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

Advanced therapies (PDF file) (December 21, 2009)
Summary of actions taken at the Dec. 3-4 plenary meeting of EMEA's Committee for Advanced Therapies (CAT).

Benfluorex (PDF file) (December 21, 2009)
EMEA Q&A on the withdrawal of medicines containing benfluorex, which is approved for use in overweight patients with diabetes.

Bipolar disorder (PDF file) (December 21, 2009)
EMEA Q&A on the review of medicines containing valproate to treat bipolar disorder.

CHMP (PDF file) (December 21, 2009)
Summary of actions taken at the Dec. 14-17 plenary meeting of EMEA's CHMP.

EMEA (PDF files) (December 21, 2009)
EMEA report on the pilot phase participation of patient/consumer representatives in meetings of the Pharmacovigilance Working Party (PhVWP), and a reflection paper on their further involvement.

Personalized medicine (PDF file) (December 21, 2009)
Letter from the Personalized Medicines Coalition to FDA asking the agency to clarify requirements for approval of targeted drugs and companion molecular diagnostics.

Regulatory science (December 21, 2009)
FDA notice of a Feb. 9 public meeting on incorporating new science into regulatory decision-making within the agency's Center for Devices and Radiological Health (CDHR) and a request for comments (see Cover Story).
FDA table of valid genomic biomarkers in the context of approved drug labels.
— CHMP 2007 report of the working group on benefit-risk assessment models and methods. (PDF file)
— CHMP reflection paper on the benefit-risk assessment methods in the context of the evaluation of MAAs of medicinal products for human use. (PDF file)

SMEs (PDF file) (December 21, 2009)
EMEA's SME Office's report on micro, small and medium-sized enterprise related activities in its fourth year of operations.
— The November issue of EMEA's SME Office news bulletin. (PDF file)
— Updated list of companies designated as SMEs by EMEA. (PDF file)

Product documentation (December 21, 2009)
Alimta: NICE preliminary appraisal recommending against the use of Alimta pemetrexed as 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, Dec. 17).
Hexvix: Briefing documents for the Dec. 17 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 9-8 that Hexvix has a favorable benefit-risk profile to detect papillary bladder cancer using fluorescence cystoscopy, from Photocure ASA (OSE:PHO) (see BioCentury Extra, Thursday, Dec. 17).
Multaq: CHMP EPAR for Multaq dronedarone to prevent recurrence of atrial fibrillation or to lower ventricular rate, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Opaxio: CHMP withdrawal assessment report for Opaxio paclitaxel poliglumex for first-line treatment of advanced non-small cell lung cancer (NSCLC) in poor performance status (PS2) patients, from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Tarceva: Briefing documents for the Dec. 16 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 12-1 against recommending approval of an sNDA for Tarceva erlotinib for first-line maintenance treatment of advanced or metastatic non-small cell lung cancer (NSCLC), from OSI Pharmaceuticals Inc. (NASDAQ:OSIP), Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit (see "Overall Survival was Not Enough").

Bioanalytical methods (PDF file) (December 14, 2009)
CHMP draft guideline on validation of bioanalytical methods.

Community-acquired pneumonia (December 14, 2009)
FDA briefing documents for the Dec. 9 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss unresolved issues for the design of clinical trials for CAP caused by bacterial pathogens.

Drug safety (PDF file) (December 14, 2009)
Government Accountability Office (GAO) report, "FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed."

EMEA (PDF file) (December 14, 2009)
Updated organizational chart for EMEA (see BioCentury Extra, Tuesday, Dec. 8).

Financial reform (PDF file) (December 14, 2009)
Text of the Wall Street Reform and Consumer Protection Act of 2009 (H.R. 4173) (see "House on Fire").

Patient-reported outcomes (PDF file) (December 14, 2009)
FDA guidance on the use of patient-reported outcome (PRO) measures to support labeling claims for medical products (see BioCentury Extra, Wednesday, Dec. 9).

Pediatric cancer (PDF file) (December 14, 2009)
Briefing documents for the Dec. 15 meeting of FDA's Oncologic Drugs Advisory Committee pediatric oncology subcommittee to discuss the pediatric formulations and dosing of cancer drugs.

PET drugs (PDF file) (December 14, 2009)
FDA final rule on current good manufacturing practice (GMP) for positron emission tomography drugs.

R&D tax credit (PDF file) (December 14, 2009)
GAO report, "The Research Tax Credit's Design and Administration Can Be Improved" (see BioCentury Extra, Thursday, Dec. 10).

Vaccines (December 14, 2009)
RAND Corp. collection of data on seasonal influenza vaccine use by adults in the U.S. (PDF file)
Institute of Medicine (IOM) report on the priorities for the national vaccine plan.

Product documentation (December 14, 2009)
Cayston: Briefing documents for the Dec. 10 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 15-2 that Cayston inhaled aztreonam lysine is a safe and efficacious treatment to improve respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa infections, from Gilead Sciences Inc. (NASDAQ:GILD) (see Cover Story), and a CHMP final assessment report detailing its rationale for approval of Cayston.
Contusugene: CHMP withdrawal assessment report for Contusugene ladenovec to treat squamous cell carcinoma of the head and neck (SCCHN), from Introgen Therapeutics Inc. (PDF file)
Crestor: Briefing documents for the Dec. 15 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss an sNDA for Crestor rosuvastatin for the primary prevention of cardiovascular disease based on results from the Phase III JUPITER trial, from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Friday, Dec. 11).
Zunrisa: CHMP withdrawal assessment report for Zunrisa casopitant to treat chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV), from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)

Cancer (PDF file) (December 7, 2009)
NICE draft guideline on diagnosing and managing metastatic malignant disease of unknown primary origin.

CHMP (PDF file) (December 7, 2009)
Detailed report of actions taken at EMEA's CHMP plenary meeting Nov. 16-19.

Cystic fibrosis (PDF file) (December 7, 2009)
EMEA guideline on the development of medicinal products to treat CF.

Dementia (PDF file) (December 7, 2009)
NICE draft quality standards for care of people with dementia.

EMEA (PDF files) (December 7, 2009)
2008 annual accounts for EMEA and the European Court of Auditors final report.

Galodinium-based contrast agents (December 7, 2009)
Briefing documents for the Dec. 8 joint meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the safety of galodinium-based contrast agents used with magnetic resonance imaging (MRI) scans.

Good clinical practice (PDF file) (December 7, 2009)
Terms of engagement and procedures in the EMEA-FDA good clinical practice initiative.

Healthcare reform (PDF file) (December 7, 2009)
Amendment to the Patient Protection and Affordable Care Act authored by Sen. Barbara Mikulski (D-Md.) that would ensure coverage at no cost for preventive healthcare screenings and care for women (see BioCentury Extra, Thursday, Dec. 3).

HIV (PDF files) (December 7, 2009)
World Health Organization (WHO) Rapid Advice on antiretroviral therapy for HIV infection in adults and adolescents and on treating pregnant women and preventing HIV infection in infants.

Immunogenicity (PDF file) (December 7, 2009)
FDA draft guidance on assay development for immunogenicity testing of therapeutic proteins.

Lupus (PDF file) (December 7, 2009)
EMEA concept paper on the need for a guideline on the clinical investigation of medicinal products to treat systemic and cutaneous lupus erythematosus.

Pediatric drugs (December 7, 2009)
Briefing documents for the Dec. 8 meeting of FDA's Pediatric Advisory Committee to discuss pediatric-focused safety reviews for various drugs.
— Draft EMEA Pediatric Committee (PDCO) standard pediatric investigation plan for allergen products for specific immunotherapy. (PDF file)

Public health countermeasures (December 7, 2009)
HHS Secretary Kathleen Sebelius' speech to the American Medical Association (AMA) announcing plans for a review of public health countermeasures against threats such as infectious diseases and bioterrorism (see "Jostling Over Pandemic Response").

Pulmonary arterial hypertension (PDF files) (December 7, 2009)
EMEA guideline on the clinical investigation of medicinal products to treat PAH and an overview of comments received.

Stroke (PDF file) (December 7, 2009)
NICE draft quality standard on caring for stroke patients.

Xenogeneic cell-based therapies (PDF file) (December 7, 2009)
EMEA guideline on xenogenetic cell-based medicinal products.

Product documentation (December 7, 2009)
Avastin: NICE 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, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, Nov. 24).
Certican: Briefing documents for the Dec. 7 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss an NDA for Certican everolimus to prevent allograft rejection following kidney transplantation, from Novartis AG (NYSE:NVS; SIX:NOVN).
Hycamtin: NICE guidance recommending the use of oral Hycamtin topotecan only in patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate and for whom treatment with cyclophosphamide, doxorubicin and vincristine is contraindicated, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, Nov. 25). (PDF file)
Zactima: EMEA Q&A on the withdrawal of an MAA for Zactima vandetanib to treat advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy, from AstraZeneca plc (LSE:AZN; NYSE:AZN). (PDF file)

Antimicrobial resistance (PDF file) (November 23, 2009)
Joint opinion by EMEA, European Center for Disease Prevention and Control (ECDC), European Food Safety Authority (EFSA) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on antimicrobial resistance focused on zoonotic infections.

Biosimilars (PDF files) (November 23, 2009)
EMEA concept paper on developing a guideline on biosimilars containing mAbs (see BioCentury Extra, Friday, Nov. 20).
Overview of comments received on EMEA's draft guideline on biosimilar medicinal products containing low-molecular-weight heparins.
Work plan for the Biosimilars Medicinal Products Working Party (BMWP) for 2010.

Breast cancer screening (November 23, 2009)
U.S. Preventive Services Task Force recommendations and supporting data on breast cancer screening (see "Tough Luck Medicine".

CHMP (PDF file) (November 23, 2009)
Summary of actions taken at the Nov. 16-19 plenary meeting of EMEA's CHMP.

EMEA (PDF files) (November 23, 2009)
Work plan for the EMEA Human Scientific Committees' Working Party with patients' and consumers' organizations for 2010.
— Second progress report on EMEA's interaction with patient and consumer organizations during 2008.

ENCePP (November 23, 2009)
European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) public consultation for its code of conduct for independence and transparency, and checklist of methodological research standards.

Healthcare reform (November 23, 2009)
— Congressional Budget Office cost estimate for the Patient Protection and Affordable Care Act.

Swine influenza A (H1N1) (PDF file) (November 23, 2009)
Federal plans to monitor immunization safety for the swine influenza A (H1N1) vaccination program.

Product documentation (November 23, 2009)
Aridol: Briefing documents for the Nov. 20 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted in favor of approval for Aridol mannitol powder inhalation test to assess bronchial hyperresponsiveness (BHR) to aid in the diagnosis of patients ages six and up with symptoms of or suggestive of asthma, from Pharmaxis Ltd. (ASX:PXS) (see "Passing the Challenge in Asthma").
Avastin: EMEA Q&A on its refusal to extend the indication for Avastin bevacizumab to include treatment of glioblastoma after relapse, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, Nov. 20). (PDF file)
ChondroCelect: CHMP EPAR for ChondroCelect to treat single symptomatic cartilage defects of the femoral condoyle of the knee, from TiGenix N.V. (Euronext:TIG).
Erbitux: EMEA Q&A on its refusal to extend the indication for Erbitux cetuximab to include first-line treatment of patients with 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) (see BioCentury, July 27). (PDF file)
Factive: EMEA withdrawal assessment report for Factive gemifloxacin to treat mild to moderate community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis, from Menarini Group and Oscient Pharmaceuticals Corp. (Pink:OSCIQ). (PDF file)
FluBlok: Briefing documents for the Nov. 19 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which voted 9-2, 6-5 and 9-2 in favor of approval of FluBlok trivalent seasonal influenza vaccine against influenza types A and B in adults 18-49, 50-64 and 65 and older, respectively, from Protein Sciences Corp. (see "The Need for Speed").
Gemesis: EMEA Q&A on its refusal of an MAA for Gemesis bercaplermin (GEM 21S) to regenerate tissue in adults with defects around the teeth, including defects within the surrounding bone and receding gums, from BioMimetic Therapeutics Inc. (NASDAQ:BMTI) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) (see BioCentury, Aug. 3). (PDF file)
Mersarex: EMEA Q&A on the withdrawal of an MAA for Mersarex iclaprim to treat complicated skin and soft tissue infections (cSSTIs), from Arpida Ltd. (SIX:ARPN) (see BioCentury, Oct. 26). (PDF file)
Nenad: EMEA Q&A on the withdrawal of an MAA for Nenad lisuride to treat restless legs syndrome (RLS), from Axxonis Pharma AG (see BioCentury Extra, Friday, Nov. 20). (PDF file)
Nexavar: NICE final appraisal determination (FAD) 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, Thursday, Nov. 19). (PDF file)
Oncophage: EMEA Q&A on the withdrawal of an MAA for Oncophage vitespen to treat earlier-stage, localized renal cell carcinoma (RCC), from Antigenics Inc. (NASDAQ:AGEN). (PDF file)
Prevnar 13: Briefing documents for the Nov. 18 meeting of FDA's Vaccines and Related Biologic Products Advisory Committee, which voted 10-1 that data support the safety and effectiveness of Prevnar 13 to prevent invasive pneumococcal disease in infants and young children, from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday, Nov. 18).
Resolor: CHMP EPAR for Resolor prucalopride to treat chronic constipation in women in whom laxatives fail to provide adequate relief, from Movetis N.V. and Johnson & Johnson (NYSE:JNJ).
Spriva: Briefing documents for the Nov. 19 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 11-1 that data support the claim that Spiriva HandiHaler tiotropium bromide reduces exacerbations of chronic obstructive pulmonary disease (COPD), from Boehringer Ingelheim GmbH and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, Nov. 19).
Sprycel: NICE preliminary appraisal recommending against the use of Sprycel dasatinib to treat chronic myelogenous leukemia (CML) when imatinib has failed because of resistance and/or intolerance, from Bristol-Myers Squibb Co. (NYSE:BMY) (see "Tough Luck Medicine").
Tasigna: NICE preliminary appraisal recommending against the use of Tasigna nilotinib to treat chronic myelogenous leukemia (CML) when imatinib has failed because of resistance and/or intolerance, from Novartis AG (NYSE:NVS; SIX:NOVN) (see "Tough Luck Medicine").
Xolair: Briefing documents for the Nov. 18 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 10-4 that data for Xolair omalizumab do not support its approval to treat asthma in children ages 6-11 with moderate to severe persistent asthma whose symptoms are inadequately controlled with inhaled corticosteroids, from Novartis AG (NYSE:NVS; SIX:NOVN) Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit. (see BioCentury Extra, Wednesday, Nov. 18).

Addiction (PDF file) (November 16, 2009)
Overview of comments received on EMEA's draft guideline on developing medicinal products to treat smoking.

Clinical trials (PDF file) (November 16, 2009)
EMEA reflection paper on the extrapolation of results from clinical studies conducted outside the EU to the EU population.

COPD (PDF file) (November 16, 2009)
NICE draft updated guideline on managing adults with chronic obstructive pulmonary disease in primary and secondary care.

Drug access (November 16, 2009)
Technology transfer principles set out by the Association of University Technology Managers and six universities that seek to increase access to drugs in developing countries (see BioCentury Extra, Monday, Nov. 9).

Gene therapy (PDF files) (November 16, 2009)
CHMP guideline on clinical monitoring and follow-up of patients administered gene therapy medicinal products, and an overview of comments received.

Insomnia (PDF file) (November 16, 2009)
CHMP draft guideline on medicinal products to treat insomnia.

Orphan drugs (PDF file) (November 16, 2009)
Summary of actions taken at the Nov. 4-5 plenary meeting of EMEA's COMP.

Patents (PDF file) (November 16, 2009)
U.S. Supreme Court oral arguments in Bilski v. Kappos regarding tests for determining the eligibility of process patents in the U.S.(see Cover Story).

Product documentation (November 16, 2009)
Arcalyst: CHMP EPAR for Arcalyst rilonacept to treat severe symptoms of cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN).
Ilaris: CHMP EPAR for Ilaris canakinumab to treat cryopyrin-associated periodic syndromes (CAPS), from Bristol-Myers Squibb Co. (NYSE:BMY) and Novartis AG (NYSE:NVS; SIX:NOVN).
MabThera: NICE preliminary appraisal recommending the use of MabThera (Rituxan-U.S.) rituximab in combination with fludarabine and cyclophosphamide to treat relapsed or refractory chronic lymphocytic leukemia, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, Nov. 11).
Vistide: CHMP revised EPAR updating the SPC to include diarrhea as a common adverse reaction for Vistide cidofovir to treat cytomegalovirus (CMV) retinitis in patients with HIV/AIDS infection and without renal dysfunction, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)

Accelerated approval (PDF file) (November 9, 2009)
GAO report, "FDA Needs to Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints" (see "Bright Lines; Dim Idea").

Advanced therapies (PDF file) (November 9, 2009)
Summary of actions taken at the Oct. 15-16 plenary meeting of EMEA's Committee for Advanced Therapies (CAT).

CMS (PDF file) (November 9, 2009)
Proposed Medicare rule, "End-Stage Renal Disease Prospective Payment System," for which the comment period closes Dec. 16 (see Cover Story).

Pharmacovigilance (PDF file) (November 9, 2009)
Work plan for the EMEA Pharmacovigilance Working Party (PhVWP) for 2010.

Swine influenza A (H1N1) (PDF files) (November 9, 2009)
European strategy for influenza A/H1N1 vaccine benefit-risk monitoring.
FDA guidance on in vitro diagnostics for swine influenza A (H1N1) for use in the 2009 H1N1 emergency.

Product documentation (November 9, 2009)
Bosatria: EMEA withdrawal assessment report for Bosatria mepolizumab to treat hypereosinophilic syndrome, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Lyrica: EMEA refusal assessment report for Lyrica pregabalin to treat fibromyalgia in adults experiencing moderate to severe pain, from Pfizer Inc. (NYSE:PFE). (PDF file)
Nplate: NICE preliminary appraisal recommending against the use of Nplate romiplostim to treat chronic idiopathic thrombocytopenia purpura, from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Thursday, Nov. 5).
Peramivir: FDA emergency use authorization (EUA) for peramivir to treat swine influenza A, from BioCryst Pharmaceuticals Inc. (NASDAQ:BRCX). (PDF file)

Asthma (PDF file) (November 2, 2009)
EMEA concept paper on the need for a revision of the CHMP note for guidance on developing medicinal products to treat asthma.

Blood products (PDF file) (November 2, 2009)
Work plan for the EMEA Blood Products Working Party (BPWP) for 2010.

CHMP (PDF file) (November 2, 2009)
Detailed report of actions taken at EMEA's CHMP plenary meeting Oct. 19-22.

Conflict of Interest (November 2, 2009)
Uniform Disclosure Form for Potential Conflicts of Interest, created by the International Committee of Medical Journal Editors (see "Contentious Objection"). (PDF file)
— Website of the BioLogos Foundation, which "promotes the search for truth in both the natural and spiritual realms seeking harmony between these different perspectives."

CIRM (November 2, 2009)
List of 14 research teams awarded a combined $250 million from the California Institute for Regenerative Medicine and two international partners to develop stem cell-based therapies for 11 diseases, including Type I diabetes and HIV/AIDS (see BioCentury Extra, Wednesday, Oct. 28).

Depression (PDF files) (November 2, 2009)
NICE updated guidances on treating and managing depression in adults and in adults with chronic physical health problems.

Healthcare reform (PDF files) (November 2, 2009)
Healthcare reform legislation released by House Speaker Nancy Pelosi (D-Calif.) that would impose more than $150 billion in rebates and other costs on drug manufacturers over a decade (see BioCentury Extra, Thursday, Oct. 29).
Letter from Generic Pharmaceutical Association (GPhA), AARP, Consumers Union and other groups asking Sen. Harry Reid (D-Nev.) and Rep. Nancy Pelosi (D-Calif.) to reduce the exclusivity period for biologics pioneers and take other steps to make the pathway more attractive to biosimilars, or "drop the biologics provision" from pending healthcare legislation (see BioCentury Extra, Wednesday, Oct. 28).

Pharmacovigilance (PDF file) (November 2, 2009)
Summary of actions taken at the Oct. 19-21 plenary meeting of CHMP Pharmacovigilance Working Party (PhVWP).

Surrogate endpoints (PDF file) (November 2, 2009)
Government Accountability Office (GAO) report on FDA's oversight of drugs approved based on surrogate endpoints, recommending the agency clarify the conditions under which it would authorize the withdrawal of drugs under the accelerated approval process (see BioCentury Extra, Monday, Oct. 26).

Swine influenza A (H1N1) (November 2, 2009)
Strategic Advisory Group of Experts (SAGE) on Immunization briefing note on issues and options from a public health perspective of swine influenza A (H1N1) (see BioCentury Extra, Friday, Oct. 30).

Product documentation (November 2, 2009)
Cimzia: CHMP EPAR for Cimzia certolizumab pegol to treat moderate to severe, active rheumatoid arthritis (RA) in adults inadequately responsive to DMARD therapy, from UCB Group (Euronext:UCB).
Efient: NICE guidance recommending use the use of Efient prasugrel to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) only when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary, when stent thrombosis has occurred during clopidogrel use or in diabetic patients. Efient is from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Wednesday, Oct. 28). (PDF file)
Hycamtin: NICE guidance recommending Hycamtin topotecan in combination with cisplatin as a treatment option for women with recurrent or stage IVB cervical cancer only in cisplatin-naive patients, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, Oct. 28). (PDF file)
Onglyza: CHMP EPAR for Onglyza saxagliptin to treat Type II diabetes, from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY).
Opaxio: EMEA Q&A on the withdrawal of an MAA for Opaxio paclitaxel poliglumex for first-line treatment of advanced non-small cell lung cancer (NSCLC) in poor performance status (PS2) patients, from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Zunrisa: EMEA Q&A on the withdrawal of an MAA for Zunrisa casopitant to treat chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV), from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)

CHMP (PDF file) (October 24, 2009)
Summary of actions taken at the Oct. 19-21 plenary meeting of EMEA's CHMP.

Clinical trials (PDF file) (October 24, 2009)
FDA guidance on investigator responsibilities on protecting the rights, safety and welfare of subjects in clinical trials of drugs, biologics and medical devices.

Blood products (PDF files) (October 24, 2009)
FDA guidance on minimally processed minimally manipulated, unrelated allogeneic placental/umbilical cord blood intended for hematopoietic reconstitution for specified indications, and a draft guidance on investigational new drug applications for such products.

Geriatrics (PDF file) (October 24, 2009)
Q&A of International Conference on Harmonization (ICH) Topic E7, Studies in Support of Special Populations: Geriatrics.

Labeling (PDF file) (October 24, 2009)
Briefing documents for the Oct. 26 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss updating labeling for susceptibility test information in systemic antibacterial drug products.

Oncolytic viruses (PDF file) (October 24, 2009)
International Conference on Harmonization (ICH) considerations on oncolytic viruses.

Pediatric drugs (PDF file) (October 24, 2009)
Summary of actions taken at the Oct. 14-16 meeting of EMEA's Pediatric Committee (PDCO).

SMEs (October 24, 2009)
List of companies designated as micro-, small- and medium-sized enterprises by EMEA.
— The October issue of EMEA's SME Office news bulletin for SMEs.

Product documentation (October 24, 2009)
ABthrax: Briefing documents for the Oct. 27 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss a BLA for ABthrax raxibacumab to treat inhalation anthrax, from Human Genome Sciences Inc. (NASDAQ:HGSI) (see BioCentury Extra, Friday, Oct. 23).
Cerezyme: CHMP updated temporary treatment recommendations for the use of Cerezyme imiglucerase to treat Gaucher's disease during the ongoing shortage of the drug, from Genzyme Corp. (NASDAQ:GENZ) (see BioCentury Extra, Friday, Oct. 23). (PDF file)
Simponi: CHMP EPAR for Simponi golimumab to treat moderate to severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis, and severe, active ankylosing spondylitis, from Johnson & Johnson (NYSE:JNJ) and Schering-Plough Corp. (NYSE:SGP).
Tyverb: NICE preliminary appraisal 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, Oct. 21).

Drug safety (PDF file) (October 19, 2009)
Work plan for the EMEA Safety Working Party (SWP).

Healthcare reform (October 19, 2009)
White House blog disputing claims in an America's Health Insurance Plans report that suggested fees assessed on drug and device companies in proposed healthcare reform legislation would be passed on to consumers (see BioCentury Extra, Monday, Oct. 12).

Influenza A viruses (PDF file) (October 19, 2009)
FDA notice soliciting comments on guidance on reagents to detect specific novel influenza A viruses.

Labeling (PDF file) (October 19, 2009)
FDA guidance on determining established pharmacologic class for use in prescribing information for human drugs and biologics.

Orphan drugs (PDF file) (October 19, 2009)
Summary of actions taken at the Oct. 6-7 plenary meeting of EMEA's COMP.

Respiratory infections (PDF file) (October 19, 2009)
FDA notice of a Nov. 12-13 public workshop on developing molecular and other tests to diagnose infections of the respiratory tract.

Product documentation (October 19, 2009)
Baraclude: CHMP revised EPAR updating the SPC to include alopecia and anaphylactoid reactions as adverse reactions to Baraclude entecavir to treat chronic HBV, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Plavix: CHMP revised EPAR updating the SPC to warn of the interactions with 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)
Sebivo: CHMP revised EPAR updating the SPC to include lactic acidosis and rhabdomyolysis as adverse reactions to Sebivo telbivudine to treat chronic HBV, from Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)

AERS (October 12, 2009)
Safety signals reported to FDA in 1Q09 through the Adverse Events Reporting System (see BioCentury Extra, Thursday, Oct. 8).

Bisphosphonates (PDF files) (October 12, 2009)
CHMP assessment report and opinion on bisphosphonates and osteonecrosis of the jaw.

Cartilage repair (PDF file) (October 12, 2009)
CHMP draft reflection paper on in vitro cultured chondrocyte containing products for cartilage repair of the knee.

Healthcare reform (PDF file) (October 12, 2009)
Congressional Budget Office (CBO) analysis of the America's Healthy Futures Act. (see BioCentury Extra, Wednesday, Oct. 7).

CHMP (October 12, 2009)
September issue of CHMP's Human Medicine Highlights.

Duodenal disease (PDF file) (October 12, 2009)
FDA draft guidance on developing drugs to treat Helicobacter pylori-associated duodenal disease in adults.

Patent reform (PDF files) (October 12, 2009)
Senate Judiciary Committee report on the Patent Reform Act of 2009, and letter of support of the act from the Department of Commerce.

Regional development (PDF file) (October 12, 2009)
Outline of the Quebec Biopharmaceutical Strategy (see Ebb & Flow).

Scientific advice (PDF file) (October 12, 2009)
EMEA/FDA general principles for parallel scientific advice.

Product documentation (October 12, 2009)
Axfibrocel-T: Briefing documents for the Oct. 9 meeting of FDA's Cellular, Tissue and Gene Therapies Advisory Committee to discuss Azfirocel-T (formerly Isolagen Therapy) to treat severe nasolabial fold wrinkles, from Fibrocell Science Inc. (OTCBB:FCSC) (formerly Isolagen Inc.). (PDF file)
Caystom: New CHMP EPAR on Cayston aztreonam lysine to treat chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis, from Gilead Sciences Inc. (NASDAQ:GILD).
Fampridine-SR: Briefing information for the Oct. 14 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to discuss Fampridine-SR to improve walking ability in patients with multiple sclerosis (MS), from Acorda Therapeutics Inc. (NASDAQ:ACOR) (see BioCentury Extra, Friday, Oct. 9).
RoActemra: NICE preliminary appraisal recommending against the use of RoActemra (Actemra—U.S.) tocilizumab to treat moderate to severe active rheumatoid arthritis, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Monday, Oct. 5).
Selzentry: Briefing information for the Oct. 8 meeting of FDA's Antiviral Drugs Advisory Committee which voted 10-4 in favor of extending the indication for Selzentry maraviroc to include use in treatment-naïve patients infected with CC chemokine receptor 5 (CCR5)-tropic HIV-1, from Pfizer Inc. (see BioCentury Extra, Thursday, Oct. 8).

Biomarkers (October 5, 2009)
Overview of comments received on FDA's Draft Guidance on E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions (see BioCentury Extra, Thursday, Oct. 1).

CHMP (PDF file) (October 5, 2009)
Detailed report of actions taken at EMEA's CHMP plenary meeting Sept. 21-24.

Combination products (PDF file) (October 5, 2009)
FDA proposed rule clarifying postmarketing safety requirements for combination products.

Healthcare reform (PDF file) (October 5, 2009)
Text of the America's Healthy Future Act, including amendments.

Pediatric drugs (PDF file) (October 5, 2009)
Summary of actions taken at the Sept. 16-18 meeting of EMEA's Pediatric Committee.

REMS (PDF file) (October 5, 2009)
FDA draft guidance on the format and content of proposed risk evaluation and mitigation strategies, REMS assessments and proposed REMS modifications (see BioCentury Extra, Wednesday, Sept. 30).

Risk Communication (PDF file) (October 5, 2009)
FDA strategic plan for risk communication outlining the agency's efforts to distribute "more meaningful" public health information (see BioCentury Extra, Wednesday, Sept. 30).

Ulcer disease (PDF file) (October 5, 2009)
FDA draft guidance on developing drugs to treat Helicobacter pylori-associated duodenal ulcer disease in adults.

Product documentation (October 5, 2009)
CorVue: Summary minutes of the July 28 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 11-5 that Phase III data did not establish that CorVue binodenoson was equivalent to generic adenosine as an adjunct to myocardial perfusion imaging (MPI), from King Pharmaceuticals Inc. (NYSE:KG). (PDF file)
Hycamtin: NICE final appraisal determination (FAD) recommending the use of oral Hycamtin topotecan only in patients with relapsed small-cell lung cancer (SCLC) for whom treatment with cyclophosphamide, doxorubicin and vincristine is contraindicated and for whom re-treatment with the first-line regimen is not considered appropriate, and against the use of IV Hycamtin for relapsed SCLC, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Micardis: Summary minutes of the July 29 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 7-0 against recommending approval of Micardis telmisartan to prevent cardiovascular events in patients at high risk of such events, from Boehringer Ingelheim GmbH. (PDF file)
Oritavancin: EMEA Q&A on the withdrawal of an MAA for oritavancin to treat complicated skin and skin structure infections (cSSSIs) caused by Gram-positive pathogens, from The Medicines Co. (NASDAQ:MDCO). (PDF file)
PegIntron: Briefing documents for the Oct. 5 meeting of FDA's Oncologic Drugs Advisory Committee to discuss an sNDA for PegIntron peginterferon alfa-2b as an adjuvant treatment of melanoma, from Schering-Plough Corp. (NYSE:SGP) and Enzon Pharmaceuticals Inc. (NASDAQ:ENZN) (see BioCentury Extra, Thursday, Oct. 1).
Votrient: Briefing documents for the Oct. 5 meeting of FDA's Oncologic Drugs Advisory Committee to discuss Votrient pazopanib to treat advanced renal cell carcinoma (RCC), from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, Oct. 1).

Advanced therapies (PDF file) (September 28, 2009)
Summary of actions taken at the Sept. 10-11 plenary meeting of EMEA's Committee for Advanced Therapies (CAT).

Bisphosphonates (PDF file) (September 28, 2009)
EMEA Q&A on the review of bisphosphonates and the risk of osteonecrosis of the jaw.

CHMP (PDF file) (September 28, 2009)
Summary of actions taken at the Sept. 21-24 plenary meeting of EMEA's CHMP.

Combination products (PDF file) (September 28, 2009)
FDA proposed rule clarifying regulations for demonstrating current good manufacturing practice for products that combine a drug and device (see BioCentury Extra, Tuesday, Sept. 22).

Embryonic stem cells (September 28, 2009)
Online registration requests for embryonic stem cell lines (hESC) to be approved for use in NIH-funded research (see BioCentury Extra, Tuesday, Sept. 22).

End-of-Phase IIa meetings (PDF file) (September 28, 2009)
FDA guidance on end-of-Phase IIa meetings, which would allow companies to discuss options for trial designs with FDA before beginning dose-ranging trials (see BioCentury Extra, Wednesday, Sept. 23). 

Innovative medicines (PDF file) (September 28, 2009)
EMEA statement on its participation in Innovative Medicines Initiative (IMI) research projects, with a second call for proposals.

Laboratory-developed tests (PDF file) (September 28, 2009)
College of American Pathologists' proposed model for ranking laboratory-developed tests by risk to determine need for oversight.

Product documentation (September 28, 2009)
Alimta: NICE guidance recommending the use of Alimta pemetrexed for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin in patients whose tumor has been confirmed as adenocarcinoma or large cell carcinoma, from Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Wednesday, Sept. 23). (PDF file)
Exalgo: Briefing documents for the Sept. 23 joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, which agreed Exalgo hydromorphone to manage moderate to severe pain in opioid-tolerant patients should have a more strict risk evaluation and mitigation strategy (REMS) than those for other drugs in its class, but did not vote on recommending approval of the compound, from Neuromed Pharmaceuticals Ltd.
Menaflex: FDA preliminary report recommending a reevaluation of the approval of a 510(k) application for Menaflex collagen meniscus implant for reinforcement and repair of soft tissue injuries of the medial meniscus, from ReGen Biologics Inc. (OTCBB:RGBO). (PDF file)
OxyContin: Briefing documents for the Sept. 24 joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, which voted 14-4 with one abstention to recommend approval of an NDA for a reformulated version of OxyContin controlled-release oxycodone to manage moderate to severe pain, from Purdue Pharma L.P.
Stelara: NICE guidance recommending the use of Stelara ustekinumab to treat plaque psoriasis in adults where the disease is severe and the psoriasis has not responded to standard systemic therapies. The recommendation also is contingent upon Johnson & Johnson (NYSE:JNJ) providing the 90 mg dose (two 45 mg vials) for people who weigh more than 100 kg at the cost of a single vial (see BioCentury Extra, Wednesday, Sept. 23). (PDF file)
Sutent: NICE guidance recommending the use of Sutent sunitinib to treat unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) resistant or intolerant to imatinib where the drug cost of the first treatment cycle is met by the manufacturer, from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday, Sept. 23). (PDF file)

Antibiotics (PDF files) (September 21, 2009)
— EMEA and European Center for Disease Control (ECDC) joint report on the gap between the frequency of multidrug-resistant bacterial infections in the EU and the development of new antibiotics.
FDA draft guidance on developing, analyzing and presenting microbiological data for systemic antibacterial drug products.

Biosimilars (PDF file) (September 21, 2009)
EMEA draft guideline on clinical and non-clinical development of similar biological medicinal products containing recombinant erythropoietins.

Cancer vaccines (PDF file) (September 21, 2009)
FDA draft guidance on clinical considerations for developing therapeutic cancer vaccines.

Diabetes (PDF file) (September 21, 2009)
FDA guidance on developing allogeneic pancreatic islet cell products to treat Type I diabetes.

Pediatric trials (PDF file) (September 21, 2009)
FDA notice of an Oct. 29-30 public workshop to solicit comments on pediatric clinical trials.

Swine influenza A (H1N1) (September 21, 2009)
FDA label and approval information on vaccines against swine influenza A (H1N1) from sanofi-aventis Group (Euronext:SAN; NYSE:SNY); Novartis AG (NYSE:NVS; SIX:NOVN); CSL Ltd. (ASX:CSL); and MedImmune LLC, a subsidiary of AstraZeneca plc (LSE:AZN; NYSE:AZN).

Product documentation (September 21, 2009)
Isentress: CHMP revised EPAR extending the indication to include use of Isentress raltegravir in combination with other antiretroviral therapies to treat HIV-1 infection in treatment-naïve adults, from Merck & Co. Inc. (NYSE:MRK). (PDF file)
Keppra: CHMP revised EPAR extending the indication to include use of Keppra levetiracetam as an adjunctive treatment of partial onset seizures with or without secondary generalization in epilepsy patients between the ages of 1 month and 4 years, from UCB Group (Euronext:UCB). (PDF file)

FDA Transparency Initiative (September 14, 2009)
— FDA Transparency Task Force mission statement.
List of participants at Aug. 11, 2009, Transparency Meeting between FDA officials with investors.
FDA Transparency Task Force Blog, including comments from Oregon Senior Assistant Attorney General David Hart.

Genetic testing (PDF file) (September 14, 2009)
U.K.'s Human Genetics Commission proposed principles covering direct-to-consumer genetic testing.

HPV diagnostics (PDF file) (September 14, 2009)
FDA draft guidance on establishing the performance characteristics of in vitro diagnostic devices to detect, or detect and differentiate HPV.

Influenza (PDF file) (September 14, 2009)
Centers for Disease Control and Prevention (CDC) updated interim recommendations for the use of antiviral medications to treat and prevent seasonal influenza and swine influenza A (H1N1) (see BioCentury Extra, Tuesday, Sept. 8).

NICE (PDF file) (September 14, 2009)
NHS experimental statistics report on the use of certain NICE-recommended medicines in the NHS in the U.K.

Orphan drugs (PDF file) (September 14, 2009)
Summary of actions taken at the Sept. 1-2 plenary meeting of EMEA's COMP.

Product documentation (September 14, 2009)
Advexin: EMEA withdrawal assessment report for Advexin contusugene ladenovec to treat Li-Fraumeni syndrome (LFS) cancers, from Introgen Therapeutics Inc. (Pink:INGNQ). (PDF file)
Nexavar: NICE second preliminary appraisal 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, Sept. 9).
Hycamtin: NICE final appraisal determination (FAD) recommending the use of Hycamtin topotecan in combination with cisplatin to treat recurrent or stage IVB cervical cancer only in cisplatin-naïve patients, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, Sept. 10). (PDF file)
Renagel: CHMP revised EPAR updating the SPC to include rash, pruritus and abdominal pain as adverse events observed during post marketing surveillance of Renagel sevelamer to control hyperphosphatemia in adult patients receiving hemodialysis or peritoneal dialysis, from Genzyme Corp. (NASDAQ:GENZ). (PDF file)

EMEA (September 7, 2009)
The August issue of EMEA's Human Medicine Highlights newsletter.

Medicare Part D (September 7, 2009)
Congressional Budget Office report, "The Estimated Change in Mediare Part D Premiums from Provisions in H.R. 3200, America's Affordable Health Choices Act of 200," plus a summary cover letter to Rep. Dave Camp (D-Mich.), ranking member of the House Ways & Means Committee (see "Filling the Hole has its Price").

Pediatric drugs (PDF file) (September 7, 2009)
Summary of actions taken at the Aug. 19-21 meeting of EMEA's Pediatric Committee (PDCO).

Postmarketing studies (PDF file) (September 7, 2009)
FDA report showing that most companies meet their postmarketing study requirements (see BioCentury Extra, Thursday, Sept. 3).

Product documentation (September 7, 2009)
Afinitor: CHMP EPAR for Afinitor everolimus to treat advanced renal cell carcinoma (RCC) in patients whose disease progressed on or after treatment with VEGF-targeted therapy, from Novartis AG (NYSE:NVS; SIX:NOVN).
Cervarix: Briefing documents for the Sept. 9 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss a BLA for Cervarix to prevent cervical cancer caused by oncogenic HPV, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Friday, Sept. 4).
Efient: NICE final appraisal determination (FAD) recommending use the use of Efient prasugrel to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) only when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary, when stent thrombosis has occurred during clopidogrel use or in diabetic patients. Efient is from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Friday, Sept. 4). (PDF file)
Gardasil: Briefing documents for the Sept. 9 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to discuss an sNDA for Gardasil to prevent genital warts caused HPV types 6 and 11 in males ages 9-26, from Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Friday, Sept. 4).

Biosimilars (PDF file) (August 31, 2009)
World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products, recommending that national regulatory agencies adopt standards for off-patent biologics similar to the European biosimilars pathway (see BioCentury Extra, Wednesday, Aug. 26).

Renal cancer (PDF file) (August 31, 2009)
NICE guidance recommending against the use of four drugs to treat advanced and/or metastatic renal cell carcinoma (RCC): Avastin bevacizumab from Roche (SIX:ROG; OTCQX:RHHBY) and Torisel temsirolimus from Wyeth (NYSE:WYE) as first-line treatment, Nexavar sorafenib from Bayer AG (Xetra:BAY) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) as both first- and second-line treatment, and Sutent sunitinib from Pfizer Inc. (NYSE:PFE) as second-line treatment (see BioCentury Extra, Wednesday, Aug. 26).

Swine influenza A (H1N1) (PDF file) (August 31, 2009)
President's Council of Advisors on Science and Technology (PCAST) report on swine influenza A (H1N1) preparations in the U.S., recommending that government and industry work to accelerate the availability of vaccines to protect against the virus, evaluate the safety and efficacy of IV administration of neuraminidase inhibitors, and agree on criteria for determining if vaccine adjuvants should be used (see BioCentury Extra, Monday, Aug. 24).

Product documentation (August 31, 2009)
Clolar: Briefing documents for the Sept. 1 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss an sNDA for Clolar clofarabine to treat acute myeloid leukemia (AML) in untreated patients ages 60 and up with at least one unfavorable baseline prognostic factor, from Genzyme Corp. (NASDAQ:GENZ) (see BioCentury Extra, Friday, Aug. 28).
Erbitux: NICE guidance recommending the use of Erbitux cetuximab as first-line treatment for metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI in cases where the metastatic disease is confined to the liver and unresectable, from Merck KGaA (Xetra:MRK) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Wednesday, Aug. 26). (PDF file)
Folotyn: Briefing documents for the Sept. 2 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) meeting to discuss an NDA for Folotyn pralatrexate to treat relapsed or refractory peripheral T cell lymphoma (PTCL), from Allos Therapeutics Inc. (NASDAQ:ALTH) (see BioCentury Extra, Friday, Aug. 28).
Istodax: Briefing documents for the Sept. 2 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) meeting to discuss an NDA for Istodax romidepsin to treat cutaneous T cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, from Gloucester Pharmaceuticals Inc. (see BioCentury Extra, Friday, Aug. 28).
Onrigin: Briefing documents for the Sept. 1 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss an NDA from for Onrigin laromustine as a single agent for remission induction therapy in patients ages 60 and up with de novo, poor-risk acute myelogenous leukemia (AML), from Vion Pharmaceuticals Inc. (OTCBB:VION) (see BioCentury Extra, Friday, Aug. 28).
Toctino: NICE guidance recommending use of Toctino alitretinoin to treat adults with severe chronic hand eczema unresponsive to potent topical corticosteroid, from Basilea Pharmaceutica AG (SIX:BSLN) (see BioCentury Extra, Wednesday, Aug. 26). (PDF file)

eSubmissions (August 24, 2006)
— FDA proposed rules requiring electronic submission of mandatory adverse event reports for human drugs and biologic products and medical devices (1)(2). (PDF files)
EMEA notice that it will only accept electronic submissions for scientific advice and protocol assistance final requests, including follow-up requests, beginning Oct. 12.

FDA (August 24, 2006)
FDA's statement of organizations, functions and delegations in agency's Office of the Commissioner following its reorganization. (PDF file)

Patents (August 24, 2006)
Draft "Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests," from the HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) (see Cover Story). (PDF file)

Regulatory transparency (August 24, 2006)
FDA notice soliciting comments on transparency initiatives for a meeting in the fall. (PDF file)

Smallpox (August 24, 2006)
FDA notice of a Sept. 1-2 public workshop to discuss the development of antiviral products to treat smallpox and related poxvirus infections. (PDF file)

Vaccines (August 24, 2006)
EMEA guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases, and overview of comments received. (PDF files)

Product documentation (August 24, 2006)
Mozobil: CHMP EPAR Mozobil plerixafor for use in combination with G-CSF to enhance mobilization of stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with lymphoma or multiple myeloma, from Genzyme Corp. (NASDAQ:GENZ).
Samsca: CHMP EPAR for Samsca tolvaptan to treat hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion in adults, from Otsuka Pharmaceutical Co. Ltd. (Tokyo:4768).
Stelara: NICE final appraisal determination (FAD) recommending use of Stelara ustekinumab to treat plaque psoriasis in adults where the disease is severe as defined by a total PASI of 10 or more and a Dermatology Life Quality Index of more than 10, from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, Aug. 17). (PDF file)

Expanded access (August 17, 2009)
FDA final rule revising a regulation to clarify the circumstances in which charging clinical trial patients for an investigational drug is appropriate (see BioCentury Extra, Wednesday, Aug. 13). (PDF file)
FDA final rule to improve expanded access to investigational drugs or biologics by individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment IND. (PDF file) (August 17, 2009)

PET scans (August 17, 2009)
CMS proposed decision memo that would remove the requirement of clinical trial participation from its coverage of PET scanning to stage treatment of newly diagnosed cervical cancer (see BioCentury Extra, Friday, August 14).

Pharmacogenomics (August 17, 2009)
Work plan for the EMEA Pharmacogenomics Working Party (PgWP) for 2010. (PDF file)

Product documentation (August 17, 2009)
Baraclude: CHMP revised EPAR updating the SPC and package leaflet to include alopecia and anaphylactoid reactions as adverse reactions for Baraclude entecavir to treat chronic HBV infection, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Bonviva: CHMP revised EPAR updating the SPC and package leaflet to change the frequency category for the adverse reactions flatulence and fatigue for Boniva ibandronate to treat osteoporosis in postmenopausal women at increased risk of fracture, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Prolia: Briefing documents for the Aug. 13 meeting of FDA's Reproductive Health Drugs Advisory Committee, which backed Prolia denosumab to treat bone loss in postmenopausal osteoporosis and in patients undergoing hormone ablation therapy for prostate cancer, and against the compound in the prevention indications and to treat patients undergoing hormone ablation for breast cancer, from Amgen Inc. (NASDAQ:AMGN) (see Cover Story).
Zonegran: CHMP revised EPAR updating the SPC with information relating to serious renal adverse events as well as serious hypersensitivity, skin and hematological adverse events for Zonegran zonisamide as adjunctive therapy in adult patients with partial seizures, with or without secondary generalization, from Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506) and Eisai Co. Ltd. (Tokyo:4523; Osaka:4523). (PDF file)

Advanced therapies (PDF files) (August 10, 2009)
EMEA draft procedural advice and draft scientific guideline for small and medium sized enterprises (SMEs) on the certification of quality and non-clinical data for advanced therapy medicinal products.

Adverse reactions (PDF file) (August 10, 2009)
EMEA priorities for adverse drug reaction research.

Diagnostics (PDF file) (August 10, 2009)
EMEA guideline on clinical evaluation of diagnostics.

EMEA (August 10, 2009)
The July issue of EMEA's Human Medicine Highlights newsletter.

Factor VIII (PDF file) (August 10, 2009)
EMEA draft guideline on the clinical investigation of recombinant and human derived factor VIII products.

Factor IX (PDF file) (August 10, 2009)
EMEA draft guideline on the clinical investigation of recombinant and human derived factor IX products.

Influenza vaccines (PDF files) (August 10, 2009)
FDA notice of emergency use authorizations (EUAs) (1) (2) for in vitro diagnostic devices to diagnose swine influenza A (H1N1) and to treat H1N1 through the use of Relenza zanamivir, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Biota Holdings Ltd. (ASX:BTA), and Tamiflu oseltamivir from Roche (SIX:ROG; OTCQX:RHHBY) and Gilead Sciences Inc. (NASDAQ:GILD).

MDUFA (PDF file) (August 10, 2009)
FDA notice on the medical device user fee rates collected under MDUFA for fiscal year 2010.

PDUFA (PDF file) (August 10, 2009)
FDA notice on the prescription drug user fee rates collected under PDUFA for fiscal year 2010.

Pediatric drugs (PDF file) (August 10, 2009)
Summary of actions taken at the July 22-24 meeting of EMEA's Pediatric Committee (PDCO).

Warfarin (August 10, 2009)
CMS final decision memo limiting coverage of pharmacogenomic testing for predicting warfarin responsiveness (see BioCentury Extra, Wednesday, Aug. 5).

Product documentation (August 10, 2009)
Alimta: NICE final appraisal determination (FAD) recommending the use of Alimta pemetrexed for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin in patients whose tumor has been confirmed as adenocarcinoma or large cell carcinoma, from Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Thursday, Aug. 6). (PDF file)
Biferonex: EMEA withdrawal assessment report for Biferonex interferon beta-1a to treat relapsing-remitting multiple sclerosis (RRMS), from Bioton S.A. and Rentschler Biotechnologie GmbH. (PDF file)
DaTSCAN: Briefing documents for the Aug. 11 meeting of FDA's peripheral and Central Nervous System Drugs Advisory Committee to discuss an NDA for DaTSCAN ioflupane I123 injection to detect the loss of functional nigrostriatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration, from General Electric Co. (NYSE:GE).
Vedrop: CHMP EPAR for Vedrop tocofersolan to treat vitamin E deficiency due to digestive malabsorption in pediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from Recordati S.p.A. (Milan:REC).

Biosimilars (August 3, 2009)
Amendment to America's Affordable Health Choices Act of 2009 (H.R. 3200), introduced by Rep. Anna Eschoo (D-Calif.), that would create a pathway for FDA approval of biosimilars and provide 12 years of market exclusivity for pioneer biologics (see BioCentury Extra, Friday, July 31). (PDF file)

CHMP (August 3, 2009)
Detailed report of actions taken at EMEA's CHMP plenary meeting July 20-23. (PDF file)

Creutzfeldt-Jakob disease (August 3, 2009)
EMEA expert workshop report on Creutzfeldt-Jakob disease risk and urine-derived medicinal products, and a concept paper calling for an updated guidance. (PDF files)

Liver injury (August 3, 2009)
FDA guidance on premarketing clinical evaluation of drug-induced liver injury. (PDF file)

Pharmacogenomics (August 3, 2009)
FDA draft guidance on context, structure and format of regulatory submissions for qualification of genomic biomarkers related to drug response. (PDF file)

Pharmacokinetics (August 3, 2009)
EMEA positions on specific questions addressed to the Efficacy Working Party therapeutic subgroup on pharmacokinetics. (PDF file)

Product documentation (August 3, 2009)
Iressa: CHMP EPAR for Iressa gefitinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating mutations of EGFR, from AstraZeneca plc (LSE:AZN; NYSE:AZN).
Micardis: Briefing documents for the July 29 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 7-0 against approval of Micardis telmisartan to prevent cardiovascular events in patients at high risk of such events, from Boehringer Ingelheim GmbH.
Saphris: Briefing documents for the July 30 meeting of FDA's Psychopharmacologic Drugs Advisory Committee, which voted 12-0 that Saphris asenapine was safe and effective in acute treatment of manic or mixed episodes in adult patients with bipolar I disorder, and 10-2 that Saphris was effective for the acute treatment of schizophrenia in adults, from Schering-Plough Corp. (NYSE:SGP) (see BioCentury Extra, Thursday, July 30).

FDA (July 27, 2009)
Government Accountability Office (GAO) report on shortcomings in the FDA budgeting and resource allocation process (see BioCentury Extra, Tuesday, July 21). (PDF file)

Innovation (July 27, 2009)
NICE report containing 25 recommendations on valuing innovation and new health technology, including one that the agency continue to base appraisals on the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY), along with with stakeholder comments and workshop presentations (see BioCentury Extra, Friday, July 24).

Nanomedicines (July 27, 2009)
Presentations from an April 29 meeting of the EMEA ad-hoc expert group on nanomedicines.

Pediatric drugs (July 27, 2009)
EMEA's Pediatric Committee (PDCO) guideline for developing medicinal products in term and preterm neonates, and an overview of comments received. (PDF files)

Swine influenza A (H1N1) (July 27, 2009)
Briefing document for the July 23 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which discussed pandemic vaccines against H1N1. (PDF file)

Transgenic animals (July 27, 2009)
EMEA concept paper on the need to revise the guideline on the use of transgenic animals in the manufacture of biological medicinal products for human use. (PDF file)

Product documentation (July 27, 2009)
CorVue: Briefing documents for the July 28 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss an NDA for CorVue binodenoson as an adjunct to myocardial perfusion imaging (MPI) for detecting perfusion abnormalities in patients with known or suspected coronary artery disease (CAD), from King Pharmaceuticals Inc. (NYSE:KG) (see BioCentury Extra, Friday, July 24).
MabThera: NICE final guidance recommending MabThera (Rituxan-U.S.) rituximab in combination with fludarabine and cyclophosphamide for first-line treatment of chronic lymphocytic leukemia (CLL), and against the use of MabThera with other chemotherapeutics, from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, July 22). (PDF file)
Vancocin: Briefing documents for the Aug. 4 meeting of FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss bioequivalence recommendations for generics of the antibiotic Vancocin vancomycin from ViroPharma Inc. (NASDAQ:VPHM) (see BioCentury Extra, Monday, July 20).
Viread: NICE final guidance recommending Viread tenofovir as monotherapy for adults with hepatitis B e antigen (HbeAG)-positive and HbeAG-negative chronic HBV infection, from Gilead Sciences Inc. (NASDAQ:GILD) (see BioCentury Extra, Tuesday, July 22). (PDF file)

Alpha-antitrypsin (July 20, 2009)
Briefing document for the July 20 meeting of FDA's Blood Products Advisory Committee to discuss clinical and surrogate endpoints for evaluating efficacy of alpha-1 proteinase inhibitors to treat alpha-antitrypsin (AAT) deficiency. (PDF file)

Antivenoms (July 20, 2009)
Briefing document for the July 20 meeting of FDA's Blood Products Advisory Committee to discuss alternative strategies to show efficacy of coral snake antivenoms. (PDF file)

Biosimilars (July 20, 2009)
Commentary by Howard Dean, former Democratic National Committee chairman, supporting Biotechnology Industry Organization(BIO) positions on biosimilars, published in The Hill newspaper (see Cover Story).
Commentary published on The Huffington Post by Democratic campaign manager Joe Trippi supporting Howard Dean's commentary on biosimilars
Commentary published on The Huffington Post by Jamie Love of Knowledge Ecology International, attacking BIO's position on biosimilars

Healthcare reform (July 20, 2009)
Text of the America's Affordable Health Choices Act of 2009 (H.R. 3200), introduced by House Democrats, that would create a government-run health provider with the power to negotiate prescription drug prices (see BioCentury Extra, Tuesday, July 14). (PDF file)

Orphan drugs (July 20, 2009)
Summary of actions taken at the July 7-8 plenary meeting of EMEA's COMP. (PDF file)

Pharmacogenomics (July 20, 2009)
Presentations from a Dec. 19 EMEA and European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on integrating pharmacogenomics early into drug development.

Postmarketing trials (July 20, 2009)
FDA draft guidance for postmarketing studies and clinical trials for drug and biological products under Section 505(o) of the Food, Drug and Cosmetic Act. (PDF file)

SBIR/STTR (July 20, 2009)
Text of the SBIR/STTR Reauthorization Act of 2009 (S. 1233), approved by the Senate, that would reauthorize the SBIR and STTR programs through 2017. (PDF file)

Product documentation (July 20, 2009)
Doxil: Briefing documents for the July 15 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 13-0 against expanding the label for Doxil doxorubicin to include the use of the drug with docetaxel to treat advanced breast cancer in patients who have received prior anthracycline treatment, from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Wednesday, July 15).
Tarceva: CHMP revised EPAR updating the SPC with safety information on corneal and gastrointestinal perforations, and skin conditions for Tarceva erlotinib to treat non-small cell lung cancer (NSCLC) and pancreatic cancer, from OSI Pharmaceuticals Inc. (NASDAQ:OSIP), Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit. (PDF file)
Toctino: NICE final appraisal determination (FAD) recommending conditions for the use of Toctino alitretinoin to treat adults with severe chronic hand eczema unresponsive to potent topical corticosteroids, from Basilea Pharmaceutica AG (SIX:BSLN) (see BioCentury Extra, Wednesday, July 15). (PDF file)
Yondelis: Briefing documents for the July 15 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 14-1 that Yondelis trabectedin in combination with Doxil doxorubicin did not represent a favorable benefit-risk ratio to treat relapsed ovarian cancer, from Johnson & Johnson (NYSE:JNJ) and PharmaMar S.A.

Competition (July 13, 2009)
Executive summary of the European Commission final report on its competition inquiry into the pharma sector (see BioCentury Extra, Wednesday, July 8). (PDF file)

EMEA (July 13, 2009)
EMEA full annual report for 2008, and a summary document. (PDF files)

Pandemic flu vaccines (July 13, 2009)
CHMP recommendations for devising a pharmacovigilance plan as part of the risk management plan to be submitted with the marketing authorization application for pandemic influenza vaccines.

Patents (July 13, 2009)
Order by the U.S. Court of Appeals for the Federal Circuit agreeing to rehear en banc a suit brought by GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Triantafyllos Tafas, an individual inventor, against the U.S. Patent and Trademark Office (see BioCentury Extra, Monday, July 6). (PDF file)

Regulatory reform (July 13, 2009)
Report of the U.S. Trade Representative on the U.S.-Japan regulatory reform and competition policy initiative, including pharmaceuticals and medical devices.

Risk-benefit (July 13, 2009)
EMEA report on expectations from patients, consumers and healthcare professionals on information related to the benefit-risk of medicines.

Stem cells (July 13, 2009)
NIH final guidelines covering extramural NIH-funded research related to human embryonic stem cells (hESCs) and certain uses of induced pluripotent stem (iPS) cells (see BioCentury Extra, Monday, July 6).

Product documentation (July 13, 2009)
Hycamtin: NICE preliminary appraisal recommending the use of oral Hycamtin topotecan only in patients with relapsed small-cell lung cancer (SCLC) for whom treatment with cyclophosphamide, doxorubicin and vincristine is contraindicated, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Tyverb: Decision by the NICE appeal panel to reconsider a March final appraisal determination recommending against use of Tyverb lapatinib in combination with capecitabine to treat advanced or metastatic breast cancer patients whose tumors overexpress HER2, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, July 9). (PDF file)
Victoza: CHMP EPAR for Victoza liraglutide to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).

Advanced therapies (PDF file) (July 6. 2009)
Summary of actions taken at the June 18-19 plenary meeting of EMEA's Committee for Advanced Therapies (CAT).

Biomarkers (PDF file) (July 6. 2009)
Overview of comments received on EMEA's draft guideline on qualification of biomarkers.

Biosimilars (PDF file) (July 6. 2009)
EMEA reflection paper on the non-clinical and clinical development of biosimilars containing recombinant interferon alfa.

CIRM (PDF file) (July 6. 2009)
California Little Hoover Commission report with recommendations for management and structural reforms at the California Institute for Regenerative Medicine (see BioCentury, Monday, June 29).

Comparative effectiveness (July 6. 2009)
Institute of Medicine (IOM) committee report requested by Congress on priorities for spending the $1.1 billion allocated for comparative effectiveness research in the American Recovery and Reinvestment Act (ARRA) (see BioCentury, July 6).
Federal Coordinating Council for Comparative Effectiveness Research report to Congress with recommendations for spending $400 million in comparative effectiveness research (CER) funding that was allocated to the HHS secretary under the American Recovery and Reinvestment Act (ARRA) (see BioCentury, Monday, June 29). (PDF file)
Papers presented at the Engelberg Center for Health Reform conference on Comparative Effectiveness Research: Priorities, Methods and Impact. (PDF file)

EMEA (July 6. 2009)
The June issue of EMEA's Human Medicine Highlights newsletter.

Product documentation (July 6. 2009)
Biferonex: EMEA Q&A on the withdrawal of an MAA for Biferonex interferon beta-1a to treat relapsing-remitting multiple sclerosis (RRMS), from Bioton S.A. and Rentschler Biotechnologie GmbH. (PDF file)
Factive: EMEA Q&A on the withdrawal of an MAA for Factive gemifloxacin to treat mild to moderate community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis, from Menarini Group and Oscient Pharmaceuticals Corp. (NASDAQ:OSCI) (see BioCentury Extra, Tuesday, June 23). (PDF file)
Yondelis: NICE preliminary appraisal recommending against the use of Yondelis trabectedin to treat advanced soft tissue sarcoma, from PharmaMar S.A. (see BioCentury, Tuesday, June 30).

Advertising (June 29, 2009)
FDA notice soliciting comments on proposed research into the impact of providing quantitative effectiveness information in direct-to-consumer (DTC) television and print advertisements for prescription drugs. (PDF file)

Antibiotics labeling (June 29, 2009)
FDA guidance on updating labeling for susceptibility test information in systemic antibacterial drug products and antimicrobial susceptibility testing devices. (PDF file)

Antifungals (June 29, 2009)
EMEA draft guidance on the clinical evaluation of agents to treat and prevent invasive fungal disease. (PDF file)

Dextropropoxyphene medicines (June 29, 2009)
EMEA Q&A on the withdrawal of marketing authorizations for dextropropoxyphene-containing medicines. (PDF file)

Influenza (June 29, 2009)
The Supplemental Appropriations Act of 2009 (H.R. 2346), which includes $8 billion to prepare for and respond to an influenza pandemic (see BioCentury Extra, Friday, June 26). (PDF file)

Patents (June 29, 2009)
Model jury instructions for patent infringement cases developed by the National Jury Instruction Project. (PDF file)

Product documentation (June 29, 2009)
Bepreve: Briefing documents for the June 26 meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee, which voted 7-0 to recommend approval of an NDA for Bepreve bepotastine to treat ocular itching associated with allergic conjunctivitis, from Ista Pharmaceuticals Inc. (NASDAQ:ISTA), Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508) and Senju Pharmaceutical Co. Ltd. (see BioCentury Extra, Friday, June 26).
Erbitux: NICE final guidance recommending against the use of Erbitux cetuximab in combination with platinum-based chemotherapy to treat recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), from Merck KGaA (Xetra:MRK) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Wednesday, June 24). (PDF file)
Lunivia: EMEA withdrawal assessment report for Lunivia eszopiclone to treat insomnia, from Sepracor Inc. (NASDAQ:SEPR) and Eisai and Co. Ltd. (Tokyo:4523; Osaka:4523). (PDF file)
Rejena: Briefing documents for the June 26 meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee, which voted 6-1 that data did not demonstrate adequate safety and efficacy for Rejena (formerly Vismed) sodium hyaluronate ophthalmic solution to treat signs and symptoms of dry eye disease, from Lantibio Inc. and TRB Chemedica International S.A. (see BioCentury Extra, Friday, June 26).
Renvela: CHMP EPAR for Renvela sevelamer carbonate to control serum phosphorus in patients with chronic kidney disease (CKD), from Genzyme Corp. (NASDAQ:GENZ).
Revlimid: NICE final technology appraisal recommending the use of Revlimid lenalidomide to treat multiple myeloma (MM) in patients who have received at least one prior treatment, from Celgene Corp. (NASDAQ:CELG).

Genetic testing (June 22, 2009)
Centers for Disease Control and Prevention recommendations for good laboratory practices for molecular genetic testing for heritable diseases and conditions.

Healthcare reform (June 22, 2009)
— December 2008 Congressional Budget Office (CBO) report on healthcare budget options (see Cover Story). (PDF file)
Draft healthcare reform legislation introduced by Reps. Charles Rangel (D-N.Y.), Henry Waxman (D-Calif.), John Dingell (D-Mich.) and George Miller (D-Calif.) that would establish a public health insurance option and also require employers to provide healthcare coverage to their workers or pay a fee (see BioCentury Extra, Friday, June 19). (PDF file)
Medicare Payment Advisory Commission report outlining options for maximizing savings from follow-on biologics, including establishing a reference pricing system for drugs administered in hospitals or physicians' offices (see BioCentury Extra, Monday, June 15). (PDF file)

Medical devices (June 22, 2009)
Government Accountability Office (GAO) opening statement and testimonies to the health subcommittee of the House Energy and Commerce Committee on shortcomings in FDA's postmarket review, postmarket surveillance and inspections of device manufacturing establishments (see BioCentury Extra, Friday, June 19).

SBIR/STTR (June 22, 2009)
Text of the SBIR/STTR Reauthorization Act of 2009 (S. 1233) approved by the Senate Committee on Small Business and Entrepreneurship that would reauthorize the SBIR and STTR programs through 2023 (see BioCentury Extra, Friday, June 19). (PDF file)

Transparency (June 22, 2009)
EMEA draft transparency policy for which the agency is soliciting comments (see BioCentury Extra, Friday, June 19). (PDF file)

Product documentation (June 22, 2009)
Hycamtin: NICE preliminary appraisal recommending against the use of Hycamtin topotecan in combination with cisplatin to treat recurrent or stage IVB cervical cancer, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, June 17).
Mabthera: NICE final appraisal determination (FAD) recommending the use of MabThera rituximab in combination with fludarabine and cyclophosphamide for first-line treatment of chronic lymphocytic leukemia (CLL), from Roche (SIX:ROG) (see BioCentury Extra, Monday, June 15). (PDF file)
Silgard: CHMP revised EPAR updating the SPC and package leaflet to include chills as an adverse event for Silgard to prevent cervical, vaginal, and vulvar cancers and precancerous or dysplastic lesions and genital warts caused by HPV types 6, 11, 16 and 18 in women ages 9-26, from Merck & Co. Inc. (NYSE:MRK) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Vectibix: CHMP revised EPAR updating the SPC and package leaflet with safety data related to dermatitis acneiform, infusion reactions, renal failure and gastrointestinal disorders for Vectibix panitumumab to treat EGFR-expressing metastatic colorectal cancer in patients whose tumor expresses wild-type K-Ras, from Amgen Inc. (NASDAQ:AMGN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). (PDF file)

Alzheimer's disease (PDF file) (June 15, 2009)
NICE final appraisal determination (FAD) recommending limited use of three AD drugs to treat moderately severe disease: Aricept donepezil from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Pfizer Inc. (NYSE:PFE); Razadyne/Reminyl galantamine from Shire plc (LSE:SHP; NASDAQ:SHPY) and Johnson & Johnson (NYSE:JNJ); and Exelon rivastigmine from Novartis AG (NYSE:NVS; SIX:NOVN). The FAD recommends use only in clinical trials for Ebixa memantine from H. Lundbeck A/S (CSE:LUN), Neurobiological Technologies Inc. (NASDAQ:NTII) and Merz GmbH & Co. KGaA (see BioCentury Extra, Thursday, June 11).

Biosimilars (June 15, 2009)
Federal Trade Commission report on follow-on biologics (FOBs), which concludes that there are no valid economic reasons to provide market exclusivity for innovator biologic products (see Cover Story). (PDF file)
Responses to House Energy and Commerce Committee questions about biosimilars, made by Frank Torti, former CSO at FDA, in 2008. (PDF file)

Comparative effectiveness (PDF file) (June 15, 2009)
The Patient-Centered Outcomes Research Act of 2009 (S.1213) introduced by Sens. Max Baucus (D-Mont.) and Kent Conrad (D-N.D.) to create a permanent infrastructure for federally funded comparative effectiveness research (CER) (see BioCentury Extra, Tuesday, June 9).

HIV (PDF file) (June 15, 2009)
Overview of comments received on EMEA's draft guideline on carcinogenicity evaluation of medicinal products to treat HIV infection.

Orphan drugs (PDF file) (June 15, 2009)
Summary of actions taken at the June 3-4 plenary meeting of EMEA's COMP.

Pediatric drugs (PDF file) (June 15, 2009)
Overview of comments received on EMEA's draft guideline on the need for non-clinical testing in juvenile animals of human pharmaceuticals for pediatric indications.

Safety (PDF file) (June 15, 2009)
EU Council recommendations to member states to establish and develop national policies and programs to improve patient safety, including recommending that states implement strategies to prevent and control healthcare-associated infections by strengthening surveillance systems for infections (see BioCentury Extra, Wednesday, June 10).

Vaccines (PDF file) (June 15, 2009)
EMEA draft guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines.

Product documentation (June 15, 2009)
Efient: NICE preliminary appraisal recommending the use of Efient prasugrel to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) only when immediate primary PCI for ST-segment-elevation myocardial infarction is necessary or stent thrombosis has occurred during clopidogrel use. Efient is from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Tuesday, June 9).
Krystexxa: Briefing documents for the June 16 meeting of FDA's Arthritis Advisory Committee meeting to discuss a BLA for Krystexxa pegloticase to treat refractory gout, from Savient Pharmaceuticals Inc. (NASDAQ:SVNT) (see BioCentury Extra, Friday, June 12).
Modigraf: CHMP EPAR for Modigraf tacrolimus to prevent transplant rejection in adult and pediatric kidney, liver or heart allograft recipients, from Astellas Pharma Inc. (Tokyo:4503).
Qutenza: CHMP EPAR for Qutenza capsaicin to treat peripheral neuropathic pain in non-diabetic adults, from NeurogesX Inc. (NASDAQ:NGSX).
Tyverb: Appeal and scrutiny letters regarding NICE's final appraisal determination (FAD) recommending against Tyverb lapatinib in combination with capecitabine to treat advanced or metastatic breast cancer patients whose tumors overexpress HER2. Tyverb is from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury, Tuesday, June 9).

CHMP (PDF file) (June 8, 2009)
Detailed report of actions taken at EMEA's CHMP plenary meeting May 26-29.

Community acquired pneumonia (PDF file) (June 8, 2009)
FDA draft guidance on the conduct of trials of antibiotics to treat CAP (see "Old Rules are Capped").

Healthcare spending (PDF file) (June 8, 2009)
Letter to President Obama from trade associations representing the pharmaceutical, medical device, insurance and hospital industries, as well as physicians and labor unions, describing plans to collectively trim the annual healthcare spending growth rate by 1.5% (see BioCentury Extra, Monday, June 1).

Influenza A (H1N1) (PDF file) (June 8, 2009)
CHMP recommendation on the antigenic composition of influenza A (H1N1) strains to be used for developing vaccines against the virus.

Pediatric drugs (June 8, 2009)
FDA briefing documents for the June 9-10 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss sNDAs for Seroquel quetiapine from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Zyprexa olanzapine from Eli Lilly and Co. (NYSE:LLY) to treat schizophrenia and bipolar mania in pediatric patients, and for Geodon ziprasidone from Pfizer Inc. (NYSE:PFE) to treat bipolar mania in pediatric patients.

Safety (June 8, 2009)
FDA report from the adverse event reporting system (AERS) for 4Q08 (see BioCentury Extra, Friday, June 5).

SBIRs (June 8, 2009)
National Research Council report on "Venture Funding and the NIH SBIR Program" (see "SBIR Scorecard").

Short-selling (PDF file) (June 8, 2009)
Government Accountability Office report on Regulation SHO, regarding SEC efforts to curb naked short selling of stock (see "Shorting Scorecard").

Transparency (June 8, 2009)
FDA's transparency task force web page (see BioCentury Extra, Tuesday, June 2).

Product documentation (June 8, 2009)
Erbitux: NICE final appraisal determination (FAD) recommending the use of Erbitux cetuximab as first-line treatment for metastatic colorectal cancer (mCRC) in combination with FOLFOX and FOLFIRI in cases where the metastatic disease is confined to the liver and unresectable, from Merck KGaA (Xetra:MRK) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Monday, June 1). (PDF file)
Ixempra: EMEA withdrawal assessment report for Ixempra ixabepilone to treat metastatic or locally advanced breast cancer, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)

Advertising (PDF file) (June 1, 2009)
FDA draft guidance on presenting risk information in prescription drug and medical device promotion.

CHMP (PDF file) (June 1, 2009)
Summary of actions taken at the May 26-29 plenary meeting of EMEA's CHMP.

Diabetes (PDF file) (June 1, 2009)
NICE partial update of its May 2008 clinical guideline on managing Type II diabetes to include the use of newer agents to control blood glucose, including the use of dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinediones and glucagon-like peptide-1 (GLP-1) mimetics.

FDA (June 1, 2009)
Commentary by FDA Commissioner Margaret Hamburg and Principle Deputy Commissioner Joshua Sharfstein in the New England Journal of Medicine, outlining their priorities for the agency (see "The Public Health (continued)").

NICE (June 1, 2009)
Request for proposals from NICE and the Medical Research Council for research into the processes and methodology NICE uses to make its coverage decisions (see BioCentury Extra, Friday, May 29).

Product documentation: (June 1, 2009)
Arzerra: Meeting materials for the FDA's Oncologic Drugs Advisory Committee, which voted 10-3 on May 29 to recommend accelerated approval of Arzerra ofatumumab to treat chronic lymphocytic leukemia (CLL), from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Genmab A/S (CSE:GEN) (see "Accelerate or not).
Conbriza: CHMP EPAR for Conbriza bazedoxifene to treat postmenopausal osteoporosis in women at increased risk of fracture, from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and Wyeth (NYSE:WYE).
Restanza: Briefing documents for the June 2 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss an NDA for Restanza cethromycin to treat mild to moderate community-acquired pneumonia (CAP), from Advanced Life Sciences Holdings Inc. (OTCBB:ADLS) (see BioCentury Extra, Friday, May 29).

Ankylosing spondylitis (PDF files) (May 25, 2009)
EMEA guidance on developing medicinal products to treat ankylosing spondylitis, and an overview of comments received.

Cellular therapies (PDF file) (May 25, 2009)
Summary of actions taken at the May 14-15 meeting of EMEA's Committee for Advanced Therapies (CAT) based on gene therapy, somatic cell therapy or tissue engineering.

Clinical trials (PDF files) (May 25, 2009)
EMEA draft guidance on missing data in confirmatory clinical trials. )
FDA notice of a June 10-11 public workshop to provide information about clinical trial requirements.

Genetic screening (May 25, 2009)
Agenda, questions and scoresheet from the May 6 meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) on screening genetic tests (see Cover Story).
HHS Secretary's Advisory Committee on Genetics, Health, and Society report on coverage and reimbursement of genetic tests and services. (PDF file)
Personalized Medicine Coalition review of the state of personalized medicine. (PDF file)
— Website for the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative.
— Website for the U.S. Preventive Services Task Force (USPSTF), which assesses the scientific evidence for the effectiveness of clinical preventive services.

HCV (PDF files) (May 25, 2009)
EMEA guidance on developing direct acting antiviral agents to treat chronic HCV, and an overview of comments received.

Influenza A (H1N1) (PDF file) (May 25, 2009)
World Health Organization's working group report on influenza A (H1N1) vaccines (see BioCentury Extra, Wednesday, May 20).

Osteoarthritis (PDF file) (May 25, 2009)
EMEA draft guidance on developing medicinal products to treat osteoarthritis.

Preemption (May 25, 2009)
President Obama's general policy regarding preemption of state law by executive departments and agencies.

Product documentation (May 25, 2009)
Cylatron: EMEA withdrawal assessment report for Cylatron peginterferon alfa-2b as an adjuvant treatment of stage III melanoma, from Schering-Plough Corp. (NYSE:SGP) and Enzon Pharmaceuticals Inc. (NASDAQ:ENZN). (PDF file)
Ixempra: EMEA Q&A on the withdrawal of an MAA for Ixempra ixabepilone to treat metastatic or locally advanced breast cancer, from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Sanvar: Briefing documents for the May 19 meeting of FDA's Gastrointestinal Drugs Advisory Committee to review Sanvar vapreotide as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension, from Debiopharm S.A.
Stelara: NICE preliminary appraisal recommending use of Stelara ustekinumab to treat plaque psoriasis in adults with certain restrictions, from Johnson & Johnson (NYSE:JNJ) and Medarex Inc. (NASDAQ:MEDX) (see BioCentury Extra, Wednesday, May 20).
Tasigna: CHMP revised EPAR updating the SPC with pharmacokinetic data from patients suffering from hepatic impairment receiving Tasigna nilotinib to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Zebinix: CHMP EPAR for Zebinix eslicarbazepine acetate as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization, from Bial-Portela & Ca. S.A.

Conflict of interest (PDF file) (May 18, 2009)
FDA request for comments on whether HHS should amend financial conflict of interest regulations, which would include expanding the scope of the regulations and disclosure of interests.

Pharmacokinetics (PDF file) (May 18, 2009)
EMEA concept paper on developing a guideline on the use of pharmacogenomic methodologies in the pharmacokinetic evaluation of medicinal products.

Reimbursement (PDF file) (May 18, 2009)
House of Commons Health Committee report regarding implementation of policies to improve access to medicines to patients covered by NHS and the potential for creating a two-tier system of access (see BioCentury Extra, Friday, May 15).

Product documentation (May 18, 2009)
Ellefore: EMEA withdrawal assessment report for Ellefore desvenlafaxine to treat major depressive disorder (MDD), from Wyeth (NYSE:WYE). (PDF file)
Humira: CHMP revised EPAR updating the SPC and package leaflet to strengthen warnings of infections for 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)
Removab: CHMP EPAR for Removab catumaxomab to treat malignant ascites in patients with EpCAM-positive carcinomas, from Fresenius SE (Xetra:FRE) and Trion Pharma GmbH.
Sanvar: Briefing documents for the May 19 meeting of FDA's Gastrointestinal Drugs Advisory Committee to discuss an NDA for Sanvar vapreotide as an adjunctive therapy to endoscopic intervention for the control of acute esophageal bleeding as a result of portal hypertension, from Debiopharm S.A. (see BioCentury Extra, Friday, May 15).
Synflorix: CHMP EPAR for Synflorix vaccine to prevent pneumococcal disease and otitis media in infants and children ages 6 weeks to 2 years, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Vorinostat MSD: EMEA withdrawal assessment report for Vorinostat MSD vorinostat to treat advanced refractory cutaneous T cell lymphoma (CTCL), from Merck & Co. Inc. (NYSE:MRK). (PDF file)

Influenza A (H1N1) (May 11, 2009)
CHMP scientific opinion on the use Relenza zanamivir from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Biota Holdings Ltd. (ASX:BTA) and Tamiflu oseltamivir from Roche (SIX:ROG) and Gilead Sciences Inc. (NASDAQ:GILD) to treat influenza A (H1N1) in specific populations.

Orphan drugs (PDF file) (May 11, 2009)
Summary of actions taken at the May 5 plenary meeting of EMEA's Committee for Orphan Medicinal Products.

Sentinel Initiative (May 11, 2009)
FDA's Sentinel Initiative report (PDF file) and website for monitoring post-market adverse events for regulated products.

Warfarin (May 11, 2009)
CMS proposed decision memo that would limit coverage of pharmacogenomic testing to predict warfarin responsiveness (see BioCentury Extra, Tuesday, May 5).

Product documentation (May 11, 2009)
Ixiaro: CHMP EPAR for Ixiaro to prevent Japanese encephalitis (JE), from Intercell AG (VSE:ICLL) and Novartis AG (NYSE:NVS; SIX:NOVN).
Mepact: CHMP EPAR for Mepact mifamurtide to treat non-metastatic, resectable osteosarcoma, from IDM Pharma Inc. (NASDAQ:IDMI).
Nexavar: NICE preliminary appraisal recommending against 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, Thursday, May 7).
Onglyza: Transcript of the April 1 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 10-2 that sufficient evidence was provided to rule out an unacceptable amount of cardiovascular risk associated with Onglyza saxagliptin to treat Type II diabetes, from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Tarceva: "Dear Healthcare Professional" letter warning of reports of fatal gastrointestinal perforation and skin conditions, as well as ocular disorders for Tarceva erlotinib to treat non-small cell lung cancer (NSCLC) and pancreatic cancer, from OSI Pharmaceuticals Inc. (NASDAQ:OSIP) and Roche (SIX:ROG) (see BioCentury Extra, Friday, May 8). (PDF file)
Theraloc: EMEA withdrawal assessment report for Theraloc nimotuzumab to treat resistant or recurrent high-grade glioma in children and adolescents, from Oncoscience AG and YM BioSciences Inc. (TSX:YM; NYSE-A:YMI) (see BioCentury Extra, Thursday, Dec. 4, 2008). (PDF file)
Victoza: Transcript of the April 2 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which split 6-6 with one abstention on a vote that concerns about preclinical C cell thyroid cancer signals should preclude marketing of Victoza liraglutide to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury, April 6). (PDF file)

CHMP (PDF file) (May 4, 2009)
Summary of actions taken at the April 20-23 plenary meeting of EMEA's CHMP.

Drug delivery (PDF file) (May 4, 2009)
FDA draft guidance on technical considerations for pen, jet and related injectors intended for use with drugs and biological products.

H1N1 flu virus (May 4, 2009)
FDA website with updated information on the H1N1 flu virus (swine flu) (see Cover Story).

Pediatric drugs (May 4, 2009)
EMEA presentations and reports from a Feb. 16 workshop on European Pediatric Network.

REMS (May 4, 2009)
Center for Drug Evaluation and Research (CDER) and the Office of Special Health Issues (OSHI) webinar on general issues related to Risk Evaluation and Mitigation Strategies and specific issues related to REMS for certain opioid analgesics.

Renal cell carcinoma (PDF file) (May 4, 2009)
NICE final appraisal determination (FAD) recommending against Avastin bevacizumab from Roche (SIX:ROG) and Torisel temsirolimus from Wyeth (NYSE:WYE) as first-line treatment of renal cell carcinoma (RCC); against Nexavar sorafenib from Bayer AG (Xetra:BAY) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) as both first- and second-line treatment of RCC; and against Sutent sunitinib from Pfizer Inc. (NYSE:PFE) as second-line treatment of RCC (see BioCentury Extra, Tuesday, April 28).

SMEs (PDF file) (May 4, 2009)
Updated EMEA guide for micro-, small- and medium-sized enterprises (SMEs) in the pharmaceutical sector on the main aspects of medicinal product legislation.

Product documentation (May 4, 2009)
Erbitux: NICE final appraisal determination (FAD) recommending against the use Erbitux cetuximab in combination with platinum-based chemotherapy to treat recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), from Merck KGaA (Xetra:MRK) (see BioCentury Extra, Wednesday, April 29). (PDF file)
Toctino: NICE preliminary appraisal recommending the use of Toctino alitretinoin to treat severe chronic hand eczema unresponsive to potent topical corticosteroids with certain restrictions, from Basilea Pharmaceutica AG (SIX:BSLN) (see BioCentury Extra, Thursday, April 30).
Zavesca: CHMP revised EPAR to extend the indication to include treatment of progressive neurological manifestations in adult patients and pediatric patients with Niemann-Pick type C disease for Zavesca miglustat, from Actelion Ltd. (SWX:ATLN) and UCB Group (Euronext:UCB). (PDF file)

Pediatric drugs (PDF file) (April 27, 2009)
Summary of actions taken at the April 1-3 meeting of EMEA's Pediatric Committee (PDCO).

SBIRs (April 27, 2009)
Testimony at the April 23 hearing on Small Business Innovation Research grants, held by the subcommittee on technology and innovation of the House Committee on Science and Technology.

Product documentation (PDF files) (April 27, 2009)
Cyanokit: CHMP revised EPAR updating the SPC and package leaflet to include preclinical data on reproduction toxicity for Cyanokit hydroxocobalamin to treat cyanide poisoning, from Merck KGaA (Xetra:MRK).
Instanyl: CHMP summary of a positive opinion for Instanyl fentanyl nasal spray to manage breakthrough pain in patients receiving opioid therapy for chronic cancer pain, from Nycomed Group A/S.
Iressa: CHMP summary of a positive opinion for Iressa gefitinib to treat non-small cell lung cancer (NSCLC), from AstraZeneca plc (LSE:AZN; NYSE:AZN).
Lyrica: CHMP Q&A on its refusal to extend the indication for Lyrica pregabalin to include treatment of fibromyalgia; from Pfizer Inc. (NYSE:PFE).
Revlimid: NICE final appraisal determination (FAD) recommending the use of Revlimid lenalidomide to treat multiple myeloma (MM) in patients who have received at least one prior treatment, from Celgene Corp. (NASDAQ:CELG) (see Cover Story).
Victoza: CHMP summary of a positive opinion for Victoza liraglutide to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).
Vimpat: CHMP revised EPAR updating the SPC and package leaflet with information on suicidal ideation and behavior for Vimpat lacosamide as an adjunctive therapy to treat partial onset seizures in epileptic patients, from UCB Group (Euronext:UCB).
Xarelto: NICE final guidance recommending the use of Xarelto rivaroxaban to prevent venous thromboembolism (VTE) in adults having elective total hip or knee replacement surgery, from Bayer AG (Xetra:BAY) (see BioCentury Extra, Wednesday, April 22).

ANDAs (PDF file) (April 20, 2009)
FDA draft guidance on submitting bioequivalence data for ANDAs.

Conflict of interest (PDF file) (April 20, 2009)
FDA-sponsored study by the Eastern Research Group on "Financial Conflict of Interest Disclosure and Voting Patterns at FDA Advisory Committee Meetings" (see "FDA Reviewing Intellectual Bias," A11).

Transparency (April 20, 2009)
EMEA presentations and documents from a Jan. 22 workshop on the development of an EMEA transparency policy.

Product documentation (April 20, 2009)
Cerepro: EMEA withdrawal assessment report for Cerepro in combination with ganciclovir sodium to treat operable high-grade glioma, from Ark Therapeutics Group plc (LSE:AKT). (PDF file)
Dynastat: CHMP revised EPAR updating the SPC and package leaflet with information about the reduction of dose-dependent adverse effects following dose reduction of opioids for Dynastat parecoxib, from Pfizer Inc. (NYSE:PFE). (PDF file)
Enbrel: CHMP revised EPAR updating the SPC and package leaflet to include information relating to opportunistic infections for Enbrel etanercept to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis, from Amgen Inc. (NASDAQ:AMGN) and Wyeth (NYSE:WYE). (PDF file)
Tasigna: CHMP revised EPAR updating the SPC with pharmacokinetic data on concomitant use of rifampin and Tasigna nilotinib to treat chronic phase and accelerated phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adults resist or intolerant to prior therapy, from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)

Thalidomide Celgene (PDF file) (April 20, 2009)
CHMP revised EPAR updating the SPC with regard to the recommended dose modifications due to peripheral neuropathy for Thalidomide Celgene for first line treatment of multiple myeloma (MM), from Celgene Corp. (NASDAQ:CELG).

CMS (April 13, 2009)
Final National Coverage Determination (NCD) to expand coverage of PET scans to guide cancer treatment (see BioCentury Extra, Thursday, April 9).

Manufacturing (PDF files) (April 13, 2009)
— International Conference on Harmonization (ICH) Q10 guidance on the establishment and maintenance of quality control systems to ensure production of pharmaceutical drug products.
— CHMP draft guidance on manufacturing and quality control of plasma-derived medicinal products.

Mass Medical Angels (April 13, 2009)
Request for proposals from Mass Medical Angels, a group founded to focus on early stage life science companies primarily in New England looking to raise $250,000 to $3 million (see BioCentury, April 13).

Orphan drugs (PDF file) (April 13, 2009)
Summary of actions taken at the April 1-2 plenary meeting of EMEA's COMP.

Product documentation (April 13, 2009)
Celvapan: CHMP EPAR for Celvapan H5N1 pandemic influenza vaccine to prevent influenza in the event of a pandemic, from Baxter International Inc. (NYSE:BAX).
Cymbalta/Xeristar: CHMP refusal assessment report against expanding the label for Cymbalta/Xeristar duloxetine to treat fibromyalgia, from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH. (PDF files)
Exjade: CHMP revised EPAR updating the SPC and package leaflet to add a warning regarding cases of pancytopenia for Exjade deferasirox to treat chronic iron overload due to blood transfusions, from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
IDflu/Intanza: CHMP EPAR for IDflu/Intanza split-virion, inactivated flu vaccine to prevent seasonal influenza in adults and the elderly, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
MabThera: CHMP revised EPAR updating the SPC and package leaflet with immunization data for non-Hodgkin's lymphoma and rheumatoid arthritis, and information on concomitant/sequential use of other DMARDs for MabThera rituximab to treat chronic lymphocytic leukemia (CLL), NHL and RA, from Biogen Idec Inc. (NASDAQ:BIIB), Roche (SIX:ROG) and Roche's Genentech Inc. unit. (PDF file)

Cellular therapies (PDF files) (April 6, 2009)
Summary of actions taken at the March 12-13 meeting of EMEA's Committee for Advanced Therapies (CAT) based on gene therapy, somatic cell therapy or tissue engineering.
FDA draft guidance on the development of cellular therapies to treat cardiac disease (see BioCentury Extra, Friday, April 3).

CMS (PDF file) (April 6, 2009)
CMS annual call letter issuing guidance to organizations that intend to offer Medicare Advantage and Medicare prescription drug plans in 2010 (see BioCentury Extra, Wednesday, April 1).

Healthcare professionals' organizations (PDF files) (April 6, 2009)
EMEA's working group with healthcare professionals' organizations (HCP WG) final recommendations, including recommendations on pharmacovigilence, proposals for action and overview of comments received.

Heparin (PDF file) (April 6, 2009)
EMEA guidance on non-clinical and clinical development of similar biological medicinal products containing low molecular weight heparins.

Laboratory-developed tests (PDF file) (April 6, 2009)
Advanced Medical Technology Association white paper requesting that FDA regulate all diagnostic tests including laboratory-developed tests (LDTs), which are currently under the remit of CMS (see BioCentury Extra, Monday, March 30).

mAbs (PDF file) (April 6, 2009)
EMEA concept paper recommending a guideline on immunogenicity assessment of mAbs intended for in vivo clinical use.

Product documentation (April 6, 2009)
Fareston: CHMP revised EPAR updating the SPC and package leaflet to add new contraindications and information on dose-related risk of QTc prolongation for Fareston toremifene for first-line treatment of hormone-dependent metastatic breast cancer in postmenopausal patients, from GTx Inc. (NASDAQ:GTXI), Ipsen Group (Euronext:IPN) and Orion Corp. (HSE:ORNAV; HSE:ORNBV). (PDF file)
Liraglutide: Briefing documents for the April 2 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which split 6-6 with one abstention on a vote that concerns about preclinical C cell thyroid cancer signals should preclude marketing of Victoza liraglutide to treat Type II diabetes, from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury, April 6).
Onglyza: Briefing documents for the April 1 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 10-2 that sufficient evidence was provided to rule out an unacceptable amount of cardiovascular risk associated with Onglyza saxagliptin to treat Type II diabetes, from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMS)(see BioCentury, April 6).
Serdolect: Briefing documents for the April 7 meeting of FDA's Psychopharmacologic Drugs Advisory Committee to discuss an NDA for Serdolect sertindole to treat schizophrenia, from H. Lundbeck A/S (CSE:LUN) (see BioCentury Extra, Friday, April 3).
Seroquel XR: Briefing documents for the April 8 meeting of FDA's Psychopharmacologic Drugs Advisory Committee to discuss the safety and efficacy of Seroquel XR quetiapine to treat major depressive disorder (MDD) and generalized anxiety disorder (GAD), from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Friday, April 3).

Biosimilars (March 30, 2009)
Pathway for Biosimilars Act (H.R. 1548), from Rep. Anna Eshoo (D-Calif.). (PDF file)
Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427) from Rep. Henry Waxman (D-Calif.). (PDF file)

CHMP (PDF file) (March 30, 2009)
Detailed report of actions taken at EMEA's CHMP plenary meeting March 16-19.

Confidentiality (March 30, 2009)
Letter from Sen. Chuck Grassley (R-Iowa) to acting FDA Commissioner Frank Torti raising concerns about a March 13 memo by Torti reminding agency employees of their legal obligation to keep certain information confidential (see BioCentury Extra, Tuesday, March 24).

Viral vectors (PDF file) (March 30, 2009)
CHMP reflection paper on quality, non-clinical and clinical issues relating to adeno-associated viral vectors.

Product documentation (March 30, 2009)
Avastin: Briefing documents for the March 31 meeting of FDA's Oncologic Drugs Advisory Committee to discuss an sBLA for Avastin bevacizumab as a single agent for previously treated glioblastoma multiforme (GBM), from Roche (SIX:ROG) and Genentech Inc. (see BioCentury Extra, Friday, March 27).
Cylatron: EMEA Q&A on the withdrawal of an MAA for Cylatron peginterferon alfa-2b as an adjuvant treatment for stage III melanoma, from Schering-Plough Corp. (NYSE:SGP) and Enzon Pharmaceuticals Inc. (NASDAQ:ENZN). (PDF file)
Fablyn: CHMP EPAR for Fablyn lasofoxifene to treat osteoporosis in post-menopausal women at increased risk of fracture, from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and Pfizer Inc. (NYSE:PFE).
MabThera: NICE preliminary appraisal recommending the use of MabThera rituximab in combination with fludarabine and cyclophosphamide, but against its use with other chemotherapeutics, for first-line treatment of chronic lymphocytic leukemia (CLL), from Roche (SIX:ROG), Genentech Inc. and Biogen Idec Inc. (NASDAQ:BIIB).
Osseor/Protelos: CHMP revised EPAR updating the SPC and package leaflet to include peripheral edema and confusional state as adverse events for Osseor/Protelos strontium ranelate to treat postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures, from Servier. (PDF files)
Stalevo: EMEA Q&A on the withdrawal of an MAA for Stalevo levodopa/carbidopa/entacapone to treat early Parkinson's disease in patients who are starting levodopa therapy, from Orion Corp. (HSE:ORNAV; HSE:ORNBV) and Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Sutent: NICE final guidance recommending the use of Sutent sunitinib for the first line treatment of advanced and/or metastatic renal cell carcinoma (RCC), from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday, March 25). (PDF file)

Alzheimer's disease (March 23, 2009)
Alzheimer’s Disease Neuroimaging Initiative (ADNI) website, providing access the project’s imaging and biomarker data on the cognitive changes associated with mild cognitive impairment (MCI) and AD.

CAP (PDF file) (March 23, 2009)
FDA draft guidance on developing drugs to treat community-acquired pneumonia (CAP) caused by bacterial pathogens (see BioCentury Extra, Thursday, March 19).

CHMP (PDF file) (March 23, 2009)
Summary of actions taken at the March 16-19 plenary meeting of EMEA's CHMP.

Comparative effectiveness (March 23, 2009)
HHS list of members appointed to the Federal Coordinating Council for Comparative Effectiveness Research, which will assist federal agencies in coordinating CER funded by the American Recovery and Reinvestment Act (see BioCentury Extra, Thursday, March 19).
— Institute of Medicine (IOM) list of appointed provisional members to a committee that will produce recommendations on national priorities for comparative effectiveness as mandated by the American Recovery and Reinvestment Act and the committee’ agenda for its March 19-20 meeting (see BioCentury Extra, Tuesday, March 17).

Product documentation (March 23, 2009)
Cayston: CHMP Q&A on its refusal of an MAA for Cayston aztreonam lysine to treat adult cystic fibrosis (CF) patients who have Pseudomonas aeruginosa infections, from Gilead Sciences Inc. (NASDAQ:GILD). (PDF file)
Emerflu: CHMP Q&A on its refusal of an MAA for Emerflu pandemic influenza vaccine to prevent H5N1 influenza in a pandemic, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Multaq: Briefing documents for the March 18 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 10-3 to recommend approval of Multaq dronedarone to treat patients with non-permanent atrial fibrillation (AF), from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury, March 23).
Thymanax/Valdoxan: CHMP EPAR for Thymanax/Valdoxan agomelatine to treat major depressive episodes in adults, from Servier and Novartis AG (NYSE:NVS; SIX:NOVN).
Xarelto: Briefing documents for the March 19 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 15-2 that Xarelto rivaroxaban has a favorable risk-benefit profile for prophylaxis of venous thromboembolism (VTE) in patients undergoing hip or knee replacement, from Johnson & Johnson (NYSE:JNJ) and Bayer AG (Xetra:BAY) (see BioCentury, March 23).

Biosimilars (March 16, 2009)
Text of the Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427), from Rep. Henry Waxman (D-Calif.), to create a pathway for FDA approval of biosimilars (see "Squaring Off on Biosimilars" ). (PDF file)
— FTC website containing comments on health care competition, including biosimilars.

FDA (March 16, 2009)
President Obama's radio address announcing the nomination of Margaret Hamburg as FDA commissioner and appointment of Joshua Sharfstein as principal deputy commissioner (see Cover Story).

HIV (PDF file) (March 16, 2009)
Overview of comments received on EMEA draft guidance on carcinogenicity evaluation of medicinal products to treat HIV infection.

Immunoglobulin (PDF files) (March 16, 2009)
EMEA draft guidance on the clinical investigation of IV immunoglobulin (IVIg) and information to include in the SPC.

Pediatric drugs (PDF file) (March 16, 2009)
Summary of actions taken at the March 4-6 meeting of EMEA's Pediatric Committee (PDCO).

Radiopharmaceuticals (PDF file) (March 16, 2009)
EMEA report to the EC on the supply shortage of radiopharmaceuticals due to a reactor shutdown.

Stem cells (March 16, 2009)
Text of President Obama's executive order revoking Bush administration restrictions on federal funding of embryonic stem cell research, and a memorandum assigning the director of the Office of Science and Technology Policy "responsibility for ensuring the highest level of integrity in all aspects of the executive branch's involvement with scientific and technological processes" (see BioCentury Extra, Monday, March 9).

Product documentation (March 16, 2009)
Efient: CHMP EPAR for Efient prasugrel to prevent atherothrombotic cardiovascular events in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS), from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY).
Vectibix: CHMP revised EPAR updating the SPC to include information on hypomagnesemia and other electrolyte disturbances in patients receiving Vectibix panitumumab to treat EGFR-expressing, wild-type K-Ras metastatic colorectal carcinoma, from Amgen Inc. (NASDAQ:AMGN).
Vorinostat: EMEA Q&A on the withdrawal of an MAA for Vorinostat MSD vorinostat to treat advanced cutaneous T cell lymphoma (CTCL), from Merck & Co. Inc. (NYSE:MRK).

Fibrinogen (PDF files) (March 9, 2009)
EMEA guidance on information to include in the SPC for human fibrinogen products and an overview of comments received.

NICE (PDF file) (March 9, 2009)
NICE proposed changes to the referral process by which the agency selects technologies for appraisal (see BioCentury Extra, Tuesday, March 3).

Orphan drugs (PDF file) (March 9, 2009)
Summary of actions taken at the March 3-4 plenary meeting of EMEA's COMP.

Patent reform (PDF file) (March 9, 2009)
Text of the Patent Reform Act of 2009 (S. 515), which would require courts to emphasize a patent's advances over prior art when setting damages in an infringement lawsuit (see BioCentury Extra, Tuesday, March 3).

Pharmacokinetics (PDF file) (March 9, 2009)
Q&A on specific questions in relation to pharmacokinetic evaluations issued by CHMP's Efficacy Working Party therapeutics subgroup on pharmacokinetics (EWP-PK).

Preemption (PDF file) (March 9, 2009)
U.S. Supreme Court opinion in Wyeth v. Levine, which ruled 6-3 that an FDA-approved label for Phenergan promethazine from Wyeth (NYSE:WYE) did not preempt state tort law in a product liability suit (see Cover Story).

Tobacco (PDF file) (March 9, 2009)
Text of the Family Smoking Prevention and Tobacco Control Act (H.R. 1256), which would give FDA authority to regulate tobacco products, as approved by the House Energy and Commerce Committee (see BioCentury, Thursday, March 5).

Product documentation (March 9, 2009)
Firmagon: CHMP EPAR for Firmagon degarelix to treat advanced hormone-dependent prostate cancer, from Astellas Pharma Inc. (Tokyo:4503) and Ferring Pharmaceuticals A/S.
Sutent: NICE preliminary appraisal recommending against the use of Sutent sunitinib to treat to unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST), from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, March 5).
Tyverb: NICE final appraisal determination (FAD) against the use of Tyverb lapatinib in combination with capecitabine to treat advanced or metastatic breast cancer patients whose tumors overexpress HER2, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, March 5). (PDF file)
Viread: NICE preliminary appraisal recommending the use of Viread tenofovir as monotherapy for hepatitis B e antigen (HBeAG)-positive or HBeAG-negative chronic HBV, from Gilead Sciences Inc. (NASDAQ:GILD) (see BioCentury Extra, Thursday, March 5).
Xarelto: NICE final appraisal determination (FAD) recommending use of Xarelto rivaroxaban to prevent venous thromboembolism (VTE) in adults having elective total hip or knee replacement surgery, from Bayer AG (Xetra:BAY) (see BioCentury Extra, Thursday, March 5). (PDF file)

Antibiotics (PDF file) (March 2, 2009)
EMEA concept paper on the need to revise the note for guidance on the evaluation of medicinal products to treat bacterial infections.

Breast cancer (PDF files) (March 2, 2009)
NICE clinical guidelines on diagnosing and treating advanced breast cancer and early and locally advanced breast cancer.

Cell therapies (PDF file) (March 2, 2009)
EMEA draft guidance on xenogenic cell-based medicinal products.

Clinical trials (PDF file) (March 2, 2009)
EMEA draft reflection paper on the extrapolation of results from clinical studies conducted outside of Europe to EU-populations.

Combination products (PDF files) (March 2, 2009)
CHMP guidance on developing fixed combination medicinal products and an overview of comments received.

COPD (PDF file) (March 2, 2009)
EMEA concept paper on the need to revise the points to consider on the clinical investigation of medicinal products for the chronic treatment of chronic obstructive pulmonary disease.

EMEA (March 2, 2009)
— The EMEA work program for 2009. (PDF file)
Minutes from the Nov. 27, 2008, EMEA Human Scientific Committees’ Working Party with patients' and consumers' organizations meeting. (PDF file)
Work plan for the EMEA Human Scientific Committees' Working Party with patients' and consumers' organizations for 2009. (PDF file)
— EMEA's February issue of Human Medicine Highlights newsletter.

GERD (PDF file) (March 2, 2009)
EMEA concept paper on the need for a guideline on the evaluation of drugs to treat gastroesophageal reflux disease (GERD).

Healthcare spending (March 2, 2009)
—House and Senate appropriations committees reconciled legislation and joint explanatory statement on the proposed FDA budget for a $325 million increase in agency’s budget for FY09 compared to FY08, which would give the agency $2 billion in appropriated funds (see BioCentury Extra, Tuesday, Feb. 24). (PDF files)
HHS budget proposal for FY10 that includes increasing rebates on Medicaid drugs, raising premiums for Medicare outpatient prescription drug coverage for higher-income beneficiaries, and allowing drug importation (see "Vague in the Extreme"). (PDF file)
— December 2008 Congressional Budget Office report on budget options for healthcare. (PDF file)

Influenza (PDF file) (March 2, 2009)
NICE technology appraisal recommending the use of Relenza zanamivir from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Biota Holdings Ltd. (ASX:BTA), or Tamiflu oseltamivir from Roche (SIX:ROG) and Gilead Sciences Inc. (NASDAQ:GILD) to treat seasonal influenza, and recommending against the use of the generic amantadine.

Laboratory-developed tests (PDF file) (March 2, 2009)
American Clinical Laboratory Association (ACLA) response asking FDA to deny a Citizen's Petition in which Genentech Inc. (NYSE:DNA) asked the agency to regulate all laboratory-developed tests (LDTs) instead of CMS (see BioCentury, Jan. 26).

PMDD (PDF file) (March 2, 2009)
EMEA concept paper on the need for a guideline on treating premenstrual dysphoric disorder (PMDD).

Pneumonia (PDF file) (March 2, 2009)
FDA notice of a public workshop on March 31-April 1 to discuss clinical trial design for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) (see BioCentury Extra, Monday, Feb. 23).

Regulatory science (March 2, 2009)
FDA report to its Science Board on the status of regulatory science (see BioCentury Extra, Tuesday, Feb. 24).

Rheumatoid arthritis (PDF file) (March 2, 2009)
NICE clinical guideline on managing RA in adults.

Product documentation (PDF files) (March 2, 2009)
Aloxi: CHMP revised EPAR updating the SPC to include additional information pertinent to the warning on QT/QTc prolongation in patients receiving Aloxi palonosetron to prevent nausea and vomiting associated with emetogenic cancer chemotherapy, from Helsinn Healthcare S.A. and Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
Vekacia: EMEA withdrawal assessment report for Vekacia ciclosporine to treat vernal keratoconjunctivitis, from Novagali Pharma S.A.

Cell-based products (PDF files) (February 23, 2009)
— FDA's final rule governing manufacture of human cell, tissue, and cellular and tissue-based products (see "Russian Roulette").
— Work plan for the EMEA Cell-Based Products Working Party (CBWP) for 2009.

CHMP (PDF file) (February 23, 2009)
Summary of actions taken at the Feb.16-19 plenary meeting of EMEA's CHMP.

Drug imports (February 23, 2009)
Draft guidance on "Good Importer Practices" issued by FDA and other U.S. government agencies (see Cover Story).

Pandemic vaccines (PDF file) (February 23, 2009)
EMEA guidance on dossier structure and content for an MAA for pandemic vaccines.

Product documentation (February 23, 2009)
— Filgrastim Hexal/Zarzio: CHMP EPAR for Filgrastim Hexal/Zarzio filgrastim, biosimilars of Neupogen filgrastim, to treat neutropenia, from Novartis AG (NYSE:NVS; SWX:NOVN).
Nplate: CHMP EPAR for Nplate romiplostim to treat chronic idiopathic thrombocytopenia purpura (ITP), from Amgen Inc. (NASDAQ:AMGN).
— Raptiva: CHMP statement and Q&A on the proposed suspension of the marketing authorization for Raptiva efalizumab to treat chronic plaque psoriasis after receiving reports of progressive multifocal leukoencephalopathy (PML), from Genentech Inc. (NYSE:DNA) and Merck KGaA (Xetra:MRK). (PDF files)
Rasilez HCT: CHMP EPAR for Rasilez HCT aliskiren/hydrochlorothiazide to treat hypertension, from Novartis AG (NYSE:NVS; SWX:NOVN).
RoActemra: CHMP EPAR for RoActemra tocilizumab to treat moderate to severe rheumatoid arthritis (RA) in adult patients who have responded inadequately or were intolerant to previous therapy with one or more disease-modifying antirheumatic drugs (DMARDs) or TNF antagonists, from Roche (SWX:ROG).

Alcohol dependence (PDF file) (February 16, 2009)
EMEA draft guidance for developing medicinal products to treat alcohol dependence.

Alpha 1-antitrypsin (PDF file) (February 16, 2009)
FDA notice of a public workshop on March 23-24 to discuss clinical efficacy endpoints for alpha 1-antitrypsin (AAT, A1AT) augmentation therapy (see BioCentury Extra, Friday, Feb. 13).

Clinical trials (PDF file) (February 16, 2009)
EMEA strategy paper on clinical trials conducted in third countries to be included in an MAA to assure the studies have been conducted in accordance with the required good clinical practice and ethical standards.

Epilepsy (PDF file) (February 16, 2009)
EMEA draft guidance for developing medicinal products to treat epileptic disorders.

HIV (PDF file) (February 16, 2009)
EMEA overview of comments regarding the agency's draft guidance on developing medicinal products to treat HIV infection.

Hypertension (PDF file) (February 16, 2009)
EMEA draft guidance for developing medicinal products to treat hypertension.

EMEA (PDF files) (February 16, 2009)
— EMEA paper describing the procedure for creating guidelines under the European pharmaceutical legislative framework.
— EMEA updated revenue and expense figures for FY09.

Orally inhaled products (PDF file) (February 16, 2009)
EMEA guidance on the requirements for clinical documentation for orally inhaled products (OIP).

Pediatric drugs (PDF files) (February 16, 2009)
— EMEA concept paper on the need to develop a pediatric addendum to the CHMP note for guidance on the clinical investigation of medicinal products to treat lipid disorders and for pulmonary arterial hypertension (PAH).
Summary of actions taken at the Feb. 4-6 meeting of EMEA's Pediatric Committee (PDCO).

Regulatory submissions (PDF file) (February 16, 2009)
FDA notice of the withdrawal of a final rule that required NDA holders to submit certain information regarding authorized generic drugs in an annual report.

Vancomycin (PDF file) (February 16, 2009)
FDA notice that the agency has extended through March 19 the period for accepting comments on the draft guidance on Bioequivalence Recommendation for Vancomycin (see " Hunter Needs New Prey").

Product documentation (February 16, 2009)
Advexin: CHMP Q&A on the withdrawal of an MAA for Advexin to treat Li-Fraumeni syndrome (LFS) cancers, from Introgen Therapeutics Inc. (Pink:INGN).
Cancidas: CHMP revised EPAR to extend the indication to include pediatric patients age 12 months to 17 years for Cancidas caspofungin to treat invasive candidiasis, invasive aspergillosis in patients who are refractory or intolerant to other therapies and fungal infections (such as Candida or Aspergillus) in febrile, neutropenic patients, from Merck & Co. Inc. (NYSE:MRK).
Exelon/Prometax: CHMP revised EPAR updating the SPC and package leaflet to include anxiety, delirium and pyrexia as common adverse events for Exelon/Prometax rivastigmine to treat Alzheimer's disease (AD) and Parkinson's disease (PD), from Novartis AG (NYSE:NVS; SWX:NOVN). (PDF files)
Sifrol: CHMP revised EPAR updating the SPC and package leaflet to include compulsive shopping, vomiting, restlessness, amnesia, visual disturbance, hyperphagia, syncope and weight decrease as adverse drug reactions for Sifrol pramipexole to treat Parkinson's disease (PD) and restless legs syndrome (RLS), from Boehringer Ingelheim GmbH and Pfizer Inc. (NYSE:PFE). (PDF files)
Stelera: CHMP EPAR for Stelera ustekinumab to treat moderate to severe plaque psoriasis in adults who have failed, are contraindicated for, or are intolerant to other systemic therapies, from Johnson & Johnson (NYSE:JNJ) and Medarex Inc. (NASDAQ:MEDX).
Tritanrix HepB: CHMP revised EPAR updating the SPC and package leaflet to include a safety warning for infants and children with severe neurological disorder vaccinated with Tritanrix HepB to prevent diphtheria, tetanus, pertussis and HBV, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)

Breast cancer (PDF files) (February 9, 2009)
National Comprehensive Cancer Network (NCCN) updated guidelines for breast cancer and breast cancer risk reduction recommending against the use of PET/CT scanning for evaluating newly diagnosed patients with early stage breast cancer (see BioCentury Extra, Wednesday, Feb. 4).

EMEA (PDF file) (February 9, 2009)
EMEA guidance for companies requesting scientific advice or protocol assistance.

Manufacturing (PDF file) (February 9, 2009)
EMEA concept paper on the need to update the annex guideline on cell culture inactivated influenza vaccines to address derivation of cell-isolated influenza vaccine.

Orphan drugs (PDF file) (February 9, 2009)
EMEA public statement on fee reduction for designated orphan medicinal products.

Post-traumatic stress disorder (PDF files) (February 9, 2009)
EMEA guidance and stakeholder comments for developing medicinal products to treat PTSD.

Renal cell carcinoma (February 9, 2009)
NICE final appraisal determination recommending the use of Sutent sunitinib as a first-line treatment for advanced and/or metastatic renal cell carcinoma (RCC), from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday, Feb. 4). (PDF file)
NICE preliminary guidance recommending against the use of Avastin bevacizumab from Roche (SWX:ROG) and Genentech Inc. (NYSE:DNA); Nexavar sorafenib from Bayer AG (Xetra:BAY) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX); and Torisel temsirolimus from Wyeth (NYSE:WYE) for first-line treatment of RCC, and recommending against Sutent sunitinib from Pfizer Inc. (NYSE:PFE) and Nexavar for second-line treatment of RCC (see BioCentury Extra, Wednesday, Feb. 4).

Safety (February 9, 2009)
FDA reports from the adverse event reporting system (AERS) spanning the first three quarters of 2008 (see BioCentury Extra, Wednesday, Feb. 4).

Product documentation (February 9, 2009)
Atripla: CHMP revised EPAR updating the SPC to include 48-week data from a study comparing Atripla emtricitabine/tenofovir/efavirenz to a highly active antiretroviral therapy (HAART) regimen to treat HIV-1 infection, from Gilead Sciences Inc. (NASDAQ:GILD) and Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Enbrel: CHMP revised EPAR to extend the indication for Enbrel etanercept to include chronic severe plaque psoriasis in children and adolescents 8 years and older who are inadequately controlled by, or intolerant to, other systemic therapies or phototherapies; from Amgen Inc. (NASDAQ:AMGN) and Wyeth (NYSE:WYE). (PDF file)
Kalbitor: FDA briefing documents for the Feb. 4 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee to review Kalbitor ecallantide (DX-88) to treat acute attacks of acute hereditary angioedema (HAE), from Dyax Corp. (NASDAQ:DYAX) (see BioCentury, Feb. 9).

Blood products (PDF file) (February 2, 2009)
Work plan for the EMEA Blood Products Working Party (BPWP) for 2009.

Economic aid (PDF file) (February 2, 2009)
Text of the House-passed American Recovery and Reinvestment Act of 2009, which would provide funding for comparative effectiveness research and a prevention and wellness fund that would support immunization, chronic disease, health promotion and genomics programs (see BioCentury Extra, Wednesday, Jan. 28).

EMEA (PDF file) (February 2, 2009)
Summary of actions taken at the Jan. 19-22 plenary meeting of EMEA's CHMP.

Labeling (February 2, 2009)
— EMEA guidance on the readability of the labeling and package leaflet of medicinal products. (PDF file)
— FDA draft guidance for standardized numerical identification for prescription drug packages to secure the drug supply chain.

Product documentation (February 2, 2009)
Acomplia: EMEA public statement on the withdrawal of marketing authorization for Acomplia rimonabant to treat obesity, from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Azopt: CHMP revised EPAR to extend the indication to include adjunct use of Azopt brinzolamide with prostaglandin analogs to decrease elevated intraocular pressure in ocular hypertension and open-angle glaucoma, from Alcon Laboratories Inc. (NYSE:ACL). (PDF file)
Effient: Briefing documents for the Feb. 3 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss an NDA for Effient prasugrel to treat acute coronary syndrome (ACS) in patients being managed with percutaneous coronary intervention (PCI), from Eli Lilly and Co. (NYSE:LLY) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) (see BioCentury Extra, Friday, Jan. 30).
Erbitux: NICE preliminary appraisals recommending against the use of Erbitix cetuximab first-line metastatic colorectal cancer, and in combination with platinum-based chemotherapy to treat recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), from Merck KGaA (Xetra:MRK), Bristol-Myers Squibb Co. (NYSE:BMY) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Thursday, Jan. 29).
Invega: EMEA Q&A on the withdrawal of an application for change in marketing authorization for Invega paliperidone prolonged-release tablets to include the treatment of acute manic episodes associated with bipolar I disorder, from Johnson & Johnson (NYSE:JNJ). (PDF file)
Revlimid: NICE preliminary appraisal recommending the use of Revlimid lenalidomide in combination with dexamethasone to treat multiple myeloma (MM) in patients who have received two or more prior therapies, from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Friday, Jan. 30).

ADHD (PDF files) (January 26, 2009)
— EMEA draft guideline for developing medicinal products to treat attention deficit hyperactivity disorder (ADHD).
— EMEA announcement and Q&A regarding a safety review of methylphenidate-containing medicines to treat ADHD, in which CHMP concluded the benefits of the drugs continue to outweigh their risks.

Bioanalytical methods (PDF file) (January 26, 2009)
EMEA concept paper recommending a CHMP guidance for the validation of bioanalytical methods for developing medicinal products.

Hypertension (PDF files) (January 26, 2009)
— CHMP concept paper recommending a pediatric addendum to the guidance on the clinical investigation on medicinal products to treat hypertension.
— CHMP draft guidance for developing medicinal products to treat pulmonary arterial hypertension (PAH).

MAAs (PDF files) (January 26, 2009)
EMEA guidance and comments regarding the time allowed for applicants to respond to questions and issues raised during the assessment of new MAAs in the centralized procedure.

Molecular diagnostics (January 26, 2009)
Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group recommendations for genetic testing to improve outcomes in patients with breast cancer and reducing morbidity and mortality in patients with metastatic colorectal cancer (CRC), and to determine genetic testing strategies in newly diagnosed CRC patients (see Cover Story).
— Citizen Petition to FDA from Genentech Inc. (NYSE:DNA) on regulation of in vitro diagnostic tests, and comments from Johns Hopkins University's Genetics and Public Policy Center (GPPC); The Coalition for 21st Century Medicine; Clinical Data Inc. (NASDAQ:CLDA); and CombiMatrix Corp. (NASDAQ:CBMXZ).
Report of the HHS Secretary's Advisory Committee on Genetics, Health and Society (SACGHS) on the U.S. system of oversight of genetic testing. (PDF file)

Nicotine dependence (PDF file) (January 26, 2009)
EMEA guidance for developing medicinal products to treat nicotine dependence.

Orphan drugs (PDF file) (January 26, 2009)
EMEA Committee for Orphan Medicinal Products (COMP) draft recommendations for the level of evidence required to support the medical plausibility and the assumption of significant benefit for an orphan designation.

Regulatory oversight (January 26, 2009)
U.S. Government Accountability Office (GAO) report that identifies "protecting public health through enhanced oversight of medical products" as a high-risk area warranting attention by Congress and the executive branch (see BioCentury Extra, Thursday, Jan. 22).

Product documentation (January 26, 2009)
Synflorix: CHMP recommendation of positive opinion for marketing authorization of Synflorix pneumococcal vaccine to prevent pneumococcal disease and acute otitis media in children ages six weeks to two years, from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Theraloc: CHMP Q&A on the withdrawal of an MAA for Theraloc nimotuzumab to treat resistant or recurrent high-grade glioma in children and adolescents, from Oncoscience AG and YM BioSciences Inc. (TSX:YM; AMEX:YMI) (see BioCentury Extra, Monday, Dec. 8, 2008). (PDF file)
Vedrop: CHMP Q&A regarding its negative opinion on a MAA for Vedrop tocofersolan to treat vitamin E deficiency in children with chronic cholestasis or cystic fibrosis, from Recordati S.p.A. (Milan:REC). (PDF file)
Vidaza: CHMP EPAR for Vidaza azacitidine to treat myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in adults who are not eligible for hematopoietic stem cell transplantation, from Celgene Corp. (NASDAQ:CELG).
Vimpat: EMEA withdrawal assessment report for Vimpat lacosamide to treat diabetic neuropathic pain, from UCB Group (Euronext:UCB). (PDF file)

Advanced therapies (PDF files) (January 19, 2009)
EMEA statement and Q&A on the formation of the Committee for Advanced Therapies (CAT) to assess quality, safety and efficacy of advanced therapy medicinal products (ATMPs), which are comprised of gene therapies, somatic cell therapies and tissue engineered products.

Antibodies (PDF files) (January 19, 2009)
EMEA guidance for development and quality requirements of monoclonal antibodies (mAbs) for medicinal and diagnostic use, and an overview of comments received.

Clinical trials (PDF file) (January 19, 2009)
FDA notice soliciting comments and information on increasing participation of certain populations in clinical trials.

Diagnostics (January 19, 2009)
EU's four-year collaborative project to develop standards for patient sample processing, tools and quality assurance schemes to improve in vitro diagnostics.

Drug imports (PDF files) (January 19, 2009)
— FDA draft guidance recommending practices and procedures for importing products into the U.S.
— FDA notice of a pilot program to help determine the practicality of developing a secure supply chain program for drugs and active pharmaceutical ingredients (APIs) produced outside the U.S. (see BioCentury Extra, Thursday, Jan. 15).

EMEA (PDF file) (January 19, 2009)
EMEA's budget and establishment plan for 2009.

Financial disclosure (PDF file) (January 19, 2009)
Report from the HHS's Office of Inspector General on FDA oversight and disclosure of financial interests by clinical investigators (see Cover Story).

Healthcare reform (PDF file) (January 19, 2009)
Biotechnology Industry Organization (BIO) paper on key principles for universal healthcare access and the fundamental roles of innovation and the private sector in U.S. healthcare.

Manufacturing (PDF file) (January 19, 2009)
FDA draft guidance for manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps) on complying with Current Good Tissue Practice (CGTP) requirements and additional requirements.

Medical devices (PDF file) (January 19, 2009)
U.S. Government Accountability Office (GAO) report recommending that FDA issue regulations requiring class III devices to be reviewed under the more stringent PMA process rather than the 510(k) process (see BioCentury Extra, Thursday, Jan. 15).

Off-label (PDF file) (January 19, 2009)
FDA final guidance outlining procedures for companies on disseminating information about off-label uses of drugs or devices (see BioCentury Extra, Tuesday, Jan. 13).

Pediatric drugs (PDF file) (January 19, 2009)
Summary of actions taken at the Jan. 7-9 meeting of EMEA's Paediatric Committee (PDCO).

Regulatory submissions (PDF file) (January 19, 2009)
— FDA final guidance to clarify which submissions to the agency should be accompanied by a certification as required under the FDA Amendments Act of 2007 (FDAAA), which require that additional information be submitted to www.ClinicalTrials.gov (see BioCentury Extra, Friday, Jan. 16).
— FDA final rule requiring companies submitting ANDAs to include all bioequivalence data from all of the company's bioequivalence studies that were conducted on the product.

Product documentation (January 19, 2009)
Aptivus: CHMP revised EPAR updating the SPC and package leaflet to include information on the interaction between bupropion and Aptivus tipranavir plus ritonavir to treat HIV-1 infection, from Boehringer Ingelheim GmbH. (PDF file)
Kuvan: CHMP EPAR for Kuvan sapropterin to treat hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency, from Merck KGaA (Xetra:MRK) and BioMarin Pharmaceutical Inc. (NASDAQ:BMRN).

CMS (January 12, 2009)
Proposed a National Coverage Determination (NCD) to expand coverage for PET scans to guide cancer treatment (see BioCentury Extra, Tuesday, Jan. 6).

EMEA (PDF file) (January 12, 2009)
Summary of actions taken at the Dec. 15-18 plenary meeting of EMEA's CHMP.

Manufacturing (PDF files) (January 12, 2009)
FDA, EMEA and the Australia's Therapeutics Goods Administration (TGA) outline of common principles and rules of engagement, and an update to a joint pilot project for a more coordinated international planning of inspections of active pharmaceutical ingredients (APIs).

Orphan drugs (PDF file) (January 12, 2009)
Summary of actions taken at the Jan. 7 plenary meeting of EMEA's Committee on Orphan Medicinal Products (COMP).

Product documentation (January 12, 2009)
ATryn: Briefing documents for the Jan. 9 meeting of FDA's Blood Products Advisory Committee, which recommended approval for ATryn to prevent peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients, from GTC Biotherapeutics Inc. (NASDAQ:GTCB) (see BioCentury Extra, Friday, Jan. 9).
Azarga: CHMP EPAR for Azarga brinzolamide/timolol to decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction, from Alcon Laboratories Inc. (NYSE:ACL).
— Exulett: EMEA withdrawal assessment report and Q&A for Exulett dalbavancin to treat complicated skin and soft tissue infections (cSSTIs), from Pfizer Inc. (NYSE:PFE). (PDF files)
Riastap: Briefing documents for the Jan. 9 meeting of FDA's Blood Products Advisory Committee, which voted 12-3 (with three abstentions) that maximum clot firmness (MCF) is a clinically meaningful surrogate and 14-0 (with four abstentions) that the Phase IV study will show whether or not MCF is correlated with clinical efficacy of Riastap human fibrinogen concentrate to treat congenital fibrinogen deficiency, from CSL Ltd. (ASX:CSL) (see BioCentury Extra, Friday, Jan. 9).
Sabril: Briefing documents for the Jan. 7-8 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted in favor of approval of Sabril vigabatrin as an adjunctive treatment for adults with refractory complex partial seizures and as a monotherapy to treat infantile spasms, from Ovation Pharmaceuticals Inc. (see BioCentury, January 12).
Zypadhera: CHMP EPAR for Zypadhera olanzapine long acting injection for the maintenance treatment of adult patients with schizophrenia, from Eli Lilly and Co. (NYSE:LLY).

Advertising (PDF file) (January 5, 2009)
FDA notice on a proposed study into the impact of distraction on consumer understanding of risk and benefit information in direct-to-consumer (DTC) prescription drug broadcast advertisements.

Asthma (PDF file) (January 5, 2009)
Comments for the Dec. 10-11 joint meeting of FDA's Pulmonary-Allergy Drugs, Drug Safety & Risk Management, and the Pediatric advisory committees that reviewed the risk-benefit of long-acting adrenergic receptor beta 2 agonists (LABAs) for the maintenance treatment of asthma patients (see BioCentury, Dec. 15, 2008).

Diagnostics (PDF file) (January 5, 2009)
FDA draft guidance on assay migration studies for in vitro diagnostics when the assay is moving to another system for which it has not been approved or licensed.

Enterovirus assays (PDF files) (January 5, 2009)
FDA guidance for developing nucleic acid amplification assays to detect enterovirus RNA, and a final rule classifying enterovirus nucleic acid assays as class II devices.

Genomic sequencing (PDF file) (January 5, 2009)
FDA notice soliciting volunteers and vendors for the Sequencing Quality Control (SEQC) project to help prepare the agency for the submission of genomic data from next-generation sequencing technologies (see BioCentury Extra, Monday, Dec. 22, 2008).

Pediatric drugs (PDF file) (January 5, 2009)
Summary of actions taken at the Dec. 10-12 meeting of EMEA's Pediatric Committee (PDCO).

Product documentation (January 5, 2009)
Avastin: FDA "Dear Healthcare Professional" letter reporting 36 intraocular adverse events related to off-label intravitreal use of Avastin bevacizumab to treat wet age-related macular degeneration (AMD) and diabetic retinopathy, from Genentech Inc. (NYSE:DNA) and Roche (SWX:ROG) (see BioCentury Extra, Monday, Dec. 22, 2008). (PDF file)
Celsentri: CHMP revised EPAR updating the SPC with in vitro data showing that P glycoprotein (MDR) is inhibited by Celsentri maraviroc to treat CC chemokine receptor 5 (CCR5)-tropic HIV-1 infection in treatment-experienced adult patients, from Pfizer Inc. (NYSE:PFE). (PDF file)
Nespo: EMEA public statement on the withdrawal of marketing authorization for Nespo darbepoetin alfa to treat symptomatic anemia associated with chronic renal failure (CRF) and symptomatic anemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy, from Amgen Inc. (NASDAQ:AMGN). (PDF file)
Neupopeg: EMEA public statement on the withdrawal of marketing authorization for Neupopeg pegfilgrastim to treat neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy, from Amgen Inc. (NASDAQ:AMGN). (PDF file)
PegIntron/Rebetol: CHMP revised EPAR updating the SPC with final data on patients with prior treatment failure who were retreated with PegIntron pegylated interferon alfa-2b plus Rebetol ribavirin to treat chronic HCV, from Enzon Pharmaceuticals Inc. (NASDAQ:ENZN) and Schering-Plough Corp. (NYSE:SGP). (PDF files)
Tygacil: CHMP revised EPAR updating the SPC to include jaundice and liver failure as adverse reactions and information regarding the resistance of Acinetobacter baumannii to Tygacil tigecycline to treat complicated skin and soft tissue infections (cSSTI) and complicated intra-abdominal infections (cIAI), from Wyeth (NYSE:WYE). (PDF file)
Vfend: CHMP revised EPAR updating the SPC with information on serious visual adverse events in patients receiving Vfend voriconazole to treat fungal infections, from Pfizer Inc. (NYSE:PFE). (PDF file)

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