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

Antibiotics (PDF files) (December 19, 2011)
— European Commission action plan on implementing faster approval processes for new antibiotics (see Cover Story).
Text of the Generating Antibiotic Incentives Now (GAIN) Act, which would provide incentives for antibiotic development.
— Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) recommendations for future collaboration between the U.S. and EU on antimicrobial resistance issues.

Biomedical research (PDF file) (December 19, 2011)
Institute of Medicine (IOM) report that found the current use of chimpanzees for biomedical research is "unnecessary" and should be limited to studies that meet criteria outlined in the report (see BioCentury Extra, Thursday, Dec. 15).

Clinical trials (PDF file) (December 19, 2011)
Report from the Presidential Commission for the Study of Bioethical Issues that said regulations for federally sponsored research involving human volunteers "generally appear to protect people from avoidable harm or unethical treatment."

CMS (December 19, 2011)
CMS results for its end-stage renal disease (ESRD) pay-for-performance program that found 70% of participants met performance criteria and will not receive Medicare payment reductions in payment year 2012.

Devices (PDF files) (December 19, 2011)
— FDA draft guidance on evaluation of sex differences in clinical studies of medical devices.
— FDA draft guidance on preparation and submission of Humanitarian Use Device designation requests.

Drug shortages (PDF files) (December 19, 2011)
— FDA interim rule that requires manufacturers that are the sole producers of critical drugs to report to the agency all interruptions in manufacturing processes, regardless of whether a drug shortage occurs (see BioCentury Extra, Thursday, Dec. 15).
— U.S. Government Accountability Office report on drug shortages that identified manufacturing problems as the primary cause in 12 out of 15 cases deemed by GAO to have had a "significant" impact on public health from January 2009 to June 2011 (see BioCentury Extra, Thursday, Dec. 15).

Gastrointestinal bleeding (PDF file) (December 19, 2011)
NICE draft clinical guideline on the management of acute upper gastrointestinal bleeding.

Medical countermeasures (PDF file) (December 19, 2011)
Text of the Pandemic and All-Hazards Preparedness Act Reauthorization (S.1855), which proposes the creation of an independent entity to provide venture capital investment in companies with products and technologies that may be used as medical countermeasures (see BioCentury Extra, Thursday, Dec. 15).

Medicare (PDF file) (December 19, 2011)
Proposal by Sen. Ron Wyden (D-Ore.) and Rep. Paul Ryan (R-Wis.) for creating private sector competition against Medicare (see BioCentury Extra, Thursday, Dec. 15).

Orphan products (PDF file) (December 19, 2011)
Summary of actions taken at the Dec. 6-7 plenary meeting of EMA's Committee for Orphan Medicinal Products (COMP).

Plasma-derived products (PDF files) (December 19, 2011)
EMA guideline on standard texts for warning statements on transmissible agents to include in summary of product characteristics and package leaflets of plasma-derived medicinal products and an overview of comments received.

Product documentation (December 19, 2011)
Brilique: Germany's Federal Joint Committee (G-BA) final benefit assessment that said cardiovascular drug Brilique ticagrelor provides an "important additional benefit" compared with clopidogrel and aspirin in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) and unstable angina; from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Thursday, Dec. 15). (PDF file)
Edarbi: CHMP EPAR for Edarbi azilsartan medoxomil to treat hypertension; from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
Esbriet: Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that said Esbriet pirfenidone provides "no additional benefit" compared with best supportive care in patients with idiopathic pulmonary fibrosis (IPF); from InterMune Inc. (NASDAQ:ITMN) (see BioCentury, December 19). (PDF file)
Faslodex: NICE final guidance recommending against Faslodex fulvestrant as an alternative to aromatase inhibitors to treat estrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women whose cancer has relapsed or progressed; from AstraZeneca plc (LSE:AZN; NYSE:AZN).(PDF file)
Komboglyze: CHMP EPAR for Komboglyze saxagliptin/metformin to treat Type II diabetes; from AstraZeneca plc (LSE:AZN; NYSE:AZN), Bristol-Myers Squibb Co. (NYSE:BMY) and Otsuka Pharmaceutical Co. Ltd.
— Plan B One-Step: Letter (PDF file) from HHS Secretary Kathleen Sebelius to FDA Commissioner Margaret Hamburg overruling an FDA recommendation and directing the agency to issue a complete response letter for a label revision to make emergency contraceptive Plan B One-Step levonorgestrel available without a prescription to women of child-bearing potential 16 years and younger (see BioCentury Extra, Wednesday, Dec. 7); Letter from Sen. Patty Murray (D-Wash.) and 13 other Senate Democrats asking the HHS Secretary to provide the "specific rationale and the scientific data" she relied on to overrule FDA's recommendation; from Teva Pharmaceuticals Industries Ltd. (NASDAQ:TEVA) (see BioCentury Extra, Tuesday, Dec. 13).
RoActemra: NICE final guidance recommending RoActemra tocilizumab to treat systemic juvenile idiopathic arthritis (sJIA) in patients ages two years and older who have responded inadequately to NSAIDs, systemic corticosteroids or methotrexate; from Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)

Autism (PDF file) (December 12, 2011)
NICE draft guidance on recognition, referral, diagnosis and management of autism in adults.

Gene patents (PDF file) (December 12, 2011)
American Civil Liberties Union and Public Patent Foundation petition to the U.S. Supreme Court to hear Association for Molecular Pathology, et al. v. U.S. PTO et al., a suit on the eligibility of genes for patenting (see BioCentury Extra, Thursday, Dec. 8).

Health technology assessments (December 12, 2011)
Position paper jointly developed by eight European healthcare industry groups on the value of industry contribution to the health technology assessment process.

Innovation (PDF file) (December 12, 2011)
U.K. Prime Minister David Cameron strategy to increase innovation in life sciences in the U.K., which includes the three-year, £180 million ($281.4 million) Biomedical Catalyst fund (see BioCentury Extra, Monday, Dec. 5).

Molecular diagnostics (PDF file) (December 12, 2011)
Oral arguments heard by the U.S. Supreme Court on Mayo Collaborative Services et al. v. Prometheus Laboratories Inc., a case the court could use to provide clarity on the patent-eligibility of methods claims for molecular diagnostics.

Neglected diseases (PDF file) (December 12, 2011)
Global Funding of Innovation for Neglected Diseases (G-Finder) survey that found global investment in R&D of new products for neglected diseases fell by 4% to $3.1 billion in 2010 (see BioCentury Extra, Thursday, Dec. 8).

R&D (December 12, 2011)
Details of compounds from AstraZeneca plc (LSE:AZN; NYSE:AZN) provided to academic researchers free of charge through a partnership with the U.K.'s Medical Research Council (see BioCentury Extra, Monday, Dec. 5).
Health Affairs article by University of British Columbia researchers that found fewer than one in eight completed studies are reported on time on ClinicalTrials.gov despite U.S. law.
— NIH PubChem database, which includes chemical and pharmaceutical data from IBM Corp. (NYSE:IBM) that contains information on more than 2.4 million compounds (see BioCentury Extra, Thursday, Dec. 8).

Stem cells (PDF files) (December 12, 2011)
Concept proposals approved by the California Institute for Regenerative Medicine for its External Innovative Initiative, Bridging Fund and the Human Pluripotent Stem Cell Initiative (see BioCentury Extra, Friday, Dec. 9).

Venture capital (PDF file) (December 12, 2011)
European Commission's EU Action Plan to improve access to finance for small- and medium-sized enterprises (SMEs), which includes a proposed regulation that seeks to make it easier for VC firms to raise funds across multiple EU member states.

Product documentation (December 12, 2011)
Adasuve: Briefing documents for the Dec. 12 meeting of FDA's Psychopharmacologic Drugs Advisory Committee meeting to discuss an NDA for Adasuve loxapine to treat agitation in patients with schizophrenia or bipolar disorder; from Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) (see BioCentury Extra, Thursday, Dec. 8).
Celsentri/Selzentry: CHMP revised EPAR updating SPC to include hepatotoxicity with allergic features as adverse events for HIV drug Celsentri/Selzentry maraviroc; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Pfizer Inc. (NYSE:PFE).
Champix: CHMP revised an EPAR updating SPC to include a warning on risk of cardiovascular and cerebrovascular events with Champix varenicline for smoking cessation; from Pfizer Inc. (NYSE:PFE).
Daxas: NICE final appraisal determination (FAD) recommending a clinical trial be conducted to determine the effectiveness of Daxas roflumilast as an add-on to bronchodilator therapy to treat severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations; from Forest Laboratories Inc. (NYSE:FRX), Merck & Co. Inc. (NYSE:MRK), Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508). (PDF file)
Evoltra: CHMP revised EPAR updating SPC to include dosing recommendations for pediatric patients with moderate renal impairment for Evoltra clofarabine to treat relapse acute lymphoblastic leukemia (ALL); from Sanofi (Euronext:SAN; NYSE:SNY).
Glivec/Gleevec: NICE preliminary appraisal recommending the use of 400 mg Glivec imatinib as first-line treatment for chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, Dec. 5).
Inlyta: Briefing documents for the Dec. 7 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 13-0 that data support a favorable benefit-risk profile for Inlyta axitinib as second-line therapy for advanced renal cell carcinoma (RCC); from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday, Dec. 7). (PDF file)
Lucentis: NICE preliminary appraisal recommending against Lucentis ranibizumab to treat macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) (see BioCentury Extra, Wednesday, Nov. 23); and NICE final guidance recommending against Lucentis to treat diabetic macular edema (DME) (see BioCentury Extra, Tuesday, Nov. 29); from Novartis AG (NYSE:NVS; SIX:NOVN), Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit. (PDF file)
Nplate: FDA documentation on a modified REMS that removed restricted distribution and data collection requirements for Nplate romiplostim to treat chronic idiopathic thrombocytopenic purpura (ITP); from Amgen Inc. (NASDAQ:AMGN) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) (see BioCentury Extra, Tuesday, Dec. 6).
Peginesatide: Briefing document for the Dec. 7 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 15-1 with one abstention that peginesatide has a favorable benefit-risk profile to treat anemia in patients with chronic kidney disease who are on dialysis; from Affymax Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see Cover Story). (PDF file)
Promacta: FDA documentation on a modified REMS that removed restricted distribution and data collection requirements for Promacta eltrombopag to treat chronic idiopathic thrombocytopenic purpura (ITP); from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Tuesday, Dec. 6).
Sprycel: NICE preliminary appraisal recommending against the use of Sprycel dasatinib as first-line treatment for chronic myelogenous leukemia (CML); from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Monday, Dec. 5).
Tasigna: NICE preliminary appraisal recommending the use Tasigna nilotinib as first-line treatment for chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, Dec. 5).

Advanced therapies (PDF file) (December 5, 2011)
Summary of actions taken at the Nov. 10-11 meeting of EMA's Committee for Advanced Therapies (CAT).

Alzheimer's disease (PDF files) (December 5, 2011)
CHMP draft qualification opinions on the use of beta amyloid (1-42) and high tau in cerebrospinal fluid for PET imaging to select patients for clinical trials evaluating predementia AD and mild to moderately severe AD.

EMA (December 5, 2011)
— EMA pilot eSubmission Gateway program to evaluate the electronic submission of centralized MAAs (see BioCentury Extra, Wednesday, Nov. 23).
— Work plans for 2012 for the Biosimilar Medicinal Products Working Party and Safety Working Party. (PDF files)

FDA (December 5, 2011)
U.S. Government Accountability Office (GAO) report on how FDA can improve its efforts to detect and prevent economic adulteration, or the deliberate substitution or addition of harmful ingredients in food and drugs.

HPV (PDF file) (December 5, 2011)
FDA guidance on the types of studies recommended to support PMAs for in vitro diagnostics for HPV (see BioCentury Extra, Tuesday, Nov. 29).

Incontinence (December 5, 2011)
EMA draft of updated guideline on clinical investigation of medicinal products to treat urinary incontinence.

Innovation (PDF file) (December 5, 2011)
U.K. Treasury 2011 Autumn Statement, which includes measures to support innovation in the U.K. (see BioCentury Extra, Wednesday, Nov. 30).

Medicare (PDF file) (December 5, 2011)
Congressional Budge Office (CBO) report on spending patterns for prescription drugs covered under Medicare Part D that found the federal government spent $62 billion on the program in 2010, or about 12% of total federal spending for Medicare for the year.

Palliative care (December 5, 2011)
U.K.'s NICE draft recommendations on prescribing opioids in palliative care.

Patient protection (PDF file) (December 5, 2011)
Minutes of the Sept. 13 meeting of EMA's Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP).

Patient-reported outcomes (December 5, 2011)
— FDA final guidance on the development of patient-reported outcome (PRO) measures to support labeling claims for medical products (See Cover Story).
— FDA draft guidance on the qualification process for drug development tools.

Pediatric drugs (PDF file) (December 5, 2011)
Summary of actions taken at the Nov. 9-11 meeting of EMA's Paediatric Committee (PDCO).

Pharmacovigilance (PDF file) (December 5, 2011)
Summary of actions taken at the Nov. 14-16 plenary meeting of EMA's Pharmacovigilance Working Party (PhVWP).

R&D (December 5, 2011)
Deloitte and Thomson Reuters report on life sciences R&D that found the year-over-year average internal rate of return (IRR) from R&D at the top 12 research-based pharmas fell to 8.4% in 2011 from 11.8% in 2010 (see BioCentury Extra, Tuesday, Nov. 22). (PDF file)

European Commission's proposed Horizon 2020 research and innovation program for 2014-20 (see BioCentury Extra, Wednesday, Nov. 30).

U.K. startups (PDF file) (December 5, 2011)
Report from bioscience incubator BioCity Nottingham Ltd. on life sciences startups in the U.K. that found a 12% decrease in the total investments raised by startups in 2006-10 compared with 2005-09.

Product documentation (December 5, 2011)
Avastin: U.K.'s NICE final appraisal determination recommending against Avastin bevacizumab as second-line therapy for metastatic colorectal cancer (mCRC); from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Eliquis: U.K.'s NICE final appraisal determination recommending Eliquis apixaban to prevent venous thromboembolic events (VTE) in adults who have undergone elective hip or knee replacement surgery; from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Monday, Nov. 28). (PDF file)
Erbitux: U.K.'s NICE final appraisal determination recommending against Erbitux cetuximab as second-line therapy for metastatic colorectal cancer (mCRC); from Merck KGaA (Xetra:MRK). (PDF file)
Gilenya: U.K.'s NICE second preliminary appraisal recommending against Gilenya fingolimod to treat relapsing-remitting multiple sclerosis (RRMS); from Novartis AG (NYSE:NVS; SIX:NOVN) and Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508) (see BioCentury Extra, Wednesday, Nov. 30).
MabThera: U.K.'s NICE final appraisal determination recommending MabThera rituximab as first-line treatment for follicular non-Hodgkin's lymphoma (NHL) in combination with cyclophosphamide, vincristine and prednisolone; from Roche (SIX:ROG; OTCQX:RHHBY) and Biogen Idec Inc. (NASDAQ:BIIB). (PDF file)
Vectibix: U.K.'s NICE final appraisal determination recommending against Vectibix panitumumab as second-line therapy for metastatic colorectal cancer (mCRC); from Amgen Inc. (NASDAQ:AMGN). (PDF file)
Vyndaqel: EMA's CHMP EPAR for Vyndaqel tafamidis to treat transthyretin (TTR) familial amyloid polyneuropathy (FAP); from Pfizer Inc. (NYSE:PFE).
Xifaxan: FDA draft guidance on the development of a generic version of 200 mg Xifaxan rifaximin that would require a clinical trial to demonstrate comparative efficacy between a generic and travelers' diarrhea drug Xifaxan; from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) (see BioCentury Extra, Tuesday, Nov. 29). (PDF file)

Antibiotics (PDF file) (November 21, 2011)
European Commission action plan on implementing faster approval processes for new antibiotics to promote antibiotic R&D and mitigate the spread of antimicrobial resistance (see BioCentury Extra, Thursday, Nov. 17).

Healthcare reform (PDF files) (November 21, 2011)
Petitions for writ of certiorari granted by the U.S. Supreme Court to hear challenges to the Patient Protection and Affordable Care Act; cases include National Federation of Independent Business et. al. v. Sebelius, et. al.; Florida, et. al. v. U.S. Department of Health and Human Services, et. al.; and U.S. Department of Health and Human Services, et. al. v. Florida, et. al. (see BioCentury Extra, Monday, Nov. 14).

HIV (PDF file) (November 21, 2011)
EMA concept paper on the need to update 2008 guidance on developing HIV products in light of new options for treatment-experienced patients that have since been approved (see BioCentury Extra, Wednesday, Nov. 16).

Medication guide (PDF file) (November 21, 2011)
FDA guidance on when a medication guide should be provided to a healthcare professional for administration to a patient instead of being dispensed directly to the patient; and when a medication guide will be required as part of a REMS.

Orphan products (PDF file) (November 21, 2011)
Summary of actions taken at the Nov. 8-9 plenary meeting of EMA's Committee for Orphan Medicinal Products (COMP).

Reimbursement (November 21, 2011)
CMS request for comment on improvements to its Coverage with Evidence Development (CED) program, which may be included in new guidance (see "CMS Aims to Revamp CED").

Rheumatoid arthritis (PDF file) (November 21, 2011)
NICE review proposal consultation of its clinical guideline on rheumatoid arthritis (RA), which includes a provisional decision recommending against updating the guidelines.

Serotonin receptor agonists (November 21, 2011)
Briefing documents for the Nov. 17 meeting of FDA's Gastrointestinal Drugs Advisory Committee, which voted 17-4 with 1 abstention against requiring companies to conduct a dedicated cardiovascular safety trial of serotonin (5-HT4) receptor agonists for gastrointestinal indications (see BioCentury Extra, Thursday, Nov. 17).

Product documentation (November 21, 2011)
Avastin: Documentation on FDA Commissioner Margaret Hamburg's decision to revoke accelerated approval of Avastin bevacizumab in combination with paclitaxel for HER2-negative metastatic breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, Nov. 18).
Halaven: NICE final appraisal determination (FAD) recommending against Halaven eribulin to treat locally advanced or metastatic breast cancer in patients whose disease has progressed after at least two chemotherapy regimens — its approved indication; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury, Wednesday, Nov. 16). (PDF file)
Plenadren: CHMP EPAR for Plenadren hydrocortisone tablet to treat adrenal insufficiency in adults; from ViroPharma Inc. (NASDAQ:VPHM).
— Provenge: Documents obtained through the Freedom of Information Act regarding CMS's National Coverage Assessment of Provenge sipuleucel-T to treat metastatic castration-resistant prostate cancer; first, second and third set of documents; from Dendreon Corp. (NASDAQ:DNDN) (see Cover Story). (PDF files)
Xifaxan: Briefing documents for the Nov. 16 meeting of FDA's Gastrointestinal Drugs Advisory Committee, which backed the design of a Phase III retreatment trial for Xifaxan rifaximin to treat irritable bowel syndrome with diarrhea (IBS-D); from Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) (see BioCentury Extra, Wednesday, Nov. 16).

Cancer vaccines (PDF file) (November 14, 2011)
FDA revised guidance on clinical development and trial design for therapeutic cancer vaccines, including late-stage trials to support a BLA.

CMS (November 14, 2011)
CMS public solicitation for comments on potential improvements to its coverage with evidence development (CED) mechanism, which provides conditional payment for items and services while generating clinical data to demonstrate their effect on health outcomes (see BioCentury Extra, Wednesday, Nov. 9).

Colorectal cancer (PDF file) (November 14, 2011)
NICE guideline on the diagnosis and management of colorectal cancer.

Diabetes (PDF file) (November 14, 2011)
NICE draft guidance on identifying individuals at high risk for developing Type II diabetes and interventions for them.

FDA (PDF file) (November 14, 2011)
FDA report that noted the agency approved 35 new drugs in the fiscal year ending Sept. 30, the second-highest number of approvals in the past decade (see BioCentury Extra, Thursday, Nov. 3).

Lung cancer (November 14, 2011)
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for lung cancer screening.

Medical devices (PDF files) (November 14, 2011)
— FDA pilot program to evaluate the use of "early feasibility" clinical studies for medical devices that would not obtain approval for a traditional feasibility study and draft guidance on the design and conduct of such early studies (see BioCentury Extra, Thursday, Nov. 10).
— FDA draft guidance that clarifies the process for approving clinical trials of medical devices, including situations where the agency might allow patients to enroll in a study while small design issues are still being solved (see BioCentury Extra, Thursday, Nov. 10). (PDF file)

Personalized medicine (PDF files) (November 14, 2011)
American Society for Clinical Oncology report recommending measures to improve development of personalized cancer medicines, including establishment of a new development approach based on cancer biology (see BioCentury Extra, Wednesday, Nov. 9).

Product documentation (November 14, 2011)
Toviaz: CHMP revised EPAR updating SPC to include a warning regarding the risk of angioedema for Toviaz fesoterodine to treat overactive bladder (OAB) syndrome; from Pfizer Inc. (NYSE:PFE) and UCB Group (Euronext:UCB).
Zyprexa/Zypadhera: CHMP revised EPAR updating SPC for schizophrenia drug Zyprexa/Zypadhera olanzapine in accordance with a classwide labeling recommendation to include information regarding use of antipsychotics during the third trimester of pregnancy and risk of abnormal muscle movements and/or withdrawal symptoms in newborns; from Eli Lilly and Co. (NYSE:LLY).

Drug shortages (November 7, 2011)
Reports accompanying President Obama's executive order to reduce prescription drug shortages, including an HHS economic analysis on the causes of drug shortages and a review of FDA's approach (PDF file) to shortages (see BioCentury Extra, Monday, Oct. 31).

FDA (PDF file) (November 7, 2011)
Text of the U.S. Senate appropriations bill for agriculture, rural development and FDA, which would increase overall FDA funding by $50M, or 2%, not including user fees (see BioCentury Extra, Wednesday, Nov. 2).

Laboratory-developed tests (PDF file) (November 7, 2011)
Text of Modernizing Laboratory Test Standards for Patients Act (H.R. 3207), which would prohibit FDA from regulating LDTs as devices.

Toxicology (PDF file) (November 7, 2011)
EMA concept paper on the need to develop toxicological guidance to identify risks associated with manufacturing different medicinal products in shared facilities.

Product documentation (November 7, 2011)
Pradaxa: NICE final appraisal determination recommending Pradaxa dabigatran to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF); from Boehringer Ingelheim GmbH (see BioCentury Extra, Monday, Oct. 31). (PDF file)
Vytorin: Briefing documents for the Nov. 2 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 16-0 to expand the label for Vytorin ezetimibe/simvastatin to include the prevention of major vascular events in patients with pre-dialysis chronic kidney disease; from Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Wednesday, Nov. 2 ).

Biologics (PDF file) (October 31, 2011)
EuropaBio informational guide on biologics, including regulation of biologics and biosimilars in Europe.

Cancer infections (October 31, 2011)
U.S. Centers for Disease Control and Prevention (CDC) website — 3 Steps Toward Preventing Infections During Cancer Treatment — providing information on the risk of infections in cancer patients receiving chemotherapy (see BioCentury Extra, Tuesday, Oct. 25).

Cancer screening (October 31, 2011)
— U.S. Preventative Services Task Force (USPSTF) draft recommendation and evidence review finding insufficient evidence to balance benefits and harms of HPV screening to detect cervical cancer in women 30 and up, but advising against its use in younger women.
— USPSTF draft recommendation and evidence review advising against use of PSA screening to detect prostate cancer in men.

Heparin (PDF file) (October 31, 2011)
Letter from Chairman Fred Upton (R-Mich.) and other Republicans on the House Committee on Energy and Commerce to FDA Commissioner Margaret Hamburg requesting information by Nov. 9 on FDA's enforcement policy regarding Chinese firms implicated by industry sources as suppliers of contaminated heparin (see BioCentury Extra, Thursday, Oct. 27).

Pharmacovigilance (PDF file) (October 31, 2011)
Summary of actions taken at the Oct. 17-19 plenary meeting of the EMA CHMP's pharmacovigilance working party (PhVWP).

Tropical diseases (October 31, 2011)
WIPO Re:Search public database from the World Intellectual Property Organizations and BIO Ventures for Global Health containing shared IP for the development of drugs, vaccines and diagnostics for neglected tropical diseases (see BioCentury Extra, Wednesday, Oct. 26).

Venous thromboembolic diseases (PDF file) (October 31, 2011)
NICE draft consultation on clinical practice guideline for the diagnosis and management of venous thromboembolic diseases, with comments due Dec. 21.

Product documentation (October 31, 2011)
Brilique: NICE final guidance recommending use of Brilique ticagrelor in combination with aspirin to treat acute coronary syndrome (ACS), including in patients with ST segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI); from AstraZeneca plc (LSE:AZN; NYSE:AZN). (PDF file)
Mepact: NICE final guidance recommending the use of Mepact mifamurtide in combination with postoperative multi-agent chemotherapy to treat high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection in children, adolescents and young adults; from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). (PDF file)
RoActemra: NICE final appraisal determination recommending RoActemra tocilizumab to treat systemic juvenile idiopathic arthritis in patients who have responded inadequately to NSAIDs, systemic corticosteroids or methotrexate; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, Oct. 26). (PDF file)

Anticoagulation (PDF file) (October 24, 2011)
American Academy of Orthopedic Surgeons (AAOS) updated clinical practice guidelines on reduction of blood clots after hip or knee replacement surgery, including use of anticoagulation therapy.

Anti-infectives (PDF file) (October 24, 2011)
Infectious Diseases Society of America (IDSA) letter to FDA Commissioner Margaret Hamburg voicing concerns the agency's guidelines on anti-infective clinical trials impede drug development (see BioCentury Extra, Thursday, Oct. 20).

Bioeconomy (October 24, 2011)
White House request for comment on its National Bioeconomy Blueprint, which will "harness biological research innovations to address national challenges in health, food, energy, and the environment" (see BioCentury Extra, Tuesday, Oct. 18).

Orphan drug (October 24, 2011)
FDA proposed rule seeking to clarify language in Orphan Drug regulations and propose areas of minor improvement (see BioCentury Extra, Thursday, Oct. 20).

Pneumonia (PDF files) (October 24, 2011)
Briefing documents for the Nov. 3-4 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss clinical trial design and endpoints for antibacterials to treat community-acquired bacterial pneumonia (CABP) and hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP) (see BioCentury Extra, Monday, Oct. 17).

R&D (PDF file) (October 24, 2011)
KPMG LLP report finding that pharma R&D productivity is "ineffectively assessed" and estimating the post-tax return on pharma's R&D spending dropped to less than 10% in 2010 from about 18% in 1990 (see BioCentury Extra, Thursday, Oct. 20).

Schizophrenia (PDF file) (October 24, 2011)
EMA concept paper proposing to integrate an appendix on depot preparations into its guidance on clinical investigation of medical products to treat schizophrenia.

Product documentation (October 24, 2011)
Bydureon: NICE preliminary appraisal recommending the use of Bydureon exenatide once weekly to treat Type II diabetes in dual and triple therapy regimens; from Eli Lilly and Co. (NYSE:LLY) and Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) (see BioCentury Extra, Monday, Oct. 17).

Alzheimer's (PDF file) (October 17, 2011)
CHMP draft qualification opinion concluding that low hippocampal volume is predictive of Alzheimer's disease-type dementia in patients with cognitive impairment (see BioCentury Extra, Wednesday, Oct. 12).

Anti-counterfeiting (PDF file) (October 17, 2011)
FDA guidance on adding physical-chemical identifiers to solid oral drugs to prevent counterfeiting.

Biodefense (PDF file) (October 17, 2011)
Bipartisan WMD Terrorism Research Center Bio-Response Report Card that found the U.S. unprepared to respond to a large-scale biological attack and recommended increased federal funding (see BioCentury Extra, Wednesday, Oct. 12).

Deficit reduction (October 17, 2011)
Letters from ranking House Democrats to the bipartisan deficit reduction supercommittee outlining several proposals for consideration by the committee when it drafts proposed legislation (see BioCentury Extra, Thursday, Oct. 13).

Depression (PDF file) (October 17, 2011)
CHMP guideline on developing medicinal products to treat depression.

Employment (PDF file) (October 17, 2011)
The President's Council on Jobs and Competitiveness interim report on increasing job growth in the U.S., including several measures that could spur biotech investment (see BioCentury Extra, Tuesday, Oct. 11).

Labeling (PDF file) (October 17, 2011)
FDA guidance on content and formatting of warnings and precautions, contraindications and boxed warning sections of labeling for prescription drugs and biologics.

Orphan drugs (PDF file) (October 17, 2011)
National Organization for Rare Disorders report that showed FDA exercised some type of flexibility during the reviews of 90 of the 135 non-cancer Orphan drugs approved between 1983 and June 30, 2010 (see BioCentury Extra, Tuesday, Oct. 11).

Porcine trypsin (PDF file) (October 17, 2011)
EMA concept paper on the need for a guideline on the quality of porcine trypsin used to manufacture human biological medicinal products.

Sequencing (October 17, 2011)
Free database from DNAnexus Inc. and Google Inc. (NASDAQ:GOOG) that contains DNA sequencing data from the NIH-hosted sequence read archive (see BioCentury Extra, Wednesday, Oct. 12).

Product documentation (October 17, 2011)
Azilect: Briefing documents for the Oct. 17 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee to discuss an sNDA for Azilect rasagiline to treat Parkinson's disease (PD); from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA).
Yervoy: NICE preliminary appraisal recommending against Yervoy ipilimumab to treat advanced malignant melanoma in adults who have received prior therapy; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Thursday, Oct. 13).

Bacterial infection (PDF file) (October 10, 2011)
EMA concept paper proposing an addendum to current guidance on therapies for bacterial infections to include indication-specific guidance on patient selection, endpoints and trial design.

Biomedical innovation (PDF file) (October 10, 2011)
FDA Driving Biomedical Innovation report that includes plans to define an expedited approval pathway for potential breakthrough therapies and publish draft guidance on the use of pathologic complete response (pCR) "as a surrogate endpoint for accelerated approval in primary high-risk breast cancer" (see BioCentury Extra, Wednesday, Oct. 5).

Biosimilars (PDF file) (October 10, 2011)
EMA concept paper proposing revision of guidance on non-clinical and clinical development of biosimilars (see BioCentury Extra, Monday, Oct. 3).

Devices (PDF file) (October 10, 2011)
FDA draft guidance on requirements for the de novo classification process for lower risk products that have been classified as class III devices because they were found not substantially equivalent to an approved comparator device.

Diabetes (PDF file) (October 10, 2011)
EMA draft guidance on developing products to treat and prevent diabetes, including guidelines for assessing cardiovascular risk (see BioCentury Extra, Friday, Oct. 7).

FDA (PDF files) (October 10, 2011)
Letters (1) (2) from the National Organization for Rare Diseases (NORD) and 30 other advocacy groups to FDA asking the agency to seek more patient input on benefit/risk decisions for investigational drugs and devices (see BioCentury Extra, Thursday, Oct. 6).

Flu vaccines (PDF file) (October 10, 2011)
EMA concept paper on revision of guidelines for manufacturing, non-clinical and clinical development of influenza vaccines.

Medical devices (PDF file) (October 10, 2011)
FDA's Center for Devices and Radiological Health (CDRH) report on agency's activities that support the medical device industry.

Prostate cancer (October 10, 2011)
U.S. Preventive Services Task Force (USPSTF) draft recommendation against using prostate-specific antigen (PSA)-based screening for prostate cancer in all men who do not have "highly suspicious" symptoms (see BioCentury Extra, Friday, Oct. 7).

Radiopharmaceuticals (PDF file) (October 10, 2011)
EMA guidance on information to be included in SPCs and package leaflet for radiopharmaceutical products.

Tax incentives (PDF file) (October 10, 2011)
Text of the Foreign Earnings Reinvestment Act (S.1671), which would temporarily allow U.S. companies to return foreign earnings for one year at a reduced tax rate of 8.8% (see BioCentury Extra, Thursday, Oct. 6).

Transparency (PDF file) (October 10, 2011)
FDA's Transparency Task Force report, which includes eight draft proposals to increase the transparency of its compliance and enforcement data to the public.

Venture funding (October 10, 2011)
National Venture Capital Association (NVCA) survey that found VC firms are decreasing their investments in biopharmaceutical and medical device companies and shifting investment away from the U.S. towards Europe and Asia (see Cover Story).

Product documentation (October 10, 2011)
Brilique: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Joint Committee (G-BA) preliminary benefit assessment report of Brilique ticagrelor to prevent atherothrombotic events in acute coronary syndrome patients; from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Tuesday, Oct. 4). (PDF file)
Dexdor: CHMP EPAR for Dexdor dexmedetomidine for sedation of adult intensive care unit patients; from Orion Corp. (HSE:ORNAV; HSE:ORNBV) and Hospira Inc. (NYSE:HSP).
Incivo: CHMP EPAR for Incivo telaprevir to treat HCV genotype 1 infection; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and Johnson & Johnson (NYSE:JNJ).
RoActemra: NICE draft guidance recommending the use of RoActemra tocilizumab for second-line therapy of rheumatoid arthritis; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Oct. 6).
Trajenta: CHMP EPAR for Trajenta linagliptin to treat Type II diabetes; from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY).

Breast cancer (October 3, 2011)
NICE quality standards for managing early, locally advanced and advance breast cancer.

Comparative effectiveness (PDF file) (October 3, 2011)
Kaiser Family Foundation-Avalere Health study of seven state Medicaid programs that found concluded comparative effectiveness research (CER) is not providing adequate information to assess the costs of drugs.

FDA (PDF file) (October 3, 2011)
FDA revised guidance on user fee waivers, reductions and refunds for drug and biological products.

Healthcare reform (PDF file) (October 3, 2011)
U.S. Department of Justice petition to the U.S. Supreme Court to review an appeals court decision that held the individual insurance mandate in the Patient Protection and Affordable Care Act is unconstitutional (see BioCentury Extra, Wednesday, Sept. 28).

NIH (PDF file) (October 3, 2011)
U.S. House Committee on Appropriations draft FY12 appropriations bill that would increase NIH funding by $1B, or 3% (see BioCentury Extra, Friday, Sept. 30).

Open innovation (October 3, 2011)
Website for the Open Innovation Drug Discovery program from Eli Lilly and Co. (NYSE:LLY),which will offer free compound screening to scientists or organizations outside of the company in exchange for first rights to negotiate a collaboration or licensing deal for screened candidates (see BioCentury Extra, Tuesday, Sept. 27).

Pain (PDF file) (October 3, 2011)
EMA concept paper on the need to revise the guidelines on clinical medicinal products to treat nociceptive pain and the clinical investigation of products to treat neuropathic pain.

PET (PDF file) (October 3, 2011)
FDA guidance on aseptic preparations for PET drugs.

Pharmacovigilance (PDF file) (October 3, 2011)
Summary of actions taken at the Sept. 19-21 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Transparency (October 3, 2011)
EMA European experts database, which lists declarations of interests from the agency's scientific advisors (see BioCentury Extra, Friday, Sept. 30).

Product documentation (October 3, 2011)
Benlysta: NICE preliminary appraisal recommending against Benlysta belimumab to treat patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy; from Human Genome Sciences Inc. (NASDAQ:HGSI) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Friday, Sept. 30).
Buccolam: CHMP EPAR for Buccolam midazolam to treat prolonged, acute, convulsive seizures in patients 3 months to 17 years; from ViroPharma Inc. (NASDAQ:VPHM).
Pharmalgen: NICE preliminary appraisal recommending the use of Pharmalgen to treat IgE-mediated bee and wasp venom allergy; from ALK-Abello A/S (CSE:ALK-B).
Thyrogen: CHMP revised EPAR updating SCP to include stroke as an adverse event for Thyrogen thyrotoropin alpha for use with a thyroglobulin test to monitor thyroid cancer and diagnose recurrence of thyroid cancer; from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY).
Vibativ: CHMP EPAR for Vibativ telavancin to treat nosocomial pneumonia, including ventilator-associated pneumonia known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA); from Astellas Pharma Inc. (Tokyo:4503) and Theravance Inc. (NASDAQ:THRX).
Votubia: CHMP EPAR for Votubia everolimus to treat subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis (TS) in patients 3 years or older who require therapeutic intervention but are not amenable to surgery; from Novartis AG (NYSE:NVS; SIX:NOVN).

Biosimilars (PDF files) (September 26, 2011)
Minutes from the Aug. 17 and Aug. 26 meetings between FDA and industry stakeholders for the biosimilars user fee program (see BioCentury Extra, Thursday, Sept. 22).

Breast cancer (September 26, 2011)
Website for the GE "healthymagination Challenge: Assembling Tools to Fight Cancer," in which General Electric Co. (NYSE:GE) and a group of venture capital firms are offering awards for innovation in breast cancer (see "Imagination in Quick Time").

Compliance (PDF file) (September 26, 2011)
Updated FDA guidance stating that any unapproved drug introduced onto the market after Sept. 19 will be subject to immediate enforcement action without prior notice or regard to the priorities set out in the agency's 2006 guidance.

Deficit reduction (PDF file) (September 26, 2011)
President Obama's deficit reduction plan that seeks to impose new rebates on Medicare drugs, strengthen the Independent Payment Advisory Board (IPAB), reduce the exclusivity period for innovator biologic drugs and tax carried interest as ordinary income (see BioCentury Extra, Monday, Sept. 19).

DME (September 26, 2011)
CMS questions for the March 21, 2012, meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss the anti-VEGF treatment of diabetic macular edema (see BioCentury Extra, Monday, Sept. 19).

Drug delivery (PDF file) (September 26, 2011)
FDA guidance on approaches to reduce residual drug substance in transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS) and topical patch products.

Drug prices (PDF file) (September 26, 2011)
U.S. Government Accountability Office (GAO) report on the benefits of manufacturer discounts in the 340B drug discount program and recommendations for improved federal oversight of the program.

FDA (September 26, 2011)
Washington Legal Foundation comments urging the agency to withdraw its draft guidance on the classification of drugs and devices (see BioCentury Extra, Thursday, Sept. 22).

Generics (PDF file) (September 26, 2011)
Generic Pharmaceutical Association (GPhA) report that concludes the use of generic prescription drugs in the U.S. saved consumers and the health care system $931B in 2001-10.

Patent fees (PDF file) (September 26, 2011)
U.S. Patent and Trademark Office (PTO) fee schedule that has been updated following the enactment of the Leahy-Smith America Invents Act.

Tax credit (September 26, 2011)
Text of the Greater Research Opportunities with Tax Help (GROWTH) Act (S. 1577), which would permanently extend and simplify the R&D tax credit (see BioCentury Extra, Wednesday, Sept. 21).

Toxicity (PDF file) (September 26, 2011)
FDA guidance on an approach to assess possible toxicity associated with exposure to a drug or biologic when a nonclinical finding of toxicity has been identified but definitive human data are unavailable.

Breast cancer (September 19, 2011)
Healthymagination Challenge from General Electric Co. (NYSE:GE) and four VC firms, which will provide grants worth up to $100,000 each for ideas that "advance early detection, more accurate diagnosis and targeted treatment of breast cancer" (see BioCentury Extra, Thursday, Sept. 15).

U.S. budget (PDF files) (September 19, 2011)
— Congressional Budget Office report that found Medicare spending would be cut by 2%, or $123B, over 2013-21 if Congress fails to enact the deficit reduction supercommittee's plan (see BioCentury Extra, Tuesday, Sept. 13).
Text of the Continuing Appropriations Resolutions (H.J. RES. 79), which would extend funding for government operations through Nov. 18 at a rate of 1.4% below FY11 levels (see BioCentury Extra, Thursday, Sept. 15).

CRPC (PDF file) (September 19, 2011)
FDA briefing documents from the Sept. 14 meeting of the Oncologic Drugs Advisory Committee, which agreed that therapies to treat non-metastatic castration-resistant prostate cancer (CRPC) should show at least a six-month delay in time to metastases to demonstrate efficacy (see "CRPC Hurdle").

Obesity (September 19, 2011)
NICE review proposal consultation on whether clinical guidelines for obesity should be updated.

Patents (PDF file) (September 19, 2011)
U.S. government neutral amicus brief filed to the U.S. Supreme Court arguing diagnostic method patents from Prometheus Laboratories Inc. are patent-eligible under Section 101 but not sections 102 and 103 of the Patent Act in Mayo Collaborative Services et al. v. Prometheus Laboratories Inc. (see BioCentury Extra, Tuesday, Sept. 13).

Public offerings (PDF file) (September 19, 2011)
Text of the Small Company Capital Formation Act (S. 1544), which would allow companies to raise up to $50M in public offerings over 12 months without being subject to stricter registration and paperwork (see BioCentury Extra, Thursday, Sept. 15).

Product documentation (September 19, 2011)
Brilique: NICE final appraisal determination (FAD) recommending Brilique ticagrelor in combination with aspirin to treat acute coronary syndrome (ACS); from AstraZeneca plc (LSE:AZN; NYSE:AZN). (PDF file)
Ferriprox: Briefing documents for the Sept. 14 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 10-2 that Ferriprox deferiprone has a favorable benefit-risk profile to treat transfusional iron overload when current chelation therapy is inadequate; from Apotex Inc. (see BioCentury Extra, Wednesday, Sept. 14).

AMD (PDF file) (September 12, 2011)
HHS inspector general report documenting the difference in the government's acquisition cost for Lucentis ranibizumab and Avastin bevacizumab for wet age-related macular degeneration;; both from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see "Statutorily Limited").

Bisphosphonates (September 12, 2011)
Briefing documents for the Sept. 9 joint meeting of FDA's Reproductive Health Drugs and Drug Safety and Risk Management advisory committees, which voted 17-6 to recommend further clarification on the duration of use for bisphosphonates to treat osteoporosis in the product labels (see BioCentury Extra, Friday, Sept. 9).

Pharmacovigilance (PDF files) (September 12, 2011)
— EC concept paper on implementing pharmacovigilance measures.
— EMA's Pharmacovigilance Inspectors Working Group (PhV IWG) annual report for 2010.

PML (PDF file) (September 12, 2011)
EMA proceedings from a July workshop with FDA and other stakeholders to identify research priorities for drug-related progressive multifocal leukoencephalopathy (PML) (see BioCentury Extra, Friday, Sept. 9).

Sanofi (PDF file) (September 12, 2011)
Sanofi (Euronext:SAN; NYSE:SNY) presentation to investors on Sept. 6, when the company said it expects average sales growth of at least 5% over 2012-15 (see BioCentury Extra, Tuesday, Sept. 6).

Product documentation (September 12, 2011)
Avastin: NICE preliminary appraisal recommending against Avastin bevacizumab as second-line therapy for metastatic colorectal cancer (mCRC); from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, Sept. 6).
Daxas: NICE draft guidance recommending an additional trial be conducted to assess effectiveness of Daxas roflumilast as an add-on to bronchodilator therapy in adults with severe chronic obstructive pulmonary disease (COPD); from Merck & Co. Inc. (NYSE:MRK) and Nycomed (see BioCentury Extra, Thursday, Sept. 8).
Erbitux: NICE preliminary appraisal recommending against Erbitux cetuximab as second-line therapy for metastatic colorectal cancer (mCRC); from Merck KGaA (Xetra:MRK) (see BioCentury Extra, Tuesday, Sept. 6).
Mepact: NICE draft guidance recommending Mepact mifamurtide in combination with postoperative multi-agent chemotherapy to treat high-grade resectable non-metastatic osteosarcoma; from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Tuesday, Sept. 6). (PDF file)
Rivaroxaban: Briefing documents for the Sept. 8 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 9-2, with one abstention, to recommend approval of rivaroxaban to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation from Bayer AG (Xetra:BAY) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, Sept. 8).
Vectibix: NICE preliminary appraisal recommending against Vectibix panitumumab as second-line therapy for metastatic colorectal cancer (mCRC); from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Tuesday, Sept. 6).

ADHD (PDF file) (September 5, 2011)
NICE review consultation to update clinical guidelines for ADHD patients.

Alcohol dependence (September 5, 2011)
NICE guideline on quality standards for treatment of alcohol dependence.

Clinical trials (PDF file) (September 5, 2011)
FDA draft guidance on developing risk-based monitoring strategies and plans for investigational studies to enhance human subject protection and quality of clinical trial data.

Labeling (PDF file) (September 5, 2011)
Citizen's Petition from Public Citizen asking FDA to allow generic drug manufacturers to independently change a drug's label (see BioCentury Extra, Thursday, Sept. 1).

Patents (PDF file) (September 5, 2011)
U.S. Court of Appeals for the Federal Circuit opinion finding that two of three disputed patents from Classen Immunotherapies Inc. are patent-eligible. The patents claim methods for evaluating and improving the safety of immunization schedules. CAFC acted after reconsidering Classen Immunotherapies Inc. v. Biogen Idec et al. on remand from the U.S. Supreme Court (see BioCentury Extra, Wednesday, Aug. 31).

PDUFA (PDF file) (September 5, 2011)
Draft of the PDUFA reauthorization deal FDA negotiated with the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), which would impose a new 60-day filing review period for NDAs (see BioCentury Extra, Thursday, Sept. 1).

Biosimilars (PDF file) (August 29, 2011)
Minutes from the July 29 meeting between FDA and public stakeholders for the user fee program for biosimilars.

Cancer (August 29, 2011)
NIH's National Cancer Institute Provocative Questions project, which will award up to $17.5M to projects aimed at solving problems for cancer treatment (see BioCentury Extra, Friday, Aug. 26).

CMS (PDF file) (August 29, 2011)
CMS bundled payment system for multiple services, including Part B drugs, which a patient receives during an "episode of care" (see BioCentury Extra, Tuesday, Aug. 23).

EMA (PDF file) (August 29, 2011)
Minutes of the June 16 annual joint meeting of EMA's Patients/Consumers Working Party (PCWP) and Healthcare Professionals Working Group (HCP WG).

Hypertension (PDF file) (August 29, 2011)
NICE updated guideline on the diagnosis and treatment of hypertension.

Multiple sclerosis (August 29, 2011)
NICE draft guidance recommending only research use of percutaneous venoplasty for chronic cerebrospinal venous insufficiency in MS patients until further evidence on its safety and clinical efficacy can be developed.

Pharma excise tax (August 29, 2011)
Internal Revenue Services (IRS) temporary regulations that will continue to require that manufacturers claim the Orphan Drug Act tax credit in order for a drug to qualify for exclusion of its sales from calculations that determine a manufacturer's total annual pharmaceutical fee liability.

Safety (PDF file) (August 29, 2011)
FDA guidance on content and formatting for submissions of developmental safety update reports (DSUR), which set a common standard for periodic reporting on drugs under development among International Conference on Harmonisation (ICH) regions.

Tropical diseases (PDF file) (August 29, 2011)
FDA draft guidance for developing drugs to treat or prevent neglected tropical diseases of the developing world (see BioCentury Extra, Tuesday, Aug. 23).

Vaccines (August 29, 2011)
Institute of Medicine (IOM) report that found "few" health problems are caused by or clearly associated with vaccines (see BioCentury Extra, Thursday, Aug. 25).

Product documentation (August 29, 2011)
-- Faslodex: U.K.'s NICE preliminary appraisal recommending against Faslodex fulvestrant as an alternative to aromatase inhibitors to treat hormone-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women whose cancer has relapsed; from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Monday, Aug. 22).
-- Orencia: NICE final guidance recommending against Orencia abatacept in combination with methotrexate to treat moderate to severe rheumatoid arthritis (RA) in adults whose disease has responded inadequately to other disease-modifying anti-rheumatic drugs (DMARDs); from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
-- Simponi: NICE final guidance recommending Simponi golimumab to treat ankylosing spondylitis in patients who have active spinal disease and have failed treatments with at least two NSAIDs; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). (PDF file)
-- Sutent: CHMP revised EPAR updating SPC to include information on thyroid dysfunction and early- and late-onset anemia for Sutent sunitinib to treat gastrointestinal stromal tumors (GIST), metastatic renal cell carcinoma (RCC) and pancreatic neuroendocrine tumors; from Pfizer Inc. (NYSE:PFE).
-- TOBI Podhaler: CHMP EPAR for TOBI Podhaler tobramycin inhaled powder (TIP) to treat Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients; from Novartis AG (NYSE:NVS; SIX:NOVN).

Branded drugs (PDF file) (August 22, 2011)
HHS Inspector General report finding that higher rebates for branded drugs led to lower costs for Medicaid compared to Medicare Part D.

Compliance (PDF file) (August 22, 2011)
FDA notice of a Sept. 19-21 meeting to discuss strategies and approaches for ensuring quality and regulatory compliance in the development of medical products.

EMA (PDF file) (August 22, 2011)
Minutes for the June 8-9 meeting EMA's Management Board.

Healthcare outcomes (August 22, 2011)
NICE notice seeking comments on the proposed library of quality standard topics on national healthcare.

Healthcare reform (PDF file) (August 22, 2011)
Opinion from a three-judge panel in the U.S. Court of Appeals for the Eleventh Circuit, which ruled 2-1 the individual insurance mandate provision in the Patient Protection and Affordable Care Act is unconstitutional (see BioCentury Extra, Monday, Aug. 15).

Imaging (PDF file) (August 22, 2011)
FDA draft guidance recommending procedures for collecting and interpreting medical images in efficacy trials of drug or biologic candidates (see BioCentury Extra, Friday, Aug. 19).

Influenza (PDF files) (August 22, 2011)
EMA guidance on quality aspects of the isolation of candidate influenza vaccine viruses in cell culture and an overview of comments received.

Medical devices (PDF file) (August 22, 2011)
FDA draft guidance clarifying how the agency determines the risk-benefit profile of a medical device during a premarket review (see BioCentury Extra, Monday, Aug. 15).

Regulatory science (PDF file) (August 22, 2011)
FDA's Strategic Plan for Regulatory Science identifying eight priorities to improve the prediction of product safety (see BioCentury Extra, Wednesday, Aug. 17).

Product documentation (August 22, 2011)
Pradaxa: NICE preliminary appraisal requesting additional data on use of Pradaxa dabigatran etexilate to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation; from Boehringer Ingelheim GmbH (see BioCentury Extra, Tuesday, Aug. 16).
Protopic: CHMP revised EPAR updating SPC to include local skin infection, application site edema and folliculitis as postmarketing adverse events for Protopic tacrolimus to treat moderate to severe atopic dermatitis; from Astellas Pharma Inc. (Tokyo:4503).
Forsteo: CHMP revised EPAR updating SPC to include nephrolithiasis as an adverse drug reaction and to revise frequencies of listed adverse drug reactions for Forsteo teriparatide to treat osteoporosis; from  Eli Lilly and Co. (NYSE:LLY).
Nexavar: CHMP revised EPAR updating SPC to include data from a Phase III trial that showed higher mortality in a subset of patients with squamous cell carcinoma of the lung who received platinum-based chemotherapies and Nexavar sorafenib, which is approved to treat hepatocellular carcinoma; from Bayer AG (Xetra:BAY) and Onyx Pharmaceuticals Inc. (NASDAQ:ONXX).
Tasigna: NICE final appraisal determination recommending Tasigna nilotinib to treat chronic myelogenous leukemia (CML) in patients resistant or intolerant to the standard 400 mg dose of imatinib; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Wednesday, Aug. 17). (PDF file)
Xgeva: CHMP EPAR for Xgeva denosumab to prevent skeletal related events in adults with bone metastases from solid tumors; from Amgen Inc. (NASDAQ:AMGN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568).

Biomarkers (PDF files) (August 15, 2011)
FDA guidance outlining the context, structure and format of biomarker qualification submissions (see BioCentury Extra, Thursday, Aug. 11).
U.K.'s Human Genetics Commission report recommending U.K. research councils and other funding agencies review their licensing requirements for gene and biomarker patents (see BioCentury Extra, Monday, Aug. 8).

Biosimilars (PDF file) (August 15, 2011)
Minutes from the July 11 meeting between FDA and industry stakeholders for the 351(k) user fee program for biosimilars (see BioCentury Extra, Monday, Aug. 8).

Clinical trials (PDF files) (August 15, 2011)
EMA draft reflection papers (1) (2) on risk-based quality management and use of interactive response technologies in clinical trials.

Compliance (PDF file) (August 15, 2011)
EMA list of all products with centralized marketing authorization that require a notification of change before an update can be made to annexes of the label.

Influenza (PDF files) (August 15, 2011)
EMA guidance on content of variation applications for live attenuated influenza vaccines, and overview of comments received.

M&A (PDF file) (August 15, 2011)
HBM Partners report on biotech and pharma M&A activity in 1H11 (see BioCentury Extra, Friday, Aug. 12).

PMDD (PDF files) (August 15, 2011)
EMA guideline for treatment of premenstrual dysphoric disorder (PMDD), and overview of comments received.

Product documentation (August 15, 2011)
Avastin: CHMP revised EPAR updating SPC to revise wording on congestive heart failure to include an increased incidence of CHF with a cumulative doxorubicin dose greater than 300 mg/m2 for Avastin bevacizumab to treat breast cancer, non-small cell lung cancer (NSCLC) and metastatic renal cell cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).
Integrilin: CHMP revised EPAR updating SPC to include information about potential immune related thrombocytopenia for Integrilin eptifibatide to prevent a myocardial infarction; from Merck & Co. Inc. (NYSE:MRK).
RoActemra: NICE preliminary appraisal asking for additional data on the use of RoActemra tocilizumab to treat systemic juvenile idiopathic arthritis in patients who have responded inadequately to NSAIDs, systemic corticosteroids and methotrexate; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, Aug. 9).
Sycrest: CHMP revised EPAR updating SPC to include information on hypersensitivity reactions with Sycrest asenapine to treat moderate to severe manic episodes associated with bipolar I disorder; from Merck & Co. Inc. (NYSE:MRK).

Angina (PDF file) (August 8, 2011)
Updated NICE guidelines for treatment of stable angina, recommending use of anti-anginal drug therapy to lower cardiovascular risk prior to revascularization procedures.

Biosimilars (August 8, 2011)
FDA article published in New England Journal of Medicine reiterating plans for a two-step regulatory process for biosimilars that includes evaluating similarity and then interchangeability (see BioCentury Extra, Wednesday, Aug. 3).

Good clinical practice (PDF file) (August 8, 2011)
FDA and EMA report on results of the pilot EMA-FDA good clinical practice (GCP) initiative to share information on inspections and GCP-related documents and to conduct collaborative inspections.

Manufacturing (PDF file) (August 8, 2011)
Australian Therapeutic Goods Administration (TGA), FDA and EMA report on the collaboration between the agencies on GMP inspections of active pharmaceutical ingredient (API) manufacturers.

Medicare Part D (August 8, 2011)
— CMS report showing that Medicare Part D doughnut hole discounts under the Patient Protection and Affordable Care Act have saved $461M through June 2011 (see BioCentury Extra, Thursday, Aug. 4).
— Government Accountability Office (GAO) report that found almost 90% of mid-year formulary changes to Medicare Part D plans in 2008-09 resulted in the addition of a drug to the formulary or increased access to an existing drug (see BioCentury Extra, Wednesday, Aug. 3). (PDF file)

PDUFA (PDF file) (August 8, 2011)
FDA prescription drug user fee rates for fiscal year 2012.

PET (PDF file) (August 8, 2011)
FDA guidance on current good manufacturing practice for PET drugs.

Pharmacovigilance (PDF file) (August 8, 2011)
Summary of actions taken at the July 18-20 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Plasma products (PDF files) (August 8, 2011)
EMA guidelines on clinical investigation of recombinant and human plasma-derived Factor VIII and Factor IX products.

Product documentation (August 8, 2011)
Avastin: CDER's summary of its arguments for its conclusion it would be "inappropriate" to permit continued approval of Avastin bevacizumab for metastatic breast cancer with a narrower label and REMS while a new confirmatory trial is conducted; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Friday, Aug. 5).
Fampyra: CHMP EPAR for Fampyra fampridine to improve walking ability in patients with multiple sclerosis (MS); from Biogen Idec Inc. (NASDAQ:BIIB), Acorda Therapeutics Inc. (NASDAQ:ACOR), and Elan Corp. plc (NYSE:ELN).
Gilenya: NICE preliminary appraisal recommending against the use of Gilenya fingolimod to treat relapsing-remitting multiple sclerosis (RRMS); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Aug. 4).
Halaven: National Comprehensive Cancer Network (NCCN) guideline recommending use of Halaven eribulin as a preferred single agent option to treat of metastatic breast cancer; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Tuesday, Aug. 2). (PDF file)
Victrelis: CHMP EPAR for Victrelis boceprevir to treat chronic HCV genotype 1 infection; from Merck & Co. Inc. (NYSE:MRK).
Xgeva: National Comprehensive Cancer Network (NCCN) guideline recommending use of Xgeva denosumab in breast cancer patients with bone metastases from solid tumors to prevent skeletal-related events (SREs); from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Tuesday, Aug. 2). (PDF file)

CHMP (PDF file) (August 1, 2011)
Detailed report of actions taken at the July 18-21 monthly meeting of EMA's CHMP.

Conflict of interest (August 1, 2011)
Eli Lilly and Co. (NYSE:LLY) registry of payments made to U.S. physicians.

COPD (August 1, 2011)
NICE guideline on quality standards for treatment of chronic obstructive pulmonary disease (COPD).

Devices (August 1, 2011)
— FDA guidance on when to submit a 510(k) for changes made to a previously cleared medical device. (PDF file)
Institute of Medicine report that concludes the 510(k) process lacks the legal basis to be a reliable premarket screen of safety and effectiveness (see BioCentury Extra, Friday, July 29).

Drug delivery (PDF file) (August 1, 2011)
EMA draft reflection paper on data required for IV liposomal products developed with reference to an innovator product.

EMA (PDF file) (August 1, 2011)
EMA draft guideline on stability testing data needed to support a variation to a marketing authorization.

Patents (PDF file) (August 1, 2011)
U.S. Court of Appeals for the Federal Circuit opinion that the composition patents held by Myriad Genetics Inc. (NASDAQ:MYGN) covering the breast cancer 1 early onset (BRCA1) and BRCA2 genes are valid, overturning a 2010 ruling by a lower court (see BioCentury Extra, Friday, July 29).

Regulatory science (PDF file) (August 1, 2011)
FDA's CDER Science Prioritization and Review Committee report on regulatory science priorities for the center (see BioCentury Extra, Monday, July 25).

Safety (PDF file) (August 1, 2011)
EMA concept paper on the need to revise the guideline on non-clinical local tolerance testing of medicinal products.

Product documentation (August 1, 2011)
Ambulight: NICE final guidance concluding there is not yet sufficient evidence to recommend adoption of Ambulight photodynamic therapy over current PDT to treat non-melanoma skin cancer; from Ambicare Health Ltd. (PDF file)
Angiomax: NICE final guidance recommending Angiox bivalirudin in combination with aspirin and clopidogrel to treat ST-segment elevation myocardial infarction (STEMI) in adults undergoing primary percutaneous coronary intervention (PCI); from The Medicines Co. (NASDAQ:MDCO). (PDF file)
Elucigene: NICE draft guidance recommending against the use of the Elucigene FH20 genetic test to confirm a clinical diagnosis of familial hypercholesterolemia (FH) or for the screening of relatives for FH; from Gen-Probe Inc. (NASDAQ:GPRO) (see BioCentury Extra, Monday, July 25). (PDF file)
LIPOchip: NICE draft guidance recommending against the use of the LIPOchip genetic test to confirm a clinical diagnosis of familial hypercholesterolemia (FH) or for the screening of relatives for FH; from Progenika Biopharma S.A. (see BioCentury Extra, Monday, July 25). (PDF file)
Ozurdex: NICE final guidance recommending use Ozurdex dexamethasone intravitreal implant to treat macular edema following central retinal vein occlusion (CRVO) and following branch retinal vein occlusion (BRVO) when laser photocoagulation is not beneficial or suitable; from Allergan Inc. (NYSE:AGN). (PDF file)
Sustiva: CHMP revised EPAR updating SPC to include information on the incidence of neural tube defects in infants exposed during the first trimester of pregnancy to Sustiva efavirenz to treat HIV infection; from Bristol-Myers Squibb Co. (NYSE:BMY) and Merck & Co. Inc. (NYSE:MRK).
Thalidomide Celgene: NICE final guidance recommending the use of Thalidomide Celgene for first-line treatment of multiple myeloma (MM); from Celgene Corp. (NASDAQ:CELG). (PDF file)
Trizivir: CHMP revised EPAR updating SPC to include a warning against concomitant use of Trizivir abacavir/lamivudine/zidovudine to treat HIV infection and other products containing lamivudine or emtricitabine; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Velcade: NICE final guidance recommending the use Velcade bortezomib for first-line treatment of multiple myeloma (MM) when patients are unable to receive the more cost-effective thalidomide; from Johnson & Johnson (NYSE:JNJ). (PDF file)
Yervoy: CHMP EPAR for Yervoy ipilimumab to treat unresectable or metastatic melanoma in adults who have received prior therapy; from Bristol-Myers Squibb Co. (NYSE:BMY).

Clinical trials (PDF file) (July 25, 2011)
HHS notice seeking comments on how regulations for protecting human subjects in research can revised to be more effective (see BioCentury Extra, Friday, July 22).

Chronic diseases (July 25, 2011)
Institute of Medicine report recommending HHS adopt a framework for national surveillance of cardiovascular and chronic lung disease.

Drug pricing (PDF file) (July 25, 2011)
Stakeholder comments received during U.K. Department of Health's consultation on DOH's proposed value-based pricing system (see BioCentury Extra, Monday, July 18).

Healthcare reform (July 25, 2011)
Institute of Medicine report recommending HHS add eight preventive services for women to the list of services covered at no cost under the Patient Protection and Affordable Care Act (see BioCentury Extra, Wednesday, July 20).

Influenza (PDF file) (July 25, 2011)
FDA guidance on establishing performance characteristics of in vitro diagnostics for detection and differentiation of influenza viruses.

Mobile apps (PDF file) (July 25, 2011)
FDA draft guidance on how the agency intends to apply its regulatory authorities to mobile applications for medical use.

Patents (PDF file) (July 25, 2011)
U.S. Patent and Trademark Office (PTO) notice proposing to revise the standard for materiality for the duty to disclose information in patent applications and reexamination proceedings in light of the decision by the U.S. Court of Appeals for the Federal Circuit in Therasense Inc. v. Becton Dickinson and Co. (see BioCentury Extra, Thursday, May 26).

Regenerative medicine (July 25, 2011)
U.K. Department of Health's report on the need for new funding from private, non-profit and public sectors to maintain the U.K.'s role in regenerative medicine.

Product documentation (July 25, 2011)
Cinryze: CHMP EPAR for Cinryze for the acute treatment and pre-procedure and routine prevention of angioedema attacks in hereditary angioedema (HAE) patients who are intolerant to or insufficiently protected by oral prevention treatments or who are inadequately managed with repeated acute treatment; from ViroPharma Inc. (NASDAQ:VPHM).
Halaven: NICE preliminary appraisal recommending against the use of Halaven eribulin to treat locally advanced or metastatic breast cancer in patients whose disease has progressed after two or more chemotherapy regimens; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Monday, July 18).
Remicade: Briefing documents for the July 21 meeting of FDA's Gastrointestinal Drugs Advisory Committee, which backed approval of Remicade infliximab for three of the five claims for pediatric ulcerative colitis (UC); from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, July 21).

Alzheimer's disease (PDF file) (July 18, 2011)
Alzheimer's Association working group recommendations to ease restrictions on the enrollment of patients who have MRI-detected brain abnormalities in trials of AD candidates targeting beta amyloid (see BioCentury Extra, Wednesday, July 13).

Anaphylaxis (PDF file) (July 18, 2011)
NICE draft clinical guideline on best practices for care of patients following emergency treatment for suspected anaphylaxis.

Biomarkers (PDF file) (July 18, 2011)
CHMP draft reflection paper on methodological issues associated with pharmacogenomic biomarkers related to clinical development and patient selection.

Biosimilars (PDF file) (July 18, 2011)
Minutes from the June 15 meeting between FDA and industry stakeholders for the 351(k) user fee program for biosimilars (see BioCentury Extra, Wednesday, July 13).

Diagnostics (July 18, 2011)
FDA draft guidance on developing in vitro companion diagnostics.

Health technology assessment (PDF file) (July 18, 2011)
Charles River Associates comparative analysis of health technology assessment (HTA) programs in 15 countries, including Canada, France, Germany and the U.K. (see BioCentury Extra, Wednesday, July 13).

Infectious diseases (PDF file) (July 18, 2011)
NICE draft clinical guidelines on prevention and control of healthcare-associated infections in primary and community care settings.

Manufacturing (PDF file) (July 18, 2011)
FDA notice on the availability of grants for the Critical Path Manufacturing Sector Research Initiative. The cooperative agreement with the National Institute for Pharmaceutical Technology and Education Initiative (NIPTE) will fund research to improve pharmaceutical manufacturing and quality.

Product documentation (July 18, 2011)
Adcetris: FDA briefing documents for the July 14 meeting of the Oncologic Drugs Advisory Committee, which unanimously recommended accelerated approval of Adcetris brentuximab vedotin to treat patients with Hodgkin's lymphoma who relapse after autologous stem cell transplant and to treat patients with anaplastic large cell lymphoma (ALCL); from Seattle Genetics Inc. (NASDAQ:SGEN) (see Cover Story).
Dapagliflozin: Briefing documents for the July 19 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss an NDA for dapagliflozin to treat Type II diabetes; from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Friday, July 15).
Lucentis: NICE final appraisal determination recommending against Lucentis ranibizumab to treat diabetic macular edema (DME); from Novartis AG (NYSE:NVS; SIX:NOVN) and Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, July 14). (PDF file)

Advanced therapies (PDF files) (July 11, 2011)
Summary of actions taken at the March 10-11 and June 16-17 meetings of EMA's Committee for Advanced Therapies (CAT).

CHMP (PDF file) (July 11, 2011)
Detailed report of actions taken at the June 20-23 monthly meeting of EMA's CHMP.

Dialysis (PDF file) (July 11, 2011)
CMS proposed rule that would change the way dialysis centers' performance is measured under the quality incentive program that links payments to performance (see BioCentury Extra, Tuesday, July 5).

Generics (July 11, 2011)
Paper from researchers at CVS Caremark Corp. (NYSE:CVS) and Brigham and Women's Hospital on cost-effectiveness of generics and their impact on preventative and healthcare costs for chronic diseases.

Infectious diseases (PDF file) (July 11, 2011)
NICE draft advice on preventing and controlling healthcare-associated infections in secondary care settings.

Innovation (PDF file) (July 11, 2011)
NHS call for evidence on how the adoption and diffusion of innovations can be accelerated across the agency.

Multiple sclerosis (PDF file) (July 11, 2011)
CHMP concept paper on the need to revise the guideline on clinical investigation of medicinal products to treat MS.

Muscular dystrophy (PDF file) (July 11, 2011)
CHMP concept paper on the need for a guideline on the treatment of Duchenne and Becker muscular dystrophy.

Stem cells (PDF file) (July 11, 2011)
Text of the Stem Cell Research Advancement Act (H.R. 2376), which would codify NIH guidelines for conducting human embryonic and adult stem cell research (see BioCentury Extra, Tuesday, July 5).

Product documentation (July 11, 2011)
Lucentis: Decision by the Patents Court of the Chancery Division of the U.K. High Court of Justice, which ruled that two patents covering a phage display screening method from the MedImmune LLC subsidiary of AstraZeneca plc (LSE:AZN; NYSE:AZN) are invalid due to obviousness and are not infringed upon by Lucentis ranibizumab to treat wet age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO); from Novartis AG (NYSE:NVS; SIX:NOVN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, July 6). (PDF file)
Nulojix: CHMP EPAR for Nulojix belatacept to prevent renal transplant rejection; from Bristol-Myers Squibb Co. (NYSE:BMY).
Torisel: CHMP revised EPAR updating SPC to include information about increased rate of fatal events in patients with moderate and severe hepatic impairment for Torisel temsirolimus to treat advanced renal cell carcinoma (RCC) and mantle cell lymphoma (MCL); from Pfizer Inc. (NYSE:PFE).

Healthcare reform (PDF file) (July 4, 2011)
Opinion from a three-judge panel in the U.S. Circuit Court of Appeals, which ruled 2-1 to uphold the constitutionality of the individual insurance mandate provision in the Patient Protection and Affordable Care Act (PPACA) (see BioCentury Extra, Wednesday, June 29).

Heart failure (PDF file) (July 4, 2011)
NICE guideline on quality standards for assessment, diagnosis and clinical management of chronic heart failure in adults.

Manufacturing (PDF file) (July 4, 2011)
FDA draft guidance on developing and manufacturing drug substances.

Pain (July 4, 2011)
Institute of Medicine report on pain management and prevention, which suggests that FDA, NIH and industry work together to develop new and faster ways to evaluate and approve new pain therapies (see BioCentury Extra, Wednesday, June 29).

Transparency (July 4, 2011)
Report from the EMD Serono Inc. unit of Merck KGaA (Xetra:MRK) on payments made to physicians in 1Q11.

Product documentation (July 4, 2011)
Brilique: NICE preliminary appraisal recommending the use of Brilique ticagrelor in combination with aspirin to treat acute coronary syndrome (ACS), including those with ST segment elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI); from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Thursday, June 30).
Herceptin: NICE final appraisal determination (FAD) recommending against Herceptin trastuzumab in combination with an aromatase inhibitor for first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit (see BioCentury Extra, Thursday, June 30). (PDF file)
Tarceva: NICE final guidance recommending against Tarceva erlotinib for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with stable disease after platinum-based first-line chemotherapy; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, June 28). (PDF file)
Tyverb: NICE final appraisal determination (FAD) recommending against Tyverb lapatinib in combination with an aromatase inhibitor for first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, June 30). (PDF file)

CHMP (PDF file) (June 27, 2011)
Summary of actions taken at the June 20-23 meeting of EMA's CHMP.

Drug labeling (PDF file) (June 27, 2011)
U.S. Supreme Court decision in Pliva Inc., et al. v. Mensing, ruling 5-4 that FDA approved labeling for generic drugs preempts claims under state tort law because federal regulations prevent generic drug manufacturers from independently changing a drug's label (see BioCentury Extra, Thursday, June 23).

Drug pricing (PDF file) (June 27, 2011)
U.K. National Health System Future Forum report that states NHS would be mandated to "consistently fund medicines with a value-based price" under a planned value-based pricing (VBP) system, and a response to the report by U.K. Department of Health (see BioCentury Extra, Monday, June 20).

Drug safety (PDF file) (June 27, 2011)
FDA plan to ensure safety and quality of imported products in response to rapidly rising imports of FDA-regulated products (see BioCentury Extra, Wednesday, June 22).

FDA/EMA (PDF file) (June 27, 2011)
EMA and FDA joint report on their interactions from September 2009-10 (see BioCentury Extra, Friday, June 24).

NSCLC (PDF file) (June 27, 2011)
FDA draft guidance on clinical trial endpoints for approval of advanced and metastatic non-small cell lung cancer drugs and biologics (see BioCentury Extra, Monday, June 20).

Prescription information (PDF file) (June 27, 2011)
U.S. Supreme Court decision in Sorrell v. IMS Health Inc., ruling 6-3 that states may not prohibit the use of information about physician healthcare practices in the marketing of medicines.

Product documentation (June 27, 2011)
BRAHMS: NICE final guidance noting additional trials are needed to support adoption of BRAHMS copeptin assay in combination with cardiac troponin testing to rule out myocardial infarction (MI) in patients presenting with acute chest pain; from Thermo Fisher Scientific Inc. (NYSE:TMO). (PDF file)
Firazyr: Briefing documents for the June 23 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 12-1 that the efficacy and safety data for Firazyr icatibant support approval to treat acute attacks of hereditary angioedema (HAE) in adults; from Shire plc (LSE:SHP; NASDAQ:SHPGY) (see "Firazyr Tips the Scales").
Leganto: CHMP EPAR for Leganto rotigotine to treat symptoms of Parkinson's disease and moderate to severe restless legs syndrome (RLS); from UCB Group (Euronext:UCB).
MabThera: NICE final guidance recommending MabThera rituximab as a first-line maintenance therapy for follicular non-Hodgkin's lymphoma (NHL) in patients who respond to first-line induction therapy with rituximab in combination with chemotherapy; from Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Orencia: NICE final appraisal determination recommending against Orencia abatacept as second-line therapy in combination with methotrexate to treat moderate to severe rheumatoid arthritis (RA); from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Thursday, June 23). (PDF file)
Revatio: CHMP revised EPAR updating SPC to expand the label for Revatio sildenafil to include treatment of pulmonary arterial hypertension (PAH) in patients aged 1-17 years; from Pfizer Inc. (NYSE:PFE).
Simponi: NICE final appraisal determination recommending Simponi golimumab to treat ankylosing spondylitis in patients who have active spinal disease and have failed treatments with at least two NSAIDs; from Merck & Co. Inc. (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, June 23), plus a NICE final guidance recommending Simponi in combination with methotrexate to treat rheumatoid arthritis (RA) in adults who have an inadequate response to previous DMARD therapy. (PDF files)

Cancer drugs (PDF file) (June 20, 2011)
Data published in Health Affairs by not-for-profit Friends of Cancer Research showing that the approval process for new cancer drugs in the U.S. was almost twice as fast as in Europe between 2003-10 (see BioCentury Extra, Friday, June 17).

Comparative effectiveness (PDF file) (June 20, 2011)
U.S. Government Accountability Office (GAO) report listing HHS awards for comparative effectiveness research funded by the American Recovery and Reinvestment Act and Patient Protection and Affordable Care Act.

Diagnostics (PDF file) (June 20, 2011)
FDA draft guidance on establishing performance characteristics of in vitro diagnostic devices intended to detect methicillin-resistant Staphylococcus aureus using culture based methods.

FDA (PDF file) (June 20, 2011)
U.S. House of Representatives FY12 budget (H.R. 2112), which would reduce overall FDA spending by 11.5% compared to FY11 and would lower appropriations for drugs and biologics oversight (see BioCentury Extra, Friday, June 17).

Hepatitis (PDF file) (June 20, 2011)
U.S. Department of Health and Human Services action plan for the prevention, care and treatment of viral hepatitis (see Cover Story).

Orphan drugs (PDF file) (June 20, 2011)
Summary of actions taken at the June 8-10 plenary meeting of EMA's COMP.

Patents (PDF files) (June 20, 2011)
Annual report on the activities of India's Controller General of Patent Designed and Trademarks, finding the number of biotechnology and drug patents granted or filed in India during 2009-10 declined compared to 2008-09 (see BioCentury Extra, Thursday, June 16).
— U.K.'s second consultation on its proposed extension of its "patent box" corporate tax incentive to cover all active patents and a second consultation on expansion of the R&D tax credit program for U.K. businesses (see BioCentury Extra, Tuesday, June 14).

Pharmacovigilance (PDF file) (June 20, 2011)
EMA's Pharmacovigilance Working Party (PhVWP) 2011 work plan.

Translational science (June 20, 2011)
Award recipients of NIH's Clinical and Translational Science Awards (CTSA) program to fund translation research (see BioCentury Extra, Tuesday, June 14).

Product documentation (June 20, 2011)
Eylea: Briefing documents for the June 17 meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee, which voted 10-0 that available safety and efficacy data are adequate for approval of Eylea aflibercept (VEGF Trap-Eye) to treat wet age-related macular degeneration (AMD); from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Bayer AG (Xetra:BAY) (see BioCentury Extra, Friday, June 17).
Ilaris: Briefing documents for the June 21 meeting of FDA's Arthritis Advisory Committee meeting to discuss an sBLA for Ilaris canakinumab to treat gouty arthritis attacks in patients who cannot obtain an adequate response with NSAIDs or colchicine; from Bristol-Myers Squibb Co. (NYSE:BMY) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, June 17).
Plavix: CHMP revised EPAR updating SPC to include information about all-cause mortality and shunt-related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt for Plavix clopidogrel to prevent atherothrombotic events after recent myocardial infarction (MI), stroke, established peripheral arterial disease (PAD), atrial fibrillation (AF) or acute coronary syndrome (ACS); from Bristol-Myers Squibb Co. (NYSE:BMY) and Sanofi (Euronext:SAN; NYSE:SNY).
Tyverb: CHMP revised EPAR updating SPC to include information on the effects of long-acting acid-lowering agents on Tyverb lapatinib to treat metastatic breast cancer patients whose tumors overexpress HER2; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Yellox: CHMP EPAR for Yellox bromfenac to treat postoperative ocular inflammation following cataract extraction; from Croma-Pharma GmbH, Ista Pharmaceuticals Inc. (NASDAQ:ISTA) and Senju Pharmaceutical Co. Ltd.

Citizen Petitions (PDF file) (June 13, 2011)
FDA guidance on Citizen Petitions and petitions for stay of action for pending applications submitted under sections 505(b)(2) or 505(j) of the Food, Drug and Cosmetic Act.

Diagnostics (PDF file) (June 13, 2011)
NICE draft manual for its Diagnostics Assessment Programme (DAP).

Drug safety (PDF file) (June 13, 2011)
FDA guidance on enforcement of safety reporting requirements for IND applications and bioavailability/bioequivalence studies.

Intellectual property (June 13, 2011)
Letter to Reps. David Dreier (R-Calif.) and Louise Slaughter (D-N.Y.), chairman and ranking member of the House Committee on Rules, respectively, from 50 House members requesting time to debate the constitutionality of patent reform bill H.R. 1249, the America Invents Act (see BioCentury Extra, Tuesday, June 7). (PDF file)
— U.S. Supreme Court decision in Board of Trustees of the Leland Stanford Junior University v. Roche Molecular Systems Inc. et al., which ruled 7-2 that the Bayh-Dole Act does not automatically grant ownership of federally funded research to universities (see BioCentury Extra, Monday, June 6). (PDF file)
— U.S. Supreme Court opinion in Microsoft Corp. v. i4i Limited Partnership, et al., ruling 8-0 that the invalidity of a patent must be proven by clear and convincing evidence (see BioCentury Extra, Thursday, June 9). (PDF file)

Nanotechnology (June 13, 2011)
FDA draft guidance on considering whether an FDA-regulated product contains nanomaterials or otherwise involve the application of nanotechnology.

Off-label use (PDF file) (June 13, 2011)
U.K. General Medicine Council draft guidance on good practice in prescribing medicines and devices, which notes the cost of a medicine can be considered when prescribing a drug off-label for an indication in which a licensed alternative is available (see BioCentury Extra, Tuesday, June 7).

Pediatrics (PDF file) (June 13, 2011)
U.S. Government Accountability Office (GAO) report on pediatric studies conducted since the reauthorization of the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA), recommending that FDA track applications during its review process and maintain aggregate data on applications subject to the legislation.

Proteins (PDF file) (June 13, 2011)
EMA draft concept paper addressing the need for a guideline on process validation of medicinal products containing biotechnology derived proteins as an active substance.

Product documentation (June 13, 2011)
— Colcrys: Letter to URL Pharma Inc. from Sen. Sherrod Brown (D-Ohio) urging the company to re-evaluate the price of Colcrys colchicine to treat gout; and a letter asking CMS Director Donald Berwick to investigate the pricing of Colcrys (see BioCentury Extra, Tuesday, June 7). (PDF files)
Effient: CHMP revised EPAR updating SPC to include information about hypersensitivity, including angioedema, thrombotic thrombocytopenic purpura and thrombocytopenia for Effient prasugrel to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention; from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Eli Lilly and Co. (NYSE:LLY).
Hizentra: CHMP EPAR for Hizentra human immune globulin as replacement therapy in patients with primary or secondary immunodeficiencies; from CSL Ltd. (ASX:CSL).
Ozurdex: NICE final appraisal determination (FAD) recommending use of Ozurdex dexamethasone intravitreal implant to treat macular edema following central retinal vein occlusion (CRVO) and following branch retinal vein occlusion (BRVO) when laser photocoagulation is not beneficial or suitable; from Allergan Inc. (NYSE:AGN) (see BioCentury Extra, Monday, June 6). (PDF file)
Rasilamlo: CHMP EPAR for Rasilamlo aliskiren/amlodipine to treat hypertension in patients not controlled with aliskiren or amlodipine alone; from Novartis AG (NYSE:NVS; SIX;NOVN).
Revolade: CHMP EPAR for Revolade eltrombopag to treat chronic idiopathic thrombocytopenic purpura (ITP) and chemotherapy-induced thrombocytopenia; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Ligand Pharmaceuticals Inc. (NASDAQ:LGND).

Branded drugs (PDF file) (June 6, 2011)
IRS guidance on implementation of the annual fee for branded prescription drugs (see BioCentury Extra, Thursday, June 2).

CHMP (PDF file) (June 6, 2011)
Summary of actions taken at the May 16-19 meeting of EMA's CHMP.

Diagnostics (June 6, 2011)
FDA draft guidance covering commercial distribution of in vitro diagnostics that are labeled for research or investigational use only (see BioCentury Extra, Wednesday, June 1).

FDA budget (PDF file) (June 6, 2011)
U.S. House Appropriations Committee FY12 appropriations bill containing funding for FDA, which includes an amendment that would prohibit funding to restrict the use of a substance or compound unless the decision is based on "hard science" and not on "factors of cost and consumer behavior" (see BioCentury Extra, Thursday, June 2).

Heparin (PDF file) (June 6, 2011)
Letter from Chairman Fred Upton and other Republican leaders of the House Committee on Energy and Commerce asking U.S. Immigration and Customs Enforcement (ICE) Director John Morton for information about the 2008 heparin contamination incident (see BioCentury Extra, Thursday, June 2).

Infectious disease (PDF file) (June 6, 2011)
EMA Infectious Diseases Working Party 2011 work plan.

Patent reform (June 6, 2011)
U.S. House Judiciary Committee report (PDF file) recommending that the full U.S. House of Representatives pass the America Invents Act (H.R. 1249); text of the bill; and a letter (PDF file) from U.S. Commerce Secretary Gary Locke expressing the Obama administration's support for the bill (see BioCentury Extra, Thursday, June 2).


PDUFA (June 6, 2011)
Summaries of meetings between FDA and industry on user fee reauthorization (see Cover Story).

Pediatric drugs (PDF file) (June 6, 2011)
Summary of actions taken at the May 18-20 meeting of EMA's Pediatric Committee (PDCO).

Pharmacoepidemiology (PDF file) (June 6, 2011)
EMA and European Network Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) guideline on methodological standards in pharmacoepidemiology.

Pharmacovigilance (PDF file) (June 6, 2011)
Summary of actions taken at the May 16-18 plenary meeting of CHMP's Pharmacovigilance Working Party (PhVWP).

Transparency (PDF file) (June 6, 2011)
EMA draft guidance outlining the types of information included in an MAA that can be publicly released after approval (see BioCentury Extra, Wednesday, June 1).

Vaccines (June 6, 2011)
UNICEF list of historical vaccine prices contracted with suppliers by the organization (see BioCentury Extra, Tuesday, May 31).

XMRV (PDF file) (June 6, 2011)
Editorial Expression of Concern by Science questioning the link between xenotropic murine leukemia virus-related virus (XMRV) and chronic fatigue syndrome (CFS) (see BioCentury Extra, Tuesday, May 31).

Product documentation (June 6, 2011)
Cubicin: CHMP revised EPAR updating SPC to include information about eosinophilic pneumonia as undesirable effect with use of Cubicin daptomycin to treat Staphylococcus aureus endocarditis and bacteremia, complicated skin and skin structure infection (cSSSI) and skin and skin structure infection (SSSI) cause by Enterococcus faecalis; from Cubist Pharmaceuticals Inc. (NASDAQ:CBST).
Emtriva: CHMP revised EPAR updating SPC to include a recommendation not to discontinue Emtriva emtricitabine in patients co-infected with HBV and HIV because post treatment exacerbations of hepatitis may lead to hepatic decompensation; Emtriva is indicated to treat HIV in combination with other antiretroviral agents; from Gilead Sciences Inc. (NASDAQ:GILD).
Kaletra: CHMP revised EPAR updating SPC to include information about the overall risk for congenital birth defects in women exposed to Kaletra lopinavir/ritonavir to treat HIV infection in combination with other anti-HIV medications; from Abbott Laboratories (NYSE:ABT).

Advanced therapies (PDF file) (May 30, 2011)
Summary of actions takes at the May 17 monthly meeting of EMA's Committee for Advanced Therapies (CAT).

Conflict of interest (PDF file) (May 30, 2011)
FDA draft guidance considering the inclusion of clinical investigators' financial disclosure information in publicly available documentation (see BioCentury Extra, Tuesday, May 24).

FDA budget (PDF file) (May 30, 2011)
House Appropriations Committee subcommittee draft of a bill that would cut FDA's FY12 budget by 12% compared to FY11 (see BioCentury Extra, Monday, May 23).

Flu vaccines (PDF file) (May 30, 2011)
U.K. Department of Health consultation document on a proposal to use a centralized system to procure and distribute seasonal flu vaccines in lieu of the current localized system (see BioCentury Extra, Wednesday, May 25).

Hepatitis (PDF file) (May 30, 2011)
U.S. Department of Health and Human Services (HHS) action plan for the prevention, care and treatment of viral hepatitis.

Manufacturing (May 30, 2011)
FDA Inspections Database that includes names and addresses of inspected facilities, inspection dates, types of FDA-regulated products involved and final inspectional classification (see BioCentury Extra, Thursday, May 26).

NCI Cooperative Groups (May 30, 2011)
Guiding principles for the reconfiguration and funding of the NCI cancer cooperative groups, authored by the group chairs (see BioCentury, March 28).

Patents (PDF file) (May 30, 2011)
U.S. Court of Appeals for the Federal Circuit ruling on Therasense Inc. v. Becton Dickinson and Co. (NYSE:BDX) concerning standards needed to prove inequitable conduct regarding patents (see BioCentury Extra, Thursday, May 26).

Pediatric drugs (PDF file) (May 30, 2011)
Summary of actions taken at the May 18-20 meeting of EMA's Pediatric Committee (PDCO).

Product documentation (May 30, 2011)
Avastin: Letter from CBER Director Karen Midthun to Genentech Inc. indicating she will allow the company to present information about future studies of Avastin bevacizumab at a June 28-29 hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label (see BioCentury Extra, Thursday, May 26).
Onsenal: CHMP Q&A on potential off-label use of pain drug Onsenal celecoxib (U.S. - Celebrex) in patients with familial adenomatous polyposis (FAP), from Pfizer Inc. (NYSE:PFE). (PDF file)
Colcrys: Letter from Sen. Herb Kohl (D-Wis.) and three members of the House of Representatives to URL Pharma Inc. asking for information about the price of gout drug Colcrys colchicine (see BioCentury Extra, Tuesday, May 24). (PDF file)
Nuedexta: Letter from Sen. Herb Kohl (D-Wis.) and three members of the House of Representatives to Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) requesting information about the price of neurology drug Nuedexta dextromethorphan/quinidine (see BioCentury Extra, Wednesday, May 25). (PDF file)

Anesthesia (PDF file) (May 23, 2011)
Memorandum of understanding between FDA and the International Anesthesia Research Society for strategies on mitigating anesthesia related neurotoxicity in children.

Alzheimer's disease (PDF files) (May 23, 2011)
— CHMP final qualification opinion concluding that that low beta amyloid (1-42) and high tau in CSF is predictive of the evolution of AD-type dementia in patients with minimal cognitive impairment, plus an overview of comments received (see BioCentury Extra, Monday, May 16).
Text of the Alzheimer's Breakthrough Act of 2011 (H.R. 1897), which seeks to increase the U.S. government's commitment to AD research (see BioCentury Extra, Tuesday, May 17).

Clinical trials (PDF file) (May 23, 2011)
EMA draft reflection paper on ethical and good clinical practice for conducting clinical trials in "third countries" for use in marketing authorization applications.

Diagnostics (PDF file) (May 23, 2011)
FDA draft guidance for Class II in vitro diagnostic devices for Bacillus species detection.

Drug spending (PDF file) (May 23, 2011)
IMS report on the global use of medicines outlook through 2015 (see BioCentury Extra, Wednesday, May 18).
Medco Health Solutions Inc. (NYSE:MHS) report on drug utilization and spending trends (see BioCentury Extra, Friday, May 20).

EMA (PDF files) (May 23, 2011)
EMA guidance on pre-submission and post-authorization procedures for users of the centralized procedure.

Product documentation (May 23, 2011)
Avandia: FDA REMS for Avandia rosiglitazone, which would significantly restrict use of the diabetes drug due to cardiovascular concerns; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, May 18). (PDF file)
— Avastin: Genentech Inc. summary of its reasoning for requesting that FDA maintain Avastin bevacizumab's accelerated approval in combination with paclitaxel for first-line HER2-negative metastatic breast cancer while the company conducts a confirmatory trial, plus 35 appendices from FDA supporting its proposal to withdraw accelerated approval (see BioCentury Extra, Monday, May 16).
Also, a letter from CDER to CBER noting that the drug center does not believe future studies of Avastin are within the scope of a hearing on FDA's proposed withdrawal of metastatic breast cancer from Avastin's label (see BioCentury Extra, Wednesday, May 18).
Horizant: FDA review documents for Horizant gabapentin enacarbil to treat restless legs syndrome (RLS); from XenoPort Inc. (NASDAQ:XNPT) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see Cover Story).
Triplix: Briefing documents for the May 19 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 13-0 in favor of requiring an additional study to evaluate whether Trilipix fenofibric acid plus a statin significantly lowers the risk of cardiovascular events in high-risk patients with mixed dyslipidemia; from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Thursday, May 19).

Biosimilars (PDF file) (May 16, 2011)
FDA proposed user fee program for biosimilar products (see BioCentury Extra, Monday, May 9).

Cystic fibrosis (PDF file) (May 16, 2011)
EMA guideline on the clinical development of medicinal products for the treatment of CF.

Generic (PDF file) (May 16, 2011)
FDA final guidance on submission of bioequivalence data for ANDAs.

Orphan drugs (PDF file) (May 16, 2011)
Summary of actions taken at the May 4-5 plenary meeting of EMA's COMP.

Risk assessment (May 16, 2011)
National Research Council report proposing a risk assessment framework for FDA to systematically evaluate and compare public health consequences of its decisions.

Product documentation (May 16, 2011)
Arava: CHMP revised EPAR updating SPC to amend the warning for interstitial lung disease (IDL) for Arava leflunomide to treat active rheumatoid arthritis (RA); from Sanofi (Euronext:SAN; NYSE:SNY).
Augment: Briefing documents for the May 12 meeting of FDA's Orthopedic and Rehabilitation Devices Panel, which voted 10-8 that the benefits of Augment Bone Graft outweighed its risks as an alternative to autograft to treat foot and ankle fractures; from BioMimetic Therapeutics Inc. (NASDAQ:BMTI) (see BioCentury Extra, Thursday, May 12).
Avastin: FDA notice outlining issues to be discussed at a June 28-29 hearing about the proposed withdrawal of metastatic breast cancer from the label of Avastin bevacizumab; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Monday, May 9). (PDF file)
RoActemra: CHMP revised EPAR updating SPC to include information about infections in patients receiving immunosuppressive agents to treat active, moderate to severe arthritis, including RoActemra tocilizumab from Roche (SIX:ROG; OTCQX:RHHBY).
Simponi: NICE draft guidance recommending the use of Simponi golimumab in combination with methotrexate to treat rheumatoid arthritis (RA) in adults who have an inadequate response to previous DMARD therapy, including methotrexate and tumor necrosis factor (TNF) inhibitors; from Merck & Co. Inc. (NYSE:MRK).

Advanced therapies (PDF file) (May 9, 2011)
Summary of actions taken at the April 7 meeting of EMA's Committee for Advanced Therapies (CAT).

Biosimilars (May 9, 2011)
— Draft EMA guideline on similar biological medicinal products containing monoclonal antibodies (see Cover Story). (PDF file)
— Health Canada guidance for sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs).

CML (May 9, 2011)
NICE draft guidance recommending against use of Sprycel dasatinib from Bristol-Myers Squibb Co. (NYSE:BMY), Tasigna nilotinib and the higher, 800 mg dose of Glivec, both from Novartis AG (NYSE:NVS; SIX:NOVN), to treat chronic myelogenous leukemia (CML) in patients resistant to the standard 400 mg dose of Glivec (see BioCentury Extra, Thursday, May 6).

Pediatric drugs (PDF file) (May 9, 2011)
Summary of actions taken at the April 18-20 meeting of EMA's Pediatric Committee (PDCO).

Product documentation (May 9, 2011)
Bonviva: CHMP revised EPAR updating SPC to include information about ocular inflammation events for Bonviva bisphosphonate/ibandronate to treat osteoporosis in postmenopausal women; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Roche (SIX:ROG; OTCQX:RHHBY).
Nplate: NICE final guidance recommending Nplate romiplostim to treat chronic idiopathic thrombocytopenic purpura (ITP) in patients whose condition is refractory to standard active treatments and rescue therapies or in patients who have severe disease and a high risk of bleeding that requires frequent courses of rescue therapies; from Amgen Inc. (NASDAQ:AMGN). (PDF file)
Simponi: NICE final guidance recommending Simponi golimumab to treat active and progressive psoriatic arthritis in adults who have an inadequate response to DMARD therapy; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). (PDF file)

Antibacterials (PDF file) (May 2, 2011)
EMA report of a Feb. 7-8 workshop on development of new antibacterials.

Biosphosphonates (PDF file) (May 2, 2011)
EMA Q&A on its review of bisphosphonates and atypical stress fractures.

Diagnostics (PDF file) (May 2, 2011)
FDA notice of a May 12 workshop to discuss methodologies for diagnostics in the postmarket setting.

Infectious disease (May 2, 2011)
Grantees of the sixth round of the Bill & Melinda Gates Foundation Grand Challenges Explorations initiative to support infectious disease research and health in developing countries (see BioCentury Extra, Friday, April 29).

Influenza (PDF files) (May 2, 2011)
— CMS proposed rule that would require certain Medicare and Medicaid providers to offer all patients an annual seasonal influenza vaccination (see BioCentury Extra, Friday, April 29).
— EMA report of lessons learned during 2009 H1N1 flu pandemic.

Medicare (May 2, 2011)
Quality measures under the CMS Hospital Value-Based Purchasing program, which will pay Medicare providers based on their performance on the benchmarks (see BioCentury Extra, Friday, April 29).

Patents (PDF file) (May 2, 2011)
U.S. Patent and Trademark Office proposed rule to reduce the time to complete ex parte and inter partes patent reexamination proceedings (see BioCentury Extra, Wednesday, April 27).

PDUFA (May 2, 2011)
Summaries of meetings between FDA and industry on user fee reauthorization, including newly posted minutes from the March 31 session where the parties conducted a final review and made minor clarifying edits to the draft PDUFA V commitment letter (see BioCentury Extra, Friday, April 29).

Rare diseases (May 2, 2011)
NIH's NCGC Pharmaceutical Collection database, a tool for screening approved drugs for use against rare and neglected diseases (see BioCentury Extra, Wednesday, April 27).

Safety (May 2, 2011)
Safety signals reported to FDA in 4Q10 through the Adverse Events Reporting System (AERS).

Stem cells (PDF file) (May 2, 2011)
Ruling from a three-judge appeals court panel overturning a U.S. District Court ruling that had prohibited federal funding for human embryonic stem cells (hESCs) (see BioCentury Extra, Friday, April 29).

Product documentation (May 2, 2011)
Avastin: EMA Q&A on CHMP's reversal of a prior decision and recommending approval of Avastin bevacizumab from in combination with capecitabine for first-line metastatic breast cancer when other chemotherapy options, including taxanes or anthracyclines, are not considered appropriate; from Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Avastin: CHMP revised EPAR updating SPC with information about proteinuria and arterial thromboembolic events for Avastin bevacizumab to treat metastatic cancer of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer, from Roche (SIX:ROG; OTCQX:RHHBY).
Boceprevir: Briefing documents for the April 27 meeting of FDA's Antiviral Drugs Advisory Committee, which voted 18-0 to recommend approval of boceprevir to treat HCV; from Merck & Co. Inc. (NYSE:MRK) (see BioCentury, May 2).
Telaprevir: Briefing documents from the April 28 meeting of FDA's Antiviral Drugs Committee, which voted 18-0 to recommend approval of telaprevir to treat HCV; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) (see BioCentury, May 2).

Alzheimer's (April 25, 2011)
National Institute on Aging and the Alzheimer's Association final guidelines for the diagnosis of AD (see BioCentury Extra, Wednesday, April 20).

CHMP (PDF file) (April 25, 2011)
Detailed report of actions taken at the April 11-14 monthly meeting of EMA's CHMP.

Drug spending (PDF file) (April 25, 2011)
IMS Health Institute for Healthcare Informatics report on the use of medicines in the U.S., which found 2010 drug spending grew at a "markedly lower rate" compared to 2009 (see BioCentury Extra, Wednesday, April 20).

Healthcare reform (PDF file) (April 25, 2011)
Letters from Chairman Fred Upton (R-Mich.) and other Republican leaders of the House Committee on Energy and Commerce to 12 interest groups, including PhRMA and AdvaMed, asking for information about negotiations with the White House before passage of the Patient Protection and Affordable Care Act (PPACA) (see BioCentury Extra, Wednesday, April 20).

ESAs (April 25, 2011)
Public comments posted since CMS's March proposed decision memo to not issue a National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs) to treat anemia in patients with chronic kidney disease (CKD) (see BioCentury Extra, Wednesday, April 20).

NICE (PDF files) (April 25, 2011)
NICE process guide and methods guide for the Medical Technologies Evaluation Program.

Patents (PDF file) (April 25, 2011)
U.S. Supreme Court oral arguments in Microsoft Corp. v. i4i Limited Partnership, et al. to determine whether the invalidity of a patent must be proven by clear and convincing evidence (see Cover Story).

Pharmacovigilance (PDF file) (April 25, 2011)
Summary of actions taken at the April 11-13 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Regulatory science (PDF file) (April 25, 2011)
Final FDA strategic priorities for 2011-15, which puts advancing of regulatory science as the agency's top priority (see BioCentury, April 25).

Vaccines (PDF file) (April 25, 2011)
EMA Vaccines Working Party (VWP) 2011 work plan.

Product documentation (April 25, 2011)
Zyprexa: CHMP revised EPAR updating SPC to include information on the potential for excessive sedation, cardiorespiratory depression and possible death with concomitant use of parenteral benzodiazepine and Zyprexa olanzapine, which is approved to treat schizophrenia and moderate to severe manic episodes; from Eli Lilly and Co. (NYSE:LLY).

Animal studies (PDF file) (April 18, 2011)
CHMP concept paper on the need for a revision of the position on the replacement of animal studies by in vitro models.

Antimicrobial resistance (April 18, 2011)
Infectious Diseases Society of America (IDSA) policy paper with recommendations to address antimicrobial resistance.

CHMP (PDF file) (April 18, 2011)
Summary of actions taken at the April 6-7 plenary meeting of EMA's CHMP.

Clinical trials (PDF file) (April 18, 2011)
FDA guidance on implementing the requirements for postmarketing studies and clinical trial as enacted by the FDA Amendments Act of 2007 (FDAAA) (see BioCentury Extra, Tuesday, April 12).

Drug prices (April 18, 2011)
White House background document regarding President Obama's deficit reduction plan, including proposals to reduce Medicare's spending on prescription drugs (see BioCentury Extra, Wednesday, April 13).

Environmental risk (PDF files) (April 18, 2011)
CHMP Q&A on the guideline on the environmental risk assessment of medicinal products, and an overview of comments received.

Influenza (PDF file) (April 18, 2011)
FDA guidance on developing drugs to treat or prevent illness cause by influenza A and B, including seasonal and pandemic varieties (see BioCentury Extra, Wednesday, April 13).

Investigator oversight (PDF file) (April 18, 2011)
FDA proposal to strengthen restrictions imposed on investigators who fail to comply with requirements for the conduct of clinical investigations or who submit false information to FDA or sponsors (see BioCentury Extra, Wednesday, April 13).

PDUFA (PDF files) (April 18, 2011)
Minutes from the Jan. 11 and Feb. 10 meetings between FDA and industry on PDUFA reauthorization.

Photosafety (PDF files) (April 18, 2011)
CHMP Q&A on the note for guidance on photosafety testing, and an overview of comments received.

Safety labeling (PDF file) (April 18, 2011)
FDA guidance on implementing the safety labeling changes enacted by the FDA Amendments Act of 2007 (FDAAA) (see BioCentury Extra, Tuesday, April 12).

Product documentation (April 18, 2011)
Altargo: CHMP revised EPAR updating SPC to include information about hypersensitivity and angioedema for Altargo retapamulin to treat impetigo and superficial skin infections; from GlaxoSmithKline plc (LSE:GSK: NYSE:GSK).
Arixtra: CHMP revised EPAR updating SPC to include data from a Phase II trial of Arixtra fondaparinux in pediatric patients to treat deep vein thrombosis (DVT); from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Avastin: FDA's Center for Drug Evaluation and Research summary of what it considers the central questions to be presented and resolved at a June 28-29 hearing on FDA's proposal to withdraw metastatic breast cancer from the label of Avastin bevacizumab, from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit (see BioCentury Extra, Tuesday, April 12).
Combivir: CHMP revised EPAR updating SPC to add angioedema as an adverse event for Combivir lamivudine/zidovudine to treat HIV infection; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Halaven: CHMP EPAR for Halaven eribulin mesylate to treat locally advanced or metastatic breast cancer; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
Kaletra: CHMP revised EPAR updating SPC to include information on the risk of hepatotoxicity for Kaletra lopinavir/ritonavir to treat HIV infection; from Abbott Laboratories (NYSE:ABT).

Cancer (PDF file) (April 11, 2011)
U.K. Department of Health response to a consultation on the Cancer Drugs Fund (see BioCentury Extra, Tuesday, April 5).

Health care reform (PDF file) (April 11, 2011)
Congressional Budget Office revised estimate of Medicare baseline projections, concluding that the Independent Payment Advisory Board would not lead to any savings from 2011-21 as previously expected (see BioCentury Extra, Thursday, April 7).

Pharmacovigilance (PDF file) (April 11, 2011)
EMA list of authorized medicines and the frequency of monitoring by the agency.

Stroke (PDF file) (April 11, 2011)
CHMP concept paper on the need for a guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic even in patients with atrial fibrillation.

Product documentation (April 11, 2011)
—Avastin: Letter from CBER Director Karen Midthun to Genentech Inc., a unit of Roche (SIX:ROG; OTCQX:RHHBY), stating she will not add additional consultants or temporary voting members to FDA's Oncologic Drugs Advisory Committee for a June 28-29 hearing on the agency's proposal to withdraw approval of Avastin bevacizumab to treat metastatic breast cancer (see BioCentury Extra, Tuesday, April 5), plus a joint statement (PDF file) from Genentech and CBER noting they have been unable to agree on "the central questions that must be answered" for a decision about withdrawing metastatic breast cancer from the label (see BioCentury Extra, Thursday, April 7).
Everolimus: Briefing documents for the April 12 meeting of FDA's Oncologic Drugs Advisory Committee to discuss an sNDA for everolimus to treat pancreatic neuroendocrine tumors; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, April 8).
Jevtana: New CHMP EPAR for Jevtana cabazitaxel for second-line treatment of metastatic hormone-refractory prostate cancer (HRPC); from sanofi-aventis Group (Euronext:SAN; NYSE:SNY).
Protopic: CHMP revised EPAR updating SPC to include information on the effect of eczema drug Protopic tacrolimus on the immunocompetence of pediatric patients; from Astellas Pharma Inc. (Tokyo:4503).
Pumarix: New CHMP EPAR for Pumarix avian influenza (H5N1) vaccine to prevent influenza in an officially declared pandemic situation; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Soliris: CHMP revised EPAR updating SPC to include information about meningococcal infections for Soliris eculizumab to treat paroxysmal nocturnal hemoglobinuria (PNH); from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN).
Sutent: Briefing documents for the April 12 meeting of FDA's Oncologic Drugs Advisory Committee to discuss an sNDA for Sutent sunitinib to treat unresectable pancreatic neuroendocrine tumors; from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Friday, April 8).
Trobalt: New CHMP EPAR for Trobalt retigabine as an adjunctive therapy for partial onset seizures in adults 18 years or older with epilepsy; from Meda AB (SSE:MEDAA), Valeant Pharmaceuticals International Inc. (NYSE:VRX; TSX:VRX) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)

CHMP (PDF file) (April 4, 2011)
Detailed report of actions taken at the March 14-17 monthly meeting of EMA's CHMP.

Clinical testing (April 4, 2011)
Center for Devices and Radiological Health (CDRH) draft charter for the Center Science Council, which will provide oversight of clinical data requirements and clinical trial policy (see BioCentury Extra, Friday April 1).

Conflicts of interest (April 4, 2011)
Reports from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK)(PDF file), Merck & Co. Inc. (NYSE:MRK)(PDF file), and Pfizer Inc. (NYSE:PFE) on payments made to healthcare professionals and academics in 2010 (see BioCentury Extra, Friday, April 1).


Diabetes (PDF file) (April 4, 2011)
International Diabetes Federation (IDF) statement recommending bariatric surgery in patients with Type II diabetes and a BMI of at least 35 kg/m2 who are not achieving treatment targets with other medical therapies (see BioCentury Extra, Monday, March 28).

Drug prices (April 4, 2011)
— U.S. Supreme Court opinion ruling that local health providers participating in the 340B drug discount program do not have a legal right to sue drug manufacturers for alleged drug overpricing (see BioCentury Extra, Wednesday, March 30). (PDF file)
— EC Transparency Directive, which covers medicinal products, places time limits on member states for making pricing and reimbursement decisions, and requires public disclosure of the criteria and reasons for such decisions (see BioCentury Extra, Friday, April 1).

EMA (April 4, 2011)
Documentation for the March 16-17 meeting of EMA's Management Board.

Meningococcal vaccines (April 4, 2011)
Briefing documents for the April 6-7 meeting of FDA's Vaccines and Related Biologic Products Advisory Committee to discuss meningococcal vaccines (see BioCentury Extra, Monday, March 28).

Patent reform (PDF file) (April 4, 2011)
Text of the America Invents Act (H.R. 1249), which seeks to reform patent legislation (see BioCentury Extra, Wednesday, March 30).

Pediatric drugs (PDF file) (April 4, 2011)
Summary of actions taken at the March 16-18 meeting of EMA's Pediatric Committee (PDCO).

Pharmacovigilance (PDF file) (April 4, 2011)
Summary of actions taken at the March 14-16 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Radiopharmaceuticals (April 4, 2011)
— EMA Radiopharmaceuticals drafting group 2011 work plan.
— EMA draft guideline on core SmPC and package leaflet for radiopharmaceuticals.

Product documentation (April 4, 2011)
— Avastin: Letter from Genentech Inc., a unit of Roche (SIX:ROG; OTCQX:RHHBY), asking CBER Director Karen Midthun to reconsider her decision to use the Oncologic Drugs Advisory Committee as the advisory body at a hearing on FDA's proposal to withdraw approval of Avastin bevacizumab to treat metastatic breast cancer, plus FDA's response to the letter (see BioCentury Extra, Monday, March 28).
Dificid: Briefing documents for the April 5 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss Dificid fidaxomicin to treat Clostridium difficile-associated diarrhea (CDAD) and to prevent the recurrence of CDAD; from Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) (see BioCentury Extra, Friday, April 1).
Gilenya: New CHMP EPAR for Gilenya fingolimod to treat relapsing multiple sclerosis (RRMS); from Novartis AG (NYSE:NVS; SIX:NOVN) and Mitusbishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508).
Movectro: CHMP withdrawal assessment report for Movectro cladribine tablets to treat relapsing forms of multiple sclerosis (RRMS); from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and Merck KGaA (Xetra:MRK. (PDF file)
Orencia: NICE draft guidance recommending against Orencia abatacept as second-line therapy in combination with methotrexate to treat moderate to severe rheumatoid arthritis; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Tuesday, March 29).
Provenge: CMS proposed decision memo supporting coverage of Provenge sipuleucel-T for its FDA-approved indication of metastatic, castrate-resistant prostate cancer who are asymptomatic or minimally symptomatic; from Dendreon Corp. (NASDAQ:DNDN) (see BioCentury Extra, Wednesday, March 30).
Teysuno: New CHMP EPAR for Teysuno tegafur/gimeracil/oteracil potassium to treat gastric cancer in combination with cisplatin; from Otsuka Pharmaceutical Co. Ltd.
Tysabri: CHMP revised EPAR updating SPC to include information about the presence of Tysabri natalizumab in breast milk; Tysabri is approved to treat multiple sclerosis (MS); from Biogen Idec Inc. (NASDAQ:BIIB) and Elan Corp. plc (NYSE:ELN).

Advanced therapies (PDF file) (March 28, 2011)
Summary of actions taken at the Feb. 10-11 meeting of EMA's Committee for Advanced Therapies (CAT).

Cancer (PDF file) (March 28, 2011)
U.K. Department of Health guidance to support operation of the Cancer Drugs Fund in 2011-12.

Clinical trials (March 28, 2011)
EU Clinical Trials Register to provide public access to information on clinical trials in the 27 EU Member States and Iceland, Liechtenstein and Norway (see BioCentury Extra, Tuesday, March 22).

Colorectal cancer (PDF file) (March 28, 2011)
NICE guidance on use of colonoscopic surveillance for the prevention of colorectal cancer in people with ulcerative colitis, Crohn's disease or adenomas.

Influenza (PDF file) (March 28, 2011)
U.K. Department of Health strategic approach to planning for and responding to demand of an influenza pandemic.

Liver fibrosis (PDF file) (March 28, 2011)
NICE Diagnostics Assessment Program report on pilot project on the assessment of non-invasive diagnostic assessment tools for the detection of liver fibrosis in patients with suspected alcohol related liver disease.

SMEs (March 28, 2011)
Second phase of EMA's register of small and medium-sized enterprises, which now includes information on company pipelines and product profiles.

Tuberculosis (PDF file) (March 28, 2011)
Updated NICE clinical guideline for diagnosis and management of TB and measures for its prevention and control.

R&D spending (PDF files) (March 28, 2011)
U.K. Treasury growth review and budget for 2011, including provisions for R&D tax credits and a "patent box" tax credit (see BioCentury Extra, Thursday, March 25).

Product documentation (March 28, 2011)
Cancidas: CHMP revised EPAR updating SPC to include information about cases of angioedema for antifungal Cancidas caspofungin acetate; from Merck & Co. Inc. (NYSE:MRK).
— Makena: Letter from Rep. Henry Waxman (D-Calif.) and two other Democratic leaders on the House Committee on Energy and Commerce to KV Pharmaceutical Co. (NYSE:KVA) concerning the price of Makena hyroxyprogesterone caproate injection, a synthetic caproate ester of naturally occurring 17 alpha-hydroxyprogesterone (17P), to reduce the risk of preterm birth (see BioCentury Extra, Thursday, March 24), plus a letter to FDA from America's Health Insurance Plans (AHIP) from requesting information on the availability of custom-compounded synthetic 17P from specialty pharmacies to "ensure affordable access" (see BioCentury Extra, Monday, March 21). (PDF files)

Biologics (PDF file) (March 21, 2011)
EMA draft concept paper on potency declaration and labeling for biologics containing modified proteins as active substance.

CHMP (March 21, 2011)
Summary of actions taken at the March 14-17 plenary meeting of EMA's CHMP (see BioCentury Extra, Friday, March 18).

Diabetes (PDF file) (March 21, 2011)
HHS's Agency for Healthcare Research and Quality (AHRQ) final comparative effectiveness review of oral diabetes medications (see BioCentury Extra, Wednesday, March 16).

Drug pricing (March 21, 2011)
— U.K. Department of Health consultation document, "A new value-based approach to the pricing of branded medicines" (see Cover Story). (PDF file)
University of York Centre for Health Economics research paper by Karl Claxton: "Value-based pricing for pharmaceuticals: Its role, specification and prospects in a newly devolved NHS." (PDF file)
—U.S. Government Accountability Office report showing that the price of commonly used prescription drugs increased at a greater rate than that of other medical goods and services from 2006 to 1Q10 (see BioCentury Extra, Monday, March 14). (PDF file)

GERD (PDF files) (March 21, 2011)
CHMP guideline on the evaluation of drugs to treat gastroesophageal reflux disease (GERD) and an overview of comments received.

Manufacturing (PDF file) (March 21, 2011)
EMA and FDA pilot program for parallel assessment of Quality by Design components of NDAs and MAAs submitted to both agencies (see BioCentury, Wednesday, March 16).

Product documentation (March 21, 2011)
Emerflu: Withdrawal assessment report for Emerflu to prevent pandemic influenza in an officially declared pandemic situation; from sanofi-aventis Group (Euronext:SAN; NYSE:SNY). (PDF file)
Fluenz: New CHMP EPAR for Fluenz intranasal live attenuated influenza vaccine (LAIV) to prevent seasonal influenza in children 12 months to less than 18 years of age; from AstraZeneca plc (LSE:AZN; NYSE:AZN).
Nplate: NICE final appraisal determination recommending Nplate romiplostim to treat chronic idiopathic thrombocytopenic purpura (ITP) in patients whose condition is refractory to standard active treatments and rescue therapies or in patients who have severe disease and a high risk of bleeding that requires frequent courses of rescue therapies; from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Wednesday, March 16). (PDF file)
Simponi: NICE final appraisal determination recommending Simponi golimumab to treat active and progressive psoriatic arthritis in adults who have an inadequate response to previous DMARD therapy; from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury, Thursday, March 17). (PDF file)
Xeplion: New CHMP EPAR for Xeplion paliperidone palmitate prolonged release suspension for the maintenance treatment of schizophrenia in adult patients stabilized with paliperidone or risperidone; from Johnson & Johnson (NYSE:JNJ).
Xiapex: New CHMP EPAR for collagenase clostridium histolyticum to treat Dupuytren's contracture in adult patients with a palpable cord; from Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) and BioSpecifics Technologies Corp. (NASDAQ:BSTC).

HIV (March 14, 2011)
European AIDS Clinical Society guidelines for the clinical management and treatment of HIV-infected adults (see BioCentury, Wednesday, March 9).

Orphan drugs (PDF file) (March 14, 2011)
Summary of actions taken at the March 8-9 plenary meeting of EMA's COMP.

Rare diseases (March 14, 2011)
Application instructions for NIH's Therapeutics for Rare and Neglected Diseases program to partner to develop candidates for rare and neglected diseases (see BioCentury, Wednesday, March 9).

Urinary incontinence (PDF file) (March 14, 2011)
FDA guidance on development of devices to treat urinary incontinence.

User fees (PDF file) (March 14, 2011)
FDA draft guidance for industry on user fee waivers, reductions and refunds for drugs and biologics.

Product documentation (March 14, 2011)
Lamictal XR: Briefing document from the March 10 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which said the Lamictal XR lamotrigine demonstrated sufficient efficacy as monotherapy for the treatment of partial seizures; from GalxoSmithKline plc (LSE:GSK; NYSE:GSK) (see "History Lesson").
Javlor: NICE final appraisal determination recommending against Javlor vinflunine for advanced or metastatic transitional cell carcinoma of the urothelial tract that has progressed following treatment with platinum based chemotherapy; from Laboratories Pierre Fabre S.A. (see BioCentury Extra, Wednesday, March 9). (PDF file)
Tarceva: NICE final appraisal determination recommending against Tarceva erlotinib for the maintenance treatment of locally advance or metastatic non-small cell lung cancer (NSCLC) in patients with stable disease after platinum-based first-line chemotherapy; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, March 9). (PDF file)
Zometa: CHMP withdrawal assessment report for Zometa zoledronic acid to treat early breast cancer; from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)

CHMP (PDF file) (March 7, 2011)
Detailed report of actions taken at the Feb. 14-17 plenary meeting of EMA's CHMP.

Conflict of interest (PDF file) (March 7, 2011)
Letter from five European advocacy groups to European Commissioner for Health and Consumer Policy John Dalli questioning possible conflict-of-interest violations by former EMA Executive Director Thomas Lonngren (see BioCentury Extra, Tuesday, Mach 1).

Insomnia (PDF files) (March 7, 2011)
CHMP guideline on medicinal products for the treatment of insomnia, and an overview of comments received.

Medicare (PDF files) (March 7, 2011)
— HHS Inspector General report describing pharmaceutical and insurance industry practices that the IG says reduce competition and increase drug costs to Medicare and Medicare beneficiaries (see BioCentury Extra, Friday, March 4).
Letter from Democrats on the House Energy and Commerce Committee asking for hearings on government findings that insurers under report Medicare Part D drug rebates in order to increase profits (see BioCentury Extra, Friday, March 4).

Orphan drugs (PDF file) (March 7, 2011)
Questions for the March 2 meeting of FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on the development of drugs for Orphan and rare diseases (see BioCentury Extra, Monday, Feb. 28).

Patient, consumer groups (PDF file) (March 7, 2011)
Minutes of the Nov. 30, 2010, meeting of the EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organizations (PCWP).

PDUFA (PDF files) (March 7, 2011)
Minutes from meetings between FDA and industry on PDUFA reauthorization held on Jan. 6, Jan. 7, Jan. 10, Jan. 18, Jan. 20 and Jan. 25.

Pediatric drugs (PDF file) (March 7, 2011)
Summary of actions taken at the Feb. 16-18 meeting of EMA's Pediatric Committee (PDCO).

Product documentation (March 7, 2011)
Indacaterol: FDA briefing documents for the March 8 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee to discuss indacaterol for chronic obstructive pulmonary disease (COPD); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, March 4).
Lucentis: NICE draft guidance recommending against Lucentis ranibizumab to treat diabetic macular edema; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, March 3).
MabThera: NICE draft guidance requesting additional data prior to recommending MabThera rituximab as first-line maintenance treatment of advanced follicular non-Hodgkin's lymphoma (NHL); from Roche (SIX:ROG; OTCQX:RHHBY) and Biogen Idec Inc. (NASDAQ:BIIB) (see BioCentury Extra, Monday, Feb. 28).

Biosimilars (PDF file) (February 28, 2001)
CHMP draft concept paper for the revision of guidelines for quality requirements of biosimilar products.

Drug safety (PDF file) (February 28, 2001)
FDA draft guidance on the use of medication guides, which aim to alleviate the burden of REMS on companies and the agency (see BioCentury Extra, Friday, Feb. 25).

EMA (PDF files) (February 28, 2001)
—EMA statement of revenue and expenditure for 2011.
—EMA Joint CHMP/CVMP Quality Working Party work plan for 2011.

Geriatrics (PDF file) (February 28, 2001)
EMA strategy for developing medicines for the elderly.

Health reform (PDF file) (February 28, 2001)
Letter from Chairman Fred Upton (R-Mich.) and other Republican members of the House Committee on Energy and Commerce seeking information about meetings the White House Office for Health Reform held with industry groups (see BioCentury Extra, Wednesday, Feb. 23).

Heparin (PDF file) (February 28, 2001)
Letter to FDA from Chairman Fred Upton (R-Mich.) and other Republican members of the House Committee on Energy and Commerce requesting information related to the 2008 heparin contamination incident (see BioCentury Extra, Thursday, Feb. 24).

HIV (PDF file) (February 28, 2001)
CHMP draft concept paper on guidance for the non-clinical and clinical development of medicinal products to prevent HIV infection.

Orphan drugs (PDF files) (February 28, 2001)
Summary of actions taken at the Feb. 8-9 plenary meeting of EMA's COMP.
Pharmaceutical Research and Manufacturers of America (PhRMA) report listing 460 products in clinical development to treat or prevent rare diseases, up from 303 products in 2007 (see BioCentury Extra, Friday, Feb. 25).

Pharmacogenomics (PDF file) (February 28, 2001)
FDA draft guidance on early phase clinical trial design for evaluating pharmacogenomics.

Pharmacovigilance (PDF file) (February 28, 2001)
Summary of actions taken at the Feb. 14-16 plenary meeting of CHMP's Pharmacovigilance Working Party (PhVWP).

Plasma-derived products (PDF file) (February 28, 2001)
CHMP draft guideline for texts and warning statements on transmissible agents included on SPCs for plasma-derived medicinal products.

Vaccines (PDF file) (February 28, 2001)
U.S. Supreme Court opinion in Bruesewitz v. Wyeth, which ruled 6-2 that the National Childhood Vaccine Injury Act of 1986 "preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by a vaccine's side effects" (see BioCentury Extra, Tuesday, Feb. 22).

Product documentation (February 28, 2001)
Alimta: CHMP revised an EPAR updating SPC to include information about Stevens-Johnson syndrome, toxic epidermal necrolysis, sepsis and hemolytic anemia for Alimta pemetrexed to treat pleural mesothelioma and non-small cell lung cancer (NSCLC); from Eli Lilly and Co. (NYSE:LLY).
Humira: U.S. Court of Appeals for the Federal Circuit ruling that patents co-owned by New York University and Johnson & Johnson (NYSE:JNJ) covering the use of antibodies against TNF alpha are invalid and therefore not infringed by autoimmune drug Humira adalimumab; from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Wednesday, Feb. 23. (PDF file)

Alzheimer's disease (PDF file) (February 21, 2011)
European Medicines Agency's CHMP draft qualification opinion concluding that low beta amyloid 42 and high tau in CSF is predictive of AD-type dementia in patients with minimal cognitive impairment (see BioCentury Extra, Friday, Feb. 18).

Cell/Gene therapy (PDF file) (February 21, 2011)
FDA guidance for developing potency tests for cellular and gene therapy products.

CHMP (PDF file) (February 21, 2011)
Summary of actions taken at the Feb. 14-17 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

EMA (PDF files) (February 21, 2011)
—Work program for 2011 for European Medicines Agency (EMA) and its Oncology Working Party.
Minutes of the Dec. 16, 2010 meeting of EMA's Management Board.

FDA (PDF files) (February 21, 2011)
Text of the Full-Year Continuing Appropriations Act 2011 (H.R.1), which seeks to cut $400M from the $2.5B President Obama requested for FDA (see BioCentury Extra, Tuesday, Feb. 15).
—FDA fiscal 2010 performance report on PDUFA.

HCV (PDF file) (February 21, 2011)
European Medicines Agency's CHMP draft guideline on clinical evaluation of medicinal products to treat chronic HCV.

Immigration (February 21, 2011)
U.K. Border Agency proposal that would make it easier for non-EU citizens applying for Ph.D.-level positions to obtain work visas (see BioCentury Extra, Thursday, Feb. 17).

Manufacturing (PDF file) (February 21, 2011)
Cooperation agreement between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the European Medicines Agency (EMA) to share resources for Good Manufacturing and Distribution Practice (GMDP).

Safety (PDF file) (February 21, 2011)
FDA draft guidance on best practices for conducting and reporting pharmacoepidemioloic safety studies using electronic healthcare data sets.

Product documentation (February 21, 2011)
Vidaza: NICE final appraisal determination (FAD) recommending Vidaza azacitidine to treat intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML) in patients who are not eligible for hematopoietic stem cell transplantation; from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Wednesday, Feb. 16). (PDF file)
Votrient: CHMP revised EPAR updating SPC to include the risk of hypertension, including newly diagnosed symptomatic episodes of elevated blood pressure, for Votrient pazopanib to treat renal cell carcinoma; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).

Anemia (PDF file) (February 14, 2011)
NICE updated guidance for treatment of anemia in patients with chronic kidney disease (CKD).

Devices (February 14, 2011)
FDA's Center for Devices and Radiological Health innovation initiative, which proposes to help speed and reduce the cost of development and regulatory review of innovative medical devices, including molecular diagnostics (see BioCentury Extra, Tuesday, Feb. 8).

Healthcare reform (February 14, 2011)
Internal Revenue Service (IRS) notice delaying its implementation deadlines for market-share based fees on drug manufacturers to address issues raised in response to its November guidance.

Manufacturing (February 14, 2011)
European Medicines Agency (EMA) updated EudraGMP database, which provides public access to information on manufacturing inspections performed by authorities from all European Economic Area (EEA) countries.

NMEs (PDF file) (February 14, 2011)
FDA's Center for Drug Evaluation and Research approvals of new molecular entities in 2010.

R&D tax credits (PDF file) (February 14, 2011)
Biotechnology Industry Organization (BIO) survey of companies that received awards from the Therapeutic Discovery Project Credit Program, showing that four of five CEO believe the program is "important to support the survivability and viability of their companies" (see BioCentury Extra, Friday, Feb. 11).

Translational science (February 14, 2011)
National Health Council (NHC) online database that seeks to connect researchers with unfunded biomedical research projects to non-governmental funding sources (see BioCentury Extra, Tuesday, Feb. 8).

Product documentation (February 14, 2011)
Herceptin: CHMP revised EPAR updating SPC to include the risk of interstitial lung disease (ILD) with use of Herceptin trastuzumab, which is approved to treat early-stage breast cancer, metastatic breast cancer and metastatic gastric cancer; from Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit.

Accelerated approval (February 7, 2011)
Briefing documents and draft questions (PDF file) for the Feb. 8 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to discuss requirements for the accelerated approval process of cancer drugs (see BioCentury Extra, Friday, Feb. 4).

Advanced therapies (PDF files) (February 7, 2011)
Summary of actions taken at the Jan. 13-14 monthly meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).
—CAT reflection paper on stem cell-base medicinal products, and an overview of comments received.

CHMP (PDF files) (February 7, 2011)
—Detailed report of actions taken at the Jan. 17-20 monthly meeting of CHMP, part of the European Medicines Agency (EMA).
—CHMP work plan for 2011-2013.

HHS (PDF files) (February 7, 2011)
Letters to HHS Secretary Kathleen Sebelius from three lawmakers requesting information on the use of the $400 million allocated to the secretary for comparative effectiveness research under the American Recovery and Reinvestment Act and for the use of the $1 billion health insurance reform implementation fund under the Patient Protection and Affordable Care Act (see BioCentury Extra, Thursday, Feb. 3).

PET imaging (PDF file) (February 7, 2011)
FDA draft guidance for the content and format of NDAs and ANDAs for PET imaging agents.

Safety (February 7, 2011)
Safety signals reported to FDA in 3Q10 through the Adverse Events Reporting System (AERS) (see BioCentury Extra, Tuesday, Feb. 1).

Product documentation (February 7, 2011)
Rapamune: CHMP revised EPAR updating SPC to include Clostridium difficile enterocolitis as an adverse event for Rapamune sirolimus to prevent organ rejection in renal transplantation; from Pfizer Inc. (NYSE:PFE).
RoActemra: CHMP revised EPAR updating SPC to include information about a patient who experienced a fatal anaphylactic reaction with her fifth infusion of RoActemra tocilizumab, which is approved to treat moderate to severe active rheumatoid arthritis (RA); from Roche (SIX:ROG; OTCQX:RHHBY).
—Tekinex: CHMP Q&A and letter from the sponsor for the withdrawal of the MAA for Tekinex omacetaxine mepesuccinate for imatinib-resistant chronic myelogenous leukemia (CML) in patients who have the BCR-ABL T315I mutation; from ChemGenex Pharmaceuticals Ltd. (ASX:CXS). (PDF files)
Valdoxan: CHMP revised EPAR updating SPC to include obesity/overweight and non-alcoholic fatty liver disease as risk factors for increases in transaminases with use of Valdoxan agomelatine to treat major depressive disorder (MDD); from Servier.

Biomarkers (January 24, 2011)
Institute of Medicine report summarizing the June 2010 workshop on biomarker and surrogate endpoint evaluation.

CHMP (PDF file) (January 24, 2011)
Summary of actions taken at the Jan. 17-20 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Devices (January 24, 2011)
— FDA plan to improve and clarify the 510(k) regulatory process for medical devices (see BioCentury Extra, Wednesday, Jan. 19).
— FDA's Center for Devices and Radiological Health (CDHR) strategic priorities for 2011.
— PricewaterhouseCoopers Medical Technology Innovation Scorecard assessing nine countries’ capacity and capability for medical technology innovation.

EMA (PDF files) (January 24, 2011)
Work plans for 2011 for European Medicines Agency's Biosimilar Medicinal Products Working Party (BMWP); Cell-based products working party; EMA/CHMP Working Group with Healthcare Professionals’ Organisations (HCP WG); and Good Manufacturing Practice/Good Distribution Practice Inspectors Working Group.

NHS (PDF file) (January 24, 2011)
Text of the Health and Social Care Bill introduced by U.K. Health Secretary Andrew Lansley to restructure the National Health Service (see BioCentury Extra, Wednesday, Jan. 19).

Orphan drugs (PDF file) (January 24, 2011)
Summary of actions taken at the Jan. 11-12 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Pediatric drugs (PDF files) (January 24, 2011)
— European Medicines Agency (EMA) report and Q&A on pediatric use of medicinal products in Europe.
— FDA notice of availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program.

Regulation (January 24, 2011)
Executive order from President Obama requiring federal agencies to design cost-effective, evidence-based regulations that are compatible with economic growth, job creation and competitiveness (see BioCentury Extra, Tuesday, Jan. 18).
Memorandum from President Obama emphasizing the need to reduce burdens on small businesses (see BioCentury Extra, Tuesday, Jan. 18).
Memorandum from President Obama requiring enforcement agencies to make publically available compliance information easily accessible, downloadable and searchable online (see BioCentury Extra, Tuesday, Jan. 18).

Transparency (January 24, 2011)
Conflict of interest information on the methodology committee of the Patient-Centered Outcomes Research Institute (PCORI), a non-profit established by the Patient Protection and Affordable Care Act to conduct comparative effectiveness research (see BioCentury Extra, Friday, Jan. 21).

Product documentation (January 24, 2011)
Amyvid: Briefing documents for the Jan. 20 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted 13-3 that current data do not support the approval of Amyvid florbetapir as a PET imaging agent to help rule out the presence of pathologically significant levels of beta amyloid in the brain; from Eli Lilly and Co. (NYSE:LLY). (PDF file)
Avastin: CHMP revised EPAR updating SPC to include information on cases of osteonecrosis of the jaw associated with co-administration of bisphosphonates and Avastin bevacizumab to treat metastatic cancer of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer, from Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit
Avastin: Genentech Inc.'s response to a notice of opportunity for a hearing about FDA's decision to withdraw approval of Avastin plus paclitaxel to support the drug's continued approval for the first-line treatment of HER2-negative metastatic breast cancer (see Cover Story). (PDF file)
Emselex: CHMP revised EPAR updating SPC to include the postmarketing adverse events mood alteration/depressed mood and hallucinations for Emselex darifenacin to treat overactive bladder syndrome; from Novartis AG (NYSE:NVS; SIX:NOVN).
Fampyra: CHMP Q&A on its negative opinion recommending against approval of Fampyra dalfampridine to improve walking ability in multiple sclerosis (MS) patients; from Biogen Idec Inc. (NASDAQ:BIIB), Acorda Therapeutics Inc. (NASDAQ:ACOR), Elan Corp. plc (NYSE:ELN) (see BioCentury Extra, Friday, Jan. 21). (PDF file)
Movectro: CHMP Q&A on its second negative opinion recommending against approval of Movectro cladribine to treat relapsing-remitting MS (RRMS); from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and Merck KGaA (Xetra:MRK) (see BioCentury Extra, Friday, Jan. 21). (PDF file)
Multaq: CHMP Q&A on the possible risk of liver injury with use of Multaq dronedarone from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Friday, Jan. 21). (PDF file)
Sutent: CHMP revised EPAR updating SPC to include information on cases of osteonecrosis of the jaw associated with co-administration of bisphosphonates and Sutent sunitinib to treat gastrointestinal stromal tumor (GIST), metastatic renal cell carcinoma (RCC) and pancreatic neuroendocrine tumors; from Pfizer Inc. (NYSE:PFE).

Biomarkers (January 24, 2011)
Institute of Medicine report summarizing the June 2010 workshop on biomarker and surrogate endpoint evaluation.

CHMP (PDF file) (January 24, 2011)
Summary of actions taken at the Jan. 17-20 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Devices (January 24, 2011)
— FDA plan to improve and clarify the 510(k) regulatory process for medical devices (see BioCentury Extra, Wednesday, Jan. 19).
— FDA's Center for Devices and Radiological Health (CDHR) strategic priorities for 2011.
— PricewaterhouseCoopers Medical Technology Innovation Scorecard assessing nine countries’ capacity and capability for medical technology innovation.

EMA (PDF files) (January 24, 2011)
Work plans for 2011 for European Medicines Agency's Biosimilar Medicinal Products Working Party (BMWP); Cell-based products working party; EMA/CHMP Working Group with Healthcare Professionals’ Organisations (HCP WG); and Good Manufacturing Practice/Good Distribution Practice Inspectors Working Group.

NHS (PDF file) (January 24, 2011)
Text of the Health and Social Care Bill introduced by U.K. Health Secretary Andrew Lansley to restructure the National Health Service (see BioCentury Extra, Wednesday, Jan. 19).

Orphan drugs (PDF file) (January 24, 2011)
Summary of actions taken at the Jan. 11-12 plenary meeting of the COMP, part of the European Medicines Agency (EMA).

Pediatric drugs (PDF files) (January 24, 2011)
— European Medicines Agency (EMA) report and Q&A on pediatric use of medicinal products in Europe.
— FDA notice of availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program.

Regulation (January 24, 2011)
Executive order from President Obama requiring federal agencies to design cost-effective, evidence-based regulations that are compatible with economic growth, job creation and competitiveness (see BioCentury Extra, Tuesday, Jan. 18).
Memorandum from President Obama emphasizing the need to reduce burdens on small businesses (see BioCentury Extra, Tuesday, Jan. 18).
Memorandum from President Obama requiring enforcement agencies to make publically available compliance information easily accessible, downloadable and searchable online (see BioCentury Extra, Tuesday, Jan. 18).

Transparency (January 24, 2011)
Conflict of interest information on the methodology committee of the Patient-Centered Outcomes Research Institute (PCORI), a non-profit established by the Patient Protection and Affordable Care Act to conduct comparative effectiveness research (see BioCentury Extra, Friday, Jan. 21).

Product documentation (January 24, 2011)
Amyvid: Briefing documents for the Jan. 20 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted 13-3 that current data do not support the approval of Amyvid florbetapir as a PET imaging agent to help rule out the presence of pathologically significant levels of beta amyloid in the brain; from Eli Lilly and Co. (NYSE:LLY). (PDF file)
Avastin: CHMP revised EPAR updating SPC to include information on cases of osteonecrosis of the jaw associated with co-administration of bisphosphonates and Avastin bevacizumab to treat metastatic cancer of the colon or rectum, breast cancer, non-small cell lung cancer (NSCLC) and kidney cancer, from Roche (SIX:ROG; OTCQX:RHHBY) and Roche's Genentech Inc. unit
Avastin: Genentech Inc.'s response to a notice of opportunity for a hearing about FDA's decision to withdraw approval of Avastin plus paclitaxel to support the drug's continued approval for the first-line treatment of HER2-negative metastatic breast cancer (see Cover Story). (PDF file)
Emselex: CHMP revised EPAR updating SPC to include the postmarketing adverse events mood alteration/depressed mood and hallucinations for Emselex darifenacin to treat overactive bladder syndrome; from Novartis AG (NYSE:NVS; SIX:NOVN).
Fampyra: CHMP Q&A on its negative opinion recommending against approval of Fampyra dalfampridine to improve walking ability in multiple sclerosis (MS) patients; from Biogen Idec Inc. (NASDAQ:BIIB), Acorda Therapeutics Inc. (NASDAQ:ACOR), Elan Corp. plc (NYSE:ELN) (see BioCentury Extra, Friday, Jan. 21). (PDF file)
Movectro: CHMP Q&A on its second negative opinion recommending against approval of Movectro cladribine to treat relapsing-remitting MS (RRMS); from Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and Merck KGaA (Xetra:MRK) (see BioCentury Extra, Friday, Jan. 21). (PDF file)
Multaq: CHMP Q&A on the possible risk of liver injury with use of Multaq dronedarone from sanofi-aventis Group (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Friday, Jan. 21). (PDF file)
Sutent: CHMP revised EPAR updating SPC to include information on cases of osteonecrosis of the jaw associated with co-administration of bisphosphonates and Sutent sunitinib to treat gastrointestinal stromal tumor (GIST), metastatic renal cell carcinoma (RCC) and pancreatic neuroendocrine tumors; from Pfizer Inc. (NYSE:PFE).

Cancer (PDF file) (January 17, 2011)
Department of Health report outlining the government's plan to improve cancer outcomes in the U.K., with the goal of saving an additional 5,000 lives per year by 2015 (see BioCentury Extra, Wednesday, Jan. 12).

CHMP (PDF file) (January 17, 2011)
Detailed report of actions taken at the Dec. 13-16 plenary meeting of the CHMP, part of the European Medicines Agency (EMA).

Clinical trials (January 17, 2011)
— European Medicines Agency's CHMP reflection paper on use of active controls in drug development (see BioCentury Extra, Wednesday, Jan. 12). (PDF file)
— FDA draft guidance on electronic source documentation in clinical investigations. (PDF file)
— U.K. Academy of Medical Sciences report recommending the creation of an independent Health Research Agency to develop an integrated approvals system for proposed clinical trials (see BioCentury Extra, Tuesday, Jan. 11).

Drug prices (PDF file) (January 17, 2011)
U.S. government amicus brief filed to the U.S. Supreme Court, supporting an appeal seeking to prevent health providers that participate in the 340B drug discount program from suing drug manufacturers for alleged overpricing (see BioCentury Extra, Monday, Jan. 10).

EMA (PDF files) (January 17, 2011)
Work plans for 2011 for European Medicines Agency's Central Nervous System Working Party (CNSWP), Gastroenterology Drafting Group; Pharmacokinetics Working Party (PKWP); Respiratory Drafting Group (RDG); Rheumatology-Immunology Working Group (RIWG), and Urology Drafting Group (UDG).

European biotechs (PDF file) (January 17, 2011)
EuropaBio Healthcare Manifesto 2011-2012 outlining guidance and recommendations for the development of an innovative, competitive and responsive European healthcare biotech industry.

Malaria (PDF file) (January 17, 2011)
World Health Organization (WHO) report and global plan calling to support and sustain national monitoring of the efficacy of antimalarial medicines to prevent wider emergence of resistance to artemisinin.

Manufacturing (PDF file) (January 17, 2011)
FDA notice of a Feb. 15-16 public workshop to explore approaches for a track and trace system for finished prescription drugs.

Osteoporosis (PDF file) (January 17, 2011)
American Association of Clinical Endocrinologists (AACE) medical guidelines for the diagnosis and treatment of postmenopausal osteoporosis (see BioCentury Extra, Tuesday, Jan. 11).

Pharmacovigilance (PDF file) (January 17, 2011)
Summary of actions taken at the Dec. 13-15 plenary meeting of CHMP's pharmacovigilance working party (PhVWP).

Transparency (PDF file) (January 17, 2011)
FDA report outlining action items and draft proposals to improve transparency to regulated industry (see BioCentury, Jan. 6).

Product documentation (January 17, 2011)
Brilique/Possia: CHMP EPAR for Brilique/Possia ticagrelor to prevent atherothrombotic events in acute coronary syndrome (ACS) patients; from AstraZeneca plc (LSE:AZN; NYSE:AZN).
Cerezyme: Dear Healthcare Professional letter notifying physicians of the resolved drug shortage for Cerezyme imiglucerase for Gaucher's disease; from Genzyme Corp. (NASDAQ:GENZ). (PDF file)
Solpura: FDA briefing documents for the Jan. 12 meeting of the Gastrointestinal Drugs Advisory Committee, which voted 7-4, with one abstention, against recommending approval of Solpura liprotamase to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF), chronic pancreatitis, pancreatectomy or other conditions; from Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Wednesday, Jan. 12).

Biologics (PDF file) (January 10, 2011)
European Medicines Agency (EMA) Biologics Working Party (BWP) 2011 work plan.

Clinical trials (PDF file) (January 10, 2011)
FDA final rule to amend informed consent regulations to require that informed consent documents and processes include a specific statement that clinical trial information will be entered into a publicly accessible databank.

Diagnostics (January 10, 2011)
Report outlining potential reforms for diagnostic reimbursement by consultant Health Advances with support from the Biotechnology Industry Organization (BIO) (see BioCentury Extra, Thursday, Jan. 6). (PDF file)
—FDA draft guidance establishing performance characteristics of in vitro diagnostics to detect antibodies to Borrelia burgdorferi. (PDF file)
—FDA draft guidance establishing performance characteristics of nucleic acid-based in vitro diagnostic devices to detect and differentiate methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).

Healthcare reform (PDF file) (January 10, 2011)
Text of the Repealing the Job-Killing Health Care Law Act, which seeks to repeal the Patient Protection and Affordable Care Act (PPACA) (see BioCentury Extra, Tuesday, Jan. 4).

PDUFA (PDF file) (January 10, 2011)
Minutes from the Dec. 6, 2010, meeting between FDA and industry on PDUFA reauthorization that includes proposals to establish a structured benefit-risk framework for drug reviews that would incorporate patient perspectives (see BioCentury Extra, Wednesday, Jan. 5).

Transparency (January 10, 2011)
FDA report on steps the agency may take to increase transparency to regulated industry (see BioCentury Extra, Thursday, Jan. 6). (PDF file)
—FDA web resource for industry that includes basic information about the regulatory process.

Product documentation (January 10, 2011)
Iressa: CHMP revised EPAR updating SPC to include an update on the frequency of hepatitis and to add GI perforation, skin fissures, bullous conditions, cutaneous vasculitis, cystitis and hemorrhagic cystitis as adverse reactions 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).
Sutent: CHMP revised EPAR extending indication of Sutent sunitinib to include treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors with disease progression; from Pfizer Inc. (NYSE:PFE).

Advanced therapies (PDF file) (January 3, 2011)
Summary of actions taken at the Dec. 9-10 plenary meeting of the Committee for Advanced Therapies (CAT), part of the European Medicines Agency (EMA).

Advisory committees (PDF file) (January 3, 2011)
FDA tentative schedule of public advisory committee meetings in 2011.

Cancer diagnostics (PDF file) (January 3, 2011)
HHS's Agency for Healthcare Research and Quality (AHRQ) draft technology assessment on genetic tests currently available for clinical use in cancers.

CHMP (PDF file) (January 3, 2011)
Summary of actions taken at the Dec. 13-16 plenary meeting of the Committee for Medicinal Products for Human Use, part of the European Medicines Agency (EMA).

Dialysis (PDF file) (January 3, 2011)
Centers for Medicare & Medicaid Services (CMS) final rule outlining a quality incentive program to link Medicare dialysis payments to performance standards (see BioCentury Extra, Wednesday, Dec. 29, 2010).

Drug safety (PDF file) (January 3, 2011)
Text of the Drug Safety Enhancement Act (H.R. 6543), which seeks to enhance FDA's authority to regulate drug safety (see BioCentury Extra, Tuesday, Dec. 21, 2010).

EMA (PDF files) (January 3, 2011)
— European Medicines Agency (EMA) 2011 budget.
Minutes of the Oct. 7, 2010 meeting of EMA's Management Board.
Working arrangement between EMA and the European Centre for Disease Prevention and Control (ECDC) to enhance cooperation and consultation between the agencies.

Hypertension (PDF file) (January 3, 2011)
European Medicines Agency (EMA) guideline on clinical investigation of medicinal products to treat hypertension.

Immunoglobulin (PDF file) (January 3, 2011)
European Medicines Agency (EMA) concept paper on revision of the note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use.

Lipid lowering agents (PDF file) (January 3, 2011)
European Medicines Agency (EMA) draft guideline evaluating lipid lowering agents.

Patient and consumer groups (PDF file) (January 3, 2011)
2011 work plan for the Scientific Committees' Working Party with Patients' and Consumers' Organizations (PCWP), part of European Medicines Agency (EMA).

Research funding (PDF file) (January 3, 2011)
U.K. government allocations of its annual science research budget for 2011-15 (see BioCentury Extra, Tuesday, Dec. 21, 2010).  

SBIR/STTR (PDF file) (January 3, 2011)
Text of the SBIR and STTR Reauthorization Act of 2010 (S. 4053), which would have reauthorized and expanded the Small Business Innovation Research (SBIR) and Small Business Technical Transfer (STTR) programs until 2018 (see BioCentury Extra, Wednesday, Dec. 29, 2010).

SMEs (January 3, 2011)
— European Medicines Agency (EMA) public registry of small and medium sized enterprises (SME) in the EU and FAQ (PDF file) on the assignment and maintenance of SME status (see BioCentury Extra, Monday, Dec. 20, 2010).
— EMA's SME office report for 2010. (PDF file)

Product documentation (January 3, 2011)
— Avastin: European Medicines Agency (EMA) Q&A on its review of Avastin bevacizumab to treat metastatic breast cancer; from Roche (SIX:ROG; OTCQX:RHHBY), plus a letter from Roche's Genentech Inc. unit to FDA requesting a hearing on the agency's proposal to withdraw the approval of Avastin for first-line treatment of HER2-negative metastatic breast cancer (see BioCentury Extra, Thursday, Dec. 23, 2010). (PDF files)
Epivir: CHMP revised EPAR updating SPC to include angioedema as an adverse event for Epivir lamivudine to treat HIV infection; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Levact: NICE final appraisal determination recommending the use of Levact bendamustine as a first-line treatment for patients with chronic lymphocytic leukemia (CLL) for whom fludarabine combination chemotherapy is not appropriate; from Mundipharma International Ltd. and Astellas Pharma Inc. (Tokyo:4503) (see BioCentury Extra, Wednesday, Dec. 22, 2010). (PDF file)
Meridia: FDA notice of the withdrawal of approval for an NDA for Meridia sibutramine to treat obesity; from Abbott Laboratories (NYSE:ABT). (PDF file)
Sprycel: CHMP revised EPAR extending the indication of Sprycel dasatinib to include to include first-line treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP); from Otsuka Pharmaceutical Co. Ltd. and Bristol-Myers Squibb Co. (NYSE:BMY).
Thalidomide: CHMP revised EPAR updating SPC to include pancytopenia, hearing loss, renal dysfunction and hypersensitivity as adverse events for thalidomide to treat multiple myeloma (MM); from Celgene Corp. (NASDAQ:CELG).
Votrient: NICE final appraisal determination recommending the use of Votrient pazopanib as a first-line treatment for patients with advanced renal cell carcinoma (RCC) who have not received prior cytokine therapy; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, Dec. 23, 2010). (PDF file)