminary appraisal recommending against the use of Javlor vinflunine to treat advanced or metastatic transitional cell carcinoma of the urothelial tract that has progressed following treatment with platinum-based chemotherapy; from Laboratoires Pierre Fabre S.A. (see BioCentury Extra, Tuesday, Nov. 23).
Lap-Band: Briefing documents for the Dec. 3 meeting of FDA's Gastroenterology and Urology Devices Panel, which voted 8-2 that the benefits of Lap-Band gastric binding system for obesity outweigh the risks in patients with a BMI of at least 35 kg/m2 or a BMI of at least 30 kg/m2 with one or more co-morbidity; from Allergan Inc. (NYSE:AGN) (see BioCentury Extra, Friday, Dec. 3).
MabThera: NICE preliminary appraisal recommending the use of MabThera rituximab as a first-line maintenance treatment of advanced follicular non-Hodgkin's lymphoma (NHL) in patients who have responded to first-line induction therapy with MabThera in combination with chemotherapy; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, Dec. 3).
Nplate: NICE second preliminary appraisal recommending Nplate romiplostim to treat chronic idiopathic thrombocytopenic purpura (ITP) in patients whose condition is refractory to standard active treatments and rescue therapies or in patients who have severe disease and a high risk of bleeding that requires frequent courses of rescue therapies (see BioCentury, Wednesday, Dec. 1).
Tarceva: NICE second preliminary appraisal recommending against Tarceva erlotinib for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with stable-disease after platinum-based first-line chemotherapy; from Roche (SIX:ROG; OTCQX:RHHBY) and Astellas Pharma Inc. (Tokyo:4503) (see BioCentury Extra, Monday, Nov. 29).
Vandetanib: Briefing documents for the Dec. 2 meeting of FDA's Oncologic Drugs Advisory Committee, which acknowledged that there are medullary thyroid cancer (MTC) patients in whom vandetanib had an acceptable risk-benefit profile; from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury, Thursday, Dec. 2).
Zenhale: European Medicines Agency (EMA) Q&A on the withdrawal of an MAA for Zenhale mometasone/formoterol inhalation aerosol as long-term maintenance to treat asthma in patients 12 years and older; from Merck & Co. Inc. (NYSE:MRK). (PDF file)

Advanced therapies (PDF file) (November 22, 2010)
European Medicines Agency's Committee for Advanced Therapies (CAT) 2010-15 work program to bring more advanced therapies to the market, including gene therapies and regenerative medicines (see BioCentury Extra, Thursday, Nov. 18).

Biologics (PDF file) (November 22, 2010)
FDA's Center for Biologics Evaluation and Research (CBER) annual report for 2009.

CHMP (PDF file) (November 22, 2010)
Summary of actions taken at the Nov. 15-18 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Gene/Cell therapy (November 22, 2010)
FDA documentation on the Nov. 2 public workshop on clinical trials of gene and cell therapies in pediatric populations.

Manufacturing (PDF files) (November 22, 2010)
FDA and European Medicines Agency (EMA) report and general principles outlining a proposal for the policies and procedures for the agencies' joint good manufacturing practice (GMP) inspection pilot program.

Medicaid (PDF file) (November 22, 2010)
Waiver proposal submitted by Montana Gov. Brian Schweitzer to CMS that would allow Montana to give Medicaid discounts on prescription drugs to all of the state's residents (see BioCentury Extra, Wednesday, Nov. 17).

Orphan drugs (PDF file) (November 22, 2010)
Summary of actions taken at the Nov. 9-10 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Patents (PDF file) (November 22, 2010)
U.S. Patent and Trademark Office (PTO) proposed changes in procedures for ex parte appeals in patent cases.

Pediatric drugs (PDF file) (November 22, 2010)
Summary of actions taken at the Nov. 10-12 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Safety (November 22, 2010)
—Amicus brief filed by the U.S. government arguing to the U.S. Supreme Court that adverse event reports may be material to investors even without statistical significance (see BioCentury Extra, Monday, Nov. 12). (PDF file)
—FDA draft guidance on improving communication of important safety information. (PDF file)

Vaccines (PDF file) (November 22, 2010)
European Medicines Agency (EMA) Q&A on the detection of unexpected viral DNA in live attenuated vaccines (see BioCentury Extra, Friday, Nov. 19).

Product documentation (November 22, 2010)
Fabrazyme: CHMP assessment report on the shortage of Fabrazyme agalsidase beta to treat Fabry's disease; from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
Faslodex: CHMP revised EPAR updating SPC to include information on patients who have failed prior anti-estrogen and aromatase inhibitor therapy receiving Faslodex fulvestrant to treat locally advanced or metastatic breast cancer in post-menopausal women; from AstraZeneca plc (LSE:AZN; NYSE:AZN).
Osseor/Protelos: CHMP revised EPAR updating SPC to include alopecia as an adverse drug reaction for Osseor/Protelos strontium ranelate to treat osteoporosis in post-menopausal women; from Servier.
Provenge: CMS documentation on the Nov. 17 Medicare Evidence Development & Coverage Advisory Committee meeting, which found there is adequate evidence that Provenge sipuleucel-T significantly improves overall survival in prostate cancer patients who meet the autologous cellular immunotherapy's FDA-approved indication of metastatic, castrate-resistant prostate cancer in patients who are asymptomatic or minimally symptomatic; from Dendreon Corp. (NASDAQ:DNDN) (see "The Provenge Message").
Provigil: CHMP Q&A on its decision reaffirming a recommendation limiting the use of sleep disorder drug Provigil modafinil based on safety concerns, including psychiatric disorders, subcutaneous tissue reactions, significant off-label use and a potential for abuse; from Cephalon Inc. (NASDAQ:CEPH). (PDF file)
Sustiva: CHMP revised EPAR updating SPC to include pharmacokinetic data in patients with or without hepatic impairment receiving Sustiva efavirenz to treat HIV-1 infection; from Bristol-Myers Squibb Co. (NYSE:BMY).
Travatan: CHMP revised EPAR updating SPC to include long-term clinical data and several adverse drug reactions for Travatan travoprost to reduce intraocular pressure (IOP); from Alcon Inc. (NYSE:ACL).

Advanced therapies (PDF files) (November 15, 2010)
European Medicines Agency (EMA) guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products and an overview of comments received.

Anthrax (PDF file) (November 15, 2010)
FDA briefing documents for the Nov. 16 meeting of the Vaccines and Related Biological Products Advisory Committee meeting to discuss a pathway for licensure of protective antigen (PA)-based anthrax vaccines for a post-exposure prophylaxis indication under FDA's Animal Rule (see BioCentury Extra, Friday, Nov. 12).

Clinical trials (PDF file) (November 15, 2010)
European Medicines Agency (EMA) updated report on the geographical origins of patients in clinical trials that are included in MAAs submitted to the agency.

Healthcare reform (PDF files) (November 15, 2010)
— Draft proposal from the co-chairs of the bipartisan National Commission on Fiscal Responsibility and Reform on reducing the national debt and spending, including healthcare costs (see BioCentury Extra, Wednesday, Nov. 10).
Letter to Rep. Paul Ryan (R-Wis.) from Congressional Budget Office Director Douglas Elmendorf that includes an analysis of the effects of healthcare reform on prescription drug prices.

Heparin (PDF file) (November 15, 2010)
U.S. Government Accountability Office (GAO) review of FDA's management of the 2008 heparin contamination crisis (see BioCentury Extra, Tuesday, Nov. 9).

PDUFA (PDF file) (November 15, 2010)
FDA notice of the reopening of the comment period on reauthorizing the PDUFA program until Oct. 31, 2011.

Pharmacogenomics (November 15, 2010)
Data reported by pharmacy benefit manager Medco Health Solutions Inc. (NYSE:MHS) from a study evaluating the effect of a pharmacy-based approach to encourage the adoption of pharmacogenomic testing (see BioCentury Extra, Tuesday, Nov. 9).

Pharmacoepidemiology (PDF file) (November 15, 2010)
European Medicines Agency (EMA) and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) draft guide on methodological standards in pharmacoepidemiology.

Postmarketing requirements (November 15, 2010)
FDA report on the status of postmarketing requirements and commitments for approved drugs and biologics (see BioCentury Extra, Monday, Nov. 8).

Product documentation (November 15, 2010)
Avastin: NICE final appraisal determination (FAD) recommending against the use of Avastin bevacizumab in combination with oxaliplatin and either 5-fluorouracil plus folinic acid or capecitabine to treat metastatic colorectal cancer; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, Nov. 12). (PDF file)
Benlysta: FDA briefing documents for the Nov. 16 meeting of the Arthritis Advisory Committee meeting to discuss a BLA for Benlysta belimumab to treat systemic lupus erythematosus (SLE); from Human Genome Sciences Inc. (NASDAQ:HGSI) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Friday, Nov. 12).
Provenge: Technology assessment for HHS's Agency for Healthcare Research and Quality (AHRQ) finding moderately strong evidence that Provenge sipuleucel-T improves clinical outcomes in prostate cancer patients, released prior to the Nov. 17 Medicare Evidence Development & Coverage Advisory Committee review of Provenge, from Dendreon Corp. (NASDAQ:DNDN) (see BioCentury Extra, Wednesday, Nov. 10). (PDF file)
Ruconest: CHMP EPAR for Ruconest conestat alfa to treat acute attacks of hereditary angioedema (HAE); from Pharming Group N.V. (Euronext:PHARM).

Gene/Cell therapy (PDF file) (November 8, 2010)
—FDA briefing documents for the Nov. 19 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee to discuss testing for replication competent retrovirus (RCR)/lentivirus (RCL) in retroviral and lentiviral vector based gene therapies.
FDA guidance on developing cellular therapies for cardiac disease. (PDF file)

Patents (November 8, 2010)
U.S. Supreme Court amicus curiae for , et al. v. U.S. PTO, et al. (see "Much Ado About DoJ").

PDUFA (November 8, 2010)
FDA minutes of stakeholder and industry meetings on PDUFA V reauthorization (see "Elastic PDUFA Deadlines").

Safety (PDF file) (November 8, 2010)
European Medicines Agency's Safety Working Party work plan for 2011.

Tax credit (November 8, 2010)
List of recipients of tax credit awards from the IRS under the Therapeutic Discovery Project Credit Program (see Cover Story).

Toxicity (PDF files) (November 8, 2010)
European Medicines Agency (EMA) guidelines on repeated dose toxicity and an overview of comments received.

Product documentation (November 8, 2010)
Champix: CHMP revised EPAR updating SPC to include safety and efficacy data from a post-marketing study evaluating Champix varenicline for smoking cessation in patients with mild to moderate chronic obstructive pulmonary disorder (COPD); from Pfizer Inc. (NYSE:PFE).
Vidaza: NICE new preliminary appraisal recommending against the use of Vidaza azacitidine to treat intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in patients who are not eligible for hematopoietic stem cell transplantation; from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Friday, Nov. 5).

Advanced therapies (PDF file) (November 1, 2010)
Summary of actions taken at the Oct. 14-15 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Cancer (PDF file) (November 1, 2010)
U.K. Department of Health consultation document outlining proposals to establish the previously planned Cancer Drugs Fund (see BioCentury Extra, Wednesday, Oct. 27).

CHMP (PDF file) (November 1, 2010)
Detailed report of actions taken at the Oct. 18-21 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

EMA (PDF file) (November 1, 2010)
European Medicines Agency (EMA) reflection paper on working parties, which includes group analysis and proposals from the agency.

Nanomedicine (PDF file) (November 1, 2010)
European Medicines Agency (EMA) summary report on a Sept. 2-3 workshop on nanomedicines.

Pharmacovigilance (PDF file) (November 1, 2010)
Summary of actions taken at the Oct. 18-20 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Product documentation (PDF files) (November 1, 2010)
Arzerra: NICE guidance recommending against the use of Arzerra ofatumumab to treat chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab; from Genmab A/S (CSE:GEN) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, Oct. 27).
Fabrazyme: CHMP updated temporary recommendations on prescribing Fabrazyme agalsidase beta to treat Fabry's disease; from Genzyme Corp. (NASDAQ:GENZ).
Gardasil: FDA briefing documents for the Nov. 17 meeting of the Vaccines and Related Biological Products Advisory Committee to discuss Gardasil HPV vaccine to prevent anal intraepithelial neoplasia (AIN) and anal cancer caused by HPV types 6, 11, 16 and 18 in males and females ages 9-26 years; from Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Friday, Oct. 29).
Prolia: NICE guidance recommending the use of Prolia denosumab for the primary and secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures for whom oral bisphosphonates are unsuitable; from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Wednesday, Oct. 27).
Revolade: NICE guidance recommending against the use of Revolade eltrombopag to treat chronic idiopathic thrombocytopenic purpura (ITP) in splenectomized patients who are refractory to other treatments and as a second-line treatment of non-splenectomized patients for whom surgery is contraindicated; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Ligand Pharmaceuticals Inc. (NASDAQ:LGND) (see BioCentury Extra, Wednesday, Oct. 27).
Victoza: NICE guidance recommending the use of 1.2 mg Victoza liraglutide to treat Type II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Wednesday, Oct. 27).
Xolair: NICE guidance recommending against the use of Xolair omalizumab to treat severe persistent asthma in children aged 6 to 11 years; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Wednesday, Oct. 27).

Bleeding (PDF file) (October 25, 2010)
FDA notice of a Dec. 9-10 public workshop to discuss the evaluation of products indicated for use to stop severe bleeding.

CHMP (PDF file) (October 25, 2010)
Summary of actions taken at the Oct. 18-21 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Drug development (PDF file) (October 25, 2010)
FDA draft guidance outlining the qualification process for drug development tools, including biomarkers and patient reported outcome instruments (see BioCentury Extra, Friday, Oct. 22).

EMA (PDF file) (October 25, 2010)
European Medicines Agency (EMA) 1H10 report from the executive director.

Genotoxic impurities (PDF file) (October 25, 2010)
European Medicines Agency (EMA) Q&A on its scientific guideline on the limits of genotoxic impurities.

Genzyme (PDF file) (October 25, 2010)
Genzyme Corp. (NASDAQ:GENZ) presentation to investors at the Oct. 22 meeting to discuss the acquisition offer from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) to acquire the biotech (see "Argument for $89").

PDUFA (PDF file) (October 25, 2010)
FDA minutes of a Sept. 29 stakeholder meeting on PUDFA V user fee reauthorization.

Pediatric drugs (PDF file) (October 25, 2010)
Summary of actions taken at the Oct. 6-8 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Opioids (October 25, 2010)
FDA briefing documents for the Oct. 21-22 joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, which agreed there is no gold standard study or studies for evaluating the actual abuse of opioid products designed to be abuse deterrent (see BioCentury Extra, Friday, Oct. 22).

Product documentation (October 25, 2010)
Invirase: CHMP Q&A (PDF file) on its review of HIV drug Invirase saquinavir, which concluded the benefit-risk balance of the drug remains positive; and FDA documentation on an updated label for Invirase warning of the risk of abnormal heart rhythms when the drug is boosted with ritonavir; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Oct. 21).
Twynsta: CHMP EPAR for Twynsta telmisartan/amlodipine to treat essential hypertension; from Boehringer Ingelheim GmbH.

Benefit-risk (PDF file) (October 18, 2010)
European Medicines Agency (EMA) report on approaches for balancing benefits and risks in decision making about medicinal products.

Blood infections (PDF files) (October 18, 2010)
European Medicines Agency (EMA) draft guideline on epidemiological data on blood transmissible infections and an overview of comments received.

Conflict of interest (PDF files) (October 18, 2010)
European Medicines Agency (EMA) policy on the handling of conflicts of interest for members of its scientific committees, and an overview of allowable interests (see BioCentury Extra, Thursday, Oct. 14).

Counterfeit medicines
(PDF file) (October 18, 2010)
FDA notice of a partnership with the World Health Organization (WHO) to develop surveillance and monitoring systems for counterfeit medicines and other supply-chain threats (see BioCentury Extra, Tuesday, Oct. 12)

Diabetes (PDF file) (October 18, 2010)
FDA notice of a Nov. 10 workshop to discuss the clinical development of autonomous systems to treat diabetes.

EMA (PDF file) (October 18, 2010)
European Medicines Agency (EMA) explanatory note on fees payable to the agency.

Generics (PDF file) (October 18, 2010)
U.K.'s Department of Health analysis of responses from a public consultation on plans to implement a formal substitution scheme for generic medicines (see BioCentury Extra, Friday, Oct. 15).

Human research (PDF file) (October 18, 2010)
FDA draft guidance on determining whether human research studies can be conducted without an IND.

Live biotherapeutics (PDF file) (October 18, 2010)
FDA draft guidance on chemistry, manufacturing, and control (CMC) information in IND submissions for early clinical trials of live biotherapeutic products

Lung cancer (PDF file) (October 18, 2010)
NICE draft guidelines on diagnosing and managing lung cancer, which partially updates 2005 guidelines.

Medicare (PDF file) (October 18, 2010)
Report commissioned by the CMS that found consolidating oral cancer drugs, pump insulin, and nebulizers under Medicare Part D would save the agency $150 mllion in total annual payments (see BioCentury Extra, Friday, Oct. 15).

Micellar systems (PDF file) (October 18, 2010)
European Medicines Agency (EMA) reflection paper on developing IV medicinal products containing active substances solubilized in micellar systems (non-polymeric surfactants).

Orphan drugs (PDF file) (October 18, 2010)
Summary of actions taken at the Oct. 6-7 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Personalized medicines (PDF files) (October 18, 2010)
U.K.'s Stratified Medicines Innovation Platform to provide funding for personalized medicine research, including documents for tumor profiling and collection of tumor data; identifying inflammation biomarkers; business models to enable companies to work together to develop drugs and companion diagnostics (see BioCentury Extra, Tuesday, Oct. 12).


Parallel review (October 18, 2010)
—Federal Register notice of FDA-CMS proposal to establish a process for overlapping pre-market evaluations when the product sponsor and both agencies agree to such parallel review (see Cover Story).
Agenda for the Medicare Evidence Development & Coverage Committee (MEDCAC) to review Provenge sipuleucel T for prostate cancer, from Dendreon Corp. (NASDAQ:DNDN).

Synthetic DNA (PDF file) (October 18, 2010)
HHS guidance on screening orders for synthetic double-stranded DNA to prevent malicious use of synthetic DNA (see BioCentury Extra, Wednesday, Oct. 13).

U.K. (October 18, 2010)
U.K. Department of Health decision on reform plans for its Advisory Non-Departmental Public Bodies.

Vaccines (PDF file) (October 18, 2010)
U.S. Supreme Court oral arguments in Bruesewitz v. Wyeth to determine whether the National Childhood Vaccine Injury Act of 1986 preempts all design defect claims against the manufacturer of a vaccine (see "Pandora's Box").

Product documentation (October 18, 2010)
Altargo: CHMP revised EPAR updating SPC to include the risk of epistaxis with intranasal use of Altargo retapamulin for the short-term treatment of superficial skin infections and to treat impetigo; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Aranesp: Briefing documents for the Oct. 18 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss the Phase III TREAT trial of Aranesp darbepoetin alfa to treat anemia in chronic kidney disease (CKD) patients with Type II diabetes; from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Thursday, Oct. 14). (PDF file)
Byetta: CHMP revised EPAR extending the indication of Byetta exenatide to include treatment of Type II diabetes in combination with thiazolidinedione with or without metformin; from Eli Lilly and Co. (NYSE:LLY) and Amylin Pharmaceuticals Inc. (NASDAQ:AMLN).
Tyverb: NICE panel decision to reject an appeal of a June final appraisal determination for Tyverb lapatinib but to reevaluate the breast cancer drug in a multi-technology appraisal with trastuzumab. The FAD recommended against Tyverb in combination with capecitabine to treat previously treated patients with advanced or metastatic breast cancer whose tumors overexpress HER2; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, Oct. 14). (PDF file)

Advanced therapies (PDF file) (October 11, 2010)
Summary of actions taken at the Sept. 16-17 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Biosimilars (PDF file) (October 11, 2010)
FDA notice of a Nov. 2-3 hearing to discuss the implementation of the Biologics Price Competition and Innovation Act, which established an abbreviated approval pathway for biosimilars (see BioCentury Extra, Monday, Oct. 4).

CHMP (PDF file) (October 11, 2010)
Detailed report of actions taken at the Sept. 20-23 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

CMS (October 11, 2010)
Letter from members of the U.S. House of Representatives asking HHS Secretary Kathleen Sebelius and CMS Administrator Don Berwick to stop additional Medicare reimbursement cuts for cancer care (see BioCentury Extra, Wednesday, Oct. 6). (PDF file)
Report from HHS's Office of Inspector General that found more than half of drug manufacturers did not fully comply with quarterly requirements to submit drug pricing data to CMS in 2008 (see BioCentury Extra, Monday, Oct. 4). (PDF file)

Colchicine products (PDF file) (October 11, 2010)
FDA notice of intent to take enforcement action against companies that manufacture and market unapproved single ingredient oral colchicine, which is used to treat and prevent gout flares and to treat familial Mediterranean fever (FMF).

Devices (October 11, 2010)
List of guidance documents FDA's Center for Devices and Radiological Health is considering developing for 2011.

EMA (PDF file) (October 11, 2010)
European Medicines Agency (EMA) annual report highlights for 2009.

Innovation (October 11, 2010)
European Commission's Innovation Union initiative to increase innovation in areas such as climate change, energy and resource scarcity, and health and aging (see BioCentury Extra, Wednesday, Oct. 6.

Intellectual property (October 11, 2010)
National Research Council report that concluded the Bayh-Dole Act of 1980, which gave universities control of IP related to the results of federally funded research, has been more effective than the prior system of governmental ownership in driving innovation and making research publically available (see BioCentury Extra, Monday, Oct. 4).
Letter from Intellectual Property Owners Association President Douglas Norman to the European Commission, European Parliament and Council of the European Union to support the creation of a single patent system in Europe (see BioCentury, Friday, Oct. 8).

Manufacturing (PDF file) (October 11, 2010)
European Medicines Agency (EMA) interim report on the international active pharmaceutical ingredients (API) inspection pilot program.

NSAIDs (PDF file) (October 11, 2010)
FDA notice of a Nov. 4 meeting of its Gastrointestinal Drugs Advisory Committee to discuss the adequacy of endoscopically documented gastric ulcers as an outcome measure to evaluate drugs intended to prevent gastrointestinal complications of NSAIDs, including aspirin.

PDUFA (October 11, 2010)
FDA PDUFA performance and financial reports for FY09.

Pediatric drugs (PDF file) (October 11, 2010)
European Medicines Agency (EMA) report on a May 31 workshop discussing the main challenges in assessing development plans for pediatric formulations.

Pharmacovigilance (PDF file) (October 11, 2010)
Summary of actions taken at the Sept. 20-22 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Rare diseases (PDF file) (October 11, 2010)
Institute of Medicine report identifying methods to accelerate R&D for rare diseases (see BioCentury Extra, Monday, Oct. 4).

Regulatory priorities (PDF file) (October 11, 2010)
FDA report outlining priorities for developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products (see BioCentury Extra, Wednesday, Oct. 6).

Product documentation (October 11, 2010)
Aricept: NICE appraisal consultation document recommending the use of Aricept donepezil for its licensed indication of mild to moderate Alzheimer's disease; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, Oct. 7).
Avastin: CHMP revised EPAR updating SPC to include a warning on adverse reactions reported following unapproved intravitreal use of cancer drug Avastin bevacizumab to treat ocular conditions; from Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit.
Copaxone: Citizen Petition submitted to FDA from Peptimmune Inc. seeking to block approval of generic versions of Copaxone glatiramer acetate to treat relapsing-remitting multiple sclerosis (RRMS); from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Ebixa: NICE appraisal consultation document recommending the use of Ebixa memantine to treat moderate Alzheimer's disease in patients intolerant to AChE inhibitors or in patients with severe AD; from H. Lundbeck A/S (CSE:LUN), Neurobiological Technologies Inc. (Pink:NTII) and Merz GmbH & Co. KGaA (see BioCentury Extra, Thursday, Oct. 7).
Exelon: NICE appraisal consultation document recommending the use of Exelon rivastigmine for its licensed indication of mild to moderate Alzheimer's disease; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Oct. 7).
Janumet/Ristfor/Ristaben: CHMP revised EPAR updating SPC to include impaired renal function as an adverse event for Janumet/Ristfor/Ristaben sitagliptin/metformin to treat Type II diabetes; from Merck & Co. Inc. (NYSE:MRK)
Razadyne/Reminyl: NICE appraisal consultation document recommending the use of Razadyne galantamine for its licensed indication of mild to moderate Alzheimer's disease; from Shire plc (LSE:SHP; NASDAQ:SHPGY) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, Oct. 7).

Comparative effectiveness (October 4, 2010)
HHS's Agency for Healthcare Research and Quality (AHRQ) list of awards to conduct comparative effectiveness research (see BioCentury Extra, Thursday, Sept. 30).

COPD (PDF file) (October 4, 2010)
NICE draft guideline on quality standards for chronic obstructive pulmonary disease (COPD).

GERD (PDF file) (October 4, 2010)
FDA notice of a Nov. 5 meeting of the agency's Gastrointestinal Drugs Advisory Committee to discuss clinical trial results of proton pump inhibitors (PPIs) in gastroespohageal reflux disease (GERD) in patients less than 1 year of age.

HSV assays (PDF files) (October 4, 2010)
FDA proposed rule and draft guidance on the reclassification of HSV 1 and 2 serological assays as class II devices from class III.

NSAIDs (PDF file) (October 4, 2010)
European Medicines Agency (EMA) concept paper on a proposed revision to the guideline for the conduct of efficacy studies for NSAIDs.

Pharmacogenetics (October 4, 2010)
— CMS technology assessment that reviewed published literature to assess the benefits and harms of three pharmacogenetic tests that predict response to cancer therapy (see BioCentury Extra, Tuesday, Sept. 28). (PDF file)
— International Serious Adverse Events Consortium (SAEC) goals for the second phase of research to identify genetic markers that could predict which patients are at risk of rare drug-related adverse events (see BioCentury Extra, Thursday, Sept. 30).

Regulatory Science (October 4, 2010)
FDA draft of strategic priorities for 2011-15, which identifies advancing regulatory science as the agency's top priority (see BioCentury Extra, Thursday, Sept. 30).

Safety (October 4, 2010)
FDA final rule (PDF file) and draft guidance for investigational new drug safety reporting requirement for INDs and bioavailability and bioequivalence studies (see BioCentury Extra, Tuesday, Sept. 28).

Product documentation (October 4, 2010)
Brinavess: CHMP EPAR for Brinavess vernakalant for converting recent onset atrial fibrillation (AF) to sinus rhythm in adults; from Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME), Astellas Pharma Inc. (Tokyo:4503) and Merck & Co. Inc. (NYSE:MRK).
Cialis: CHMP revised EPAR updating SPC to include information on concomitant use of Cialis tadalafil with other phosphodiesterase-5 (PDE-5) inhibitors to treat erectile dysfunction (ED); from Eli Lilly and Co. (NYSE:LLY).
Emtriva: CHMP revised EPAR updating SPC to include a recommendation not to discontinue treatment with Emtriva emtricitabine to treat HIV infection in patients co-infected with HIV and HBV who have advanced liver disease or cirrhosis; from Gilead Sciences Inc. (NASDAQ:GILD).
Herceptin: NICE final appraisal decision (FAD) recommending Herceptin trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-positive, metastatic adenocarcinoma of the stomach or gastro-esophageal junction in patients who have not received prior treatment and whose tumors express high levels of HER2, as defined by a positive immunohistochemistry score of 3 (IHC3 positive); from Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit (see BioCentury Extra, Wednesday, Sept. 29). (PDF file)
Provenge: CMS draft questions posted for the Nov. 17 meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to discuss Provenge sipuleucel-T to treat metastatic, castrate-resistant prostate cancer; from Dendreon Corp. (NASDAQ:DNDN) (see BioCentury Extra, Monday, Sept. 27).
Rapiscan: CHMP EPAR for Rapiscan regadenoson for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in adults unable to undergo adequate exercise stress; from Gilead Sciences Inc. (NASDAQ:GILD) and Astellas Pharma Inc. (Tokyo:4503).

Anti-arrhythmics (PDF file) (September 27, 2010)
CHMP addendum to its guideline on anti-arrhythmics on atrial fibrillation (AF) and atrial flutter.

CHMP (PDF file) (September 27, 2010)
Summary of actions taken at the Sept. 20-23 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Clinical trials (PDF files) (September 27, 2010)
—European Medicines Agency (EMA) guideline on missing data from confirmatory clinical trials.
—European Medicines Agency (EMA) draft reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples.

Comparative effectiveness (September 27, 2010)
U.S. Government Accountability Office (GAO) list of members it appointed to the board of the Patient-Centered Outcomes Research Institute (PCORI), established by the Patient Protection and Affordable Care Act to conduct comparative effectiveness research (see BioCentury Extra, Thursday, Sept. 23).

Competitiveness (September 27, 2010)
Executive summary of "Rising Above the Gathering Storm, Revisited: Rapidly Approaching Category 5," a report prepared for the National Academy of Sciences, National Academy of Engineering, and Institute of Medicine, which concludes that the U.S. competitive outlook has worsened since 2005.

COPD (PDF file) (September 27, 2010)
CHMP draft guidelines covering the development of therapeutics for chronic obstructive pulmonary disease (COPD) (see BioCentury Extra, Monday, Sept. 20).

Drug safety (September 27, 2010)
Draft discussion of legislation from Reps. John Dingell (D-Mich.), Henry Waxman (D-Calif.) and two other representatives that would grant FDA authority and funding for regulation of drugs manufactured outside the U.S (see BioCentury Extra, Tuesday, Sept. 21). (PDF file)
FDA notice of a Nov. 16-17 workshop to discuss activities and plans for the agency's Safe Use Initiative. (PDF file)
Safety signals reported to FDA in 2Q10 through the Adverse Events Reporting System (AERS) (see BioCentury Extra, Tuesday, Sept. 21).

EMA (PDF file) (September 27, 2010)
Minutes of a July 2 drafting meeting on the framework for the interaction between European Medicines Agency (EMA) and healthcare professional organizations.

H. pylori (PDF file) (September 27, 2010)
FDA draft guidance on establishing the performance characteristics of in vitro diagnostics to detect Helicobacter pylori infection.

Humanitarian vouchers (PDF file) (September 27, 2010)
U.S. Patent and Trademark Office (PTO) proposal to award fast-track ex parte re-examination vouchers as an incentive for the development of technologies that have humanitarian uses (see BioCentury Extra, Thursday, Sept. 23).

Orphan drugs (PDF file) (September 27, 2010)
Summary of actions taken at the Sept. 7-9 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Ovarian cancer (PDF file) (September 27, 2010)
NICE draft guidance on detection, diagnosis and management of ovarian cancer.

Pediatric drugs (PDF file) (September 27, 2010)
Summary of actions taken at the Sept. 8-10 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Renal insufficiency (PDF file) (September 27, 2010)
European Medicines Agency (EMA) concept paper on need for guidance on the clinical investigation of medicinal products to slow progression of renal insufficiency.

Product documentation (September 27, 2010)
Avandia: Q&A (PDF file) on CHMP's recommended suspension of Avandia rosiglitazone in Europe and FDA documentation on its decision to restrict use of the diabetes drug; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see Cover Story).
Ecalta: CHMP revised EPAR updating SPC to include information on infusion-associated undesirable reactions for Ecalta anidulafungin to treat invasive candidiasis; from Pfizer Inc. (NYSE:PFE).
InductOs: CHMP revised EPAR updating SPC to include a recommendation against the use in patients with history or clinical suspicion of malignancy at the site of application with InductOs dibotermin alfa to treat acute tibia fractures in adults, and as an adjunct to open fracture reduction and intramedullary nail fixation; from Pfizer Inc. (NYSE:PFE).
RotaTeq: Q&A on EMA's review of RotaTeq rotavirus vaccine to prevent gastroenteritis caused by rotavirus infections in infants from six weeks of age; from Merck & Co. Inc. (NYSE:MRK). (PDF file)
Sycrest: CHMP EPAR for Sycrest asenapine to treat moderate to severe manic episodes associated with bipolar I disorder; from Merck & Co. Inc. (NYSE:MRK).
Vfend: CHMP revised EPAR updating SPC to include data on risk of squamous cell carcinoma in patients receiving Vfend voriconazole to treat fungal infections; from Pfizer Inc. (NYSE:PFE).
Zeftera: CHMP refusal assessment report for Zeftera ceftobiprole to treat complicated skin and soft tissue infections (cSSTI); from Basilea Pharmaceutica AG (SIX:BSLN). (PDF file)

Cancer (PDF file) (September 20, 2010)
European Medicines Agency (EMA) concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products.

Contrast agents (September 20, 2010)
FDA drug safety podcast for healthcare professionals on warnings for using gadolinium-based contrast agents in patients with kidney dysfunction.

Creutzfeldt-Jakob (PDF file) (September 20, 2010)
FDA notice of an Oct. 28-29 meeting of FDA's Transmissible Spongiform Encephalopathies Advisory Committee to discuss the agency's risk assessment of the variant Creutzfeldt-Jakob disease and product labeling to address the risk.

Depression (PDF file) (September 20, 2010)
FDA notice of an Oct. 8 meeting of FDA's Neurological Devices Panel of the Medical Devices Advisory Committee to discuss clinical trial design issues for devices to treat depression.

Diabetes (PDF file) (September 20, 2010)
HHS's Agency for Healthcare Research and Quality (AHRQ) report on trends in the treatment of diabetes from 1997 to 2007 (see BioCentury Extra, Friday, Sept. 17).

Drug safety (September 20, 2010)
Commentary by three FDA scientists in the New England Journal of Medicine, warning of the risks of premature conclusions about drug safety based on meta-analyses (see "Thalidomide 50 Years Later").

FDA/CMS (PDF file) (September 20, 2010)
FDA and CMS request for comments on plans to create a process for parallel review of medical products, which the agencies said would reduce the time between FDA approvals and CMS national coverage determinations (see BioCentury Extra, Thursday, Sept. 16).

HCV (PDF file) (September 20, 2010)
FDA draft guidance on developing direct-acting antivirals to treat chronic HCV (see BioCentury Extra, Monday, Sept. 13).

Influenza (PDF file) (September 20, 2010)
Council of the EU recommendations for pandemic preparedness based on lessons learned from the swine influenza A (H1N1) pandemic (see BioCentury Extra, Monday, Sept. 13).

Prostate cancer (PDF file) (September 20, 2010)
Prostate Cancer Act (S. 3775), introduced by Sen. Jon Tester (D-Mont.), which would expand prostate cancer research at the U.S. Department of Defense, HHS and the Department of Veterans Affairs (see BioCentury Extra, Tuesday, Sept. 14).

Stem cells (September 20, 2010)
Stem Cell Research Advancement Act, introduced by Sen. Arlen Specter (D-Pa.), which would provide federal funding for human embryonic stem cell (hESC) research (see BioCentury Extra, Thursday, Sept. 16).

Tropical diseases (PDF file) (September 20, 2010)
FDA notice on the fee rate for using a tropical disease priority review voucher for FY2011.

Product documentation (September 20, 2010)
Arzerra: NICE final appraisal determination (FAD) recommending against the use of Arzerra ofatumumab for chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Genmab A/S (CSE:GEN) (see BioCentury Extra, Thursday, Sept. 16). (PDF file)
Glivec (Gleevec): NICE final appraisal determination (FAD) recommending against the use of 600 or 800 mg/day Glivec imatinib to treat unresectable and/or metastatic gastrointestinal stromal tumors (GIST) in patients whose disease has progressed after treatment with a 400 mg/day dose; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Sept. 16). (PDF file)
Isentress: CHMP revised EPAR updating SPC to include thrombocytopenia as an uncommon adverse reaction for Isentress raltegravir to treat HIV infection; from Merck & Co. Inc. (NYSE:MRK).
Lorcaserin: Briefing documents for the Sept. 16 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 9-5 that the benefit-risk profile of lorcaserin did not support approval to treat obesity; from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) (see Cover Story).
Meridia: Briefing documents for the Sept. 15 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which was split 8-8 on whether to withdraw Meridia sibutramine to treat obesity from the U.S. market; from Abbott Laboratories (NYSE:ABT) (see "Meridia's Malaise,"). (PDF file)
Pradaxa: Briefing documents for the Sept. 20 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss an NDA for Pradaxa dabigatran to prevent stroke and systemic embolism in patients with atrial fibrillation (AF); from Boehringer Ingelheim GmbH (see BioCentury Extra, Thursday, Sept. 16).
Revolade: NICE final appraisal determination (FAD) recommending against the use of Revolade eltrombopag to treat chronic idiopathic thrombocytopenic purpura (ITP) in splenectomized patients who are refractory to other treatments and as a second-line treatment of non-splenectomized patients for whom surgery is contraindicated; from  GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Ligand Pharmaceuticals Inc. (NASDAQ:LGND) (see BioCentury—Extra, Tuesday, Sept. 14). (PDF file)
Viramune: CHMP revised EPAR updating SPC to include information on patient groups at risk for developing hypersensitivity reactions with use of Viramune nevirapine to treat HIV infection; from Boehringer Ingelheim GmbH.
Vivitrol: Briefing documents for the Sept. 16 meeting of FDA's Psychopharmacologic Drugs Advisory Committee, which voted 12-1 to recommend approval of an sNDA to extend the label for Vivitrol naltrexone to prevent relapse to opioid use in opioid-dependent patients; from Alkermes Inc. (NASDAQ:ALKS) (see "Comparative Addiction,").
Vpriv: CHMP EPAR for Vpriv velaglucerase alfa to treat Gaucher's disease; from Shire plc (LSE:SHP; NASDAQ:SHPGY).

Animal rule (PDF file) (September 13, 2010)
FDA notice of a Nov. 5 public meeting to discuss regulatory and scientific challenges of developing medical countermeasures under the agency's Animal Rule.

Clinical trials (PDF file) (September 13, 2010)
European Medicines Agency agenda for a Sept. 6-7 workshop to discuss a draft reflection paper on clinical trials conducted in third countries and submitted to EMA.

Gadolinium-based contrast agents (September 13, 2010)
FDA drug safety communication on the risk of nephrogenic systemic fibrosis (NSF) associated with the use of gadolinium-based contrast agents in patients with kidney dysfunction.

Gene/Cell therapy (PDF file) (September 13, 2010)
FDA notice of a Nov. 2 public workshop to discuss best practices related to clinical trials of gene and cell therapies in pediatric populations as well as challenges and considerations in the review of the studies.

Healthcare reform (September 13, 2010)
CMS's Office of the Actuary updated national health spending projections to include the effect of healthcare legislation (see BioCentury Extra, Thursday, Sept. 9).

Meta-analyses (September 13, 2010)
New England Journal Medicine perspective article by three FDA officials concluding that "measured restraint" should be used when evaluating meta-analyses to identify potential safety signals in marketed drugs (see BioCentury Extra, Thursday, Sept. 9).

Patents (PDF file) (September 13, 2010)
U.S. Patent and Trademark Office (PTO) updated guidance including principles of obviousness explained in a 2007 U.S. Supreme Court ruling in KSR International Co. v. Teleflex Inc.

Regulation (September 13, 2010)
Institute of Medicine report: "Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease" (see Cover Story).
—"FDA Science and Mission at Risk," report prepared for the FDA Science Board by its subcommittee on science and technology. (PDF file)

Suicidality (PDF file) (September 13, 2010)
FDA draft guidance on prospectively assessing the occurrence of treatment-emergent suicidality in clinical trials (see BioCentury Extra, Thursday, Sept. 9).

Product documentation (September 13, 2010)
Abilify: NICE preliminary appraisal requesting additional information for Abilify aripiprazole to treat schizophrenia in patients ages 15-17 years; from Bristol-Myers Squibb Co. (NYSE:BMY) and Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768) (see BioCentury Extra, Friday, Sept. 10).
Abraxane: CHMP revised EPAR updating SPC to include ventricular dysfunction, congestive heart failure and pancytopenia as rare adverse reactions for Abraxane nab-paclitaxel to treat metastatic breast cancer; from Abraxis BioScience Inc. (NASDAQ:ABII) and Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768).
Evicel: CHMP revised EPAR updating SPC to include information on the risk of air embolism associated with spray applications of Evicel to reduce local bleeding during an operation when standard techniques are not sufficient; from Johnson & Johnson (NYSE:JNJ).
Kaletra: CHMP revised EPAR updating SPC to include an analysis of the frequency and causality of adverse drug reactions for Kaletra lopinavir/ritonavir to treat HIV-1 infection; from Abbott Laboratories (NYSE:ABT).
Rebetol: CHMP revised EPAR updating SPC to remove the adverse event Raynaud's disease for Rebetol ribavirin to treat HCV infection; from Merck & Co. Inc. (NYSE:MRK).
Stelara: CHMP revised EPAR updating SPC to include a warning about the possibility of delayed hypersensitivity reactions for Stelara ustekinumab to treat moderate to severe plaque psoriasis; from Bristol-Myers Squibb Co. (NYSE:BMY) and Johnson & Johnson (NYSE:JNJ).
Tasigna: CHMP revised EPAR updating SPC to include 24-month follow-up safety and efficacy data from a Phase II trial evaluating Tasigna nilotinib to treat chronic and accelerated phase chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN).
Victoza: NICE final appraisal determination (FAD) recommending the use of the 1.2 mg dose of Victoza liraglutide to treat Type II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Thursday, Sept. 9). (PDF file)

ABSSSI (PDF file) (September 6, 2010)
FDA draft guidance on developing drugs to treat acute bacterial skin and skin structure infections (ABSSSI) (see BioCentury Extra, Thursday, Aug. 26).

Atrial fibrillation (PDF file) (September 6, 2010)
European Society of Cardiology (ESC) guidelines for managing atrial fibrillation (AF) (see BioCentury Extra, Monday, Aug. 30).

Contrast agents (PDF file) (September 6, 2010)
European Medicines Agency Q&A on the EMA's review of galodinium-based contrast agents.

Myocardial revascularization (PDF file) (September 6, 2010)
European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) updated guidelines for myocardial revascularization that include two new antiplatelet options since the guidelines were last issued in 2005 (see BioCentury Extra, Tuesday, Aug. 31).

Nicotine replacement (PDF file) (September 6, 2010)
FDA notice of public workshop on Oct. 26-27 to discuss risks and benefits of long-term use of nicotine replacement therapy (NRT) products.

Non-inferiority trials (PDF file) (September 6, 2010)
U.S. Government Accountability Office (GAO) report on FDA's use of non-inferiority trials in its NDA review process (see BioCentury Extra, Monday, Aug. 30).

Patient medication information (PDF file) (September 6, 2010)
FDA notice of a Sept. 27-28 public hearing to discuss developing and distributing patient medication information (PMI) to patients who are prescribed drug products.

Transparency (September 6, 2010)
FDA's FDA-TRACK performance management system to monitor more than 100 FDA program offices using data from performance measures established each year (see BioCentury Extra, Tuesday, Aug. 31).

Women's health (PDF file) (September 6, 2010)
FDA notice of a Sept. 22 meeting to discuss current and future activities in the areas of women's health research and educational outreach.

Product documentation (September 6, 2010)
Ceftaroline: Briefing documents for the Sept. 7 meeting of FDA's Anti-Infective Drugs advisory committee to discuss an NDA for ceftaroline to treat complicated skin and skin structure infections (cSSSIs) and community-acquired bacterial pneumonia (CABP); from Forest Laboratories Inc. (NYSE:FRX) (see BioCentury Extra, Thursday, Sept. 2).
Fendrix: CHMP revised EPAR updating SPC to modify the frequency classification of allergic reactions with use of Fendrix hepatitis B (HBV) vaccine; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Lucentis: CHMP revised EPAR updating SPC to include information on risk factors associated with the development of a retinal pigment epithelial tear and/or high pigment epithelial retinal detachment with Lucentis ranibizumab to treat wet age-related macular degeneration (AMD); from Novartis AG (NYSE:NVS; SIX:NOVN) and Roche (SIX:ROG; OTCQX:RHHBY).
Mycamine: CHMP revised EPAR updating SPC to include toxic skin eruption as an undesirable effect and information on the interaction between amphotericin B and Mycamine micafungin to treat invasive candidiasis and esophageal candidiasis, and to prevent candida infection in patients undergoing allogeneic hematopoietic stem cell transplantation or those expected to have neutropenia; from Astellas Pharma Inc. (Tokyo:4503).
Onglyza: CHMP revised EPAR updating SPC to include long-term data for Onglyza saxagliptin as an add-on therapy to glibenclamide, thiazolidinedione and metformin to treat Type II diabetes; from Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768), AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY).
Privigen: CHMP revised EPAR updating SPC to include information on the risk of hemolysis/hemolytic anemia with use of Privigen human normal immunoglobulin as a replacement therapy in immunodeficiency and for immunomodulation in immune-mediated diseases; from CSL Ltd. (ASX:CSL).

ABSSSI (PDF file) (August 30, 2010)
FDA draft guidance on developing drugs to treat acute bacterial skin and skin structure infections (ABSSSIs), impetigo and minor cutaneous abscesses (see BioCentury Extra, Thursday, Aug. 26).

Clinical trials (PDF file) (August 30, 2010)
FDA notice of a Nov. 4-5 public workshop to discuss informed consent, inspections of clinical investigators, investigational review boards (IRBs), research sponsors and regulations relating to drugs, biologics and medical devices.

Chronic heart failure (PDF file) (August 30, 2010)
NICE updated clinical guideline on diagnosing and managing chronic heart failure in adults.

Economic stimulus (PDF file) (August 30, 2010)
Report released by U.S. Vice President Joe Biden highlighting some of the projects supported by the American Recovery and Reinvestment Act funding dedicated to innovation in transportation, energy, IT and medical research (see Ebb & Flow).

Patient and consumer groups  (PDF file) (August 30, 2010)
Minutes of the June 16 meeting of the European Medicines Agency (EMA) Scientific Committees' Working Party with Patients' and Consumers' Organizations (PCWP).

Shareholder rights (August 30, 2010)
New Securities and Exchange Commission rules (PDF file) regarding the rights of shareholders to nominate directors to a company's board, and a statement by SEC Commissioner Mary Schapiro (see Ebb & Flow).

Product documentation (August 30, 2010)
Avastin: NICE second preliminary appraisal recommending against the use of Avastin bevacizumab in combination with oxaliplatin and either 5-fluorouracil plus folinic acid or capecitabine to treat metastatic colorectal cancer (mCRC); from Roche (SIX:ROG; OTCQX:RHHBY) (see "Breast Cancer Blockade").
—Enbrel: NICE guidance recommending the use of Enbrel etanercept to treat severe active rheumatoid arthritis (RA) in patients who had an inadequate response to, or are intolerant of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab; and a NICE guidance recommending the use of Enbrel to treat active and progressive psoriatic arthritis who have peripheral arthritis with three or more tender or swollen joints and whose disease has not responded to at least two DMARDs; from Pfizer Inc. (NYSE:PFE) and Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Wednesday, Aug. 25). (PDF files)
Enoxaparin: U.S. District Court for the District of Columbia opinion denying a request by sanofi-aventis Group (Euronext:SAN; NYSE:SNY) seeking a preliminary injunction that would have directed FDA to withdraw approval of a generic version of anticoagulant Lovenox enoxaparin; from Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Aug. 26).
Glivec: NICE guidance recommending against the use of Glivec imatinib (Gleevec - U.S.) for adjuvant treatment of gastrointestinal stromal tumors (GIST) after surgery; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Wednesday, Aug. 25). (PDF file)
—Humira: NICE guidance recommending the use of Humira adalimumab to treat severe active rheumatoid arthritis (RA) in patients who had an inadequate response to, or are intolerant of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab; and a NICE guidance recommending the use of Humira to treat active and progressive psoriatic arthritis who have peripheral arthritis with three or more tender or swollen joints and whose disease has not responded to at least two DMARDs; from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Wednesday, Aug. 25). (PDF files)
Invega: CHMP revised EPAR updating SPC to include adverse drug reactions for Invega paliperidone to treat schizophrenia; from Johnson & Johnson (NYSE:JNJ).
MabThera: NICE guidance recommending the use of MabThera rituximab in combination with methotrexate to treat severe active rheumatoid arthritis (RA) in patients who had an inadequate response to, or are intolerant of, other DMARDs, including at least one TNF inhibitor; from Biogen Idec Inc. (NASDAQ:BIIB) and Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, Aug. 25). (PDF file)
Multaq: NICE guidance recommending the use of Multaq dronedarone as second-line therapy for non-permanent atrial fibrillation (AF) in patients with additional cardiovascular factors; from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Aug. 25). (PDF file)
Orencia: NICE guidance recommending use of Orencia abatacept to treat severe active rheumatoid arthritis (RA) in patients who had an inadequate response to, or are intolerant of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Wednesday, Aug. 25). (PDF file)
—Remicade: NICE guidance recommending the use of Remicade infliximab to treat severe active rheumatoid arthritis (RA) in patients who had an inadequate response to, or are intolerant of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab; and NICE guidance recommending use of Remicade to treat active and progressive psoriatic arthritis who have peripheral arthritis with three or more tender or swollen joints and whose disease has not responded to at least two DMARDs; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Wednesday, Aug. 25). (PDF files)
RoActerma: NICE guidance recommending the use of RoActemra tocilizumab in combination with methotrexate to treat moderate to severe active rheumatoid arthritis (RA) in patients who responded inadequately to TNF alpha inhibitors and rituximab or cannot receive rituximab; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, Aug. 25). (PDF file)
Thalidomide Celgene: NICE final appraisal determination (FAD) recommending Thalidomide Celgene thalidomide in combination with an alkylating agent and a corticosteroid for first-line treatment of multiple myeloma in patients for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate; from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Thursday, Aug. 26). (PDF file)
Velcade: NICE final appraisal determination (FAD) recommending Velcade bortezomib in combination with an alkylating agent and a corticosteroid to treat multiple myeloma in patients unable to tolerate or has contraindications to thalidomide, or when high-dose chemotherapy with stem cell transplantation is considered inappropriate; from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, Aug. 26). (PDF file)

Devices (PDF file) (August 23, 2010)
FDA notice of a Sept. 14 public meeting on reauthorizing the medical device user fee program.

Diagnostics (PDF file) (August 23, 2010)
FDA notice of the reopening of the comment period on laboratory-developed tests (LDTs) until Sept. 15.

Gene therapy (PDF files) (August 23, 2010)
CHMP's Gene Therapy Working Party (GTWP) work plan and adopted objectives and procedures for 2010.

Influenza (PDF file) (August 23, 2010)
President's Council of Advisors on Science and Technology (PCAST) report on ways to improve vaccine response against pandemic influenza and other outbreaks (see BioCentury Extra, Thursday, Aug. 19).

Medical countermeasures (August 23, 2010)
HHS review of medical countermeasures identifying five areas of focus to address (see "HHS Lays Off Risk").

Pediatric drugs (PDF file) (August 23, 2010)
Summary of actions taken at the Aug. 4-6 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Product documentation (August 23, 2010)
Cymbalta: Briefing documents for the Aug. 19 meeting of FDA's Anesthetic and Life Support Drugs Advisory Committee, which voted 8-6 in favor of approving an sNDA to expand the pain indications for Cymbalta duloxetine; from Eli Lilly and Co. (NYSE:LLY) (see Cover Story).
Sodium oxybate: Briefing documents for the Aug. 20 meeting of FDA's Arthritis and the Drug Safety and Risk Management advisory committees, which voted 20-2 that the benefit/risk profile of sodium oxybate did not support approval to treat fibromyalgia; from Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) (see BioCentury Extra, Friday, Aug. 20).
Tyverb: CHMP revised EPAR updating SPC to include information related to acute renal failure arising from dehydration due to severe diarrhea in patients receiving Tyverb lapatinib to treat HER-2 positive breast cancer; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

Cardiovascular devices (August 16, 2010)
FDA notice of a Sept. 30 public workshop to discuss clinical trial design for developing pediatric cardiovascular devices.

Cell-based products (PDF files) (August 16, 2010)
European Medicines Agency (EMA) work plan for the Cell-based Products Working Party for 2010, and mandates, objectives and rules of procedure for the CPWP temporary working party.

Electronic data (PDF file) (August 16, 2010)
European Medicines Agency (EMA) reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.

Heart transplants (August 16, 2010)
The International Society of Heart and Lung Transplantation guidelines for heart transplant recipients published in The Journal of Heart and Lung Transplantation (see BioCentury Extra, Thursday, Aug. 12).

Manufacturing (PDF file) (August 16, 2010)
FDA and the European Medicines Agency (EMA) proposed outline and advice to applicants describing the policies and procedures for the agencies' joint good manufacturing practice (GMP) inspection pilot program.

NICE (PDF file) (August 16, 2010)
—Compilation of NICE technology appraisal decisions from 2000 through 2010.
—Office of Health Economics report on a Sept. 25, 2009, forum on valuing innovation in healthy technology assessment (HTA), which was funded by Pfizer Inc. (NYSE:PFE).

Vaccines (PDF file) (August 16, 2010)
European Medicines Agency (EMA) guideline on quality, non-clinical and clinical aspects of live recombinant viral vector vaccines.

Product documentation (August 16, 2010)
Avastin: Letter from Susan G. Komen for the Cure and the Ovarian Cancer National Alliance to FDA urging the agency to allow continued use of Avastin bevacizumab for breast cancer despite an FDA panel's recommendation to remove the indication from the drug's label; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, Aug. 13).
Potiga: Briefing documents for the Aug. 11 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted 13-0 that substantial evidence was provided on the effectiveness of Potiga ezogabine as an adjunctive therapy for partial-onset seizures; from Valeant Pharmaceuticals International (NYSE:VRX) (see BioCentury Extra, Wednesday, Aug. 11).
Prezista: CHMP revised EPAR updating SPC to include a warning regarding a higher than expected rash rate when raltegravir is co-administered with Prezista darunavir to treat HIV; from Johnson & Johnson (NYSE:JNJ).
Tamiflu: CHMP revised EPAR updating SPC to include information on resistance of Tamiflu oseltamivir to treat and prevent influenza; from Roche (SIX:ROG; OTCQX:RHHBY) and Gilead Sciences Inc. (NASDAQ:GILD).
Xolair: NICE final appraisal determination (FAD) recommending against the use of Xolair omalizumab to treat severe persistent asthma in children aged six to 11 years; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Aug. 12). (PDF file)
Zeffix: CHMP revised EPAR restricting the therapeutic indication for Zeffix lamivudine in chronic HBV infection to patients with compensated liver disease only when use of an alternative antiviral with a higher barrier to genetic resistance is not available or appropriate; from Shire plc (LSE:SHP; NASDAQ:SHPGY) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

510(k) (August 9, 2010)
Reports from FDA's 510(k) Working Group and Utilization of Science in Regulatory Decision Making committee on 510(k) recommendations (see BioCentury Extra, Wednesday, Aug. 4).

ADHD (PDF files) (August 9, 2010)
European Medicines Agency (EMA) guidance on developing medicinal products to treat ADHD, and an overview of comments received.

Antibiotics (PDF file) (August 9, 2010)
European Medicines Agency (EMA) draft guideline on setting specifications for related impurities in antibiotics.

Cancer (August 9, 2010)
Rarer Cancers Foundation (RCF) recommendations for implementing the U.K.'s Cancer Drugs Fund (see BioCentury Extra, Friday, Aug. 6).

Drug delivery (PDF files) (August 9, 2010)
—FDA draft guidance to minimize residual drug substance in transdermal and related drug delivery systems at the end of labeled use period.
—European Medicines Agency (EMA) concept paper on the revision of the note for guidance on quality of modified release oral dosage forms and transdermal dosage forms.

Epilepsy (PDF file) (August 9, 2010)
NICE draft guidance updating the pharmacological aspects of its clinical guideline on managing epilepsy in adults and children in primary and secondary care (see BioCentury Extra, Friday, Aug. 6).

FDA budget (PDF file) (August 9, 2010)
Letter to HHS Secretary Kathleen Sebelius from five lawmakers calling upon her to request FY12 funding for FDA that addresses the "serious funding deficits" faced by the agency (see BioCentury Extra, Thursday, Aug. 5).

Genetic tests (PDF file) (August 9, 2010)
Report from the Human Genetics Commission, an advisory body of the U.K. government, recommending a set of standards and principles to regulate direct-to-consumer genetic tests (see BioCentury Extra, Thursday, Aug. 5).

Immunoglobulin (PDF files) (August 9, 2010)
European Medicines Agency (EMA) guidance on developing human IV immunoglobulin (IVIg), and an overview of comments received.

Pharmacokinetics  (PDF file) (August 9, 2010)
European Medicines Agency (EMA) positions on specific questions addressed to the efficacy working party therapeutic subgroup on pharmacokinetics.

Radioactive drugs (PDF file) (August 9, 2010)
FDA guidance to provide information on whether using radioactive drugs for certain research purposes may be conducted under an IND.

REMS (August 9, 2010)
FDA docket for the July 27-28 public meeting on developing and implementing risk evaluation and mitigation strategies (REMS) for drugs and biologics (see "Fixing Unintended Consequences," AX).

User fees (PDF files) (August 9, 2010)
FDA notice on the medical device user fee rates collected under MDUFA for fiscal year 2011.
FDA notice on the prescription drug user fee rates collected under PDUFA for fiscal year 2011.

Product documentation (August 9, 2010)
Increlex: CHMP revised EPAR updating SPC to include information on injection site reactions and systemic hypersensitivity for Increlex mecasermin to treat growth failure in patients under 18 years of age who have severe primary insulin-like growth factor-1 deficiency; from Ipsen Group (Euronext:IPN) and Roche (SIX:ROG; OTCQX:RHHBY).
Invanz: CHMP revised EPAR updating SPC to include a recommendation against concomitant use of valproic acid and Invanz ertapenem to prevent surgical site infection following elective colorectal surgery in adults and to treat intra-abdominal infections, community acquired pneumonia (CAP), acute gynecological infections and diabetic foot infections of the skin and soft tissue; from Merck & Co. Inc. (NYSE:MRK).
Ozurdex: CHMP EPAR for Ozurdex dexamethasone to treat macular edema; from Allergan Inc. (NYSE:AGN).
Taxotere: CHMP revised EPAR extending the indication of Taxotere docetaxel to include adjuvant treatment of operable node-negative breast cancer in combination with doxorubicin and cyclophosphamide; from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).

Advanced therapies (PDF file) (August 2, 2010)
Summary of actions taken at the July 15-16 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Cancer drugs (PDF file) (August 2, 2010)
U.K. Department of Health report showing that British consumption of cancer drugs launched in the past five years is well below that of comparator nations (see BioCentury Extra, Tuesday, July 27).

CHMP (PDF file) (August 2, 2010)
Detailed report of actions taken at the July 19-22 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Creutzfeldt-Jakob disease (PDF files) (August 2, 2010)
—Draft position statement from CHMP and the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) on Creutzfeldt-Jakob disease and advanced therapy medicinal products.
—Draft position statement from CHMP on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products.

Dialysis (PDF files) (August 2, 2010)
—Centers for Medicare & Medicaid Services final rule establishing a bundled payment rate for dialysis services administered to end-stage renal disease patients (see BioCentury Extra, Monday, July 26)
—CMS proposed rule outlining a quality incentive program to link Medicare dialysis payments to performance standards starting Jan. 1, 2012 (see BioCentury Extra, Monday, July 26).

Epilepsy (PDF file) (August 2, 2010)
Overview of comments received on the European Medicines Agency (EMA) guideline on clinical investigation of medicinal products in the treatment of epileptic disorders.

NICE (August 2, 2010)
U.K. Department of Health review of 18 government-funded organizations, which includes a proposal to expand NICE's authority to evaluate social care of the elderly and disabled (see BioCentury Extra, Monday, July 26).

Opioids (PDF files) (August 2, 2010)
European Medicines Agency (EMA) conclusion and Q&A regarding its review of modified-release oral opioids to manage pain.

Orphan drugs (PDF file) (August 2, 2010)
European Medicines Agency (EMA) recommendations on elements required to support the medical plausibility and the assumption of significant benefit for an orphan designation.

Patents (PDF file) (August 2, 2010)
U.S. Patent and Trademark Office (PTO) interim guidance in determining patent eligibility of process claims in view of the U.S. Supreme Court decision in Bilski v. Kappos in June (see BioCentury Extra, Tuesday, July 27).

Pharmacovigilance (PDF file) (August 2, 2010)
Summary of actions taken at the July 19-20 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

R&D funding (August 2, 2010)
Five-year program under which the Indian Department of Biotechnology and the Wellcome Trust each will contribute $34.8M to support R&D of affordable drugs, vaccines, diagnostics and devices (see BioCentury Extra, Thursday, July 29).

Product documentation (August 2, 2010)
Daxas: CHMP EPAR for Daxas roflumilast to treat severe chronic obstructive pulmonary disease (COPD); from Nycomed.
Iressa: NICE guidance recommending use of Iressa gefitinib for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) only in patients with an EGFR mutation and then only if the pharma provides the drug at a fixed price under a patient access scheme; from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury, Wednesday, July 28). (PDF file)
MabThera: NICE guidance recommending use of MabThera rituximab in combination with fludarabine and cyclophosphamide to treat relapsed or refractory chronic lymphocytic leukemia (CLL) except in patients who have not previously responded to fludarabine or have relapsed within six months of treatment, or have previously been treated with MabThera; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, July 28). (PDF file)
Orencia: CHMP revised EPAR updating SPC to extend the indication for Orencia abatacept to include use with methotrexate to treat moderate to severe active rheumatoid arthritis (RA) in patients who responded inadequately to previous therapy with one or more DMARDs, including methotrexate or a TNF alpha inhibitor; from Bristol-Myers Squibb Co. (NYSE:BMY). 
Revatio: Briefing documents for the July 29 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee that discussed but did not vote on a question of whether available hemodynamics data in children could be used to support pediatric approval of pulmonary arterial hypertension (PAH) drug Revatio sildenafil; from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, July 28).
Vidaza: NICE appeals panel decision for the agency to reappraise Vidaza azacitidine to treat intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in patients who are not eligible for hematopoietic stem cell transplantation, because the original appraisal against NHS use of the drug only included one of two possible comparators; from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Monday, July 26).
Xeloda: NICE guidance recommending use of Xeloda capecitabine in combination with a platinum-based regimen for first-line treatment of inoperable advanced gastric cancer; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, July 28). (PDF file)

CHMP (PDF file) (July 26, 2010)
Summary of actions taken at the July 19-22 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Genetic testing (July 26, 2010)
FDA letters notifying 14 companies that the genetic testing kits they market do not have FDA clearance or approval (see BioCentury Extra, Tuesday, July 20).
U.S. Government Accountability Office (GAO) report from an undercover investigation that concluded direct-to-consumer (DTC) genetic tests from four companies provide results that are "misleading and of little use to customers" (see BioCentury Extra, Thursday, July 22). (PDF file)

HIV (PDF file) (July 26, 2010)
World Health Organization (WHO) updated guidelines on antiretroviral therapy for HIV infection in adults and adolescents.

Medical devices (PDF file) (July 26, 2010)
FDA notice of it is withdrawing a final rule requiring submission of information on pediatric subpopulations that suffer from a disease or condition that a device is intended to treat, diagnose or cure after the agency received significant adverse comments.

Orphan drugs (PDF file) (July 26, 2010)
Summary of actions taken at the July 7-8 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Pharmacovigilance (PDF file) (July 26, 2010)
European Medicines Agency (EMA) twenty-first pandemic pharmacovigilance weekly update.

Safety (PDF files) (July 26, 2010)
European Medicines Agency (EMA) policy on communicating emerging safety-related issues on medicines for human use.
EMA Q&A on the note for guidance on photosafety testing.
European Medicines Agency (EMA) Q&A on guideline on the environmental risk assessment of medicinal products for human use.

Toxicity (PDF files) (July 26, 2010)
European Medicines Agency (EMA) reflection paper on non-clinical evaluation of drug-induced liver injury.
EMA Q&A on the withdrawal of the note for guidance on single dose toxicity.
Memorandum of understanding between FDA, agencies of the National Institutes of Health (NIH) and Environmental Protection Agency's Office of Research and Development to strengthen the existing collaboration on the research, development, validation and translation of new and innovative test methods that characterize key steps in toxicity pathways.

Product documentation (July 26, 2010)
Avastin: Briefing documents for the July 20 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 12-1 to recommend removing the first-line treatment of HER2-negative metastatic breast cancer indication from the label of Avastin bevacizumab; from Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit.
Lovenox: FDA report in response to a 2003 Citizen's Petition from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) asking the agency not to approve any generics for the pharma's anticoagulant Lovenox enoxaparin (see BioCentury Extra, Friday, July 23). (PDF file)
Pegasys: CHMP revised EPAR updating SPC to include the posology of HIV/HCV co-infected patients and safety related information for Pegasys peginterferon alfa-2a to treat chronic HCV and HBV; from Roche (SIX:ROG; OTCQX:RHHBY).
Reyataz: CHMP revised EPAR extending the indication of Reyataz atazanavir to include the treatment of HIV-infected children and adolescents above the age of six in combination with other antiretrovirals; from Bristol-Myers Squibb Co. (NYSE:BMY).
— Rotarix: European Medicines Agency (EMA) conclusion and Q&A on the review confirming the positive benefit-risk of Rotarix rotavirus vaccine to prevent gastroenteritis due to rotavirus infection; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF files) 

Alzheimer's disease (July 19, 2010)
National Institute on Aging and the Alzheimer's Association drafts of three criteria for the diagnosis of Alzheimer's disease (AD) (see BioCentury Extra, Wednesday, July 14).

Companion diagnostics (PDF file) (July 19, 2010)
European Medicines Agency (EMA) draft reflection paper on co-developing pharmacogenomic biomarkers and assays in the context of drug development (see BioCentury Extra, Monday, July 12).

Conflict of interest (PDF files) (July 19, 2010)
Johnson & Johnson (NYSE:JNJ) reports from three of its units, Ortho-McNeil-Janssen Pharmaceuticals Inc., Centocor Ortho Biotech Inc. and Tibotec Therapeutics detailing their payments to U.S. physicians who consulted with the company or participated on a speaker bureau in 1Q10.


Preventative services (July 19, 2010)
Regulations jointly released by HHS and the departments of Labor and Treasury requiring new health plans to cover preventive services and eliminate copayments, coinsurance or deductibles for those services (see BioCentury Extra, Wednesday, July 14).

Vaccines (July 19, 2010)
Webinar held on July 13 on FDA's safety monitoring of approved vaccines.

Product documentation (July 19, 2010)
Avandia: Briefing documents for the July 13-14 meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees to review Avandia rosiglitazone from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), and a Senate Finance Committee press release and report on GSK's handling of Avandia data.
Avaglim: CHMP revised EPAR updating SPC to include data from the Phase III RECORD trial and to include cardiac safety data from an update of a meta-analysis of 42 short-term studies investigating cardiac ischemia for Avaglim rosiglitazone/glimepiride to treat Type II diabetes; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Avandamet: CHMP revised EPAR updating SPC to include data from the Phase III RECORD trial and to include cardiac safety data from an update of a meta-analysis of 42 short-term studies investigating cardiac ischemia for Avandamet rosiglitazone/metformin to treat Type II diabetes; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Humira: CHMP revised EPAR updating SPC to remove the recommendation for concomitant administration of corticosteroid during induction treatment with Humira adalimumab to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, ankylosing spondylitis and Crohn's disease; from Abbott Laboratories (NYSE:ABT). (PDF file)
Mirapexin/Sifrol: CHMP revised EPAR updating SPC to include negative data from a trial evaluating patients ages 6-17 with Tourette's disorder receiving Mirapexin/Sifrol pramipexole to treat Parkinson's disease (PD) and restless leg syndrome (RLS); from Boehringer Ingelheim GmbH. (PDF files)
Multaq: NICE final appraisal determination (FAD) recommending the limited use of Multaq dronedarone as second-line therapy for non-permanent atrial fibrillation in patients with additional cardiovascular risk factors; from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Friday, July 16). (PDF file)
Qnexa: Briefing documents for the July 15 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 10-6 that the benefit-risk profile for Qnexa phentermine/topiramate did not support approval to treat obesity; from Vivus Inc. (NASDAQ:VVUS)
Viagra: CHMP revised EPAR updating SPC to include Stevens Johnson syndrome and toxic epidermal necrolysis as adverse drug reactions for Viagra sildenafil to treat erectile dysfunction; from Pfizer Inc. (NYSE:PFE). (PDF file)

AAV vectors (PDF files) (July 12, 2010)
European Medicines Agency (EMA) reflection paper on the quality, non-clinical and clinical issues related to developing recombinant adeno-associated viral (AAV) vectors, and overview of comments received.

Advanced therapies (PDF file) (July 12, 2010)
Summary of actions taken at the June 17-18 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

CMS/FDA (July 12, 2010)
Memorandum of understanding between FDA and Centers for Medicare & Medicaid Services to share information about the review and use of drugs, biologics, devices and foods, including dietary supplements.

Inspections (July 12, 2010)
FDA notice on its plans to begin inspections to evaluate industry's compliance with 21 CFR 11 (Part 11) regulations, which cover clinical, regulatory and manufacturing records stored in electronic form (see BioCentury Extra, Thursday, July 8).

Lipid disorders (PDF file) (July 12, 2010)
European Medicines Agency (EMA) draft pediatric addendum to the CHMP note for guidance on the clinical investigation of medicinal products to treat lipid disorders.

Safety (July 12, 2010)
— European Medicines Agency's 2011 priorities for adverse drug reaction research under Framework Programme 7 (FP7) (see BioCentury Extra, Thursday, July 8). (PDF file)
Institute of Medicine interim report on Ethical Issues in Studying the Safety of Approved Drugs (see BioCentury Extra, Friday, July 9).

Scientific advice (PDF file) (July 12, 2010)
European Medicines Agency (EMA) guidance for companies requesting scientific advice or protocol assistance.  

Transparency (July 12, 2010)
Webcast of a July 6 meeting sponsored by Friends of Cancer Research, Ewing Marion Kauffman Foundation, Council for American Medical Innovation and others on the role of academia in drug discovery, including a discussion on the need to publish complete response letters (see BioCentury Extra, Wednesday, July 7).

Product documentation (July 12, 2010)
Avandia: Briefing documents, agenda (PDF file), draft questions (PDF file), slides and meeting roster (PDF file) for the July 13-14 joint meeting of FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees to discuss the cardiovascular safety of Avandia rosiglitazone to treat Type II diabetes; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see "Cacophony Won't Help").
— Avastin: CHMP revised EPAR updating SPC to include the risk of developing infusion and hypersensitivity reactions with use of Avastin bevacizumab to treat metastatic breast cancer, metastatic colorectal cancer, unresectable or metastatic non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC), plus a NICE preliminary appraisal recommending against the use of Avastin in combination with a taxane for the first-line treatment of metastatic breast cancer; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, July 9).
Fabrazyme: European Medicines Agency (EMA) revised temporary treatment recommendations for Fabrazyme agalsidase beta to treat Fabry's disease; from Genzyme Corp. (NASDAQ:GENZ) (see BioCentury Extra, Tuesday, July 6). (PDF file)
Herceptin: NICE preliminary appraisal recommending against the use of Herceptin trastuzumab in combination with cisplatin and capecitabine or 5-fluorouracil to treat HER2-positive, metastatic adenocarcinoma of the stomach or gastro-esophageal junction in patients who have not received prior treatment; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, July 6).
Humenza: CHMP EPAR for Humenza AF03 adjuvanted swine influenza A (H1N1) vaccine to prevent influenza in an officially declared pandemic situation; from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Kiovig: CHMP revised EPAR updating SPC to include safety information for Kiovig IV human immunoglobulin (IVIg) to treat primary immunodeficiency syndromes; from Baxter International Inc. (NYSE:BAX).
Mepact: NICE preliminary appraisal recommending against the use of Mepact mifamurtide in combination with postoperative multi-agent chemotherapy to treat high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection; from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Friday, July 9).
Sutent: CHMP revised EPAR updating SPC to include information for patients with renal impairment receiving Sutent sunitinib to treat unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST) and metastatic renal cell carcinoma (RCC); from Pfizer Inc. (NYSE:PFE).
Torisel: CHMP revised EPAR updating SPC to include Stevens-Johnson syndrome as an adverse drug reaction for Torisel temsirolimus to treat renal cell carcinoma (RCC) and mantle cell lymphoma; from Pfizer Inc. (NYSE:PFE).
Votrient: CHMP EPAR for Votrient pazopanib for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who received prior cytokine therapy for advanced disease; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

CHMP (PDF file) (July 5, 2010)
Detailed report of actions taken at the June 21-24 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Conflict of interest (PDF file) (July 5, 2010)
The International Committee of Medical Journal Editors revised uniform conflict-of-interest electronic reporting form (see BioCentury Extra, Thursday, July 1.

Drug safety (July 5, 2010)
Safety signals reported to FDA in 1Q10 through the Adverse Events Reporting System (AERS) (see BioCentury Extra, Thursday, July 1).

Nanomedicines (PDF) (July 5, 2010)
European Medicines Agency (EMA) notice of a Sept 2-3 workshop to discuss nanomedicines.

Pediatric drugs (PDF files) (July 5, 2010)
—European Medicines Agency (EMA) revised priority list for studies into off-patent pediatric medicinal products for 2010.
—EMA draft revised priority list for studies into off-patent pediatric medicinal products for 2011.

Pharmacovigilance (PDF file) (July 5, 2010)
Summary of actions taken at the June 21-23 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

REMS (PDF file) (July 5, 2010)
FDA proposed class-wide REMS for long-acting and extended-releases opioids, which includes a medication guide and prescriber and patient education programs, as well as a timetable for assessing the effectiveness of the REMS (see BioCentury Extra, Monday, June 28).

Stem cells (PDF file) (July 5, 2010)
European Medicines Agency (EMA) summary of a May 10 workshop on stem cell-based therapies.

Product documentation (July 5, 2010)
Afinitor: NICE final appraisal determination (FAD) recommending against the use of Afinitor everolimus for second-line treatment of advanced renal cell carcinoma (RCC); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, July 2). (PDF file)
Brilence: CHMP Q&A on the withdrawal of the MAA for Brilence bazedoxifene to treat osteoporosis in post-menopausal women; from Pfizer Inc. (NYSE:PFE). (PDF file)
Provenge: CMS tracking sheet and links to public comments regarding a National Coverage Analysis of autologous cellular immunotherapy treatment of metastatic prostate cancer, for which only Provenge sipuleucel-T from Dendeon Corp. (NASDAQ:DNDN) has been approved by FDA (see "Ring-Fencing Provenge").
RoActerma: NICE final appraisal determination (FAD) recommending the use of RoActemra tocilizumab in combination with methotrexate to treat moderate to severe active rheumatoid arthritis (RA) in patients who responded inadequately to TNF alpha inhibitors and rituximab; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, July 2). (PDF file)
Zeftera: CHMP Q&A on its refusal of an MAA for Zeftera ceftobiprole to treat complicated skin and soft tissue infections (cSSTI); from Basilea Pharmaceutica AG (SIX:BSLN) and former partner Johnson & Johnson (NYSE:JNJ). (PDF file)

CHMP (PDF file) (June 28, 2010)
Summary of actions taken at the June 21-24 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Clinical trials (June 28, 2010)
Report by HHS Inspector General calling on FDA to increase its monitoring of clinical trials conducted outside the U.S (see BioCentury Extra, Tuesday, June 22).

Conflict of interest (June 28, 2010)
Webcast of the June 10 meeting of the Advisory Committee to the Director of the NIH, including a discussion about excluding industry presentations from the American Heart Association meeting starting at minute 108.
— Accreditation Council for Continuing Medical Education (ACCME) statements about its policy limiting CME presentations by industry scientists. (PDF file)

COPD (June 28, 2010)
NICE updated guidance on the diagnosis, treatment and care of adults with chronic obstructive pulmonary disease (COPD).

In vitro diagnostics (June 28, 2010)
FDA compilation of frequently asked questions regarding studies of in vitro diagnostic device studies (see BioCentury Extra, Friday, June 25). (PDF file)

Lupus (June 28, 2010)
FDA final guidance on the development of products to treat systemic lupus erythematosus (SLE) and for lupus nephritis caused by SLE (see BioCentury Extra, Tuesday, June 22). (PDF files)

Medicare reimbursement (June 28, 2010)
Study published in Health Affairs by a senior health economist at the RAND Corp. and colleagues, concluding that savings that had been anticipated from Medicare reimbursement cuts for chemotherapy in 2005 may have been partially offset by physicians who prescribed more of the cancer drugs and favored use of more expensive ones (see BioCentury Extra, Monday, June 21).

Swine influenza A (H1N1) (June 28, 2010)
FDA notice of issuance of 7 emergency use authorizations (EUAs) for certain in vitro diagnostics to test for swine influenza A (H1N1). (PDF file)

Product documentation (June 28, 2010)
Alimta: NICE guidance recommending the use of Alimta pemetrexed for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology; from Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Wednesday, June 23). (PDF file)
Arzerra: NICE preliminary appraisal recommending against the use of Arzerra ofatumumab to treat chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Genmab A/S (CSE:GEN) (see BioCentury Extra, Thursday, June 24).
Axura: CHMP revised EPAR updating SPC to include drug hypersensitivity as an adverse drug reaction for Axura memantine to treat patients with moderate to severe Alzheimer's disease (AD); from Merz GmbH & Co. KGaA.
Ebixa: CHMP revised EPAR updating SPC to include drug hypersensitivity as an adverse reaction for Ebixa memantine to treat patients with moderate to severe Alzheimer's disease (AD), from H. Lundbeck A/S (CSE:LUN).
Enbrel: NICE final appraisal recommending use of Enbrel etanercept from Pfizer Inc. (NYSE:PFE) and Amgen Inc. (NASDAQ:AMGN) to treat patients with rheumatoid arthritis (RA) who have responded inadequately to other DMARDs or are unable to receive methotrexate or MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, June 25). (PDF file)
Glivec: NICE final appraisal recommending against use of Glivec imatinib for adjuvant treatment of gastrointestinal stromal tumors (GIST) after surgery; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, June 25). (PDF file)
Humira: NICE final appraisal recommending use of Humira adalimumab from Abbott Laboratories (NYSE:ABT) to treat patients with rheumatoid arthritis (RA) who have responded inadequately to other DMARDs or are unable to receive methotrexate or MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, June 25). (PDF file)
Nivestim: New CHMP EPAR for Nivestim filgrastim to prevent febrile neutropenia and to reduce the duration of chemotherapy-induced neutropenia; from Hospira Inc. (NYSE:HSP).
Orencia: NICE final appraisal recommending use of Orencia abatacept from Bristol-Myers Squibb Co. (NYSE:BMY) to treat patients with rheumatoid arthritis (RA) who have responded inadequately to other DMARDs or are unable to receive methotrexate or MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, June 25). (PDF file)
Prezista: CHMP revised EPAR updating SPC to include severe skin reactions, hepatotoxicity, drug hypersensitivity, osteonecrosis, toxic epidermal necrolysis and angioedema as adverse reactions for Prezista darunavir to treat HIV-1 infection in treatment-experienced and treatment-naïve adults in combination with ritonavir and other antiretrovirals; from Johnson & Johnson (NYSE:JNJ).
Prolia: New CHMP EPAR for Prolia denosumab to treat osteoporosis in postmenopausal women at increased risk of fractures and to treat bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures; from Amgen Inc. (NASDAQ:AMGN).
Remicade: NICE final appraisal recommending use of Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) to treat patients with rheumatoid arthritis (RA) who have responded inadequately to other DMARDs or are unable to receive methotrexate or MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, June 25). (PDF file)

Diagnostics (PDF file) (June 21, 2010)
Commentary by FDA Commissioner Margaret Hamburg and NIH Director Francis Collins in the New England Journal of Medicine on the lack of FDA oversight of laboratory-developed tests (LDTs) (see BioCentury Extra, Wednesday, June 16).

Drug addiction (PDF file) (June 21, 2010)
Working arrangement between the European Medicines Agency (EMA) and the European Monitoring Center for Drugs and Drug Addiction (EMCDDA).

Genetically modified cells (PDF file) (June 21, 2010)
European Medicines Agency (EMA) draft guideline on the on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells.

Orphan Drugs (June 21, 2010)
FDA's Rare Disease Repurposing Database, which lists approved drugs with Orphan Drug designations for other indications (see BioCentury Extra, Friday, June 18).

Pediatric drugs (PDF file) (June 21, 2010)
Summary of actions taken at the June 9-11 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Pharmacovigilance (PDF file) (June 21, 2010)
European Medicines Agency (EMA) twentieth pandemic pharmacovigilance weekly update.

R&D tax credit (PDF files) (June 21, 2010)
Qualifying Therapeutic Discovery Project application, which comprises Form 8942 and the Project Information Memorandum, for companies with fewer than 250 employees to be eligible to receive a tax credit or grant worth up to 50% of their qualified R&D expenses, plus website containing IRS and HHS Q&As on the application process under Section 48D of the tax code (see "Government as LP").

Radiopharmaceuticals (PDF file) (June 21, 2010)
European Medicines Agency (EMA) workshop outcome and recommendations on the current use and future needs of radiopharmaceuticals labeled with radionuclides produced in reactors and possible alternatives.

Safety (June 21, 2010)
FDA website with postmarketing drug safety evaluations of approved products (see BioCentury Extra, Tuesday, June 15).

SBA venture funding (PDF file) (June 21, 2010)
Text of H.R. 5297, the Small Business Jobs and Credit Act of 2010, passed by the House, which includes a provision to allocate $1 billion for the Small Business Administration to invest in venture funds that invest in qualifying small and early-stage businesses ("see Government as LP").

Product documentation (June 21, 2010)
Arzerra: CHMP EPAR for Arzerra ofatumumab to treat chronic lymphocytic leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab; from Genmab A/S (CSE:GEN) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Bridion: CHMP revised EPAR updating SPC to include information on situations with increased bleeding risk for Bridion sugammadex for the reversal of neuromuscular blockade induced by rocuronium or vecuronium; from Merck & Co. Inc. (NYSE:MRK).
Ella: Briefing documents for the June 17 meeting of FDA's Reproductive Health Drugs Advisory Committee, which voted 11-0 that sufficient information was provided to conclude that ella ulipristal reduces the likelihood of pregnancy when taken within 120 hours after unprotected intercourse or a known or suspected contraceptive failure; from HRA Pharma S.A. (see BioCentury Extra, Thursday, June 17).
Flibanserin: Briefing documents for the June 18 meeting of FDA's Reproductive Health Drugs Advisory Committee, which voted 11-0 that the data did not demonstrate an acceptable overall risk/benefit profile for flibanserin to treat hypoactive sexual desire disorder (HSDD) in premenopausal women; from Boehringer Ingelheim GmbH (see BioCentury Extra, Friday, June 18).
Lyrica: CHMP revised EPAR updating SPC to include warnings of the potential for abuse, occurrence of convulsions and reports of encephalopathy cases for Lyrica pregabalin to treat peripheral and central neuropathic pain, from Pfizer Inc. (NYSE:PFE).
Prolia: NICE preliminary appraisal recommending the use of Prolia denosumab for the primary and secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures for whom oral bisphosphonates are unsuitable; from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Friday, June 18).
Tarceva: NICE preliminary appraisal recommending against the use of Tarceva erlotinib for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with stable disease after platinum-based first-line chemotherapy; from Roche (SIX:ROG; OTCQX:RHHBY) and OSI Pharmaceuticals Inc. (NASDAQ:OSIP) (see BioCentury Extra, Wednesday, June 16).
Toviaz: CHMP revised EPAR updating the SPC to include information on urinary retention and gastroesophageal reflux for Toviaz fesoterodine to treat symptoms of overactive bladder (OAB); from UCB Group (Euronext:UCB) and Pfizer Inc. (NYSE:PFE).
Victoza: NICE second preliminary appraisal recommending the use of  the 1.2 mg dose of Victoza liraglutide to treat Type II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Monday, June 14).
Yondelis: NICE preliminary appraisal recommending against the use of Yondelis trabectedin in combination with pegylated liposomal doxorubicin to treat patients with relapsed platinum-sensitive ovarian cancer, from PharmaMar S.A. (see BioCentury Extra, Friday, June 18).

Cytogenetic tests (PDF file) (June 14, 2010)
FDA request for comments on a June 30 public meeting to discuss performance evaluation, determination of clinical significance, result reporting and interpretation for array-based cytogenetic tests.

Drug delivery (PDF file) (June 14, 2010)
European Medicines Agency (EMA) concept paper on the need to revise the note for guidance on modified-release oral and transdermal dosage forms.

Kidney transplant (PDF file) (June 14, 2010)
FDA notice of a June 28-29 public workshop to discuss scientific issues in developing medical products to prevent and/or treat acute antibody mediated rejection (AMR) in kidney transplant recipients.

Lung cancer (June 14, 2010)
Lung Cancer Alliance open access website designed to allow patients to donate CT scans and clinical data to increase and accelerate research for lung cancer screening, diagnosis, treatment and drug development.

Orphan drugs (PDF file) (June 14, 2010)
Summary of actions taken at the June 1-2 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Personal genetic testing (June 14, 2010)
FDA letters to genomics companies requesting information regarding their respective personal genetic testing kits and noting that the tests, which the agency said meet the definition of devices, have not been submitted for regulatory clearance or approval. The tests include KnomeComplete from Knome Inc.; Navigenics Health Compass from Navigenics Inc.; deCODEme Complete Scan from deCode Genetics ehf; 23andMe Personal Genome Service from 23andMe Inc.; and Infinium HumanHap550 Array from Illumina Inc. (NASDAQ:ILMN), which decode and 23andMe use in their tests (see BioCentury Extra, Friday, June 11).

Product documentation (June 14, 2010)
Circadian: CHMP revised EPAR updating SPC to include a change in the duration of treatment with Circadin melatonin to treat primary insomnia characterized by poor quality of sleep in patients aged 55 years or older; from Neurim Pharmaceuticals Ltd.
Enbrel: NICE final appraisal determination (FAD) recommending the use of Enbrel etanercept to treat adults with active and progressive psoriatic arthritis who have peripheral arthritis with three or more tender or swollen joints and whose disease has not responded to at least two DMARDs; from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Friday, June 11). (PDF file)
Fingolimod: Briefing documents for the June 10 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted 25-0 that fingolimod (FTY720) was effective at reducing the clinical exacerbations of multiple sclerosis and that the safety of the 0.5 mg dose justified approval for MS; from Novartis AG (NYSE:NVS; SIX:NOVN) (see Cover Story).
Humira: NICE final appraisal determination (FAD) recommending the use of Humira adalimumab to treat adults with active and progressive psoriatic arthritis who have peripheral arthritis with three or more tender or swollen joints and whose disease has not responded to at least two DMARDs; from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Friday, June 11). (PDF file)
Remicade: NICE final appraisal determination (FAD) recommending the use of Remicade infliximab to treat adults with active and progressive psoriatic arthritis who have peripheral arthritis with three or more tender or swollen joints and whose disease has not responded to at least two DMARDs; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Friday, June 11). (PDF file)
Revolade: NICE preliminary appraisal recommending against the use of Revolade eltrombopag to treat chronic idiopathic thrombocytopenic purpura (ITP) in splenectomized patients who are refractory to other treatments and as a second-line treatment of non-splenectomized patients for whom surgery is contraindicated; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Ligand Pharmaceuticals Inc. (NASDAQ:LGND) (see BioCentury Extra, Thursday, June 10).
Rotarix: FDA transcript of the May 7 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which concluded that the benefits of Rotarix rotavirus vaccine from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) currently outweigh the risks of potential harm from viral contaminants (see BioCentury Extra, Friday, May 7). (PDF file)
RotaTeq: FDA transcript of the May 7 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which concluded that the benefits of RotaTeq rotavirus vaccine from Merck & Co. Inc. (NYSE:MRK) currently outweigh the risks of potential harm from viral contaminants (see BioCentury Extra, Friday, May 7). (PDF file)
— Tyverb: NICE final appraisal determination (FAD) (PDF file) recommending against the use of Tyverb lapatinib in combination with capecitabine to treat previously treated patients with advanced or metastatic breast cancer whose tumors overexpress HER2, except in clinical trials; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, June 9); plus a revised EPAR from CHMP extending the indication of Tyverb in combination with an aromatase inhibitor to include treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer whose tumor overexpress HER2 not currently intended for chemotherapy.
Vectibix: CHMP revised EPAR updating SPC to include two post-marketing reports of fatal infusion reaction for Vectibix panitumumab for second-line treatment of EGFR-expressing colorectal cancer after the failure of chemotherapies in patients with wild-type K-Ras tumors; from Amgen Inc. (NASDAQ:AMGN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).

Advanced therapies (PDF file) (June 7, 2010)
Summary of actions taken at the May 11-12 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Animal testing (PDF files) (June 7, 2010)
FDA rejection of a Citizen's Petition filed by the Mandatory Alternatives Petition Coalition, and the Citizen's Petition asking the agency require drug and medical device companies to submit data only from non-animal test methods (NATMs) whenever NATMs are available. 

Cardiac failure (PDF file) (June 7, 2010)
European Medicines Agency (EMA) concept paper on the need to revise the addendum to the guidance on developing medicinal products to treat acute cardiac failure.

Genetic testing (June 7, 2010)
NIH request for information (RIF) on the agency's plan to develop the Genetic Testing Registry (GTR).

ITP (PDF file) (June 7, 2010)
European Medicines Agency (EMA) concept paper on the need for a guideline on developing thrombopoetin receptor agonists to treat chronic idiopathic thrombocytopenic purpura.

Knee repair (PDF file) (June 7, 2010)
Overview of comments received on the European Medicines Agency (EMA) reflection paper on in vitro cultured chondrocyte-containing products for cartilage repair of the knee.

PAH (PDF file) (June 7, 2010)
CHMP draft pediatric addendum to the agency's guideline on developing medicinal products to treat pulmonary arterial hypertension.

Pharmacovigilance (PDF file) (June 7, 2010)
European Medicines Agency (EMA) 19th pandemic pharmacovigilance weekly update.

Transparency (June 7, 2010)
FDA Transparency Task Force report and commentary (PDF file) in the New England Journal of Medicine on proposed measures to improve the agency's transparency, including the public release of refuse-to-file and complete response letters at the time they are sent to drug sponsors (see "Seeking Clarity").

Product documentation (June 7, 2010)
Altargo: CHMP revised EPAR updating SPC to include information on the mechanism of resistance to Altargo retapamulin and its potential for cross-resistance with other drugs to treat superficial skin infections; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Doribax: CHMP revised EPAR updating SPC to include thrombocytopenia as an adverse reaction and to update neutropenia as a less frequent adverse reaction for Doribax doripenem to treat nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections; from Johnson & Johnson (NYSE:JNJ) and Shionogi & Co. Ltd. (Tokyo:4507; Osaka:4507).
Enbrel: CHMP revised EPAR updating SPC to include reports of hypoglycemia in patients receiving diabetes drugs and Enbrel etanercept to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis; from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE).
Silwens: CHMP withdrawal assessment report for Silwens eplivanserin to treat insomnia; from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Trizivir: CHMP revised EPAR updating SPC to include the recommendation of testing for the HLA-B*5701 allele before restarting Trizivir abacavir/lamivudine/zidovudine to treat HIV infection; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Thalidomide Celgene: NICE preliminary appraisal recommending Celgene's thalidomide in combination with an alkylating agent and a corticosteroid for first-line treatment of multiple myeloma in patients for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate; from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Wednesday, June 2).
Velcade: NICE preliminary appraisal recommending Velcade bortezomib for first-line treatment of multiple myeloma only in patients for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate and who are unable to tolerate, or have contraindications to, thalidomide; from Johnson & Johnson (NYSE:JNJ) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Wednesday, June 2).
Xolair: NICE preliminary appraisal recommending against the use of Xolair omalizumab to treat severe persistent allergic asthma in children aged six to 11 years; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, June 1).

Basal cell carcinomas (PDF file) (May 31, 2010)
NICE updated recommendations on the diagnosis and removal of low risk basal cell carcinomas.

Clinical trials (PDF file) (May 31, 2010)
European Medicines Agency (EMA) draft reflection paper on ethical and good clinical practice aspects of clinical trials of medicinal products conducted in countries outside the EU and submitted in MAAs to the agency.

Constipation (PDF file) (May 31, 2010)
NICE clinical guidelines on diagnosing and managing idiopathic childhood constipation in primary and secondary care.

Creutzfeldt-Jakob disease (PDF file) (May 31, 2010)
FDA guidance on revised preventative measures to reduce the possible risk of transmission of CJD and variant CJD by blood and blood products.

HCV (May 31, 2010)
NICE guidance recommending use of peginterferon alfa and ribavirin to treat chronic HCV in patients previously treated with the combination or with peginterferon monotherapy, or those who are co-infected with HIV.
The drugs include: Pegasys peginterferon alfa-2a and Copegus ribavirin from Roche (SIX:ROG; OTCQX:RHHBY); ViraferonPeg peginterferon alfa-2b from Merck & Co. Inc. (NYSE:MRK); and Rebetol ribavirin from Enzon Pharmaceuticals Inc. (NASDAQ:ENZN) and Merck.

Medicare (PDF file) (May 31, 2010)
CMS revised guidance on the implementation of the Medicare Coverage Gap Discount Program included in the Patient Protection and Affordable Care Act (see BioCentury Extra, Monday, May 24).

NICE reform (May 31, 2010)
Outline of policy priorities of new U.K. Conservative Prime Minister David Cameron and Liberal Democrat Deputy Prime Minister Nick Clegg, including reforming NICE to use a "system of value-based" pricing and creation of a cancer drugs fund (see BioCentury Extra, Wednesday, May 26).

Pediatric drugs (PDF file) (May 31, 2010)
Summary of actions taken at the May 19-21 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Pharmacovigilance (PDF file) (May 31, 2010)
Summary of actions taken at the May 17-19 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

PMDD (PDF file) (May 31, 2010)
European Medicines Agency (EMA) draft guideline on treating premenstrual dysphoric disorder.

Safety (May 31, 2010)
FDA and NIH Safety Reporting Portal website, which can be used to report adverse events occurring in human gene transfer trials (see BioCentury Extra, Monday, May 24).
FDA notice of a memorandum of understanding between the agency and Drugs.Com to extend the reach of FDA Consumer Health Information. (PDF file)

Somatropin (PDF file) (May 31, 2010)
NICE guidance recommending somatropin human growth hormone as an option for children with growth failure caused by: growth hormone deficiency, Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, being born small for gestational age with subsequent growth failure at 4 years of age or later and short stature homeobox-containing gene (SHOX) deficiency.
The products include: Omnitrope from Novartis AG (NYSE:NVS; SIX:NOVN); Humatrope from Eli Lilly and Co. (NYSE:LLY), Norditropin from Novo Nordisk A/S (CSE:NVO; NYSE:NVO), NutropinAq from Ipsen Group (Euronext:IPN), Saizen from Merck KGaA (Xetra:MRK); and Zomacton from Ferring Pharmaceuticals A/S.

Synthetic biology (May 31, 2010)
Letter from President Obama requesting that the Presidential Commission for the Study of Bioethical Issues undertake a study of the ethical issues associated with synthetic biology (see "Let There Be Hype"). (PDF file)
Testimony and webcast of the May 27 House Commerce Committee hearing on synthetic genomics.

Product documentation (May 31, 2010)
Egrifta: Briefing documents for the May 27 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 16-0 to recommend approval of Egrifta tesamorelin to treat excess abdominal fat in HIV-infected patients with lipodystrophy; from Theratechnologies Inc. (TSX:TH) (see " Cutting the VAT").
Gemesis: CHMP refusal assessment report for Gemesis bercaplermin to regenerate tissue in adults with defects around the teeth; from BioMimetic Therapeutics Inc. (NASDAQ:BMTI) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568). (PDF file)
Iressa: NICE final appraisal determination (FAD) recommending the use of Iressa gefitinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) only in patients with an EGFR mutation and then only if the company provides the drug at a fixed price, from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Thursday, May 27). (PDF file)
Motavizumab: Briefing documents for the June 2 meeting of FDA's Antiviral Drugs Advisory Committee to discuss a BLA for motavizumab to prevent serious respiratory syncytial virus (RSV); from the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Friday, May 28).
Nexavar: NICE guidance recommending against the use of Nexavar sorafenib to treat advanced hepatocellular carcinoma (HCC) in patients for whom surgical or locoregional therapies have failed or are not suitable; from Bayer AG (Xetra:BAY) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) (see BioCentury Extra, Wednesday, May 26). (PDF file)
Plavix: CHMP revised EPAR updating SPC to include information on the interaction between CYP2C19 inhibitors, including some proton pump inhibitors, and Plavix clopidogrel to treat prevent atherothrombotic events; from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Remicade: CHMP revised EPAR updating SPC to include viral infections to the list of serious infections and risk of neutropenia with concurrent use of anakinra and Remicade infliximab to treat rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK).
Rotarix: CHMP revised EPAR updating SPC to include reactogenicity and safety data from a pooled analysis of clinical trials for Rotarix vaccine to prevent gastroenteritis due to rotavirus infection; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Xeloda: NICE final appraisal determination (FAD) recommending the use of Xeloda capecitabine in combination with a platinum-based regimen to treat inoperable advanced gastric cancer; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, May 27). (PDF file)

CHMP (PDF file) (May 24, 2010)
Summary of actions taken at the May 17-20 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Comparative effectiveness (PDF file) (May 24, 2010)
Standardized guidelines for comparative effectiveness research (CER) of drugs to be included in formularies from health benefits company WellPoint Inc. (NYSE:WLP) (see BioCentury Extra, Wednesday, May 19).

Conflict of interest (PDF file) (May 24, 2010)
HHS request for comments on whether the agency should amend its regulations covering financial conflict of interests in Public Health Service-funded research (see BioCentury Extra, Wednesday, May 19).

Drug pricing (PDF file) (May 24, 2010)
Agreement between the Australian government and Medicines Australia to lower prices of drugs on the country's Pharmaceutical Benefits Scheme (PBS) in exchange for a commitment from the government not to implement new policies to generate price-related savings from the PBS until June 30, 2014 (see BioCentury Extra, Monday, May 17).

EMA (PDF files) (May 24, 2010)
European Medicines Agency (EMA) 2009 annual report and annex.

Healthcare reform (PDF file) (May 24, 2010)
Treasury Department guidelines for grants and credits issued under the therapeutic discovery tax credit provisions of the Affordable Care Act (see Cover Story).

Knee repair (PDF file) (May 24, 2010)
European Medicines Agency (EMA) reflection paper on in vitro cultured chondrocyte containing products for cartilage repair of the knee.

Neglected tropical diseases (May 24, 2010)
ChEMBL Neglected Tropical Diseases archive, a repository for open access screening and medicinal chemistry data for potential compounds to treat neglected diseases (see BioCentury Extra, Thursday, May 20).

Orphan drugs (PDF files) (May 24, 2010)
Summary of actions taken at the May 5-6 plenary meeting of the COMP, part of the European Medicines Agency (EMA).
EMA summary on the progress of orphan legislation over the last 10 years.

Pharmacovigilance (May 24, 2010)
European Medicines Agency (EMA) eighteenth pandemic pharmacovigilance weekly update.

Synthetic biology (PDF files) (May 24, 2010)
Article published in Science by researchers at the J. Craig Venter Institute describing the creation of a synthetic genome based on the natural genome of Mycoplasma mycoides (see BioCentury Extra, Thursday, May 20).
Letter from the White House asking the newly appointed Presidential Committee for the Study of Bioethical Issues to study the implications of synthetic biology (see BioCentury Extra, Friday, May 21).

Product documentation (May 24, 2010)
Aldurazyme: CHMP revised EPAR updating SPC to include erythema as an adverse event for Aldurazyme laronidase to treat non-neurological manifestations of mucopolysaccharidosis I (MPS I), from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN).
Humira: NICE guidance recommending the use of Humira adalimumab to treat severe active Crohn's disease in adults whose disease has not responded to conventional therapy, or who are intolerant of or have contraindications to conventional therapy; from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Thursday, May 20). (PDF file)
Kepivance: CHMP revised EPAR updating SPC to restrict the indication of Kepivance palifermin to patients with hematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous hemopoietic stem cell support; from Amgen Inc. (NASDAQ:AMGN) and Swedish Orphan Biovitrum (SSE:BVT).
Remicade: NICE guidance recommending the use of Remicade infliximab to treat severe active Crohn's disease in adults and children ages 6-17 and to treat active fistulizing Crohn's disease for populations that have not responded to, who are intolerant of, or have contraindications to conventional therapy; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Thursday, May 20). (PDF file)
Revlimid: CHMP revised EPAR updating SPC to include a warning on myocardial infarction (MI) for Revlimid lenalidomide to treat relapsed or refractory multiple myeloma in combination with dexamethasone; from Celgene Corp. (NASDAQ:CELG).
Tyvaso: CHMP withdrawal assessment report for Tyvaso treprostinil to treat pulmonary arterial hypertension (PAH); from United Therapeutics Corp. (NASDAQ:UTHR). (PDF file)

Biomarkers (May 17, 2010)
Institute of Medicine (IOM) report recommending a framework for the evaluation of biomarkers and surrogate endpoints in chronic disease (see BioCentury Extra, Wednesday, May 12).

Genzyme (May 17, 2010)
Genzyme Corp. (NASDAQ:GENZ) website documenting the changes in manufacturing operations at the company.

Healthcare reform (PDF file) (May 17, 2010)
Congressional Budget Office estimates on the potential effects of the Patient Protection and Affordable Care Act (H.R. 3590) on discretionary spending (see BioCentury Extra, Wednesday, May 12).

Patient and consumer groups (PDF file) (May 17, 2010)
Minutes of the March 5 joint meeting of the European Medicines Agency (EMA) Scientific Committees' Working Party with Patients' and Consumers' Organizations (PCWP) and the Working Group with Healthcare Professionals’ Organizations.

Pediatric research (PDF file) (May 17, 2010)
European Medicines Agency (EMA) report on the March 16 workshop of the European Pediatric Research Network (EnprEMA).

Translational research (PDF file) (May 17, 2010)
FDA request for comments for a June 2 joint public meeting with NIH to discuss how the agencies can collaborate to advance the translation of biomedical research into approved diagnostics and therapies.

Transparency (May 17, 2010)
European Ombudsman draft recommendation suggesting the European Medicines Agency (EMA) should make adverse events reports available to the public (see BioCentury Extra, Tuesday, May 11).

Product documentation (May 17, 2010)
Copaxone: FDA letter rejecting a second Citizen Petition seeking to block approval of generic versions of Copaxone glatiramer acetate to treat relapsing-remitting multiple sclerosis (RRMS), from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) (see BioCentury Extra, Thursday, May 13). (PDF file)
Naproxcinod: Briefing documents for the May 12 joint meeting of FDA's Arthritis Drugs and Drug Safety and Risk Management committees, which voted 16-1, with one abstention, against recommending approval of naproxcinod to treat the signs and symptoms of osteoarthritis, from NicOx S.A. (Euronext:COX) (see Cover Story). (PDF file)
Promacta: Dear Healthcare Professional letter notifying physicians of portal venous thromboses observed in patients with chronic liver disease receiving Promacta eltrombopag to treat thrombocytopenia, from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, May 13). (PDF file)
Viread: CHMP EPAR updating SPC to include long term safety data from two pivotal clinical trials for Viread tenofovir disoproxil to treat HBV, from Gilead Sciences Inc. (NASDAQ:GILD).

Diabetes (PDF file) (May 10, 2010)
Minutes from an April 17, 2009 meeting of the European Medicines Agency (EMA) pediatric diabetes mellitus experts group.

Drug safety (May 10, 2010)
Safety signals reported to FDA in 4Q09 through the Adverse Events Reporting System (AERS).

Epilepsy (PDF file) (May 10, 2010)
Conclusions from a Sept. 1, 2009 meeting of the European Medicines Agency (EMA) pediatric epilepsy experts group.

GnRH agonists (May 10, 2010)
FDA drug safety communication about a safety review of gonadotropin-releasing hormone agonists for an increased risk of diabetes and cardiovascular disease in men receiving androgen deprivation therapy (ADT) to treat prostate cancer (see BioCentury Extra, Monday, May 3).

HIV (PDF file) (May 10, 2010)
Report from a May 16, 2009 meeting of the European Medicines Agency (EMA) pediatric HIV experts group.

Medicare (PDF file) (May 10, 2010)
CMS draft guidance on implementing the Medicare Coverage Gap Discount Program enacted under the Patient Protection and Affordable Care Act (H.R. 3590) (see BioCentury Extra, Monday, May 3).

Nanomedicine (PDF file) (May 10, 2010)
European Medicines Agency (EMA) notice of a Sept. 2-3 workshop on nanomedicines.

PDUFA (PDF files) (May 10, 2010)
— FDA financial report on PDUFA fee revenues and expenditures in fiscal 2008.
— FDA fiscal 2008 performance report on PDUFA.

Pharmacogenetics (PDF file) (May 10, 2010)
European Medicines Agency (EMA) draft guideline covering the use of pharmacogenetic studies in the pharmacokinetic evaluation of drug candidates (see BioCentury Extra, Friday, May 7).

Pharmacovigilance (PDF file) (May 10, 2010)
European Medicines Agency (EMA) seventeenth pandemic pharmacovigilance weekly update.

Rotavirus vaccines (May 10, 2010)
Briefing documents for the May 7 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which concluded the benefits of rotavirus vaccines Rotarix from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and RotaTeq from Merck & Co. Inc. (NYSE:MRK) currently outweigh the risks of potential harm from viral contaminants (see BioCentury Extra, Friday, May 7).

Product documentation (May 10, 2010)
Adcirca: CHMP revised EPAR updating SPC to include cerebrovascular hemorrhagic events as an adverse event for Adcirca tadalafil to treat pulmonary arterial hypertension (PAH), from United Therapeutics Corp. (NASDAQ:UTHR) and Eli Lilly and Co. (NYSE:LLY).
Aldara: CHMP revised EPAR updating SPC to include safety information about application site reactions and disorders observed in the pediatric population for Aldara imiquimod to treat basal cell carcinoma (BCC) and genital warts in adults, from Graceway Pharmaceuticals LLC and Meda AB (SSE:MEDAA).
Fuzeon: CHMP revised EPAR updating SPC to remove the risk of pneumonia for Fuzeon enfuvirtide to treat HIV infection, from Roche (SIX:ROG; OTCQX:RHHBY).
Glivec: CHMP revised EPAR updating SPC to include palmoplantar erythrodysesthesia syndrome as a post-marketing adverse reaction for Glivec imatinib (U.S. - Gleevec) to treat chronic myelogenous leukemia (CML) and gastrointestinal stromal tumors (GIST), from Novartis AG (NYSE:NVS; SIX:NOVN).
Intanza: CHMP revised EPAR updating SPC to include immunogenicity data for Idflu/Intanza split-virion, inactivated flu vaccine to prevent seasonal influenza in adults, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Menveo: CHMP EPAR for Menveo to prevent invasive disease caused by Neisseria meningitides serogroups A, C, Y and W135 in people ages 11 and up, from Novartis AG (NYSE:NVS; SIX:NOVN).
Tamiflu: European Medicines Agency (EMA) compassionate use summary for Tamiflu oseltamivir to treat critically ill patients with suspected or confirmed pandemic or seasonal influenza, who cannot take authorized oral or nasal antivirals, from Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Tepadina: CHMP EPAR for Tepadina thiotepa as a conditioning treatment prior to autologous or allogeneic hematopoietic progenitor cell transplantation, from Adienne Pharma & Biotech.

Advanced therapies (PDF file) (May 3, 2010)
Summary of actions taken at the April 15-16 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Antifungal agents (PDF files) (May 3, 2010)
CHMP guideline on developing antifungal agents to treat and prevent invasive fungal disease, and an overview of comments received.

Bioequivalence (PDF file) (May 3, 2010)
European Medicines Agency (EMA) concept paper on the need to develop an appendix to the guideline on bioequivalence regarding the presentation of biopharmaceutical and bioanalytical data in MAAs.

CHMP (PDF file) (May 3, 2010)
Summary of actions taken at the April 19-22 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Clinical trials (PDF file) (May 3, 2010)
European Medicines Agency (EMA) concept paper on the need for a guideline on the use of subgroup analyses in randomized controlled trials.

Drug interaction (PDF file) (May 3, 2010)
European Medicines Agency (EMA) draft guidance on the investigation of drug interactions.

HCV (PDF file) (May 3, 2010)
European Medicines Agency (EMA) concept paper on the need for revision of the guideline on developing medicinal products to treat HCV.

Heparin (PDF file) (May 3, 2010)
Letter from Reps. Joe Barton (R-Texas) and Michael Burgess (R-Texas) to FDA Commissioner Margaret Hamburg regarding the agency's investigation into the 2007 heparin contamination (see BioCentury Extra, Friday, April 30).

Pharmacovigilance (PDF file) (May 3, 2010)
Summary of actions taken at the April 19-20 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Schizophrenia (PDF file) (May 3, 2010)
European Medicines Agency (EMA) concept paper on the need to revise the note for guidance on developing medicinal products to treat schizophrenia.

Urinary incontinence (PDF file) (May 3, 2010)
European Medicines Agency (EMA) concept paper on the need to revise the note for guidance on developing medicinal products to treat urinary incontinence.

Product documentation (May 3, 2010)
Arepanrix: CHMP EPAR for Arepanrix adjuvanted swine influenza A (H1N1) vaccine to prevent influenza in an officially declared pandemic, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Avandia: Science Advisory From the American Heart Association and American College of Cardiology Foundation regarding cardiovascular risks of using thiazolidinedione drugs such as Avandia rosiglitazone, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see Commentary).
Impulsor: CHMP refusal assessment report for Impulsor milnacipran to treat fibromyalgia syndrome, from Laboratoires Pierre Fabre S.A. and marketed in the U.S. as Savella by Cypress Bioscience Inc. (NASDAQ:CYPB), and Forest Laboratories Inc. (NYSE:FRX) (PDF file)
Joulferon: CHMP Q&A on the withdrawal of an MAA for Joulferon albinterferon alfa-2b to treat chronic HCV, from Human Genome Sciences Inc. (NASDAQ:HGSI) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Provenge: FDA label for Provenge sipuleucel-T to treat metastatic castrate-resistant prostate cancer, from Dendreon Corp. (NASDAQ:DNDN) (see Cover Story). (PDF file)
Revolade: CHMP EPAR for Revolade eltrombopag to treat thrombocytopenia in adults with chronic idiopathic thrombocytopenic purpura (ITP), from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

Advisory committees (PDF file) (April 26, 2010)
FDA draft guidance on the public availability of advisory committee members' financial interest information and waivers (see BioCentury Extra, Wednesday, April 21).

Alcohol dependence (PDF file) (April 26, 2010)
Overview of comments received on the European Medicines Agency (EMA) draft guideline on developing medicinal products to treat alcohol dependence.

CHMP (PDF file) (April 26, 2010)
Summary of actions taken at the March 19-22 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Diabetes (PDF file) (April 26, 2010)
HHS's Agency for Healthcare Research and Quality (AHRQ) draft comparative effectiveness review of oral medications for Type II diabetes (see BioCentury Extra, Friday, April 23).

Drug prices (PDF file) (April 26, 2010)
Drug trend report from pharmacy benefits manager Express Scripts Inc. (NASDAQ:ESRX), showing that specialty and branded drug prices rose 11.5% and 9.1%, respectively in 2009.

Patent reform (PDF file) (April 26, 2010)
U.S. Department of Commerce white paper concluding that patent reform would encourage economic growth and job creation (see BioCentury Extra, Wednesday, April 21).

Pediatric drugs (PDF file) (April 26, 2010)
Summary of actions taken at the April 14-16 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

Pharmacovigilence (PDF file) (April 26, 2010)
European Medicines Agency (EMA) sixteenth pandemic pharmacovigilance weekly update.

Safety (April 26, 2010)
Institute of Medicine web page describing the "consensus study" requested by FDA to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs (see Cover Story).
— Institute of Medicine 2006 report: "The Future of Drug Safety: Promoting and Protecting the Health of the Public" and FDA's response (PDF file) (see Cover Story).
— Government Accountability Office 2009 report: "Drug Safety: FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed." (PDF file)
European Medicines Agency (EMA) report on its risk-benefit methodology project. (PDF file)

Swine influenza A (H1N1) (PDF file) (April 26, 2010)
FDA notice of issuance of 10 emergency use authorizations (EUAs) for certain in vitro diagnostics to test for swine influenza A (H1N1).

Transparency (April 26, 2010)
Web page for FDA's Center for Devices and Radiological Health (CDRH) Transparency Initiative.

Product documentation (April 26, 2010)
Acurox: Briefing documents for the April 22 meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee, which voted 19-1 against recommending approval of Acurox oxycodone/niacin to treat moderate to severe pain, from Acura Pharmaceuticals Inc. (NASDAQ:ACUR) and King Pharmaceuticals Inc. (NYSE:KG) (see "Hot and Bothered," BioCentury, April 26, 2010). (PDF file)
Fabrazyme: European Medicines Agency (EMA) revised temporary treatment recommendations for Fabrazyme agalsidase beta to treat Fabry's disease, from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
Ixiaro: CHMP revised EPAR updating SPC to include immunogenicity and safety data for Ixiaro to prevent Japanese encephalitis (JE), from Intercell AG (VSE:ICLL; OTCQX:INRLF) and Novartis AG (NYSE:NVS; SIX:NOVN).
Remicade: CHMP revised EPAR updating SPC to include pediatric malignancy and leukemia in the existing warning on malignancies and lymphoproliferative disorders for Remicade infliximab to treat rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis ankylosing spondylitis, psoriatic arthritis and psoriasis, from Johnson & Johnson (NYSE:JNJ).

Clinical trials (April 19, 2010)
Institute of Medicine report recommending the National Cancer Institute (NCI) strengthen its Clinical Trials Cooperative Group Program through an overhaul of its organization, management and funding.

Labeling (PDF file) (April 19, 2010)
FDA notice of a June 24-25 public workshop on developing guidance on naming, labeling and packaging practices to reduce medication errors.

Orphan drugs (PDF file) (April 19, 2010)
Summary of actions taken at the April 7-8 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Stem cells (PDF file) (April 19, 2010)
European Medicines Agency (EMA) public statement on concerns over unregulated medicinal products containing stem cells.

Product documentation (April 19, 2010)
Afinitor: CHMP revised EPAR updating the SPC to include information regarding reported cases of HBV reactivation based on the review of a signal prompted by a fatal outcome during an ongoing clinical study for Afinitor everolimus to treat advanced renal cell carcinoma, from Novartis AG (NYSE:NVS; SIX:NOVN).
Orencia: CHMP revised EPAR extending the indication of Orencia abatacept to include treatment of moderate to severe, active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients ages six and up who showed an inadequate response to one or more DMARD, from Bristol-Myers Squibb Co. (NYSE:BMY).
Pancreaze: FDA Q&A on Pancreaze pancrelipase delayed-release capsules to treat pancreatic exocrine insufficiency, from Johnson & Johnson (NYSE:JNJ).
Xyrem: CHMP revised EPAR updating the SPC to include weight decrease, suicidal ideation and suicidal attempt as adverse events for Xyrem sodium oxybate to treat narcolepsy with cataplexy, from Jazz Pharmaceuticals Inc. (NASDAQ:JAZZ) and UCB Group (Euronext:UCB).

Biosimilars (PDF files) (April 12, 2010)
European Medicines Agency (EMA) concept papers on similar biological products containing recombinant follicle stimulation hormone (FSH) and recombinant Interferon (IFN) beta.

Healthcare professionals' (PDF file) (April 12, 2010)
Revised 2010 work plan for the CHMP's Working Group with Healthcare Professionals’ Organizations.

PDUFA (April 12, 2010)
FDA webinar to inform stakeholders about the PDUFA program.

Pharmacovigilance (PDF file) (April 12, 2010)
European Medicines Agency (EMA) 15th pandemic pharmacovigilance weekly update.

Transparency (PDF file) (April 12, 2010)
HHS Open Government Plan, which details the agency's steps to make itself more transparent (see BioCentury Extra, Wednesday, April 7).

Product documentation (April 12, 2010)
Altargo: CHMP revised EPAR updating the SPC to reflect data from a pediatric pharmacokinetics study for Altargo retapamulin to treat impetigo, infected small lacerations, abrasions or sutured wounds, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Daxas: Briefing documents for the April 7 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 10-5 that safety and efficacy data do not provide substantial evidence to support the approval of Daxas roflumilast to treat chronic obstructive pulmonary disease (COPD), from Forest Laboratories Inc. (NYSE:FRX) and Nycomed (see Cover Story).
Rotarix: FDA notice of a May 7 public advisory committee meeting of the agency's Vaccines and Related Biological Products Advisory Committee on the presence of DNA from the porcine circovirus type 1 in batches of Rotarix oral vaccine to prevent gastroenteritis due to rotavirus infection, from GlaxoSmithKline plc (LSE:GSK;NYSE:GSK). (PDF file)

CHMP (PDF file) (April 5, 2010)
Summary of actions taken at the March 15-19 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Conflict of interest (April 5, 2010)
Report from Pfizer Inc. (NYSE:PFE) detailing payment or exchanges of value given to licensed U.S. healthcare professionals who consulted with the company from July 1, 2009 to Dec. 31, 2009 (see BioCentury Extra, Wednesday, March 31).

DTC advertising (PDF file) (April 5, 2010)
Proposed FDA rule that the major statement in direct-to-consumer advertisements relating to the side effects and contraindications of a prescription drug be presented in a clear, conspicuous and neutral manner.

Patents (PDF file) (April 5, 2010)
U.S. District Court for the Southern District of New York opinion that patents covering the BRCA1 and BRCA2 genes are invalid in a suit brought by Myriad Genetics Inc. (NASDAQ:MYGN) against the U.S. Patent and Trademark Office (see "Bracketing the BRCA Appeal").

Pediatric drugs (PDF file) (April 5, 2010)
Summary of actions taken at the March 17-19 meeting of the Pediatric Committee (PDCO), part of the European Medicines Agency (EMA).

SMEs (PDF file) (April 5, 2010)
News bulletin for small and medium-sized enterprises from the SME Office, part of the European Medicines Agency (EMA).

Stem cells (PDF file) (April 5, 2010)
European Medicines Agency (EMA) reflection paper on stem cell-based medicinal products.

Toxicity (PDF files) (April 5, 2010)
European Medicines Agency (EMA) guideline on repeated dose toxicity and an overview of comments received.

Tuberculosis (PDF file) (April 5, 2010)
FDA notice and request for comments on a June 7-8 public workshop to advance the development of diagnostic tests and biomarkers for tuberculosis (TB).

Product documentation (April 5, 2010)
Alimta: NICE final appraisal determination recommending the use of Alimta pemetrexed for maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology, from Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Thursday, April 1). (PDF file)
DuoCover/DuoPlavin: CHMP EPAR for DuoCover/DuoPlavin clopidogrel/acetylsalicylic acid to prevent atherothrombotic events in adults already receiving Plavix clopidogrel and acetylsalicylic acid, from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Multaq: NICE second preliminary appraisal recommending the limited use of Multaq dronedarone as second-line therapy for non-permanent atrial fibrillation (AF) in patients with additional cardiovascular risk factors, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Tuesday, March 30).
Stalevo: FDA drug safety communication on the ongoing safety review of Stalevo levodopa/carbidopa/entacapone to treat patients with Parkinson's disease and the increased incidence of prostate cancer in patients receiving the drug, from Orion Corp.  (HSE:ORNAV; HSE:ORNBV) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, April 1).

Advanced therapies (PDF file) (March 29, 2010)
Summary of actions taken at the March 11-12 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Bacterial Infections (PDF file) (March 29, 2010)
CHMP draft guideline on developing medicinal products to treat bacterial infections.

Cardiovascular (PDF file) (March 29, 2010)
NICE clinical guideline on the early management of unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI) (see BioCentury Extra, Wednesday, March 24).

Clinical trials (PDF file) (March 29, 2010)
FDA notice of a May 5-6 public workshop to discuss informed consent, inspections of clinical investigators, investigational review boards (IRBs), research sponsors and regulations relating to drugs, biologics and medical devices.

ESAs (March 29, 2010)
APPRISE Oncology Program, which is part of an REMS designed for healthcare providers treating chemotherapy-induced anemia (CIA) with erythropoiesis stimulating agents, including Aranesp darbepoetin alfa and Epogen epoetin alfa from Amgen Inc. (NASDAQ:AMGN) and Procrit epoetin alfa from Johnson & Johnson (NYSE:JNJ).

IBS (PDF file) (March 29, 2010)
FDA draft guidance on the design of clinical trials for diarrhea- or constipation-predominant irritable bowel syndrome (IBS-D or IBS-C) (see BioCentury Extra, Monday, March 22).

Immunoglobulin (PDF file) (March 29, 2010)
European Medicines Agency (EMA) draft guideline on developing human IV immunoglobulin (IVIg).

Labeling (PDF file) (March 29, 2010)
FDA guidance regarding development of standardized numerical identifiers (SNIs) for prescription drug packages.

Neuropathic pain (PDF file) (March 29, 2010)
NICE clinical guideline on the use of neuropathic pain drugs in non-specialist settings (see BioCentury Extra, Wednesday, March 24).

Patient and consumer groups (PDF file) (March 29, 2010)
Minutes of the Sept. 30, 2009 European Medicines Agency (EMA) Human Scientific Committees' Working Party meeting with Patients' and Consumers' Working Party (PCWP).

Pharmacovigilance (PDF files) (March 29, 2010)
European Medicines Agency (EMA) fourteenth pandemic pharmacovigilance weekly update and monthly report from the pharmacovigilance working party (PhVWP).

Tuberculosis (March 29, 2010)
The Working Group on New Tuberculosis Drugs blog, which provides information on treatments and research on TB.

Product documentation (March 29, 2010)
Cerepro: CHMP Q&A on the withdrawal of an MAA for Cerepro sitimagene ceradenovec to treat operable malignant glioma, from Ark Therapeutics Group (LSE:AKT). (PDF file)
Glivec: NICE preliminary appraisal requesting clarification of existing data for Glivec imatinib (U.S. - Gleevec) for the adjuvant treatment of gastrointestinal stromal tumors (GISTs) after surgery, from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, March 26).
Recothrom: CHMP withdrawal assessment report for Recothrom as an aid in surgery to improve hemostasis where standard surgical techniques are insufficient, from Bayer AG (Xetra:BAY) and ZymoGenetics Inc. (NASDAQ:ZGEN). (PDF file)
Rotarix: European Medicines Agency (EMA) statement on the presence of porcine circovirus type 1 in batches of Rotarix oral vaccine to prevent gastroenteritis due to rotavirus infection, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Monday, March 22). (PDF file)
Tyvaso: CHMP Q&A on the withdrawal of an MAA for Tyvaso treprostinil sodium to treat pulmonary arterial hypertension (PAH), from United Therapeutics Corp. (NASDAQ:UTHR). (PDF file)
Vimpat: CHMP revised EPAR updating the SPC to include in vivo data from an interaction study with midazolam in patients receiving Vimpat lacosamide as an adjunctive therapy to treat partial-onset seizures, from UCB Group (Euronext:UCB). (PDF file)
Zyprexa: CHMP revised EPAR updating the SPC to include a warning on sudden cardiac death, urinary incontinence as an uncommon adverse reaction and revise information on elevated plasma prolactin concentration for Zyprexa olanzapine to treat schizophrenia and moderate to severe manic episodes in adults, from Eli Lilly and Co. (NYSE:LLY). (PDF file)

CDER (PDF file) (March 22, 2010)
Center for Drug Evaluation and Research ombudsman's annual report for 2009.

Drug prices (March 22, 2010)
Letters from Chairman of the Senate Special Committee on Aging Sen. Herb Kohl (D-Wis.) requesting an explanation for why Americans pay more for prescription drugs as patients in other industrialized nations, sent to AstraZeneca plc (LSE:AZN; NYSE:AZN); GlaxoSmithKline plc (LSE:GSK; NYSE:GSK); Eli Lilly and Co. (NYSE:LLY); Novartis AG (NYSE:NVS; SIX:NOVN); Pfizer Inc. (NYSE:PFE); and sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Wednesday, March 17).

DTC advertising (PDF file) (March 22, 2010)
FDA notice soliciting comments on the reporting requirements, including third party disclosure, contained in the agency's regulations on prescription drug advertisements.

EMA (March 22, 2010)
— European Medicines Agency (EMA) work program for 2010. (PDF file)
Minutes of the Dec. 8, 2009, meeting of the European Medicines Agency (EMA) Patients' and Consumers' Working Party (PCWP). (PDF file)

Genetic testing (March 22, 2010)
Website of NIH's Genetic Testing Registry (GTR), which will serve as a public database of the availability, validity and usefulness of genetic tests (see BioCentury Extra, Thursday, March 18).

Influenza vaccines (PDF file) (March 22, 2010)
EU recommendation for the seasonal influenza vaccine composition for the 2010/2011 season.

I-SPY (March 22, 2010)
Website for the I-SPY 2 trial, an adaptive clinical trial involving simultaneous testing of five investigational compounds and associated biomarkers in breast cancer (see "Spies Plot Revolution").

LABAs (March 22, 2010)
Briefing documents for the March 10-11 joint meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Communication Advisory Committee, which voted that randomized controlled trials would best evaluate serious asthma outcomes with marketed long-acting beta-2 agonists (LABAs) when added to corticosteroids compared to corticosteroids alone to treat asthma (see Cover Story).

Nanomedicines (PDF file) (March 22, 2010)
Agenda for an April 26-27 European Medicines Agency (EMA) workshop on nanomedicines.

PDUFA (March 22, 2010)
FDA notice of an April 12 public workshop to solicit comments on reauthorizing the PDUFA program. (PDF file)
— Text of the FDA Improvement Act 2010 (H.R. 4816), introduced by Rep. Maurice Hinchey (D-N.Y.), which would prohibit the agency from collecting fees paid by companies and would instead make fees payable to the general fund of the Treasury (see BioCentury Extra, Monday, March 15). (PDF file)

Renal impairment (March 22, 2010)
FDA revised draft guidance on conducting studies to assess the influence of renal impairment on the pharmacokinetics of an investigational drug. (PDF file)

Product documentation (March 22, 2010)
Nenad: CHMP withdrawal assessment report for Nenad lisuride transdermal patch to treat moderate to severe idiopathic restless legs syndrome (RLS), from Axxonis Pharma AG. (PDF file)
Nivestim: CHMP summary of positive opinion for Nivestim filgrastim to treat neutropenia,  from Hospira Inc. (NYSE:HSP). (PDF file)
Plavix: CHMP public statement warning on interaction between proton-pump inhibitors and Plavix clopidogrel to treat acute coronary syndrome (ACS), from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Scintimun: CHMP EPAR for Scintimun besilesomab for scintigraphic imaging for determining the location of inflammation/infection in adults with suspected osteomyelitis, from Ion Beam Applications S.A. (Euronext:IBAB).
Zocor: FDA drug safety communication on the ongoing safety review of increased risk of muscle injury in patients receiving high-dose Zocor simvastatin to reduce cholesterol, from Merck & Co. Inc. (NYSE:MRK).

Biologics (PDF file) (March 15, 2010)
CHMP draft guideline on the requirements for quality documentation concerning biological medicinal products in clinical trials.

MAAs (PDF file) (March 15, 2010)
CHMP study on its recent experience with peer review in the evaluation of MAAs.

Malaria (PDF file) (March 15, 2010)
World Health Organization (WHO) guideline to treat malaria (see BioCentury Extra, Wednesday, March 10).

Pharmacovigilance (PDF file) (March 15, 2010)
European Medicines Agency (EMA) thirteenth pandemic pharmacovigilance weekly update.

Transparency (PDF files) (March 15, 2010)
FDA transcript and summary of January "listening sessions" on ways to increase transparency between the agency and industry, with a notice soliciting comments  (see BioCentury Extra, Thursday, March 11).

Viral vaccines (PDF file) (March 15, 2010)
FDA final guidance on the characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications (see BioCentury Extra, Tuesday, March 9).

Product documentation (March 15, 2010)
Erbitux: CHMP variation assessment report against expanding the label for Erbitux cetuximab for first-line treatment of EGFR-expressing advanced or metastatic non-small cell lung cancer (NSCLC) in combination with platinum-based chemotherapy, from Merck KGaA (Xetra:MRK), Bristol-Myers Squibb Co. (NYSE:BMY) and Eli Lilly and Co. (NYSE:LLY) (PDF file)
Oncophage: CHMP withdrawal assessment report for Oncophage vitespen to treat renal cell carcinoma, from Antigenics Inc. (NASDAQ:AGEN). (PDF file)
Plavix: Product label with a black box warning of diminished effectiveness in patients with a genetic variation in cytochrome P450 2C19 (CYP2C19) for Plavix clopidogrel to treat acute coronary syndrome (ACS), from Bristol-Myers Squibb Co. (NYSE:BMY) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Friday, March 12).

Alcohol dependence (PDF file) (March 8, 2010)
CHMP guideline on developing medicinal products to treat alcohol dependence.

Compassionate access (PDF file) (March 8, 2010)
Text of the Compassionate Access Act (H.R. 4732), introduced by Rep. Diane Watson (D-N.Y.), which seeks to create a conditional approval system that would allow companies to market new drugs based on Phase I data for life-threatening conditions for which there are no adequate therapies (see BioCentury Extra, Thursday, March 4).

Crohn's disease (PDF file) (March 8, 2010)
NICE final appraisal determination recommending the use of Humira adalimumab from Abbott Laboratories (NYSE:ABT) and Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) to treat severe active Crohn's disease in patients who have not responded to, who are intolerant of, or have contraindications to conventional therapy (see BioCentury Extra, Friday, March 5).

EMA (PDF file) (March 8, 2010)
European Medicines Agency (EMA) revenue and expenditure statement for FY10 (see BioCentury Extra, Thursday, March 4).

Hematological cancers (PDF files) (March 8, 2010)
CHMP appendix to the guideline on confirmatory studies in patients with hematological malignancies, and overview of comments received.

Orphan drugs (PDF file) (March 8, 2010)
Summary of actions taken at the March 2-3 plenary meeting of COMP, part of the European Medicines Agency (EMA).

Preclinical trials (PDF file) (March 8, 2010)
FDA guidance on nonclinical studies evaluating anticancer pharmaceuticals.

Rheumatoid arthritis (March 8, 2010)
NICE preliminary appraisal recommending the use of MabThera rituximab from Roche (SIX:ROG; NASDAQ:RHHBY) to treat RA after a TNF inhibitor has failed, but against the use of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE); Humira adalimumab from Abbott Laboratories (NYSE:ABT); Orencia abatacept from Bristol-Myers Squibb Co. (NYSE:BMY); and Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Wednesday, March 3).

Product documentation (March 8, 2010)
Avastin: CHMP refusal assessment report against expanding the label for Avastin bevacizumab to treat glioblastoma after relapse, from Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Esbriet: Briefing documents for the March 9 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee to discuss an NDA for Esbriet pirfenidone to treat idiopathic pulmonary fibrosis (IPF), from InterMune Inc. (NASDAQ:ITMN) (see BioCentury Extra, Friday, March 5).
MabThera: NICE final appraisal determination recommending use of MabThera rituximab in combination with fludarabine and cyclophosphamide to treat relapsed or refractory chronic lymphocytic leukemia (CLL), from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, March 4). (PDF file)
Oleptro: FDA-approved medication guide for Oleptro trazodone to treat major depressive disorder (MDD), from Labopharm Inc. (TSX:DDS; NASDAQ:DDSS). (PDF file)
RoActemra: NICE preliminary appraisal recommending against the use of RoActemra tocilizumab to treat moderate to severe rheumatoid arthritis in three settings, while seeking more information on its use in two others, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, March 5).
Vidaza: NICE final appraisal determination recommending against the use of Vidaza azacitidine to treat intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in patients who are not eligible for hematopoietic stem cell transplantation, from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Thursday, March 4). (PDF file)

Advanced therapies (March 1, 2010)
— European Medicines Agency (EMA) updated list of new summaries of scientific recommendations on the classification of advanced therapy medicinal products.
Summary of actions taken at the Feb. 11-12 plenary meeting of EMA's Committee for Advanced Therapies (CAT). (PDF file)

CalPERS (March 1, 2010)
List of funds where CalPERS has invested under its Alternative Investment Management (AIM) program (see "AIMming Bigger").

CHMP (PDF file) (March 1, 2010)
Summary of actions taken at the Feb. 15-19 plenary meeting of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use.

Clinical trials (PDF file) (March 1, 2010)
FDA draft guidance on adaptive design clinical trials for drugs and biologics (see BioCentury Extra, Thursday, Feb. 25).

ESAs (March 1, 2010)
Panel voting questions for the March 24 meeting of CMS's Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to review the evidence on the use of erythropoiesis stimulating agents to treat anemia in patients who have chronic kidney disease (CKD) (see BioCentury Extra, Monday Feb. 22).

Healthcare reform (March 1, 2010)
Summary of President Obama's healthcare reform legislation (see BioCentury Extra, Monday, Feb. 22).

Non-inferiority trials (PDF file) (March 1, 2010)
FDA draft guidance on non-inferiority clinical trials (see BioCentury Extra, Friday, Feb. 26).

Pharmacovigilance (PDF file) (March 1, 2010)
European Medicines Agency (EMA) twelfth pandemic pharmacovigilance weekly update.

Regulatory science (March 1, 2010)
FDA-NIH Joint Leadership Council charter and request for grant applications, issued as part of the agencies' regulatory science collaboration (see BioCentury Extra, Wednesday, Feb. 24).

Stem cells (PDF file) (March 1, 2010)
NIH notice soliciting comments on its proposed revision to the definition of human embryonic stem cells (hESCs) in its stem cell guidelines (see BioCentury Extra, Tuesday, Feb. 23).

Product documentation (March 1, 2010)
Abilify: CHMP withdrawal assessment report on a request to extend the indication for Abilify aripiprazole to treat major depressive episodes as an adjunctive treatment in patients who have had inadequate response to at least one antidepressant monotherapy, from Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768) and Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Belatacept: Briefing documents for the March 1 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss a BLA for belatacept to prevent organ rejection and to preserve a functioning allograft in adult patients receiving renal transplant, from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Friday, Feb. 26).
Cialis: CHMP revised EPAR updating the SPC to include information on low blood pressure in patients concurrently using adrenergic receptor alpha (ADRA) antagonists with Cialis tadalafil to treat erectile dysfunction, from United Therapeutics Corp. (NASDAQ:UTHR) and Eli Lilly and Co. (NYSE:LLY). (PDF file)
Cimzia: NICE final appraisal determination recommending Cimzia certolizumab pegol to treat rheumatoid arthritis (RA) provided the first 12 weeks of treatment are provided for free, from UCB Group (Euronext:UCB) (see BioCentury Extra, Thursday, Feb. 25). (PDF file)
Invirase: FDA safety communication warning of potential QT prolongation in patients receiving ritonavir in combination with Invirase saquinavir to treat HIV infection, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, Feb. 23).
Silodyx/Urorec: CHMP EPAR for Silodyx/Urorec silodosin to treat signs and symptoms of benign prostatic hyperplasia (BPH), from Recordati S.p.A. (Milan:REC).
Yondelis: NICE final guidance recommending Yondelis trabectedin to treat advanced soft tissue sarcoma when treatment with anthracyclines and ifosfamide has failed or patients are intolerant of, or have contraindications to, anthracyclines and ifosamide, from PharmaMar S.A. (see BioCentury Extra, Thursday, Feb. 25). (PDF file)

Adverse events (February 22, 2010)
Safety signals reported to FDA in 2Q09 through the Adverse Events Reporting System (see BioCentury Extra, Thursday, Feb. 18).

CHMP (PDF file) (February 22, 2010)
Summary of actions taken at the Feb. 15-18 plenary meeting of European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use.

CIRM (February 22, 2010)
Text of the California state Senate bill SB 1064, introduced by Democratic Sen. Elaine Alquist, that would require management and structural reforms at the California Institute for Regenerative Medicine (CIRM) (see BioCentury Extra, Thursday, February 18).

Data falsification (PDF file) (February 22, 2010)
Proposed FDA rule to require sponsors to report any falsification of data in preclinical or clinical testing to the agency within 45 days after the sponsor becomes aware of the information.

ESAs (February 22, 2010)
FDA documentation on the risk evaluation and mitigation strategy (REMS) required for all erythropoiesis-stimulating agents for cancer (see "APPRISE is Enough").

Pharmacovigilance (PDF file) (February 22, 2010)
European Medicines Agency (EMA) eleventh pandemic pharmacovigilance weekly update.

Product documentation (February 22, 2010)
Relenza: CHMP conditions for compassionate use of IV Relenza zanamivir to treat influenza, from Biota Holdings Ltd. (ASX:BTA) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Rifaximin: Briefing documents for the Feb. 23 meeting of FDA's Gastrointestinal Drugs Advisory Committee to discuss an NDA for 550 mg rifaximin for the maintenance of remission of hepatic encephalopathy, from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) (see BioCentury Extra, Friday, Feb. 19).
Sebivo: CHMP revised EPAR updating the SPC to include information suggesting that patients who failed to achieve virological response following treatment with lamivudine within 24 weeks are unlikely to respond with Sebivo telbivudine monotherapy to treat chronic HBV infection from Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
— Victoza: NICE preliminary appraisal recommending the use of 1.2 mg Victoza liraglutide in triple therapy regimens to treat Type II diabetes and a New England Journal of Medicine article on FDA's review of an NDA for Victoza to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Tuesday, Feb. 16).

Bioequivalence (PDF files) (February 15, 2010)
CHMP guideline on the investigation of bioequivalence and overview of comments received.

Diabetes (PDF file) (February 15, 2010)
CHMP draft guideline on the clinical investigation of medicinal products to treat diabetes mellitus. 

Epileptic disorders (PDF file) (February 15, 2010)
CHMP guideline on the clinical investigation of medicines to treat epileptic disorders.

Osteoarthritis (PDF files) (February 15, 2010)
CHMP guideline on the clinical investigation of medicinal products to treat osteoarthritis and overview of comments received.

Orphan drugs (PDF file) (February 15, 2010)
Summary of actions taken at the Feb. 2-3 plenary meeting of European Medicines Agency's (EMA) COMP.

Pharmacovigilance (PDF files) (February 15, 2010)
European Medicines Agency (EMA) ninth and tenth pandemic pharmacovigilance weekly update.

Product documentation (February 15, 2010)
Afinitor: NICE preliminary appraisal recommending against the use of Afinitor everolimus for second-line treatment of advanced renal cell carcinoma (RCC), from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, Feb. 9).
Betaferon: CHMP revised EPAR updating the SPC to include five-year follow-up data from the Phase III BENEFIT trial of Betaferon interferon beta 1b to treat multiple sclerosis, from Bayer AG (Xetra:BAY). (PDF file)
Omapro: Briefing documents for the postponed meeting of FDA's Oncologic Drugs Advisory Committee to discuss an NDA for Omapro omacetaxine to treat imatinib-resistant chronic myelogenous leukemia in patients with the BCR-ABL T315I mutation, from ChemGenex Pharmaceuticals Ltd. (ASX:CXS) (see BioCentury Extra, Monday, Feb. 8).
Pixuvri: Briefing documents for the postponed meeting of FDA's Oncologic Drugs Advisory Committee to discuss an NDA for Pixuvri pixantrone to treat relapsed or refractory aggressive non-Hodgkin's Lymphoma (NHL), from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) (see BioCentury Extra, Monday, Feb. 8).
Sprycel: NICE updated preliminary appraisal recommending against the use of Sprycel dasatinib from Bristol-Myers Squibb Co. (NYSE:BMY) to treat chronic myelogenous leukemia (CML) in patients intolerant to Glivec imatinib from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, Feb. 9).
Tasigna: NICE updated preliminary appraisal recommending against the use of Tasigna nilotinib to treat chronic myelogenous leukemia (CML) in patients intolerant to Glivec imatinib, both from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, Feb. 9).
Thelin: CHMP revised EPAR updating the SPC to include data from trials supporting the extension of indication for Thelin sitaxsentan to treat pulmonary arterial hypertension (PAH) in WHO Functional Class II patients, from Encysive Pharmaceuticals Inc., now Pfizer Inc. (NYSE:PFE). (PDF file)
Zutectra: CHMP EPAR for subcutaneous Zutectra human hepatitis B immunoglobulin to prevent HBV re-infection in HBV-DNA negative patients >=6 months after liver transplantation for HBV-induced liver failure, from Biotest AG (Xetra:BIO).

California biomedical outlook (February 8, 2010)
PricewaterhouseCoopers and California Healthcare Institute 2010 report of the impact of the biomedical sector on California’s economy.

Guidance calendar (PDF file) (February 8, 2010)
FDA's Center for Drug Evaluation and Research (CDER) listing of new guidance documents to be published in 2010.

Health spending (February 8, 2010)
CMS report on health spending projections through 2019, published online in Health Affairs (see BioCentury Extra, Thursday, Feb. 4).

Statistics (PDF file) (February 8, 2010)
FDA guidance on the use of Bayesian statistical methods in the design and analysis of clinical trials for medical devices (see BioCentury Extra, Friday, Feb. 5).

Advanced therapies (PDF file) (February 1, 2010)
Summary of actions taken at the Jan. 14-15 plenary meeting of European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT).

Bioterrorism (PDF file) (February 1, 2010)
"Report Card" from the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, which said the Obama administration has failed to develop adequate measures to prevent biological attacks from causing mass casualties (see BioCentury Extra, Tuesday, Jan. 26).

Cell-based products (PDF file) (February 1, 2010)
European Medicines Agency (EMA) work plan for the cell-based products working party (CPWP) for 2010.

CHMP (PDF file) (February 1, 2010)
Summary of actions taken at the Jan. 18-21 plenary meeting of European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use.

Compassionate use (PDF file) (February 1, 2010)
European Medicines Agency (EMA) Q&A on the compassionate use of medicines in the EU.

Drug abuse (PDF file) (February 1, 2010)
FDA draft guidance on developing drugs that have abuse potential (see BioCentury Extra, Tuesday, Jan. 26).

EMA (PDF file) (February 1, 2010)
European Medicines Agency (EMA) draft Road Map to 2015, which outlines its strategic priorities for the next five years (see BioCentury Extra, Tuesday, Jan. 26).

Orphan drugs (PDF files) (February 1, 2010)
European Medicines Agency (EMA) general information, principles, and practical information for sponsors of orphan medicinal products.

Patents (PDF file) (February 1, 2010)
U.S. Patent and Trademark Office notice of interim policies for patent term adjustment in light of Wyeth v. Kappos and recalculation request form for holders of patents issued within the past 180 days (see BioCentury, Jan. 25).

Pharmacovigilance (PDF files) (February 1, 2010)
European Medicines Agency's (EMA) eighth pandemic pharmacovigilance weekly update and monthly report from the pharmacovigilance working party (PhVWP).

Venous thromboembolism (PDF files) (February 1, 2010)
NICE guidance on reducing the risk of venous thromboembolism.

Product documentation (February 1, 2010)
Iressa: NICE preliminary appraisal for Iressa gefitinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC), requesting more information on the clinical and cost effectiveness of the drug, from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Friday, Jan. 29).
Rapamune: CHMP revised EPAR updating the SPC to include ascites, fluid accumulation, diabetes mellitus and hepatic veno-occlusive disease in patients receiving Rapamune sirolimus to prevent kidney transplant rejection, from Pfizer Inc. (NYSE:PFE). (PDF file)
Victoza: FDA Q&A for patients and providers on the approval of Victoza liraglutide to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Monday, Jan. 25).

CDRH (PDF file) (January 25, 2010)
Center for Devices and Radiological Health (CDRH) FY 2010 Strategic Priorities, including the implementation of recommendations made by the center's 510(k) working group (see BioCentury Extra, Wednesday, Jan. 20).

Embryonic stem cells (PDF files) (January 25, 2010)
Presentation by the NIH Advisory Committee to the Director Working Group for hESC Review, discussing the eligibility of the human embryonic stem cell line WA01 (H1) from the WiCell Research Institute for listing in the NIH Human Embryonic Stem Cell Registry.
WiCell Research Institute's submission to the Advisory Committee to the Director for its WA01 cell line.
Working Group for Embryonic Stem Cell Eligibility Review report on the WA01 cell line.

Healthcare professionals (PDF file) (January 25, 2010)
Minutes of the Oct. 29, 2009 meeting of CHMP's Working Group with Healthcare Professionals’ Organizations.

Patient and consumer groups (PDF file) (January 25, 2010)
Human Scientific Committees' Working Party revised work plan with patient and consumer organizations for 2010.

Pharmacovigilance (PDF file) (January 25, 2010)
EMEA seventh pandemic pharmacovigilance weekly update.

Product documentation (PDF files) (January 25, 2010)
Cimzia: NICE final appraisal determination recommending Cimzia certolizumab pegol to treat rheumatoid arthritis (RA) provided the first 12 weeks of treatment are provided for free, from UCB Group (Euronext:UCB) (see BioCentury Extra, Thursday, Jan. 21).
Ramvocid: CHMP withdrawal assessment report for Ramvocid oritavancin to treat complicated skin and skin structure infections (cSSSIs) caused by Gram positive pathogens, from The Medicines Co. (NASDAQ:MDCO).

Clinical trials (PDF file) (January 18, 2010)
FDA draft guidance for institutional review boards (IRBs) and clinical investigators providing regarding the criteria, process and frequency of continuing review in clinical investigation approval.

EMEA (PDF file) (January 18, 2010)
EMEA budget and establishment plan for 2010.

Gene therapy (PDF file) (January 18, 2010)
Work plan for EMEA's Gene Therapy Working Party (GTWP) for 2010.

Heart failure (PDF file) (January 18, 2010)
NICE draft guidelines on the management of chronic heart failure in adults (see BioCentury Extra, Jan. 15).

Manufacturing (PDF file) (January 18, 2010)
CHMP Q&A on the guideline on the limits of genotoxic impurities.

Patents (PDF file) (January 18, 2010)
U.S. Court of Appeals for the Federal Circuit (CAFC) decision denying an appeal by the U.S. Patent and Trademark Office (PTO) in a suit brought by Wyeth (now Pfizer Inc. (NYSE:PFE), and Elan Corp. plc (NYSE:ELN) to extend the term of two patents covering antibodies against beta amyloid to treat Alzheimer's disease (AD) (see BioCentury Extra, Thursday, Jan. 14).

Safety (PDF file) (January 18, 2010)
Work plan for EMEA's Safety Working Party (SWP) for 2010-2011.

Swine influenza A (H1N1) (January 18, 2010)
Letter from FDA Commissioner Margaret Hamburg to healthcare professionals on monitoring H1N1 vaccine safety and encouraging continued vaccination efforts.

Transparency (January 18, 2010)
FDA website intended to help the public understand how the agency operates (see BioCentury, Tuesday, Jan. 12).

Vaccines (PDF file) (January 18, 2010)
Work plan for EMEA's Vaccines Working Party (VWP) for 2010.

Product documentation (January 18, 2010)
Carbaglu: Briefing documents for the Jan. 13 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 12-0 that the risk-benefit profile of Carbaglu carglumic acid supports its approval to treat hyperammonemia due to hepatic enzyme N-acetylglutamate synthetase (NAGS) deficiency, from Recordati S.p.A. (Milan:REC) (see BioCentury, Wednesday, Jan. 13).
Kaletra: CHMP revised EPAR updating the SPC to include interaction information on Kaletra lopinavir/ritonavir and tipranavir to treat HIV infection, from Abbott Laboratories (NYSE:ABT). (PDF file)
Sustiva: CHMP revised EPAR updating the SPC to include interaction information on the anticoagulant warfarin and Sustiva efavirenz to treat HIV infection, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Yondelis: CHMP revised EPAR extending the indication to include use of Yondelis trabectedin in combination with doxorubicin to treat relapsed platinum-sensitive ovarian cancer, from PharmaMar S.A., Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768) and Johnson & Johnson (NYSE:JNJ). (PDF file)

Absenteeism (PDF file) (January 11, 2010)
FDA draft guidance on planning for the effects of high absenteeism during emergencies to ensure availability of medically necessary drug products.

Alternative medicine (January 11, 2010)
— National Center for Complementary and Alternative Medicine (NCCAM) background information on homeopathy (see "Shaken, Not Stirred").
NIH grant to study dilution and succession in homeopathic remedy dose-response patterns.
NH clinical trial of shamanic healing for women with temporomandibular joint disorders (TMDs).

Contrast imaging (PDF file) (January 11, 2010)
FDA guidance on considerations for developing contrast imaging devices and drug products (see BioCentury Extra, Tuesday, Jan. 5).

CHMP (PDF file) (January 11, 2010)
Report from the December 14-17 meeting of EMEA's CHMP.

ESAs (January 11, 2010)
Paper by FDA's Center for Drug Evaluation and Research (CDER), "Erythropoiesis-Stimulating Agents — Time for a Reevaluation," published online in the New England Journal of Medicine (see BioCentury Extra, Wednesday, Jan. 6).

Generics (PDF file) (January 11, 2010)
U.K. Department of Health consultation document and request for comments on proposals for allowing generic substitution (see BioCentury Extra, Jan. 5).

GERD (PDF file) (January 11, 2010)
EMEA draft guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease.

Health security (PDF files) (January 11, 2010)
U.S. National Health Security strategy and an Interim Implementation Guide (see BioCentury Extra, Thursday, Jan. 7).

Mammograms (January 11, 2010)
Society of Breast Imaging (SBI) and the American College of Radiology (ACR) guidance on breast cancer screening with imaging.

Product documentation (January 11, 2010)
Bystolic: Briefing documents for the Jan. 11 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss an sNDA for Bystolic nebivolol to treat congestive heart failure, from Forest Laboratories Inc. (NYSE:FRX) (see BioCentury Extra, Thursday, Jan. 7).
Mersarex: CHMP withdrawal assessment report for Mersarex iclaprim to treat complicated skin and soft tissue infections (cSSTIs), from Arpida Ltd. (SIX:ARPN). (PDF file)
Onbrez Breezhaler: New CHMP EPAR for Onbrez Breezhaler indacaterol as a once-daily maintenance bronchodilator treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD), from Novartis AG (NYSE:NVS; SIX:NOVN).
Prevenar 13: New CHMP EPAR for Prevenar 13 to vaccinate infants and children from invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae, from Pfizer Inc. (NYSE:PFE).
Zavesca: Briefing documents for the Jan. 12 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss an sNDA for Zavesca miglustat to treat progressive neurological manifestations in patients with Niemann-Pick type C disease, from Actelion Ltd. (see BioCentury Extra, Friday, Jan. 8).

Allergy immunotherapy (PDF file) (January 4, 2010)
EMEA draft standard pediatric investigation plan for allergen products for specific immunotherapy.

Sentinel initiative (January 4, 2010)
List of speakers and registration information for the Jan. 11 public workshop to discuss FDA's Sentinel electronic drug and device safety monitoring initiative (see BioCentury Extra, Wednesday, Dec. 30).

Product documentation (January 4, 2010)
Multaq: NICE preliminary appraisal recommending against the use of Multaq dronedarone to treat atrial fibrillation, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Monday, Dec. 28).
Vytorin/Zetia: FDA update of its safety review of Vytorin ezetimibe/simvastatin and Zetia simvastatin from Merck & Co. Inc. (NYSE:MRK), finding it unlikely that the cholesterol drugs increase the risk of cancer or cancer-related death (see BioCentury Extra, Tuesday, Dec. 22).
Yondelis: NICE final appraisal determination recommending Yondelis trabectedin to treat advanced soft tissue sarcoma when treatment with anthracyclines and ifosfamide has failed or patients are intolerant of, or have contraindications to, anthracyclines and ifosamide, from PharmaMar S.A. (see "U.K. or Bust"). (PDF file)