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

Biosimilar insulin (PDF file) (December 24, 2012)
EMA's CHMP draft guidelines on the non-clinical and clinical requirements for biosimilar insulin products (see BioCentury Extra, Wednesday, Dec. 19)

Clinical trials (PDF file) (December 24, 2012)
FDA draft guidance outlining enrichment strategies to improve the efficiency of clinical trials (see BioCentury Extra, Monday, Dec. 17).

Comparative-effectiveness research (December 24, 2012)
Patient-Centered Outcomes Research Institute (PCORI) list of 25 award recipients, which received awards totaling $40.7 million over three years for comparative clinical effectiveness research projects addressing the first four of PCORI's five research priorities (see BioCentury Extra, Tuesday, Dec. 18).

CPRIT (PDF file) (December 24, 2012)
Letter from Texas state officials to the Cancer Prevention and Research Institute of Texas requesting that the institute "fully address the concerns that have been raised about its process and operations" prior to awarding new grants (see BioCentury Extra, Friday, Dec. 21).

EMA (December 24, 2012)
— EMA eSubmission web client where registered applicants may submit centralized procedure electronic Common Technical Document (eCTD) applications, effective Jan. 15.
— Work plans for 2013 for EMA's Biologics Working Party and Infectious Diseases Working Party. (PDF files)

Safety (PDF files) (December 24, 2012)
FDA guidance on safety reporting requirements for INDs and bioavailability and bioequivalence studies and specific guidance on the requirements for small businesses.

Product documentation (December 24, 2012)
Ampligen: Briefing documents for the Dec. 20 meeting of FDA's Arthritis Advisory Committee, which voted 8-5 that Hemispherx failed to demonstrate sufficient efficacy and safety of Ampligen rintatolimod to treat chronic fatigue syndrome (CFS); from Hemispherx Biopharma Inc. (NYSE-M:HEB). (PDF file)
Avastin: NICE draft guidance recommending against Avastin bevacizumab for first-line treatment of advanced ovarian cancer in combination with paclitaxel and carboplatin; from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Monday, Dec. 17).
Fycompa: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report concluding Fycompa perampanel to treat epilepsy provides "no additional benefit" over comparators requested by Germany's Federal Joint Committee (G-BA); from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Monday, Dec. 17). (PDF file)
Jakavi: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) assessment report that estimates Orphan myelofibrosis drug Jakavi ruxolitinib will cost the German statutory health insurance funds (GKV) more than EUR 50 million per year; from Incyte Corp. (NASDAQ:INCY) and Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, Dec. 17). (PDF file)
Revolade: NICE draft guidance recommending the use of Revolade eltrombopag to treat idiopathic thrombocytopenic purpura (ITP); from Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Monday, Dec. 17).

End-stage renal disease (PDF file) (December 17, 2012)
U.S. Government Accountability Office (GAO) report recommending that Congress consider requiring HHS to adjust the bundled payment rate for end-stage renal disease (ESRD) patients to reflect the use of bundled dialysis items and services (see BioCentury Extra, Tuesday, Dec. 11).

Medicaid (PDF file) (December 17, 2012)
HHS FAQ on exchanges, market reforms and Medicaid, which includes a response that says states that opt to only partially expand Medicaid coverage under the Medicaid expansion provision of the Affordable Care Act will not be eligible for federal funding to cover the cost of people who would be newly eligible for Medicaid (see BioCentury Extra, Tuesday, Dec. 11).

Medical device excise tax (PDF files) (December 17, 2012)
— U.S. Internal Revenue Service final regulations and interim guidance on implementing the medical device excise tax (see BioCentury Extra, Wednesday, Dec. 12).
Letter from a group of U.S. Senators and Senators-elect to Senate Majority Leader Harry Reid (D-Nev.) asking him to request a delay on the implementation of the medical device excise tax, which is slated to take effect on Jan. 1, 2013 (see BioCentury Extra, Wednesday, Dec. 12).

Social anxiety disorder (PDF file) (December 17, 2012)
The U.K.'s NICE draft guidance on the recognition and treatment of social anxiety disorder.

U.K. life science strategy (PDF file) (December 17, 2012)
U.K. industrial strategy report noting that the U.K. has received more than L1 billion ($1.6 billion) in new private life science investment over the last year due in part to the Strategy for Life Sciences (see BioCentury Extra, Tuesday, Dec. 11).

Product documentation (PDF files) (December 17, 2012)
Yervoy: The U.K.'s NICE final guidance recommending the use of Yervoy ipilimumab to treat advanced melanoma in patients who have received prior chemotherapy; from Bristol-Myers Squibb Co. (NYSE:BMY).
Zelboraf: The U.K.'s NICE final guidance recommending the use of Zelboraf vemurafenib to treat BRAF V600 mutation-positive, unresectable or metastatic melanoma; from Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Roche (SIX:ROG; OTCQX:RHHBY) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568).
Zohydro: Briefing documents for the Dec. 7 meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2, with one abstention, against approval of Zohydro ER hydrocodone bitartrate to manage moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is required for an extended period of time; from Zogenix Inc. (NASDAQ:ZGNX) and Alkermes plc (NASDAQ:ALKS) (see BioCentury, Dec. 17).

Benchmark plans (PDF file) (December 10, 2012)
Avalere Health LLC report, based on information released by CMS, tallying the number of drugs that must be covered under essential health benefits benchmark plans of each state (see BioCentury Extra, Tuesday, Dec. 4).

CIRM (December 10, 2012)
Institute of Medicine independent review of California Institute for Regenerative Medicine's programs, operations and strategies (see BioCentury Extra, Thursday, Dec. 6).

Clinical data (December 10, 2012)
EMA call for nominations to join advisory groups to help develop a policy on the proactive publication of clinical trial data. 

EMA (PDF file) (December 10, 2012)
EMA list of applications for human medicines under review by the agency's CHMP as of Nov. 22.

FDA (PDF file) (December 10, 2012)
FDA report that said the agency approved 35 new drugs in the fiscal year ending Sept. 30 (see BioCentury Extra, Wednesday, Dec. 5). 

Immunoglobulin (PDF files) (December 10, 2012)
EMA draft guidance on the clinical investigation of hepatitis B immunoglobulin.
EMA draft guidance on the clinical investigation of subcutaneous or intramuscular human immunoglobulin.

Labeling (PDF file) (December 10, 2012)
The Medicines and Healthcare products Regulatory Agency (MHRA) guidance on reclassifying a prescription-only medicine as an OTC medicine.

Pharmacovigilance (PDF files) (December 10, 2012)
Minutes from the Oct. 29-31 meeting of EMA's Pharmacovigilance Risk Assessment Committee.
— EMA updated Q&A to support implementation of pharmacovigilance legislation.

R&D costs (December 10, 2012)
Office of Health Economics (OHE) study estimating the mean R&D cost to get to a new drug approval is $1.5 billion, adjusted for inflation through 2011 (see BioCentury Extra, Monday, Dec. 3).

Product documentation (December 10, 2012)
Enbrel: EMA's CHMP revised EPAR updating SPC to include scleritis as an adverse reaction for Enbrel etanercept to treat polyarticular juvenile idiopathic arthritis, chronic severe plaque psoriasis, rheumatoid arthritis (RA), psoriatic arthritis, severe ankylosing spondylitis and plaque psoriasis; from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE).
Eylea: EPAR from EMA's CHMP for Eylea aflibercept to treat wet age-related macular degeneration (AMD); from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Bayer AG (Xetra:BAYN).
Iluvien: The U.K.'s NICE final appraisal determination (FAD) recommending against the use of Iluvien fluocinolone acetonide intravitreal implant to treat chronic diabetic macular edema (DME); from Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA). (PDF file)
Inlyta: The U.K.'s NICE preliminary appraisal recommending against Inlyta axitinib to treat advanced renal cell carcinoma (RCC) in patients who failed treatment with sunitinib or a cytokine; from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, Dec. 6).
Orencia: The U.K.'s NICE draft guidance recommending IV Orencia abatacept in combination with methotrexate to treat moderate to severe rheumatoid arthritis (RA) in adults whose disease has responded inadequately to two DMARDs; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Wednesday, Dec. 5). 
Signifor: Germany's Federal Joint Committee (G-BA) final assessment concluding that Signifor pasireotide provides a "marginal" degree of additional benefit for patients with Cushing's disease for whom surgery is not an option or has failed; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Friday, Dec. 7). (PDF file)
Zohydro: Briefing documents for the Dec. 7 meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2, with one abstention, against approval of Zohydro ER hydrocodone bitartrate to manage moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is required for an extended period of time; from Zogenix Inc. (NASDAQ:ZGNX) and Alkermes plc (NASDAQ:ALKS) (see BioCentury Extra, Friday, Dec. 7). (PDF file)

Breakthrough drugs (PDF file) (December 3, 2012)
Developing Standards for Breakthrough Therapy Designation Issue brief developed for Friends of Cancer Research/Brookings Institution conference on clinical cancer research (see BioCentury, Dec. 3).

Budget (PDF file) (December 3, 2012)
Congressional Budget Office report saying it will now account for an "offsetting effect" on medical spending when calculating the budgetary effect of future legislation or proposals on prescription drug use under Medicare (see BioCentury Extra, Thursday, Nov. 29).

Clinical trials (PDF file) (December 3, 2012)
Joint statement from the Association of the British Pharmaceutical Industry (ABPI) and other industry stakeholders welcoming the European Commission's proposed regulation to simplify the process of conducting multinational clinical trials (see BioCentury Extra, Monday, Nov. 26).

CMS
— Centers for Medicare & Medicaid Services (CMS) list of potential National Coverage Determinations (NCDs) topics, which includes genetic testing and whole genome sequencing (see BioCentury Extra, Wednesday, Nov. 28).
— CMS updated draft guidance that would give the agency greater flexibility to apply its coverage with evidence development (CED) mechanism (see BioCentury Extra, Friday, Nov. 30). (December 3, 2012)
— HHS's Office of the Inspector General report recommending CMS consider seeking legislative authority to implement least costly alternative policies for clinically comparable Medicare Part B drugs under "appropriate circumstances" (see BioCentury Extra, Tuesday, Nov. 27). (PDF file) (December 3, 2012)

Drug shortages (PDF file) (December 3, 2012)
EMA reflection paper on medicinal product supply shortages caused by manufacturing/GMP compliance problems.

Essential health benefits
— HHS proposed rule to increase the number of drugs eligible for reimbursement by insurers under the Affordable Care Act's essential health benefits requirements (see BioCentury Extra, Tuesday, Nov. 20). (PDF file) (December 3, 2012)
— HHS proposed rule on implementing and expanding employment-based wellness programs (see BioCentury Extra, Tuesday, Nov. 20). (December 3, 2012)
— HHS proposed rule prohibiting health insurance companies from discriminating because of a preexisting or chronic condition (see BioCentury Extra, Tuesday, Nov. 20). (December 3, 2012)

FDA (December 3, 2012)
Not-for-profit Partnership for Public Service report calling for FDA to take steps to improve its hiring process and improve management, retention and development of talent (see BioCentury Extra, Tuesday, Nov. 20).

Gene/Cell therapy (PDF file) (December 3, 2012)
FDA draft guidance on preclinical development of cellular and gene therapy products.

Healthcare spending (PDF file) (December 3, 2012)
The European Commission and the Organization for Economic Co-operation and Development (OECD) joint report showing that EU health spending fell in 2010 due to governments’ efforts to reduce budgetary deficits, reductions in wages and employment levels and increasing direct payments by households for certain services and pharmaceuticals.

HIV/AIDS (PDF files) (December 3, 2012)
— FDA draft guidance on the development of vaginal microbicides to prevent HIV infection.
— Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing medicines and vaccines under development to treat HIV infection.
— PhRMA report on the evolution of HIV/AIDS treatment from an acute, fatal disease to a chronic, manageable condition.
— The President’s Emergency Plan for AIDS Relief (PEPFAR) blueprint outlining U.S. commitment to help create an AIDS-free generation, including support of research to develop new technologies for prevention and care.
— U.S. Preventive Services Task Force (USPSTF) draft guidelines recommending screening for HIV infection in people ages 15-65 years, children younger than 15 years and adults over 65 years who are at increased risk for HIV infection, and pregnant women (see BioCentury Extra, Tuesday, Nov. 20).

Investigational review boards (PDF file) (December 3, 2012)
FDA draft guidance on investigational review board (IRB) responsibilities for determining whether clinical investigators overseeing a trial are sufficiently qualified, whether the research facility is adequate and whether the proposed clinical investigation has appropriately sought out an IND or IDE from the agency.

NICE (PDF file) (December 3, 2012)
IMS Health report on the reasons for variations in uptake of medicines recommended by the U.K.'s NICE across the country's National Health Service(NHS).

Obesity (PDF file) (December 3, 2012)
Guidance from the U.K.'s NICE saying there is inadequate evidence about long-term safety of laparoscopic gastric plication to treat severe obesity.

PDUFA V (December 3, 2012)
FDA list of deadlines for PDUFA V implementation, which includes publishing by the end of next year a draft plan to develop and implement a structured benefit-risk assessment for NDAs (see BioCentury Extra, Tuesday, Nov. 27).

Pediatric asthma (PDF file) (December 3, 2012)
EMA report on the Oct. 20 meeting of pediatric asthma experts to provide input in revising agency asthma guideline.

Pharmacogenomics (PDF file) (December 3, 2012)
EMA report on the Oct. 8-9 workshop on pharmacogenomics.

Pharmacovigilance (PDF file) (December 3, 2012)
European Commission consultation seeking input from stakeholders on the time needed to implement new product labeling requirements under pharmacovigilance legislation that took effect in July (see BioCentury Extra, Tuesday, Nov. 27).

Product documentation (December 3, 2012)
Adcetris: CHMP EPAR for Adcetris brentuximab vedotin to treat anaplastic large cell lymphoma (ALCL) and Hodgkin's lymphoma; from Seattle Genetics Inc. (NASDAQ:SGEN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
Esbriet: NICE draft guidance recommending against Esbriet pirfenidone to treat mild to moderate idiopathic pulmonary fibrosis (IPF); from InterMune Inc. (NASDAQ:ITMN) (see BioCentury Extra, Thursday, Nov. 29).
Picato: CHMP EPAR for Picato ingenol mebutate gel to treat actinic keratosis; from Leo Pharma A/S.
Sirturo: Briefing documents for the Nov. 28 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 18-0 that efficacy data for Sirturo bedaquiline supported accelerated approval to treat multi-drug-resistant tuberculosis (TB); from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Wednesday, Nov 28). (PDF file)
Valdoxan/Thymanax: EMA's CHMP revised EPAR updating SPC to include information on cases of liver injury, hepatitis and jaundice, as well as vomiting, weight increase and decrease as adverse events for Valdoxan agomelatine to treat major depressive disorder (MDD); from Novartis AG (NYSE:NVS; SIX:NOVN) and Servier.
Vibativ: Briefing documents for the Nov. 29 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 13-2 to recommend expanding the label for Vibativ telavancin to include treating nosocomial pneumonia when other alternatives are not suitable and 9-6 against expanding the label to treat nosocomial pneumonia without the restriction of unsuitable alternatives; from Theravance Inc. (NASDAQ:THRX) (see BioCentury, Dec. 3). (PDF file)
Victoza: EMA's CHMP revised EPAR updating SPC to include anaphylactic  reactions, rash and pruritus as adverse reactions for Type II diabetes drug Victoza liraglutide; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).

Antibiotics (PDF files) (November 19, 2012)
Food and Drug Administration Safety and Innovation Act, which incorporates the Generating Antibiotic Incentives Now (GAIN) Act (see Cover Story).
EMA Addendum to the note for guidance on evaluation of medicinal products indicated to treat bacterial infections (CPMP/EWP/558/95 REV 2) to address indication-specific clinical data.
Infectious Diseases Society of America description of the Limited Population Antibacterial Drug (LPAD) Approval Mechanism.

Crohn's disease (PDF file) (November 19, 2012)
EMA concept paper recommending revision of the guidelines on the clinical development of medicinal products to treat Crohn's disease.

Chronic constipation (PDF file) (November 19, 2012)
EMA concept paper on the need for a guideline on the clinical development of medicinal products to treat chronic constipation.

European funding (November 19, 2012)
Online European funding network capmatch medical, which connects life science companies that are seeking capital with investors.

FDA (November 19, 2012)
U.S. District Court for the District of Columbia opinion that said FDA is not required to release in full a subset of withheld or redacted internal documents related to the employment of current and former agency employees who are now suspected of leaking confidential information (see BioCentury Extra, Tuesday, Nov. 13).

Medicare (PDF file) (November 19, 2012)
Government Accountability Office (GAO) report analyzing trends in use and expenditures for high-expenditure Part B drugs and estimating Medicare's proportion of total U.S. expenditures for the drugs.

NSAIDs (PDF file) (November 19, 2012)
EMA's CHMP assessment report on cardiovascular risk of non-selective NSAIDs.

PCORI (PDF file) (November 19, 2012)
Patient-Centered Outcomes Research Institute (PCORI) request for proposals to create an inventory that details a defined set of characteristics of research data networks.

Rare diseases (November 19, 2012)
Joint declaration on 10 key principles for rare disease patient registries from the National Organization for Rare Disorders (NORD), the European Organization for Rare Diseases (EURORDIS) and the Canadian Organization for Rare Disorders (CORD).

Ulcerative colitis (PDF file) (November 19, 2012)
EMA concept paper recommending revision of the guidelines on the clinical development of medicinal products to treat ulcerative colitis.

Product documentation (November 19, 2012)
Heplisav: Briefing documents for the Nov. 15 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which voted 8-5 with one abstention that not enough safety data had been gathered to support approval of Heplisav to prevent HBV infection; from Dynavax Technologies Corp. (NASDAQ:DVAX) (see BioCentury Extra, Nov. 15).
Q-Pan: Briefing documents for the Nov. 14 meeting of FDA's Vaccines and Related Biological Products Advisory Committee, which voted 14-0 that safety and immunogenicity data support accelerated approval of Q-Pan H5N1 adjuvanted vaccine to prevent disease in adults who are at an increased risk of exposure to the influenza A virus subtype H5N1; from GlaxoSmithKline plc (LSE:GSK: NYSE:GSK) (see BioCentury Extra, Nov. 14).
Xalkori: EMA's CHMP EPAR for Xalkori crizotinib to treat previously treated, advanced non-small cell lung cancer (NSCLC) in patients whose tumors are anaplastic lymphoma kinase (ALK)-positive; from Pfizer Inc. (NYSE:PFE).

Biosimilars (PDF file) (November 12, 2012)
Letter to FDA from a group of university associations requesting the agency require biosimilar applicants provide proof that they have notified reference product sponsors (see BioCentury Extra, Friday, Nov. 9).

Bioterrorism (PDF files) (November 12, 2012)
— FDA draft guidance to establish analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostics.
— FDA notice of a Nov. 29-30 public workshop to discuss melioidosis and glanders, which are caused by the bioterrorism agents Burkholderia pseudomallei and B. mallei, respectively (see BioCentury Extra, Wednesday, Nov. 7).

Clinical trials (PDF file) (November 12, 2012)
Canadian Senate Standing Committee on Social Affairs, Science and Technology report calling on the government to improve its clinical trial infrastructure and bring its clinical trial requirements and obligations in line with other countries.

Deficit (PDF file) (November 12, 2012)
Congressional Budget Office (CBO) report on the magnitude and causes of the U.S. federal government’s budgetary imbalance, various options for bringing spending and taxes into closer alignment, and criteria that lawmakers and the public might use to evaluate different approaches to deficit reduction (see Cover Story).

Drug reimbursement (PDF file) (November 12, 2012)
U.S. Centers for Medicare & Medicaid Services' 2013 final rule for Medicare's outpatient prospective payment system (OPPS) (see BioCentury Extra, Wednesday, Nov. 7).

Healthcare costs (PDF file) (November 12, 2012)
National Coalition on Health Care report recommending a seven-year exclusivity period for biologics and reduced reimbursement for Medicare Part B drugs (see Cover Story).

Pharmacovigilance (PDF file) (November 12, 2012)
Minutes from the Oct. 1-3 meeting of EMA's Pharmacovigilance Risk Assessment Committee.

Product documentation (November 12, 2012)
Pasireotide: Briefing documents for the Nov. 7 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which voted 10-0 that efficacy and safety data for pasireotide support approval to treat Cushing's disease; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Wednesday, Nov. 7). (PDF file)
Ryzodeg: Briefing documents for the Nov. 8 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which voted 8-4 that sufficient safety and efficacy data were provided to support approval of Ryzodeg insulin Degludec/insulin aspart for Type I and II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Thursday, Nov. 8). (PDF file)
Tresiba: Briefing documents from the Nov. 8 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which voted 8-4 that sufficient safety and efficacy data were provided to support approval of Tresiba insulin Degludec for Type I and II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Thursday, Nov. 8). (PDF file)
Xolair: The U.K.'s NICE draft guidance that no longer recommends the use of Xolair omalizumab in adults as add-on therapy to optimized standard therapy for severe, persistent allergic asthma; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Nov. 8).

Compounding pharmacies (PDF files) (November 5, 2012)
Congressional report from Rep. Edward Markey (D-Mass.) concluding that State Boards of Pharmacy do not "consistently oversee" the safety of drugs made by compounding pharmacies (see BioCentury Extra, Tuesday, Oct. 30).
Text of the Verifying Authority and Legality in Drug (VALID) Compounding Act, which would give FDA authority to oversee compounding pharmacy practices (see BioCentury Extra, Friday, Nov. 2).

Osteoporosis (PDF file) (November 5, 2012)
EMA concept paper on the need to revise guidelines for evaluating medicinal products to treat glucocorticoid osteoporosis.

Pharmacovigilance (November 5, 2012)
Summary of actions taken at the Oct. 29-31 meeting of EMA's Pharmacovigilance Risk Assessment Committee.

Product documentation (PDF files) (November 5, 2012)
Raxibacumab: Briefing documents for the Nov. 2 meeting of FDA’s Anti-Infective Drugs Advisory Committee, which recommended approval of raxibacumab to treat inhalational anthrax; from the Human Genome Sciences Inc. subsidiary of GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Yervoy: The U.K.’s NICE final appraisal determination (FAD) recommending the use of 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, Nov. 1).
Zelboraf: The U.K.’s NICE final appraisal determination (FAD) recommending the use of Zelboraf vemurafenib to treat patients with unresectable locally advanced or metastatic melanoma in patients who are BRAF V600-mutation positive; from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Nov. 1).

FDA (October 29, 2012)
— FDA's Center for Biologics Evaluation and Research (CBER) annual report for 2011.
— FDA list of new molecular entities (NMEs) approved by the agency this year (see BioCentury Extra, Tuesday, Oct. 23).

Generics (PDF files) (October 29, 2012)
FDA notices on generic drug user fees for fiscal 2013 authorized by the Generic Drug User Fee Amendments (GDUFA) of 2012 for new generic drug submissions and applications in the backlog as of Oct. 1.

Hormone therapy (October 29, 2012)
U.S. Preventive Services Task Force (USPSTF) final recommendation against the use of hormone therapy to prevent chronic conditions in postmenopausal women.

Patents (PDF file) (October 29, 2012)
The U.K.'s Intellectual Property Office proposal to provide the same level of protection against patent infringement suits to companies running U.K. trials of novel drugs as it does to those testing generics (see BioCentury Extra, Wednesday, Oct. 24).

Pediatric trials (PDF file) (October 29, 2012)
EMA report on a workshop held late last year on ethical considerations for pediatric trials.

Psoriasis (PDF file) (October 29, 2012)
The U.K.'s NICE clinical guideline for assessing and managing psoriasis.

Supply chain (PDF file) (October 29, 2012)
U.S. Senate Health, Education, Labor and Pensions Committee discussion draft of legislation, which would create a national system for tracking and tracing pharmaceutical products (see BioCentury Extra, Wednesday, Oct. 24).

U.K. (PDF file) (October 29, 2012)
U.K. Department of Health annual report for 2011-12.

Product documentation (October 29, 2012)
Adcirca/Cialis: EMA's CHMP revised EPAR updating SPC to include a warning regarding the risk of angioedema for Adcirca/Cialis tadalafil to treat pulmonary arterial hypertension (PAH); from Eli Lilly and Co. (NYSE:LLY) and Nippon Shinyaku Co. Ltd. (Tokyo:4516; Osaka:4516).
Bronchitol: The U.K.'s NICE final appraisal determination recommending Bronchitol mannitol as an add-on therapy to best standard of care to treat cystic fibrosis (CF) patients for whom treatment with recombinant human deoxyribonuclease (rhDNase) or osmotic agents like hypertonic saline are not appropriate, and who have rapidly declining lung function defined as a 2% or more annual decline in forced expiratory volume in one second (FEV1); from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) (see BioCentury Extra, Thursday, Oct. 25). (PDF file)
Colobreathe: The U.K.'s NICE preliminary appraisal recommending against the use of Colobreathe colistimethate sodium to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients; from Forest Laboratories Inc. (NYSE:FRX).
Ryzodeg: FDA conflict-of-interest waiver for a physician participating in the Nov. 8 meeting of the agency's Endocrinologic and Metabolic Drugs Advisory Committee, which includes concerns about the cardiovascular safety of Ryzodeg insulin Degludec/insulin aspart to treat Type I and II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Thursday, Oct. 25). (PDF file)
TOBI Podhaler: The U.K.'s NICE preliminary appraisal recommending TOBI Podhaler tobramycin inhalation powder to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients if nebulized tobramycin is considered an appropriate treatment; from Novartis AG (NYSE:NVS; SIX:NOVN).
Tresiba: FDA conflict-of-interest waiver for a physician participating in the Nov. 8 meeting of the agency's Endocrinologic and Metabolic Drugs Advisory Committee, which includes concerns about the cardiovascular safety of Tresiba insulin Degludec to treat Type I and II diabetes; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Thursday, Oct. 25). (PDF file)
Xgeva: The U.K.'s NICE final guidance recommending the use of Xgeva denosumab to prevent skeletal-related events (SREs) in patients with bone metastases from breast cancer and from solid tumors other than prostate cancer if bisphosphonates would otherwise be prescribed; from Amgen Inc. (NASDAQ:AMGN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568). (PDF file)

Advanced therapies (PDF file) (October 22, 2012)
Summary of actions taken at the Oct. 11-12 meeting of EMA's Committee for Advanced Therapies (CAT).

Conflict of interest (PDF file) (October 22, 2012)
EMA overview of acceptable interests in handling conflicts of interest of agency scientific committee members and experts.

Heart failure (PDF file) (October 22, 2012)
EMA revised draft guideline on clinical investigation of products to treat acute heart failure.

Single cell analysis (October 22, 2012)
NIH award recipients for single cell analysis research (see BioCentury Extra, Tuesday, Oct. 16).

Stem cells (October 22, 2012)
California Institute for Regenerative Medicine (CIRM) and Alliance for Regenerative Medicine guide for developing stem cells in the U.S.

Product documentation (October 22, 2012)
Cyklokapron: NICE evidence summary stating that a large international study showed that off-label use of Cyklokapron tranexamic acid to treat and prevent severe bleeding following trauma significantly increases the proportion of patients who survive their injuries; from Pfizer Inc. (NYSE:PFE).
Dacogen: EPAR from EMA's CHMP for Dacogen decitabine to treat newly diagnosed de novo or secondary acute myelogenous leukemia (AML) in patients 65 years and older; from Astex Pharmaceuticals Inc. (NASDAQ:ASTX), Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Johnson & Johnson (NYSE:JNJ).
Gattex: Briefing documents for the Oct. 16 meeting of FDA's Gastrointestinal Drugs Advisory Committee, which voted 12-0 that Gattex teduglutide is effective and that the benefits outweigh its risks for treating adults with short bowel syndrome (SBS); from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) (see BioCentury, Oct. 22).
Kynamro: Briefing documents for the Oct. 18 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 9-6 that efficacy and safety data for Kynamro mipomersen support approval to treat patients with homozygous familial hypercholesterolemia (hoFH); from Isis Pharmaceuticals Inc. (NASDAQ:ISIS) and the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Thursday, Oct. 18). (PDF file)
Lomitapide: Briefing documents for the Oct. 17 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 13-2 that efficacy and safety data for lomitapide support approval to treat homozygous familial hypercholesterolemia (hoFH); from Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) (see BioCentury Extra, Wednesday, Oct. 17). (PDF file)
Procoralan: NICE final appraisal determination recommending use of Procoralan ivabradine to treat chronic heart failure in combination with standard therapy, including beta blockers, or when beta blockers are contraindicated or not tolerated; from Ono Pharmaceutical Co. Ltd. (Tokyo:4528; Osaka:4528) and Servier. (PDF file)
Seebri/Enurev/Tovanor: CHMP EPAR for Seebri/Enurev/Tovanor Breezhaler glycopyrronium bromide as a once-daily, inhaled maintenance bronchodilator therapy for chronic obstructive pulmonary disease (COPD); from Vectura Group plc (LSE:VEC), Novartis AG (NYSE:NVS; SIX:NOVN) and Sosei Group Corp. (Tokyo:4565).

Acute bacterial sinusitis (PDF file) (October 25, 2012)
FDA final guidance on developing drugs to treat acute bacterial sinusitis.

Compounding pharmacies (PDF file) (October 25, 2012)
Letter from Rep. Edward Markey (D-Mass.) to FDA asking for information on how many enforcement actions FDA has taken on compounding pharmacies and whether the agency keeps records on compounding pharmacies (see BioCentury Extra, Tuesday, Oct. 9).

Conflict of interest (PDF file) (October 25, 2012)
European Court of Auditors report concluding that EMA and three other EU agencies have not adequately managed conflict of interest situations (see BioCentury Extra, Thursday, Oct. 11).

Crohn's disease (PDF file) (October 25, 2012)
The U.K.'s NICE clinical guideline on managing Crohn's disease.

Drug security (PDF file) (October 25, 2012)
Text of the SAFE DOSES Act (H.R. 4223), which President Obama signed into law and provides new penalties for the theft of medical products (see BioCentury Extra, Monday, Oct. 8).

EMA (PDF files) (October 25, 2012)
Agenda for the Oct. 4 meeting of EMA's Management Board.
—EMA mid-year report from the executive director.

Infectious diseases (October 25, 2012)
Not-for-profit BIO Ventures for Global Health public database of shared IP for the development of drugs, vaccines and diagnostics for neglected tropical diseases, malaria and tuberculosis (TB) (see BioCentury Extra, Friday, Oct. 12).

Obesity (October 25, 2012)
FDA officials' discussion in The New England Journal of Medicine on the development and regulatory process that led to the approval this year of obesity drugs Belviq lorcaserin from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) and marketing partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Qsymia phentermine/topiramate from Vivus Inc. (NASDAQ:VVUS) (see BioCentury Extra, Friday, Oct. 12).

Pediatric drugs (PDF file) (October 25, 2012)
Summary of actions taken at the Oct. 3-5 meeting of EMA's Pediatric Committee.

Schizophrenia (PDF file) (October 25, 2012)
EMA guidance on developing products, including depot formulations, to treat schizophrenia.

Stem cells (PDF file) (October 25, 2012)
Petition from James Sherley and Theresa Deisher to the U.S. Supreme Court to review an appellate court ruling that permits federal funding for human embryonic stem cells (hESCs) research (see BioCentury Extra, Friday, Oct. 12).

Product documentation (October 25, 2012)
Gattex: Briefing documents for the Oct. 16 meeting of FDA's Gastrointestinal Drugs Advisory Committee to discuss an NDA for Gattex teduglutide to treat short bowel syndrome; from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) (see BioCentury Extra, Friday, Oct. 12).
Revlimid: EMA's CHMP benefit-risk assessment report reiterating that the committee needs mature overall survival data before it can make a decision on whether to approve an expanded label for multiple myeloma (MM) drug Revlimid lenalidomide; from Celgene Corp. (NASDAQ:CELG) (see BioCentury Extra, Wednesday, Oct. 10). (PDF file)

Advisory committees (PDF file) (October 8, 2012)
FDA request for nominations for voting members to serve on the Allergenic Products Advisory Committee; Blood Products Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee; and Transmissible Spongiform and Encephalopathies Advisory Committee.

Bovine serum (PDF file) (October 8, 2012)
EMA draft guideline on the use of bovine serum in manufacturing human biological products.

Health research (PDF file) (October 8, 2012)
Australia's Strategic Review of Health and Medical Research draft consultation paper, which recommends the country invest A$2-A$3 billion ($2.1-$3.1 billion) in health research over the next 10 years (see BioCentury Extra, Friday, Oct. 5).

Hypertension (PDF file) (October 8, 2012)
NICE draft quality standard for managing primary hypertension in adults.

Lipid disorders (PDF file) (October 8, 2012)
EMA's CHMP pediatric addendum to the committee's guideline on the clinical investigation of medicinal products to treat lipid disorders, which highlights specific pediatric issues.

Obesity (PDF file) (October 8, 2012)
EMA concept paper on the need to revise guidelines on clinical evaluation of weight control products.

Otitis media (PDF file) (October 8, 2012)
FDA guidance for developing drugs to treat acute bacterial otitis media.

PCAST (PDF file) (October 8, 2012)
President's Council of Advisors on Science and Technology report "Propelling Innovation in Drug Discovery, Development, and Evaluation" recommending increased federal investments in translational and regulatory science (see BioCentury, Oct. 8).

Pharmacokinetics (PDF file) (October 8, 2012)
Pharmacokinetics Working Party of EMA's CHMP positions on specific questions relating to pharmacokinetic evaluations.

Pharmacovigilance (October 8, 2012)
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) highlights from its Oct.1-3 meeting.

PMA (October 8, 2012)
FDA's 2Q12 list of available safety and effectiveness summaries of PMA approvals and denials announced during the quarter.

Safety (October 8, 2012)
EMA list showing the submission frequency of periodic safety reports for approved drugs.

VTE (PDF file) (October 8, 2012)
NICE draft quality standard on diagnosing and treating venous thromboembolic (VTE) diseases.

Product documentation (October 8, 2012)
Jakavi: CHMP EPAR for Jakavi ruxolitinib to treat chronic idiopathic myelofibrosis, post-polycythemia vera myelofibrosis or essential thrombocythemia myelofibrosis; from Incyte Corp. (NASDAQ:INCY) Novartis AG (NYSE:NVS; SIX:NOVN).
Lucentis: NICE draft guidance recommending Lucentis ranibizumab for diabetic macular edema (DME) with central retinal thickness of at least 400 um; from Novartis AG (NYSE:NVS; SIX:NOVN) and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Oct. 4).
Teysuno: Germany's Federal Joint Committee (G-BA) preliminary benefit assessment that said Teysuno tegafur/gimeracil/oteracil offers no additional benefit over capecitabine or 5-fluorouracil (5-FU) as first-line treatment of advanced gastric cancer in combination with cisplatin; from Nordic Group and Otsuka Pharmaceutical Co. Ltd. (see BioCentury Extra, Wednesday, Oct. 3). (PDF file)

Advanced therapies (October 1, 2012)
EMA list of European experts who will be assembled into flexible drafting groups along with members of the Committee for Advanced Therapies (CAT) for EMA tasks, including creating guidance documents (see BioCentury Extra, Monday, Sept. 24).

Antimicrobials (PDF files) (October 1, 2012)
FDA draft guidance on the development of drugs to treat complicated intra-abdominal infection and final guidance for the development of antimicrobial drugs to treat acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (see BioCentury Extra, Friday, Sept. 29).

EMA (October 1, 2012)
EMA notice seeking participants for website user-experience research.

Gene patents (PDF file) (October 1, 2012)
American Civil Liberties Union and Public Patent Foundation second petition to the U.S. Supreme Court to hear Association for Molecular Pathology, et al. v. U.S. PTO, et al., a suit about the eligibility of genes for patenting (see BioCentury Extra, Tuesday, Sept. 25).

Innovative drugs (PDF file) (October 1, 2012)
President's Council of Advisors on Science and Technology report on "Propelling Innovation in Drug Discovery, Development, and Evaluation" that says the U.S. should implement policies that will double the output of new, innovative medicines for important unmet medical needs within 15 years (see BioCentury Extra, Tuesday, Sept. 25).

Patients (PDF files) (October 1, 2012)
— Institute of Medicine (IOM) discussion paper on communicating with patients on healthcare evidence.
— Pharmaceutical Research and Manufacturers of America (PhRMA) principles to guide interactions between pharmas and patient organizations (see BioCentury Extra, Friday, Sept. 29).

PCORI (PDF file) (October 1, 2012)
Patient-Centered Outcomes Research Institute public survey asking for specific research questions, which would be incorporated into future calls for grant proposals (see BioCentury Extra, Wednesday, Sept. 26).

U.S. budget (PDF file) (October 1, 2012)
Text of the continuing resolution (H.RES.117), which would extend funding at current levels for government operations through March 27, 2013 (see BioCentury Extra, Monday, Sept. 24).

Product documentation (October 1, 2012)
Actilyse: NICE final guidance updating the U.K. agency's previous recommendation on the use of stroke drug Actilyse alteplase to include use within 4.5 hours of the onset of symptoms after intracranial hemorrhage has been excluded instead of within 3 hours; from Boehringer Ingelheim GmbH and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).  (PDF file)
Januvia: CHMP revised EPAR updating SPC to include back pain as an adverse drug reaction with an unknown frequency for Januvia sitagliptin to treat Type II diabetes; from Merck & Co. Inc. (NYSE:MRK).

PCORI (September 24, 2012)
Patient Centered Outcomes Research Institute call for proposals for up to $96 million in grants for research projects addressing four of its five broad priorities (see BioCentury Extra, Monday, Sept. 17).

Pharmacogenomics (PDF file) (September 24, 2012)
EMA agenda for an Oct. 8-9 workshop to discuss the use of pharmacogenomics in clinical development (see BioCentury Extra, Wednesday, Sept. 19).

R&D (PDF files) (September 24, 2012)
Text of the National Pediatric Research Network Act (H.R. 6163) passed by the U.S. House of Representatives, which would allow NIH to award grants to fund research focused on preventing, diagnosing or treating pediatric rare diseases or conditions (see BioCentury Extra, Thursday, Sept. 20).
Text of the Recalcitrant Cancer Research Act (H.R. 733) passed by the U.S. House of Representatives, which would create an initiative within NIH's National Cancer Institute (NCI) to guide research on recalcitrant cancers — those with five-year survival rates less than 50% (see BioCentury Extra, Thursday, Sept. 20).

Sepsis (PDF file) (September 24, 2012)
U.K.'s NICE clinical guidelines on the prevention and management of neutropenic sepsis in cancer patients.

Trauma (PDF files) (September 24, 2012)
U.S. Department of Veterans Affairs and the Department of Defense overview of the newly created Consortium to Alleviate PTSD (CAP) to study post-traumatic stress disorder (PTSD), and the Chronic Effects of Neurotrauma Consortium (CENC) to study mild traumatic brain injury (TBI) (see BioCentury Extra, Thursday, Sept. 20).

User fees (PDF file) (September 24, 2012)
Text of the FDA User Fee Corrections Act of 2012 (H.R. 6433), which was passed by the U.S House of Representatives and would allow FDA to collect newly enacted generic drug user fees, but does not include a provision that would allow FDA to collect new biosimilar user fees (see BioCentury Extra, Thursday, Sept. 20).

Product documentation (September 24, 2012)
Bretaris/Eklira Genuair: CHMP EPAR for Bretaris/Eklira Genuair aclidinium bromide to treat chronic obstructive pulmonary disease (COPD); from Almirall S.A. (Madrid:ALM) and Forest Laboratories Inc. (NYSE:FRX).
Enbrel: CHMP revised EPAR updating SPC to include information on the risk of opportunistic infections with autoimmune drug Enbrel etanercept; from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE).
Reyataz: CHMP revised EPAR updating SPC to include information on drug interactions between HIV drug Reyataz atazanavir and statins; from Bristol-Myers Squibb Co. (NYSE:BMY).
— Signifor: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) assessment report that said Cushing's drug Signifor pasireotide would cost the German statutory health insurance funds (GKV) EUR 8.6-EUR 19.3 million ($11.2-$25.2 million) per year; and Germany's Federal Joint Committee (G-BA) preliminary assessment summarizing data for Signifor from marketing authorization studies; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, Sept. 17). (PDF files)
Tygacil: CHMP revised EPAR updating SPC to include information on the potential development of super-infections and to add impaired healing as an adverse event of Tygacil tigecycline to treat complicated skin and skin structure infections (cSSSIs) and complicated intra-abdominal infections; from Pfizer Inc. (NYSE:PFE).
Zinforo: CHMP EPAR for Zinforo ceftaroline to treat complicated skin and soft tissue infections (cSSTI) and community-acquired bacterial pneumonia (CABP); from AstraZeneca plc (LSE:AZN; NYSE:AZN), Forest Laboratories Inc. (NYSE:FRX) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).

EMA (PDF files) (September 17, 2012)
— EMA revised rules for implementing fees payable to the agency and an explanatory note on the rules.
Minutes from the June 7 meeting of EMA's Management Board.

FDA (PDF files) (September 17, 2012)
— FDA's Center for Devices and Radiological Health (CDRH) new standard operating procedure for resolving internal differences of opinion in regulatory decision-making (see BioCentury Extra, Tuesday, Sept. 11).
Text of the continuing resolution (H.J. RES. 117), which was passed by the U.S. House of Representative and would extend funding at current levels for government operations but would not allow FDA to collect new biosimilar and generic user fees under programs signed into law this year (see BioCentury Extra, Monday, Sept. 17).

HHS (PDF file) (September 17, 2012)
U.S. Office of Special Counsel report concluding that HHS Secretary Kathleen Sebelius violated the Hatch Act when she made remarks advocating for the reelection of President Obama during a February speech at the Human Rights Campaign Gala (see BioCentury Extra, Wednesday, Sept. 12).

HIV (September 17, 2012)
HHS common patient assistance program application, which allows HIV-infected individuals to apply for multiple assistance programs for HIV/AIDS medications with a single form.

NICE (September 17, 2012)
NICE notice of a series of seminars on how the agency defines value for the medical device and diagnostic industry (see BioCentury Extra, Thursday, Sept. 13).

Ovarian cancer (September 17, 2012)
U.S. Preventive Services Task Force (USPSTF) final recommendation statement against screening for ovarian cancer in asymptomatic women.

Product documentation (PDF files) (September 17, 2012)
Lixivaptan: Briefing documents for the Sept. 13 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which recommended against approval of lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH); from Cornerstone Therapeutics Inc. (NASDAQ:CRTX) (see BioCentury Extra, Thursday, Sept. 13).
Phenylephrine hydrochloride injection: Briefing documents for the Sept. 13 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 8-2 against recommending approval of phenylephrine injection to treat acute hypotension; from the West-Ward Pharmaceutical Corp. subsidiary of Hikma Pharmaceuticals plc (LSE:HIK).

Crowd funding (September 10, 2012)
BioIndustry Association (BIA) report calling for the creation of Citizens' Innovation Funds, a crowd funding initiative to invest in private British companies (see BioCentury Extra, Tuesday, Sept. 4).

FDA (September 10, 2012)
Alliance for a Stronger FDA statement that said budget sequestration will likely cut about $294 million out of FDA's $3.65 billion budget for activities other than tobacco regulation (see BioCentury Extra, Tuesday, Sept. 4).

Genomics (September 10, 2012)
The Encyclopedia of DNA Elements (ENCODE) consortium's decade-long project to describe all functional elements of the human genome, which found 80% of the human genome contains elements linked to biochemical function (see BioCentury Extra, Wednesday, Sept. 5).

Healthcare spending (September 10, 2012)
Institute of Medicine (IOM) report calling for sweeping reforms of the U.S. healthcare system (see BioCentury Extra, Thursday, Sept. 6).

NIH (PDF file) (September 10, 2012)
NIH working group's June report on developing a "sustainable and diverse" biomedical research workforce to ensure U.S. competitiveness (see BioCentury Extra, Wednesday, Sept. 5).

Orphan drugs (September 10, 2012)
Registration for an FDA and EMA workshop on Oct. 12 to provide an overview of the agencies' Orphan Drug designation programs (see BioCentury Extra, Thursday, Sept. 6).

Patents (PDF file) (September 10, 2012)
U.S. Patent and Trademark Office's notice seeking comments on a proposed fee schedule for patents; comments are due Nov. 25.

Pediatric drugs (PDF file) (September 10, 2012)
EMA's Pediatric Committee inventory of cardiovascular pediatric medicines as part of a public consultation seeking to identify the needs in therapeutic areas in which there should be R&D of pediatric medicines; comments are due Oct. 30.

Product documentation (September 10, 2012)
Makena: U.S. District Court for the District of Columbia ruling dismissing a suit from KV Pharmaceutical Co. (OCTQB:KVPHQ) against FDA over the company's preterm birth drug Makena hydroxyprogesterone caproate (see BioCentury Extra, Thursday, Sept. 6).
Mepact: CHMP revised EPAR updating SPC to include febrile neutropenia as a common adverse event for Mepact mifamurtide to treat osteosarcoma; from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
Pradaxa: CHMP revised EPAR updating SPC to include a warning against the use of stroke prevention drug Pradaxa dabigatran etexilate in patients with prosthetic valve disease; from Boehringer Ingelheim GmbH.
Thalidomide Celgene: CHMP revised EPAR updating SPC to add a new warning and update safety information regarding allergic reactions for Thalidomide Celgene to treat multiple myeloma; from Celgene Corp. (NASDAQ:CELG).
Tobramycin inhalation powder: Briefing documents for the Sept. 5 meeting of FDA's Anti-Infective Drugs Advisory Committee, which voted 13-1 that there was adequate evidence of safety and evidence to support the use of tobramycin inhalation powder for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Monday, Sept. 10). (PDF file)

Cancer drugs (September 3, 2012)
U.K.'s Department of Health statement on the number of patients who have received cancer drugs and money spent by strategic health authorities under the interim cancer drugs funding arrangements and the Cancer Drugs Fund.

Chronic kidney disease (September 3, 2012)
U.S. Preventive Services Task Force (USPSTF) final recommendation statement concluding there is insufficient evidence to assess the benefits and risks for routine screening for chronic kidney disease (CKD) in asymptomatic adults.

FDA (PDF file) (September 3, 2012)
Republican National Convention platform, which includes promises to reform FDA, support biomedical research and oppose embryonic stem cell research (see BioCentury Extra, Wednesday, Aug. 29).

JOBS (PDF file) (September 3, 2012)
SEC proposed rule implementing provisions under the Jumpstart Our Businesses Startups (JOBS) Act to allow companies to use general solicitation and advertising to offer securities to accredited investors.

Medical devices (September 3, 2012)
— FDA notice of a Sept. 10 meeting and request for comments regarding the medical device postmarket surveillance system in the U.S. (PDF file)
— FDA notice of a Sept. 12-13 public workshop to discuss the use of registries of medical device data for postmarket surveillance, clinical trials and evidence appraisal (see BioCentury Extra, Tuesday, Aug. 28).

Medical outcomes (PDF file) (September 3, 2012)
NIH's Observational Medical Outcomes Partnership proposed research priorities and tasks for 2013-16; comments are due Sept. 15.

PCORI (September 3, 2012)
Patient Centered Outcomes Research Institute (PCORI) documentation on three planned workshops — scheduled for Oct. 27-28, Dec. 4 and Dec. 5 — to discuss the draft process for generating and selecting research topics (see BioCentury Extra, Wednesday, Aug. 29).

Startup funding (September 3, 2012)
Rock Health application for entry into the healthcare IT incubator's fourth class of startups (see BioCentury Extra, Tuesday, Aug. 28).

Product documentation (September 3, 2012)
Actilyse: NICE final appraisal determination (FAD) updating the U.K. agency's previous recommendation on the use of stroke drug Actilyse alteplase to include use within 4.5 hours of the onset of symptoms after intracranial hemorrhage has been excluded instead of within 3 hours; from Boehringer Ingelheim GmbH and the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Humira: Briefing documents for the Aug. 28 meeting of FDA's Gastrointestinal Drugs Advisory Committee, which voted 15-2 that the benefits of Humira adalimumab outweigh the potential risks in patients with moderately to severely active ulcerative colitis; from Abbott Laboratories (NYSE:ABT) (see BioCentury Extra, Tuesday, Aug. 28). (PDF file)
Zonegran: CHMP revised EPAR updating SPC to include alopecia as a common adverse drug reaction for seizure drug Zonegran zonisamide; from Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506) and Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).

Antibiotics (PDF file) (August 27, 2012)
NICE guidance on use of antibiotics to prevent and treat early onset neonatal infection.

CalPERS (PDF file) (August 27, 2012)
California Public Employees’ Retirement System (CalPERS) five-year strategic plan for meeting the retirement and health benefits needs of its members.

Devices (August 27, 2012)
Registration for the Aug. 30 FDA workshop to discuss postapproval studies for class III devices regulated under PMA regulations (see BioCentury Extra, Monday, Aug. 20).

IOM (August 27, 2012)
Institute of Medicine summary of a June workshop to discuss implementation of the Cures Acceleration Network (CAN), a program that will allow NIH to fund R&D at biopharma companies.

JOBS Act (August 27, 2012)
SEC FAQ on research provisions in Title I of the Jumpstart Our Businesses Startups (JOBS) Act.

NIH (August 27, 2012)
NIH policy to give extra scrutiny to grant applications from researchers who already receive $1 million or more per year under active NIH awards (see BioCentury Extra, Wednesday, Aug. 22).

Stem cells (August 27, 2012)
U.S. Court of Appeals for the District of Columbia Circuit ruling that upheld a lower court's 2011 dismissal of a suit claiming NIH violated a law prohibiting federal funds for research in which a human embryo is destroyed (see BioCentury Extra, Friday, Aug. 24).

Venture tax (August 27, 2012)
European Commission public consultation seeking evidence of direct tax problems that arise when venture capital is invested across borders and possible solutions; comments are due Nov. 5.

Product documentation (August 27, 2012)
Avastin: NICE final guidance recommending against Avastin bevacizumab in combination with capecitabine for first-line treatment of metastatic breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Alimta: CHMP revised EPAR updating SPC to include anaphylactic shock as an adverse reaction for Alimta pemetrexed to treat pleural mesothelioma and non-small cell lung cancer (NSCLC); from Eli Lilly and Co. (NYSE:LLY).
Humira: Briefing documents for the Aug. 28 meeting of the Gastrointestinal Drugs Advisory Committee to discuss an sBLA for Humira adalimumab to treat moderately to severely active ulcerative colitis in adults who failed conventional therapies; from Abbott Laboratories (NYSE:ABT) and Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Friday, Aug. 24).
Xgeva: NICE final appraisal determination (FAD) recommending the use of Xgeva denosumab to prevent skeletal-related events (SREs) in patients with bone metastases from breast cancer and from solid tumors other than breast and prostate cancer for whom zoledronic acid would be indicated; and against use in patients with hormone-refractory prostate cancer (HRPC); from Amgen Inc. (NASDAQ:AMGN). (PDF file)

Atrial fibrillation (PDF file) (August 20, 2012)
EMA draft guidance on clinical investigation of therapies to prevent stroke and systemic embolic events in patients with non-valvular atrial fibrillation.

HCV (PDF file) (August 20, 2012)
U.S. Centers for Disease Control and Prevention final guidance recommending a one-time test for HCV infection for all U.S. baby boomers, the generation born between 1945-65 (see BioCentury Extra, Friday, Aug. 17).

HPV (August 20, 2012)
U.K.'s Joint Committee on Vaccination and Immunization call for evidence to support consideration of new dosing schedules and additional patient populations for HPV vaccines, including men who have sex with men.

Patents (PDF files) (August 20, 2012)
— U.S. Court of Appeals for the Federal Circuit ruling reiterating that composition and method claims in patents from Myriad Genetics Inc. (NASDAQ:MYGN) covering the breast cancer 1 early onset (BRCA1) and BRCA2 genes are valid under Section 101 of the Patent Act (see BioCentury Extra, Thursday, Aug. 16).
— U.S. Federal Trade Commission proposed rule that would require biotech and pharma companies to report all "commercially significant" patent licensing deals to the FTC and Department of Justice for antitrust review (see BioCentury Extra, Friday, Aug. 17).

Suicidal ideation (PDF file) (August 20, 2012)
FDA draft guidance on assessing treatment-emergent suicidal ideation and behavior in clinical trials of drug and biologics.

Budget (PDF file) (August 13, 2012)
Text of the Sequestration Transparency Act (H.R. 5872), which President Obama signed into law last week. The act requires his office to submit a report within 30 days to Congress detailing the estimated budget cuts federal agencies would face under the Budget Control Act's sequestration provisions (see BioCentury Extra, Wednesday, Aug. 8).

COPD (PDF file) (August 13, 2012)
EMA final guideline covering the development of therapeutics for chronic obstructive pulmonary disease (COPD) (see BioCentury Extra, Thursday, Aug. 9).

Medical devices (August 13, 2012)
EMA website documenting CHMP public assessment reports for ancillary substances included in medical devices.

Neurology (PDF files) (August 13, 2012)
— NICE clinical guideline on management of lower urinary tract dysfunction in neurological disease.
— NICE draft guideline on the recognition and management of psychosis and schizophrenia in children.

NICE (PDF file) (August 13, 2012)
U.K.'s NICE Citizens Council final report on assessing future costs and health benefits.

Osteoporosis (PDF file) (August 13, 2012)
NICE clinical guideline on assessing the risk of fragility fracture in osteoporosis patients.

Pediatric drugs (PDF file) (August 13, 2012)
FDA nomination request for pediatric products to be discussed at the Dec. 4 meeting of the Oncologic Drugs Advisory Committee's pediatric subcommittee.

Peripheral arterial disease (PDF file) (August 13, 2012)
NICE clinical guideline for diagnosing and managing lower limb peripheral arterial disease.

Value-based pricing (PDF file) (August 13, 2012)
The U.K. Department of Health and the Association of the British Pharmaceutical Industry (ABPI) joint statement that they will begin negotiations in September for the proposed value-based pricing system (see BioCentury Extra, Monday, Aug. 6).

Product documentation (August 13, 2012)
Afinitor: CHMP revised EPAR updating SPC to expand the label of Afinitor everolimus to include treatment of postmenopausal women with hormone receptor-positive, HER2-negative breast cancer that has progressed after treatment with a non-steroidal aromatase inhibitor; from Novartis AG (NYSE:NVS; SIX:NOVN).
Bronchitol: CHMP EPAR for Bronchitol mannitol to treat cystic fibrosis; from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY).
Fycompa: CHMP EPAR for Fycompa perampanel as an adjunctive therapy for partial-onset seizures in epilepsy patients 12 years and older with or without secondarily generalized seizures; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
Iluvien: NICE draft guidance recommending against the use of Iluvien fluocinolone acetonide intravitreal implant to treat chronic diabetic macular edema (DME); from Alimera Sciences Inc. (NASDAQ:ALIM) and pSivida Corp. (NASDAQ:PSDV; ASX:PVA) (see BioCentury Extra, Wednesday, Aug. 8).
Kalydeco: CHMP EPAR for Kalydeco ivacaftor to treat cystic fibrosis in patients six years and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator (CFTR) gene; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX).
Procoralan: NICE draft guidance recommending Procoralan ivabradine to treat chronic heart failure in combination with standard therapy, including beta-blockers, or when beta-blockers are contraindicated or not tolerated; from Servier.
Truvada: U.S. Centers for Disease Control and Prevention interim guidelines recommending the use of Truvada emtricitabine/tenofovir as a pre-exposure prophylaxis (PrEP) to prevent HIV infection in heterosexually active adults who are at very high risk of infection (see BioCentury Extra, Friday, Aug. 10); from Gilead Sciences Inc. (NASDAQ:GILD).
Zelboraf: NICE draft guidance requesting additional information before the agency can recommend the use of Zelboraf vemurafenib to treat patients with unresectable locally advanced or metastatic melanoma who are BRAF V600-mutation positive; from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Aug. 9).

EMA (PDF file) (August 6, 2012)
EMA report on interactions over the last three years with the Japanese Ministry of Health, Labor and Welfare and the Pharmaceuticals and Medical Devices Agency.

Gastroenterology (August 6, 2012)
FDA registration website for a Sept. 19-21 and Sept. 24 public workshop to discuss endpoints for registration trials of therapeutics for gastrointestinal diseases (see BioCentury Extra, Friday, Aug. 3).

Healthcare legislation (August 6, 2012)
Text of the Massachusetts Senate healthcare bill that would set a cap for the growth of the state's healthcare costs over the next 10 years (see BioCentury Extra, Tuesday, July 31).

Health outcomes (August 6, 2012)
U.K.'s NICE menu of 44 proposed indicators recommended by the Commissioning Outcomes Framework (COF) Advisory Committee to measure health outcomes achieved by clinical commissioning groups.

Hemophilia (PDF file) (August 6, 2012)
EMA reflection paper on immune tolerance induction in hemophilia A patients with inhibitors.

Immunoglobulin (August 6, 2012)
EMA draft guidance on information to be included in the SPCs for subcutaneous and intramuscular human normal immunoglobulin.

Orphan drugs (PDF file) (August 6, 2012)
Pilot terms of reference for cooperation between the EU and Japan on Orphan products.

Pharmacovigilance (PDF files) (August 6, 2012)
EMA draft modules on good pharmacovigilance practices: Module IV, on pharmacovigilance audits; and Module XV, safety communication.

Product documentation (PDF files) (August 6, 2012)
Benlysta: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Benlysta belimumab provides a "significant" degree of additional benefit over "optimized standard therapy" in patients with autoantibody-positive systemic lupus erythematosus (SLE); from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Thursday, Aug. 2).
Fampyra: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Fampyra fampridine provides no additional benefit over physiotherapy in multiple sclerosis (MS) patients with walking disability; from Acorda Therapeutics Inc. (NASDAQ:ACOR) and Biogen Idec Inc. (NASDAQ:BIIB) (see BioCentury Extra, Thursday, Aug. 2).
Yervoy: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Yervoy ipilimumab provides an "important additional benefit" over best supportive care in patients with advanced malignant melanoma who have received previous therapy; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Thursday, Aug. 2).

Counterfeit drugs (July 30, 2012)
Joint statement advocating international coordination and patient education to reduce the illegal sale of medicines by illegitimate online drug sellers; from International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA) and Japanese Pharmaceutical Manufacturers Association (JPMA).

Diagnostics (PDF file) (July 30, 2012)
Briefing documents for the July 25 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC), which voted 16-0, with one abstention, that an imaging test would provide useful clinical information if it identified only clear cell renal cell carcinoma (RCC) — but not other types of cancer in the kidney — in patients with an indeterminate renal mass (see BioCentury Extra, Wednesday, July 25).

Drug shortages (PDF files) (July 30, 2012)
FDA letter responding to a June congressional report that claimed drug shortages were "largely sparked" by agency actions (see BioCentury Extra, Wednesday, July 25).

Fostering Innovation Act (PDF file) (July 30, 2012)
Biotechnology Industry Organization (BIO) testimony before the U.S. House of Representatives Committee on Financial Services and Subcommittee on Capital Markets and Government Sponsored Enterprises supporting the Fostering Innovation Act (H.R. 6161), which would ease regulatory burdens for small public companies by changing SEC filing classifications.

Orphan drugs (PDF files) (July 30, 2012)
— EMA documentation on relevant sources for Orphan disease prevalence data.
— EMA report on a workshop that concluded the agency’s Committee for Orphan Medicinal Products (COMP) should provide a better definition and structure of scientific evidence for significant benefit of Orphan drugs.

Patents (PDF file) (July 30, 2012)
U.S. Patent and Trademark Office proposed rules to implement the “first-inventor-to-file” provision of the Leahy-Smith America Invents Act (AIA); comments are due Oct. 5.

PCORI (PDF file) (July 30, 2012)
Patient Centered Outcomes Research Institute (PCORI) draft list of standards for conducting comparative-effectiveness research; comments are due Sept. 14 (see BioCentury Extra, Monday, July 23).

Transparency (PDF file) (July 30, 2012)
EMA notice of a Nov. 22 workshop to discuss how to implement the agency's plan to proactively release clinical data for approved drugs; registration is open until Oct. 31 and space is limited to 150 (see BioCentury, July 30).

Product documentation (PDF files) (July 30, 2012)
Lucentis: Briefing documents for the July 26 meeting of FDA's Dermatologic and Ophthalmic Drug Advisory Committee meeting, which voted 10-0 that safety and efficacy data support approval of the 0.3 mg dose of Lucentis ranibizumab for diabetic macular edema (DME) and 8-2 that data for the 0.5 mg dose of the drug also support approval; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, July 26).
Ocriplasmin: Briefing documents for the July 26 meeting of FDA's Dermatologic and Ophthalmic Drug Advisory Committee meeting, which voted 10-0 that the benefits of ocriplasmin outweigh the potential risks for the vitreomacular adhesion (VMA) treatment; from ThromboGenics N.V. (Euronext:THR) (see BioCentury, July 30).
Xarelto: NICE final guidance recommending the use of Xarelto rivaroxaban to treat deep vein thrombosis (DVT) and prevent recurrent DVT and pulmonary embolism following an acute DVT; from Bayer AG (Xetra:BAYN) and Johnson & Johnson (NYSE:JNJ).

Clinical trials (PDF file) (July 23, 2012)
European Commission proposed regulation  that seeks to make it easier for sponsors to conduct multinational clinical trials in Europe (see BioCentury Extra, Tuesday, July 17).

Diagnostics (PDF file) (July 23, 2012)
Centers for Medicare & Medicaid Services proposed 2013 physician fee schedule, which includes a call for public comments on whether to reimburse diagnostics and molecular pathology tests through the Physician Fee Schedule or the Clinical Laboratory Fee Schedule.

Early access (PDF file) (July 23, 2012)
Proposal by U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to allow early access to unlicensed products for life threatening, chronic, or seriously debilitating conditions without adequate treatment options (see BioCentury Extra, Tuesday, July 17).

Orphan products (PDF file) (July 23, 2012)
Summary of actions taken at the July 10-11 meeting of EMA's Committee for Orphan Medicinal Products (COMP).

Pathologic complete response (PDF file) (July 23, 2012)
A link to FDA's draft guidance on the use of pathologic complete response as a surrogate endpoint for neoadjuvant breast cancer. Comments on the guidance are due July 30 (see BioCentury, July 23).

Pediatric drugs (PDF file) (July 23, 2012)
Summary of actions taken at the July 4-6 meeting of EMA's Pediatric Committee (PDCO).

Pharmacovigilance (PDF files) (July 23, 2012)
Agenda for the July 19-20 inaugural meeting of EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
— EMA draft consultation document on product information changes as a result of implementing new provisions under the pharmacovigilance legislation.

Biosimilars (PDF file) (July 16, 2012)
Indian biosimilars guidelines that said India will allow sponsors to skip clinical efficacy trials if several conditions are met for showing comparability to the reference biologic (see BioCentury Extra, Wednesday, July 11).

DEA (July 16, 2012)
U.S. Drug Enforcement Administration proposal to increase the 2012 aggregate production quotas for schedule I and II controlled substances, which includes active pharmaceutical ingredients contained within many ADHD drugs and painkillers.

Drug interactions (PDF file) (July 16, 2012)
EMA updated guideline for studying drug interactions between new products and approved drugs.

EMA (PDF files) (July 16, 2012)
— EMA list of applications for human medicines under CHMP review.
— EMA Scientific Advice Working Party meeting and deadline dates for scientific advice or protocol assistance request submissions.

Medical devices (PDF file) (July 16, 2012)
FDA draft guidance outlining its pre-submission program, which will provide recommendations and procedures for medical device manufacturers who want feedback prior to submitting an Investigational Device Exemption (IDE) or marketing application.

Neurology (PDF file) (July 16, 2012)
Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing medicines in clinical trials or under FDA review for mental illnesses and addictive disorders.

Non-hematologic malignancies (PDF file) (July 16, 2012)
Briefing document for the July 24 meeting of FDA's Oncologic Drugs Advisory Committee to consider a proposal that would ease requirements for the independent evaluation of radiographic review in trials for non-hematologic malignancies that use progression-free survival (PFS) as a primary endpoint (see BioCentury Extra, Wednesday, July 11).

Parkinson's disease (PDF files) (July 16, 2012)
EMA updated guideline and Q&A for developing products to treat PD.

Patents (PDF file) (July 16, 2012)
U.S. Patent and Trademark Office memo to patent examiners providing interim guidance on determining the eligibility of process claims involving laws of nature for patenting following the U.S. Supreme Court's decision in Mayo Collaborative Services et al. v. Prometheus Laboratories Inc.

PDUFA (PDF file) (July 16, 2012)
Text of the PDUFA reauthorization bill FDA Safety and Innovation Act (S. 3187), which President Obama signed into law (see BioCentury Extra, Monday, July 9).

REMS (PDF files) (July 16, 2012)
FDA final classwide REMS for extended-release and long-acting opioids that requires companies to make educational programs available to prescribers at no or nominal cost (see BioCentury Extra, Monday, July 9).

Product documentation (July 16, 2012)
Avastin: NICE final appraisal determination (FAD) recommending against Avastin bevacizumab in combination with capecitabine for first-line metastatic breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Dificlir: NICE evidence summary that concludes Dificlir fidaxomicin was non-inferior to vancomycin to treat Clostridium difficile infection; from Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) and Astellas Pharma Inc. (Tokyo:4503) (see BioCentury Extra, Friday, July 13).
Rienso: CHMP EPAR for Rienso ferumoxytol to treat iron deficiency anemia in chronic kidney disease (CKD) patients; from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
RoActemra: CHMP revised EPAR updating SPC with safety information regarding the risk of infection related to interstitial lung disease for RoActemra tocilizumab to treat moderate-to-severe active rheumatoid arthritis (RA) and active systemic juvenile idiopathic arthritis; from Roche (SIX:ROG; OTCQX:RHHBY).
Tarceva: CHMP revised EPAR updating SPC to include folliculitis and acne/dermatitis acneiform as adverse reactions for Tarceva erlotinib to treat advanced or metastatic non-small cell lung cancer (NSCLC) and pancreatic cancer; from Roche (SIX:ROG; OTCQX:RHHBY).

Bacterial infections (PDF file) (July 9, 2012)
EMA's CHMP draft addendum providing indication-specific guidance to a January final guideline on developing therapeutics to treat bacterial infections (see BioCentury Extra, Thursday, July 5).

Biosimilars (PDF file) (July 9, 2012)
EMA final guidance on developing biosimilar versions of products containing mAbs (see BioCentury, July 9).

CMS (PDF file) (July 9, 2012)
Centers for Medicare & Medicaid Services proposed rule that would make changes to a quality incentive program that provides payments to dialysis facilities based on performance to improve the quality of dialysis care (see BioCentury Extra, Tuesday, July 3).

Cystic fibrosis (PDF files) (July 9, 2012)
EMA program and call for expression of interest for an invitation-only workshop on Sept. 27-28 to discuss outcome measures for cystic fibrosis (CF) (see BioCentury Extra, Tuesday, July 3).

Diabetes (PDF file) (July 9, 2012)
EMA final guidance on developing products to treat and prevent diabetes (see BioCentury Extra, Tuesday, July 3).

Drug assessments (July 9, 2012)
European network for Health Technology Assessment (EUnetHTA) draft guidelines covering methods for conducting relative effectiveness assessments of new drugs (see BioCentury Extra, Thursday, July 5).

Drug spending (July 9, 2012)
U.K. Office of Health Economics report commissioned by the Association of the British Pharmaceutical Industry that found NHS spending on medicines is "under control," while expenditure on innovative branded medicines is projected to shrink as a proportion of the healthcare budget over the next three years.

JOBS Act (July 9, 2012)
SEC Chairman Mary Schapiro's testimony on implementation of the Jumpstart Our Business Startups Act to the U.S. House Oversight & Government Reform Committee's TARP, financial services and bailouts of public and private Programs subcommittee (see BioCentury Extra, Monday, July 2).  

Pharmacovigilance (July 9, 2012)
EU pharmacovigilance legislation that puts in place rules adopted in 2010 and creates the Pharmacovigilance Risk Assessment Committee to assess the risk management of medicines for human use (see BioCentury Extra, Monday, July 2).

Squamous lesions (July 9, 2012)
College of American Pathologists (CAP) and American Society for Colposcopy and Cervical Pathology (ASCCP) recommendations providing standardization of diagnostic terminology for HPV-associated squamous lesions.

Product documentation (July 9, 2012)
Avastin: CHMP revised EPAR updating SPC to include final overall survival (OS) data from the Phase III GOG-0218 trial of Avastin bevacizumab to treat ovarian cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). 
Edurant: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Edurant rilpivirine from Johnson & Johnson (NYSE:JNJ) provides a "marginal" degree of additional benefit over Sustiva efavirenz from Bristol-Myers Squibb Co. (NYSE:BMY) plus base therapy to treat HIV infection in treatment-naïve patients (see BioCentury Extra, Thursday, July 5). (PDF file)
Eviplera: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Eviplera emtricitabine/tenofovir/rilpivirine from Gilead Sciences Inc. (NASDAQ:GILD) and Johnson & Johnson (NYSE:JNJ) plus base therapy provides a "marginal" degree of additional benefit over Sustiva efavirenz from Bristol-Myers Squibb Co. (NYSE:BMY) to treat HIV infection in treatment-naive patients (see BioCentury Extra, Thursday, July 5). (PDF file)
Makena: FDA Q&A clarifying a June 15 statement which found no major safety problems in an analysis of compounded hydroxyprogesterone caproate products, which have been used as a cheaper alternative for preterm birth drug Makena hydroxyprogesterone; from KV Pharmaceutical Co. (NYSE:KV-A) and Hologic Inc. (NASDAQ:HOLX) (see BioCentury Extra, Monday, July 2).
Nulojix: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Nulojix belatacept provides a "marginal" degree of benefit over cyclosporine A in preventing organ rejection in a subgroup of kidney transplant patients; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Thursday, July 5). (PDF file)
Yervoy: CHMP revised EPAR updating SPC to include pre- and post-natal development study data in cynomolgus monkeys for Yervoy ipilimumab to treat advanced melanoma; from Bristol-Myers Squibb Co. (NYSE:BMY).

Cardiovascular disease (PDF file) (July 2, 2012)
U.S. Preventive Services Task Force (USPSTF) updated recommendation advising intensive behavioral dietary counseling for adults with hyperlipidemia and other risk factors for cardiovascular and diet-related chronic disease.

Clinical trials (PDF file) (July 2, 2012)
European Commissioner for Health and Consumer Policy John Dalli's speech at the European American Business Council announcing his commitment to introduce legislation to revise the EU's clinical trials directive to make Europe more attractive for clinical research (see BioCentury Extra, Friday, June 29).

Healthcare reform (PDF file) (July 2, 2012)
U.S. Supreme Court's decision ruling 5-4 that the Patient Protection and Affordable Care Act's mandate requiring that most U.S. citizens and legal aliens obtain health insurance was constitutional under Congress's taxing authority (see Cover Story).

Lupus (PDF file) (July 2, 2012)
FDA notice on its withdrawal of 2010 guidance on the development of products to treat systemic lupus erythematosus (SLE) and lupus nephritis caused by SLE (see BioCentury Extra, Wednesday, June 27).

Meningitis (July 2, 2012)
NICE quality standard on bacterial meningitis and meningococcal septicemia in subjects under 16 years of age.

Obesity (July 2, 2012)
U.S. Preventive Services Task Force (USPSTF) final recommendation to manage obesity with behavioral interventions.

PDUFA (PDF files) (July 2, 2012)
Text of the reconciled PDUFA reauthorization bill FDA Safety and Innovation Act (S. 3187), which the U.S. Senate passed (see Cover Story).
— FDA's PDUFA reauthorization performance goals and procedures for fiscal 2013-17.
— FDA presentation on meeting PDUFA goals, trends in drug approvals and PDUFA reauthorization

Pharmacovigilance (PDF files) (July 2, 2012)
EMA finalized modules on good pharmacovigilance practices: Module I: pharmacovigilance systems and their quality systems; Module II: pharmacovigilance system master file; Module V: risk management systems; Module VI: management and reporting of adverse reactions to medicinal products; Module VII: periodic safety update reports; Module VIII: post-authorization safety studies; Module IX: signal management.

Psoriasis (PDF file) (July 2, 2012)
European Expert Working Group for Healthcare in Psoriasis white paper funded by Johnson & Johnson (NYSE:JNJ) for improving the quality of care for patients with psoriasis.

Sickle cell episodes (PDF file) (July 2, 2012)
NICE guideline on managing acute painful sickle cell episodes in the hospital.

Venous thromboembolic diseases (PDF file) (July 2, 2012)
NICE clinical guideline for diagnosing and treating venous thromboembolic diseases.

Product documentation (PDF files) (July 2, 2012)
Botox: NICE final guidance recommending the use of Botox onabotulinumtoxinA to prevent chronic migraines in patients who have not responded to at least three preventative medications and whose headaches are not being caused by medication overuse; from Allergan Inc. (NYSE:AGN).
Herceptin: NICE final guidance recommending against Herceptin trastuzumab in combination with an aromatase inhibitor as first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQ:RHHBY).
Tarceva: NICE final guidance recommending the use of Tarceva erlotinib as first-line treatment for locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC); from Roche (SIX:ROG; OTCQ:RHHBY).
Tyverb: NICE final guidance recommending against Tyverb lapatinib in combination with an aromatase inhibitor as first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Zytiga: NICE final guidance recommending Zytiga abiraterone in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel-containing therapy; from Johnson & Johnson (NYSE:JNJ) and BTG plc (LSE:BTG).

Biosimilars (PDF file) (June 25, 2012)
Transcript of European Commissioner for Health and Consumer Policy John Dalli's speech at the European Generic Medicines Association annual conference announcing that the EC will change its interpretation of existing biosimilars legislation to begin accepting data showing comparability to ex-EU versions of reference products (see BioCentury Extra, Thursday, June 21).

Conflict of interest (PDF file) (June 25, 2012)
EMA procedure on incomplete or incorrect conflict of interest declarations for management board members.

FDA budget (PDF file) (June 25, 2012)
White House statement of administration policy opposing a FY13 appropriations bill from the U.S. House of Representatives that would set FDA's budget at a level lower than the administration's request (see BioCentury Extra, Thursday, June 21).

Intellectual property (PDF files) (June 25, 2012)
— Biotechnology Industry Organization-commissioned report examining the role of IP rights in research, development and commercialization of biotech products and inventions in developed, emerging and developing economies.
— BIO report on the economic impact of academic patent licensing on the U.S. economy.

Neglected diseases (June 25, 2012)
— BIO Ventures for Global Health (BVGH) and BIO report on biotech participation in neglected diseases R&D.

Orphan products (PDF file) (June 25, 2012)
Summary of actions taken at the June 12-13 meeting of EMA's Committee for Orphan Medicinal Products (COMP).

PCORI (June 25, 2012)
Patient Centered Outcomes Research Institute (PCORI) details on the recipients of 50 pilot project awards to develop research methods and patient outcomes instruments (see BioCentury Extra, Monday, June 18).

PDUFA (PDF file) (June 25, 2012)
Text of the reconciled PDUFA reauthorization bill, FDA Safety and Innovation Act (S. 3187), passed by the U.S. House of Representatives (see BioCentury Extra, Wednesday, June 20).

Pediatric drugs (PDF file) (June 25, 2012)
Summary of actions taken at the June 6-8 meeting of EMA's Pediatric Committee (PDCO).

Pharmacovigilance (PDF file) (June 25, 2012)
EMA concept paper proposing fees for pharmacovigilance activities (see BioCentury Extra, Thursday, June 21).

Product documentation (June 25, 2012)
Kyprolis: Briefing documents for the June 20 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC), which voted 11-0, with one abstention, that Kyprolis carfilzomib has a favorable benefit-risk profile to treat patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior lines of therapy; from Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) (see BioCentury, June 25). (PDF file)
—Replagal: Australian Therapeutic Goods Administration public assessment report (PDF file) for Replagal agalsidase alfa to treat Fabry's disease from Shire plc (LSE:SHP; NASDAQ:SHPGY); and Fabry Support & Information Group website, which includes patient comments on switching to Replagal agalsidase alfa from Fabry's disease therapy Fabrazyme agalsidase beta from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) (see Cover Story).
Semuloparin: Briefing documents for the June 20 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC), which voted 14-1, with one abstention, against recommending approval of semuloparin for thromboprophylaxis in cancer patients; from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Wednesday, June 20). (PDF file)

Antibodies (PDF file) (June 18, 2012)
EMA final guidance on assessing the immunogenicity of mAbs intended for clinical use (see BioCentury Extra, Friday, June 15).

Biosimilars (PDF file) (June 18, 2012)
EMA final guidance on the development of biosimilar versions of products containing mAbs that would allow sponsors to use pharmacodynamic markers as "pivotal evidence" of comparable efficacy to the reference mAb (see BioCentury Extra, Friday, June 15).

Gastrointestinal bleeding (PDF file) (June 18, 2012)
NICE clinical guideline on managing acute upper gastrointestinal bleeding.

Gout (PDF file) (June 18, 2012)
EMA concept paper on the need to develop guidelines on the clinical development of medicinal products to treat gout.

Healthcare reform (June 18, 2012)
CMS's Office of the Actuary report that said prescription drug spending is expected to grow 8.8% in 2014 as the major provisions of the Affordable Care Act take effect, up 6.4 percentage points from an estimated growth rate of 2.4% in 2013 (see BioCentury Extra, Tuesday, June 12).

Irritable bowel syndrome (PDF file) (June 18, 2012)
EMA concept paper in which CHMP is considering changes to 2003 guidance on the design of clinical trials for irritable bowel syndrome (see BioCentury Extra, Tuesday, June 12).

Product documentation (June 18, 2012)
Caprelsa: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that found Caprelsa vandetanib offers no additional benefit over best supportive care to treat advanced medullary thyroid cancer; from AstraZeneca plc (LSE:AZN; NYSE:AZN) (see BioCentury Extra, Friday, June 15). (PDF file)
Keppra: CHMP revised EPAR updating SPC to include panic attack as an undesirable effect for Keppra levetiracetam to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures; from UCB Group (Euronext:UCB). 
— Perjeta: FDA review document and approval letter for Perjeta pertuzumab to treat previously untreated HER2-positive metastatic breast cancer in combination with Herceptin trastuzumab and docetaxel; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see Cover Story). (PDF files)
Xgeva: NICE revised draft guidance that removes a prior recommendation in favor of the use of Xgeva denosumab to prevent skeletal-related events (SREs) in patients with bone metastases from hormone-refractory prostate cancer (HRPC); from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Monday, June 11).
— Zelboraf: NICE draft guidance recommending against Zelboraf vemurafenib to treat unresectable or metastatic melanoma in patients with BRAFV600 mutations (see BioCentury Extra, Thursday, June 14); Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report (PDF file) that found Zelboraf provides "significant" additional benefit over dacarbazine for the indication (see BioCentury Extra, Friday, June 15); from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY).
Zytiga: CHMP revised EPAR updating SPC to include bone fractures as an adverse reaction for Zytiga abiraterone to treat metastatic castration-resistant prostate cancer (CRPC); from BTG plc (LSE:BGC) and Johnson & Johnson (NYSE:JNJ).

CIRM (PDF file) (June 11, 2012)
The California Institute for Regenerative Medicine (CIRM) 2012 final strategic plan, which includes plans to fund at least 10 stem cell projects in Phase I or II trials across five or more disease areas over the next five years (see BioCentury Extra, Thursday, June 7).

EMA (PDF files) (June 11, 2012)
— EMA annual report of activities in 2011.
— EMA list of applications for human medicines under CHMP review as of May 31.

FDA (PDF file) (June 11, 2012)
U.S. House Appropriations Committee's agriculture subcommittee FY13 appropriations bill that would set FDA's FY13 overall budget at $2.48 billion, down $16.3 million from $2.5 billion in FY12 (see BioCentury, Wednesday, June 6).

Innovation (June 11, 2012)
U.K. Office of Health Economics report on examples of incremental innovation, which accompanied comments from the CEO of the Association of the British Pharmaceutical Industry that said that the U.K. government is too focused on encouraging "breakthrough drugs" at the expense of incremental innovation (see BioCentury Extra, Wednesday, June 6).

Medical device tax (PDF files) (June 11, 2012)
Text of the Healthcare Costs Reduction Act (H.R. 436) passed by the U.S. House of Representatives, which would repeal the medical device excise tax (see BioCentury Extra, Thursday, June 7).
— White House statement of administration policy opposing H.R. 436 (see BioCentury Extra, Thursday, June 7).

PCORI (PDF file) (June 11, 2012)
Patient Centered Outcomes Research Institute (PCORI) draft list of standards for conducting comparative-effectiveness research that will eventually be used to score and evaluate applications for funding (see BioCentury Extra, Tuesday, June 5).

Pediatric drugs (June 11, 2012)
EU Ombudsman draft recommendation suggesting EMA draft guidelines for how the agency's pediatric committee analyzes waiver requests as well as improving documentation of committee decisions (see BioCentury Extra, Thursday, June 7).

R&D (June 11, 2012)
— EU's Innovative Medicines Initiative (IMI) third wave of research projects, which include: PreDiCT-TB for model-based preclinical development of anti-tuberculosis (TB) drug combinations; ABIRISK to develop tools to predict immune response to biopharmaceuticals; DIRECT to research patient stratification for personalized Type II diabetes treatments; BIOVACSAFE to develop biomarkers for enhanced vaccine immunosafety; MIP-DILI to develop tests for drug-induced liver injury; and EU-AIMS to develop research tools and diagnostics for autism spectrum disorder (see BioCentury Extra, Friday, June 8).
Quintiles Transnational Corp. report on shareholder opinions on the role of risk in drug development. (PDF file)

Safety (PDF file) (June 11, 2012)
EMA's CHMP draft position paper on potential medication errors caused by confusion of newly introduced medicinal products with existing products that have similar active substances.

Product documentation (June 11, 2012)
Amyvid: Online training program for Amyvid florbetapir, which is approved as a PET imaging agent to estimate beta amyloid neuritic plaque density in patients with cognitive impairment; from Eli Lilly and Co. (NYSE:LLY).
Eliquis: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Eliquis apixaban provides a "marginal degree" of additional benefit in preventing venous thromboembolic events (VTEs) in patients who have undergone hip replacement surgery, but not in patients who received knee replacement surgery; from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, June 7). (PDF file)
Signifor: CHMP EPAR for Signifor pasireotide to treat patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed; from Novartis AG (NYSE:NVS; SIX:NOVN).
Vyndaqel: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Vyndaqel tafamidis provides a "marginal degree" of additional benefit for transthyretin (TTR) familial amyloid polyneuropathy (FAP); from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, June 7). (PDF file)

Biomanufacturing (PDF file) (June 4, 2012)
EMA draft guidelines on quality of biological active substances produced by transgene expression in animals.

Breast cancer (PDF file) (June 4, 2012)
FDA draft guidance on the use of pathologic complete response (pCR) as a surrogate endpoint for accelerated approval of neoadjuvant therapies for high-risk early stage breast cancer (see BioCentury Extra, Tuesday, May 29).

CIRM (PDF file) (June 4, 2012)
2012 Strategic Plan approved by CIRM's governing board.

EMA (PDF file) (June 4, 2012)
Minutes of the Feb. 28 annual joint meeting of EMA's Patients/Consumers Working Party (PCWP) and Healthcare Professionals Working Group (HCP WG).

Healthcare reform (June 4, 2012)
Confidential emails (PDF file) and memo (PDF file) released by Republicans detailing negotiations in 2009 between the Obama administration and the Pharmaceutical Research and Manufacturers of America (PhRMA) related to healthcare reform legislation; and memo (PDF file) from House Democrats and joint statement from Reps. Henry Waxman (D-Calif.) and Diana DeGette (D-Colo.) in response to the Republican memo (see BioCentury Extra, Thursday, May 31).

IBS (PDF file) (June 4, 2012)
FDA final guidance on the design of clinical trials for diarrhea- or constipation-predominant irritable bowel syndrome (IBS-D or IBS-C) (see BioCentury Extra, Wednesday, May 30).

PDUFA reauthorization (PDF file) (June 4, 2012)
Text of the Food and Drug Administration Reform Act of 2012 (H.R. 5651) that would reauthorize PDUFA, passed by the U.S. House of Representatives (see BioCentury Extra, Wednesday, May 30).

Pediatric drugs (PDF file) (June 4, 2012)
Summary of actions taken at the May 14-16 meeting of EMA's Pediatric Committee (PDCO).

Pharmacovigilance (PDF file) (June 4, 2012)
Summary of actions taken at the May 21-23 plenary meeting of EMA's Pharmacovigilance Working Party (PhVWP).

R&D (PDF files) (June 4, 2012)
Results of the May 30-31 meeting of the Council of the European Union, which agreed on the main elements of Horizon 2020, an EU research and innovation program for 2014-20.
— Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing cancer medicines in clinical testing or under FDA review.
Quintiles Transnational Corp. white paper on the current practice and future impact of modeling and simulation throughout the drug development process.

Product Documentation (June 4, 2012)
Bronchitol: NICE draft guidance recommending against Bronchitol mannitol for use in cystic fibrosis (CF) patients aged 18 years and older as an add-on therapy to best standard of care; from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) (see BioCentury Extra, Thursday, May 31).
Xarelto: NICE final appraisal determination (FAD) recommending the use of Xarelto rivaroxaban to treat deep vein thrombosis (DVT) and prevent recurrent DVT and pulmonary embolism following an acute DVT; from Bayer AG (Xetra:BAYN) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, May 31). (PDF file)

Epilepsy (May 28, 2012)
Not-for-profit Epilepsy Therapy Project pipeline documenting investigational and approved products for epilepsy.  

Heart failure (PDF file) (May 28, 2012)
European Society of Cardiology 2012 guidelines for diagnosis and treatment of acute and chronic heart failure.

Opioids (PDF file) (May 28, 2012)
NICE clinical guidelines on use of opioids for pain in palliative care.

Orphan products (PDF file) (May 28, 2012)
Summary of actions taken at the May 10-11 plenary meeting of EMA's Committee for Orphan Medicinal Products (COMP).

Ovarian cancer (May 28, 2012)
NICE quality standard on recognizing early symptoms of ovarian cancer.

PCORI (May 28, 2012)
Patient Centered Outcomes Research Institute (PCORI) funding announcement to award $120 million in grants in 2012 after its board voted to formally adopt a revised set of research priorities and agenda (PDF file) (see BioCentury Extra, Tuesday, May 22).

PDUFA (PDF files) (May 28, 2012)
Text of the Food and Drug Administration Safety and Innovation Act (S. 3187) passed by the U.S. Senate to reauthorize PDUFA that includes several amendments, including one from Sen. Tom Coburn (R-Okla.) that would require independent assessment of the drug review and approval process (see BioCentury Extra, Friday, May 25).
White House statement of administration policy supporting S. 3187 to reauthorize PDUFA (see BioCentury Extra, Thursday, May 24).

Pediatric drugs (PDF file) (May 28, 2012)
Summary of actions taken at the April 11-13 meeting of EMA's Pediatric Committee.

Pharmacovigilance (PDF file) (May 28, 2012)
EMA Q&A on implementation of pharmacovigilance legislation.

Prostate cancer (May 28, 2012)
U.S. Preventative Services Task Force (USPSTF) final recommendation against using prostate-specific antigen (PSA)-based screening for prostate cancer in all age groups (see BioCentury Extra, Monday, May 21).

Safety (PDF files) (May 28, 2012)
EMA's CHMP draft orientation paper of 2013 priorities for adverse drug reaction research under Framework Programme 7 (FP7), including long-term safety effects of antipsychotics in dementia patients, long-term adverse skeletal effects of bisphosphonates, and DNA collection and studies on the genetic causes of adverse drug reactions such as angiotensin-converting enzyme inhibitor-related angioedema and statin-induced myopathy.

Startups (PDF file) (May 28, 2012)
Text of the Startup Act 2.0 (S. 3217) that aims to change tax requirements for startup investments and amend visa regulations to create new businesses and jobs (see BioCentury Extra, Tuesday, May 22).

Product documentation (May 28, 2012)
Nimenrix: CHMP EPAR for Nimenrix to vaccinate patients ages 12 months and older against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Tafamidis: Briefing documents for the May 24 meeting of FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which voted 13-4 that surrogate endpoint data for tafamidis were robust enough to predict a clinical benefit in patients with transthyretin (TTR) familial amyloid polyneuropathy (FAP); from Pfizer Inc. (NYSE:PFE) (see BioCentury, May 28).
Vimpat: CHMP revised EPAR updating SPC to include hallucination as an adverse drug reaction for Vimpat lacosamide as an adjunctive therapy for partial-onset seizures; from UCB Group (Euronext:UCB).
Xarelto: Briefing documents for the May 23 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 6-4, with one abstention, against recommending approval of 2.5 mg twice-daily Xarelto rivaroxaban to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS), non-ST-elevation myocardial infarction or unstable angina; from Bayer AG (Xetra:BAYN) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Wednesday, May 23).

Alzheimer's disease (PDF file) (May 21, 2012)
HHS national plan to develop new prevention and treatment approaches for AD by 2025 (see BioCentury Extra, Tuesday, May 15).

Carcinogenicity (PDF files) (May 21, 2012)
International Conference on Harmonization concept paper and business plan to develop guidance on rodent carcinogenicity testing to assess the risk of human carcinogenicity of drugs.

EMA (PDF file) (May 21, 2012)
EMA list of applications for human medicines under CHMP review.

PDUFA (PDF file) (May 21, 2012)
Congressional Budget Office (CBO) report that said the U.S. Senate version of PDUFA reauthorization legislation (S. 2516) would provide FDA with about $6.4 billion in user fees over 2013-17 (see BioCentury Extra, Monday, May 14).

Psoriasis (PDF file) (May 21, 2012)
NICE draft clinical guideline on managing psoriasis.

Vaccines (PDF file) (May 21, 2012)
FDA and World Health Organization (WHO) plan to research new vaccine trial designs and ways to enhance postmarketing surveillance of vaccine safety (see BioCentury Extra, Tuesday, May 15).

Product documentation (PDF file) (May 21, 2012)
Zytiga: NICE final appraisal determination (FAD) recommending Zytiga abiraterone in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel-containing therapy; from Johnson & Johnson (NYSE:JNJ) and BTG plc (LSE:BGC) (see BioCentury Extra, Tuesday, May 15).

Corruption (PDF file) (May 14, 2012)
Indian parliamentary report that found sufficient evidence of a "collusive nexus" between the country's drug regulator and pharmaceutical companies to expedite approval of drugs (see BioCentury Extra, Thursday, May 10).

Medicare (May 14, 2012)
CMS's Medicare Evidence Development & Coverage Advisory Committee agenda for a May 16 meeting to review the characteristics of evidence required for the agency's Coverage with Evidence Development (CED) designation (see BioCentury Extra, Thursday, May 10).

NICE (May 14, 2012)
U.K.'s NICE report from an advisory panel recommending an increase in the value attached to a drug's long-term benefit when calculating cost-effectiveness estimates per quality-adjusted year (QALY) (see BioCentury Extra, Friday, May 11).

Obesity (PDF file) (May 14, 2012)
Briefing documents for the May 10-11 meeting of FDA's Gastroenterology and Urology Devices Panel to discuss issues in the development of weight loss devices placed endoscopically or laparoscopically (see BioCentury Extra, Tuesday, May 8).

PDUFA (PDF file) (May 14, 2012)
U.S. House Energy and Commerce Committee new draft PDUFA reauthorization bill that is more closely aligned with the Senate PDUFA bill than previous versions (see BioCentury Extra, Monday, May 7).

Psoriasis (PDF file) (May 14, 2012)
NICE draft clinical guideline on managing psoriasis.

Respiratory diseases (PDF file) (May 14, 2012)
NHS companion document to its outcome strategy for chronic obstructive pulmonary disease (COPD) and asthma.

Product documentation (May 14, 2012)
Botox: NICE final appraisal determination (FAD) recommending the use of Botox onabotulinumtoxinA to prevent chronic migraines in patients who have not responded to at least three preventative medications and whose headaches are not caused by medication overuse; from Allergan Inc. (NYSE:AGN) (see BioCentury Extra, Thursday, May 10). (PDF file)
Halaven: CHMP revised EPAR updating SPC to include pancreatitis as an undesirable effect for Halaven eribulin mesylate to treat locally advanced metastatic breast cancer in patients who have progressed after two or more chemotherapy regimens; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523).
Jevtana: NICE final guidance recommending against the use of Jevtana cabazitaxel as a second-line treatment for prostate cancer in combination with prednisone or prednisolone; from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Thursday, May 10). (PDF file)
Lorcaserin: Briefing documents for the May 10 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 18-7, with one abstention, that the benefit-risk profile for lorcaserin supports approval to treat obesity; from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) (see BioCentury, May 14).
Tarceva: NICE draft guidance recommending the use of Tarceva erlotinib as first-line treatment for locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC), from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Wednesday, May 9). (PDF file)
Tofacitinib: Briefing documents for the May 9 meeting of FDA's Arthritis Advisory Committee, which voted 8-2 in favor of recommending approval of tofacitinib to treat moderately to severely active rheumatoid arthritis (RA) in patients who had inadequate response to one or more DMARDs; from Pfizer Inc. (NYSE:PFE) (see BioCentury, May 14).
Truvada: Briefing documents for the May 10 meeting of FDA's Antiviral Drugs Advisory Committee, which concluded the benefit-risk profile for Truvada emtricitabine/tenofovir supports the drug's use as pre-exposure prophylaxis to reduce risk of HIV-1 infection in uninfected adults; from Gilead Sciences Inc. (NASDAQ:GILD) (see BioCentury, May 14).

Benefit-risk (May 7, 2012)
Institute of Medicine report that said FDA should consolidate benefit-risk information for approved drugs into publicly available repositories created for each product (see BioCentury Extra, Tuesday, May 1).

Chronic kidney disease (May 7, 2012)
U.S. Preventative Services Task Force (USPSTF) draft recommendation statement that concludes there is insufficient evidence to assess the benefits and risks for routine screening for chronic kidney disease (CKD) in asymptomatic adults.

Clinical trials (PDF file) (May 7, 2012)
FDA final rule amending regulations to expand the scope of clinical investigator disqualification.

Crohn's disease (PDF file) (May 7, 2012)
NICE draft clinical guideline on managing Crohn's disease in adults and children.

FDA (PDF file) (May 7, 2012)
U.S. Government Accountability Office report that said FDA met its predefined performance goals in 10 of 11 years during FY2000-10 (see BioCentury Extra, Tuesday, May 1).

Gene/Cell therapy (PDF file) (May 7, 2012)
EMA's Committee for Advanced Therapies (CAT) guideline on developing medicinal products containing genetically modified cells.

Repurposing (May 7, 2012)
NIH's National Center for Advancing Translational Science (NCATS) request for comments on its initiative to partner with pharmas to repurpose compounds (see BioCentury Extra, Thursday, May 3).

Vaccines (May 7, 2012)
Global Regulatory Utilization of Vaccine Safety and Surveillance (GRUVSS) Initiative launched by FDA's Center for Biologics Evaluation and Research (CBER) to improve global pharmacovigilance of vaccines.

Product documentation (May 7, 2012)
Abraxane: CHMP revised EPAR updating SPC to include a warning regarding close monitoring for signs and symptoms of pneumonitis and to amend the frequency of interstitial pneumonitis for Abraxane nab-paclitaxel to treat breast cancer; from Celgene Corp. (NASDAQ:CELG).
Arcalyst: Briefing documents for the May 8 meeting of FDA's Arthritis Advisory Committee that said Arcalyst rilonacept had a "small" treatment effect to prevent gout flares in adults initiating uric acid-lowering therapy; from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) (see BioCentury Extra, Friday, May 4).
Benlysta: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) benefit assessment that said Benlysta belimumab offers no additional benefit over "optimized standard therapy" for systemic lupus erythematosus (SLE); from Human Genome Sciences Inc. (NASDAQ:HGSI) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, May 2). (PDF file)
Fampyra: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) benefit assessment that said Fampyra fampridine offers no additional benefit over physiotherapy in multiple sclerosis patients with walking disability; from Biogen Idec Inc. (NASDAQ:BIIB) (see BioCentury Extra, Wednesday, May 2). (PDF file)
Iressa: CHMP revised EPAR updating SPC to include a warning of keratitis and ulcerative keratitis for Iressa gefitinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC); from AstraZeneca plc (LSE:AZN; NYSE:AZN).
Valdoxan: CHMP revised EPAR updating SPC to include increased gamma-glutamyl transferase, increased alkaline phosphatase and hallucinations as side effects for Valdoxan agomelatine to treat major depressive disorder (MDD); from Servier.
Vidaza: CHMP revised EPAR updating SPC to include cellulitis as an adverse drug reaction for Vidaza azacitidine to treat acute myelogenous leukemia (AML), chronic myelomonocytic leukemia (CMML) and myelodysplastic syndrome (MDS); from Celgene Corp. (NASDAQ:CELG).
Yervoy: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Yervoy ipilimumab provides an "important additional benefit" over best supportive care in patients with advance malignant melanoma who have received previous therapy; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Wednesday, May 2). (PDF file)

Avian influenza (April 30, 2012)
Statement from NIH Director Francis Collins supporting recommendations from the National Science Advisory Board for Biosecurity (NSABB) to publish two revised manuscripts covering the transmissibility of the avian influenza (H5N1) virus in mammals (see BioCentury Extra, Monday, April 23).

EMA (April 30, 2012)
EMA's eSubmission Gateway allowing companies to submit centralized MAAs electronically (see BioCentury Extra, Tuesday, April 24).

FDA (April 30, 2012)
— FDA's Center for Drug Evaluation and Research (CDER) report outlining actions taken by the agency to enhance the quality, accountability and timeliness of its postmarket drug safety decisions.
— FDA report on strategies the agency is using to ensure that imported food, drugs, medical devices and other regulated products meet the same standards for safety and quality as those manufactured domestically. (PDF file)

Headaches (PDF file) (April 30, 2012)
NICE draft clinical guideline on the diagnosis and management of headaches in young people and adults.

PCORI (PDF file) (April 30, 2012)
Patient Centered Outcomes Research Institute (PCORI) proposed changes to its draft research priorities and agenda in response to public comments (see BioCentury Extra, Wednesday, April 25).

PDUFA (PDF file) (April 30, 2012)
U.S. Senate Health, Education, Labor and Pensions Committee PDUFA reauthorization manager's amendment that would eliminate limits on the numbers of conflict-of-interest waivers FDA can issue for advisory committee members (see BioCentury Extra, Tuesday, April 24).

Product documentation (April 30, 2012)
Avastin: HHS's Office of the Inspector General report documenting the difference in Medicare payments for off-label use of cancer drug Avastin bevacizumab to treat wet age-related macular degeneration (AMD) in 1Q10 compared to those for wet AMD drug Lucentis ranibizumab; both drugs from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, April 24). (PDF file)
Benlysta: NICE final appraisal determination (FAD) recommending against Benlysta belimumab to treat active, autoantibody-positive systemic lupus erythematosus (SLE); from Human Genome Sciences Inc. (NASDAQ:HGSI) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Gilenya: NICE final guidance recommending Gilenya fingolimod for a subset of patients that have highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon; from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Glivec/Gleevec: NICE final guidance recommending the use of 400 mg Glivec imatinib as first-line treatment of chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Herceptin: NICE final appraisal determination (FAD) recommending against Herceptin in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Incivo: NICE final guidance recommending Incivo telaprevir in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infections in adults with compensated liver disease; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and Johnson & Johnson (NYSE:JNJ). (PDF file)
Sprycel: NICE final guidance recommending against Sprycel dasatinib as first-line treatment of chronic myelogenous leukemia (CML); from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Tasigna: NICE final guidance recommending the use of Tasigna nilotinib as first-line treatment of chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN).  (PDF file)
Tykerb: NICE final appraisal determination (FAD) recommending against Tykerb lapatinib in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
Victrelis: NICE final guidance recommending Victrelis boceprevir in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infections in adults with compensated liver disease; from Merck & Co. Inc. (NYSE:MRK). (PDF file)

Benefit assessments (PDF file) (April 23, 2012)
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) notice of a June 22 meeting to discuss the benefit assessment process under the country's AMNOG drug pricing law (see BioCentury Extra, Tuesday, April 17).

Biosimilars (April 23, 2012)
Comments from trade groups and industry members on FDA's three draft biosimilars guidances, which included concerns about the documents' uncertainty on exclusivity terms (see BioCentury Extra, Tuesday, April 17).

Clinical trials (PDF file) (April 23, 2012)
EMA reflection paper on ethical and good clinical practice (GCP) requirements for clinical trials conducted outside of the EU and submitted in MAAs to the agency.

Diabetes (April 23, 2012)
American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) updated position statement on managing hyperglycemia in Type II diabetics.

EMA (April 23, 2012)
Summary of actions taken at the April 16-19 plenary meeting of EMA's CHMP.

FDA (PDF file) (April 23, 2012)
U.S. Government Accountability Office (GAO) report that recommends FDA develop a comprehensive inventory of its IT systems, develop an integrated master schedule for modernization efforts and assess information needs to identify opportunities for sharing.

H5N1 (PDF file) (April 23, 2012)
National Science Advisory Board for Biosecurity (NSABB) final recommendations submitted to NIH on the publication of two revised manuscripts covering the transmissibility of the avian influenza (H5N1) virus in mammals (see BioCentury Extra, Monday, April 16).

JOBS Act (April 23, 2012)
SEC FAQ on general applicability under Title I of the Jumpstart Our Businesses Startups (JOBS) Act, which provides scaled disclosure provisions for emerging growth companies.

Obesity (April 23, 2012)
FDA request for comments on a proposed survey to quantify the benefit-risk preferences of obesity patients in the U.S. (see BioCentury Extra, Friday, April 20).

Patents (April 23, 2012)
U.S. Supreme Court opinion in Caraco Pharmaceutical Laboratories Ltd. et. al. v. Novo Nordisk A/S et. al. that said generics companies can use the counterclaim provision in the Hatch-Waxman Act to challenge inaccurate patent information submitted to FDA by NDA sponsors (see BioCentury Extra, Tuesday, April 17).

PDUFA (April 23, 2012)
U.S. House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions Committee discussion drafts of PDUFA reauthorization legislation (see BioCentury Extra, Wednesday, April 18).
— Text of the PATIENTS' FDA Act (S. 2292), which is designed to complement the proposed PDUFA reauthorization deal and proposes to improve the transparency, accountability and efficiency of FDA's decision-making process for drugs and devices (see BioCentury Extra, Wednesday, April 18).

Stem cells (April 23, 2012)
California Institute for Regenerative Medicine's Strategic Partnership Awards Initiative that plans to award up to $30 million across three or more stem cell projects (see BioCentury Extra, Tuesday, April 17).

Vaccines (April 23, 2012)
— Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing vaccines in clinical testing or under FDA review. (PDF file)
— European Commission request for proposals for a EUR 2 million ($2.6 million) prize to develop alternatives to cold-chain technologies for vaccine formulation, preservation and transportation.

Product documentation (April 23, 2012)
Avastin: NICE draft guidance recommending against Avastin bevacizumab in combination with capecitabine for first-line treatment of metastatic breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Tuesday, April 17).
Edurant: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said there was a "substantial" degree of benefit for Edurant rilpivirine to treat HIV infection in treatment-naive patients; from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, April 16). (PDF file)
Eviplera: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said the agency found no additional benefit for Eviplera emtricitabine/tenofovir/rilpivirine to treat HIV infection in treatment-naive patients; from Gilead Sciences Inc. (NASDAQ:GILD) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, April 16). (PDF file)
Halaven: Germany's Federal Joint Committee (G-BA) final benefit assessment that said breast cancer drug Halaven eribulin mesylate provides a "slight" degree of additional benefit over chemotherapy in a subgroup of patients who are no longer eligible for treatment with taxanes or anthracyclines; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Thursday, April 19). (PDF file)
Nulojix: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Nulojix belatacept provides a "small degree" of additional benefit compared with generic cyclosporine A in preventing organ rejection in a subgroup of kidney transplant patients; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Monday, April 16). (PDF file)

Biosimilars (PDF file) (April 16, 2012)
EMA regulatory procedural advice for biosimilar applicants that provides an overview of the agency's position on issues that are typically addressed during the course of pre-submission meetings.

Collaborations (PDF file) (April 16, 2012)
Tufts Center for the Study of Drug Development report on the number and type of collaborations between biopharmaceutical companies and academic medical centers.

JOBS Act (April 16, 2012)
-- SEC guidance on the confidential submission process for emerging growth companies and changes to the requirements for Exchange Act registration and deregistration under the JOBS Act (see Cover Story).
-- SEC call for comments during its rulemaking process for the recently enacted Jumpstart Our Business (JOBS) Act, which promotes capital formation for small companies (see Cover Story).

PhRMA (PDF files) (April 16, 2012)
-- Pharmaceutical Research and Manufacturers of America (PhRMA) 2012 Industry Profile, which provides an overview of the industry.
-- PhRMA Biopharmaceuticals in Perspective chart pack, which provides information about prescription medicines and their role in the healthcare system.

Preventative health (April 16, 2012)
Institute of Medicine report recommending a tax on all medical care transactions to fund a minimum package of state and local preventative health services (see BioCentury Extra, Wednesday, April 11).

Process validation (PDF file) (April 16, 2012)
EMA draft guideline on process validation.

R&D (April 16, 2012)
The U.K.'s Biomedical Catalyst fund call for applications from small- to medium-size companies for awards on research in sectors aimed at addressing healthcare challenges (see BioCentury Extra, Wednesday, April 11).

Transparency (April 16, 2012)
Article published in PLoS Medicine by a researcher from the Johns Hopkins University School of Medicine and colleagues that said full clinical trial reports for authorized drugs should be made publicly available; and perspective article published by European regulators in PLoS Medicine warning of the risks associated with open access to trial data and calling for debate to establish data transparency standards (see BioCentury Extra, Wednesday, April 11).

Product documentation (April 16, 2012)
-- Atriance: CHMP revised EPAR updating SPC to include rhabdomyolysis and increased blood creatine phosphokinase as rare adverse events for Atriance nelarabine to treat T cell acute lymphoblastic leukemia and lymphoma; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
-- Vancocin: FDA letter denying a Citizen's Petition from ViroPharma Inc. (NASDAQ:VPHM) to delay approval of any generic versions of the company's oral antibiotic Vancocin vancomycin and to require that sponsors use in vivo clinical data to establish bioequivalence (see BioCentury Extra, Tuesday, April 10).
-- Victrelis: CHMP revised EPAR updating SPC to include information on drug interactions with ritonavir-boosted HIV protease inhibitors for Victrelis boceprevir to treat chronic HCV genotype 1 infection; from Merck & Co. Inc. (NYSE:MRK).

Accelerated approval (PDF file) (April 9, 2012)
U.S. Senate's Health Labor and Pension Committee discussion draft of the Drug Approval and Patient Access bill that would expand FDA's use of accelerated approval and Fast Track designation (see BioCentury Extra, Thursday, April 5).

Alzheimer's disease (PDF files) (April 9, 2012)
— EMA's CHMP final qualification opinion concluding that the combination of low beta amyloid (1-42) and high tau in cerebrospinal fluid (CSF), and amyloid-related PET imaging, can be used to identify patients with mild to moderate AD who are at increased risk to have an underlying AD neuropathology (see BioCentury Extra, Thursday, April 5).
— EMA's CHMP final qualification opinion concluding that positive/negative PET imaging of amyloid can be used as a biomarker to identify patients in clinical trials with predementia AD who are at increased risk to have an underlying neuropathology (see BioCentury Extra, Thursday, April 5).

CMS (April 9, 2012)
Public comments received by Centers for Medicare & Medicaid Services 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, April 9).

Drug safety (April 9, 2012)
EMA draft document listing the expected timeline for safety update submissions from sponsors on 3,155 drug products (see BioCentury Extra, Wednesday, April 4).

Health Canada (PDF file) (April 9, 2012)
Fraser Institute report that found in 2010 Health Canada took an average of 527 days to approve new drugs, while the country's provinces took an additional 358 days to approve reimbursement (see BioCentury Extra, Friday, April 6).

R&D (April 9, 2012)
— U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) Clinical Practice Research Datalink (CPRD), which will provide researchers access to patient data for clinical trial recruitment and observational studies.
— U.S. government policy on the oversight of life sciences dual use research of concern that instructs federal departments and agencies that conduct or fund life sciences research to review all research projects involving 15 "high-consequence" pathogens and toxins, and develop appropriate risk mitigation measures (see BioCentury Extra, Monday, April 2). (PDF file)

Safety (April 9, 2012)
Institute of Medicine report that recommends 13 steps that FDA and other organizations can take to improve regulatory systems for food and drug safety oversight in developing nations.

Product documentation (April 9, 2012)
Halaven: NICE final guidance recommending against Halaven eribulin to treat locally advanced or metastatic breast cancer in patients whose disease has progressed after at least two chemotherapy regimens; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Tuesday, April 3). (PDF file)
Mirabegron: Briefing documents for the April 5 meeting of FDA's Reproductive Health Drugs Advisory Committee, which voted 7-4, with one abstention, in favor of approval of mirabegron for overactive bladder; from Astellas Pharma Inc. (Tokyo:4503) (see BioCentury Extra, Thursday, April 5).
Sativex: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Sativex sublingual cannabis extract spray provided "no additional benefit" to treat spasticity in multiple sclerosis (MS) patients; from GW Pharmaceuticals Inc. (LSE:GWP) (see BioCentury Extra, Monday, April 2). (PDF file)

Alzheimer's disease (PDF file) (April 2, 2012)
EMA CHMP concept paper recommending the postponement of an update to the clinical guideline on medicinal products to treat Alzheimer's disease (AD) and other dementias until new validated data on diagnostic criteria and potential biomarkers become available.

Amyotrophic lateral sclerosis (PDF file) (April 2, 2012)
EMA concept paper recommending revision of the guidelines for clinical investigation of medicinal products to treat amyotrophic lateral sclerosis (ALS).

Cell lines (April 2, 2012)
Cancer Cell Line Encyclopedia developed by Novartis AG (NYSE:NVS; SIX:NOVN) and the Broad Institute of MIT and Harvard that catalogues the genetic and molecular profiles of about 1,000 human cancer cell lines used in drug R&D.

Healthcare reform (PDF files) (April 2, 2012)
Oral arguments heard by the U.S. Supreme Court on challenges to the Patient Protection and Affordable Care Act (PPACA) on: whether the law's individual insurance mandate challenge is barred by the Anti-Injunction Act; the constitutionality of the mandate; the severability of the mandate from the rest of PPACA; and the constitutionality of PPACA's expansion of Medicaid (see " Collateral Damage").

Infectious diseases (PDF file) (April 2, 2012)
EMA concept paper recommending revision of guidance on the development of DNA vaccines against infectious diseases.

Medical devices (PDF file) (April 2, 2012)
FDA final guidance that seeks to clarify how the agency determines the risk-benefit profile of a medical device during a premarket review (see BioCentury Extra, Tuesday, March 27).

Obesity (PDF file) (April 2, 2012)
Briefing documents for the March 28-29 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 17-6 that obesity drugs without a theoretic risk or signal for cardiovascular harm will need to be tested in a CV outcomes trial (see BioCentury Extra, Thursday, March 29).

Transparency (PDF file) (April 2, 2012)
EMA and the Heads of Medicines Agencies (HMA) joint guidance for a Europe-wide approach to identify which information included in an MAA can be publicly released after approval (see BioCentury Extra, Tuesday, March 27).

Product documentation (April 2, 2012)
Avamys: CHMP revised EPAR updating SPC to include headache as a possible side effect for Avamys fluticasone furoate nasal spray to treat allergic rhinitis; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Gilenya: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Gilenya fingolimod provides a "slight" degree of additional benefit for severe, rapidly progressing relapsing-remitting multiple sclerosis (RRMS); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, March 29). (PDF file)
Incivo: Germany's Federal Joint Committee (G-BA) final benefit assessment that said HCV drug Incivo telaprevir in combination with pegylated interferon and ribavirin — standard of care — provides an additional benefit in treatment-naive and treatment-experienced patients over standard of care, but the degree of benefit is not quantifiable; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, March 29). (PDF file)
Jevtana: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Jevtana cabazitaxel provided a "slight" degree of additional benefit over palliative care and best supportive care for all patients with hormone-refractory metastatic prostate cancer for whom docetaxel is no longer an option; from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Thursday, March 29). (PDF file)
Omontys: FDA label for Omontys peginesatide to treat anemia in chronic kidney disease (CKD) patients who are on dialysis; from Affymax Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Tuesday, March 27). (PDF file)
Trajenta: Germany's Federal Joint Committee (G-BA) final benefit assessment that found no additional benefit for diabetes drug Trajenta linagliptin because the dossier was incomplete; from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Thursday, March 29). (PDF file)
Vidaza: CHMP revised EPAR updating SPC to include injection site necrosis and tumor lysis syndrome as rare adverse drug reactions for Vidaza azacitidine to treat myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML); from Celgene Corp. (NASDAQ:CELG).
Xarelto: NICE final appraisal determination (FAD) recommending the use of Xarelto rivaroxaban to prevent stroke and systemic embolism in patients with atrial fibrillation (AF) with one or more risk factors; from Bayer AG (Xetra:BAYN)  and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, March 29). (PDF file)
Xgeva: NICE draft guidance recommending the use of Xgeva denosumab to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors; from Amgen Inc. (NASDAQ:AMGN) (see BioCentury Extra, Thursday, March 29).
Zytiga: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Zytiga abiraterone provides a "significant" degree of additional benefit to patients with metastasized castration-resistant prostate cancer for whom docetaxel is no longer an option; from BTG plc (LSE:BGC) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Thursday, March 29). (PDF file)

Drug delivery (PDF file) (March 26, 2012)
EMA reflection paper on developing IV medicinal products containing active substances solubilized in micellar system.

Patents (PDF file) (March 26, 2012)
U.S. Supreme Court opinion that said two patents from Prometheus Laboratories Inc. on the use of biomarkers to help determine a patient's treatment are not eligible for patenting.

Predictive tests (March 26, 2012)
Institute of Medicine report that calls for increased FDA involvement in the development process of predictive tests that use "omics" technologies — genomics, epigenomics, proteomics or metabolomics (see BioCentury Extra, Friday, March 24).

U.K. (PDF files) (March 26, 2012)
— Text of the Health and Social Care Bill passed by the U.K. parliament to restructure the National Health Service (see BioCentury Extra, Thursday, March 23).
U.K. Treasury 2012 budget, which includes provisions to reduce the corporate tax rate in 2012 to 24% from 26%, with additional 1% decreases in 2013 and 2014. Other provisions that could affect the U.K. life sciences industry include a L100 million ($158.3 million) fund to improve university research facilities (see BioCentury Extra, Thursday, March 23).

Product documentation (March 26, 2012)
Cholestagel: CHMP revised EPAR updating SPC to include abdominal distension, dysphagia and pancreatitis as adverse events for Cholestagel colesevelam to treat primary familial hypercholesterolemia; from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY).
Glivec/Gleevec: NICE final appraisal determination (FAD) recommending the use of 400 mg Glivec imatinib as first-line treatment of chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Marqibo: Briefing documents for the March 21 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 7-4, with two abstentions, that Marqibo vincristine has a favorable benefit-risk profile to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in patients with two or more relapses or in patients whose cancer has progressed following two or more leukemia therapies; from Talon Therapeutics Inc. (OTCBB:TLON) and Tekmira Pharmaceuticals Corp. (TSX:TKM; NASDAQ:TKMR) (see BioCentury Extra, Wednesday, March 21). (PDF file)
Sprycel: NICE final appraisal determination (FAD) recommending against Sprycel dasatinib as first-line treatment of chronic myelogenous leukemia (CML); from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)
Tasigna: NICE final appraisal determination (FAD) recommending the use of Tasigna nilotinib as first-line treatment of chronic myelogenous leukemia (CML); from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Zelboraf: CHMP EPAR for Zelboraf vemurafenib to treat unresectable or metastatic melanoma in patients with BRAF V600 mutations; from Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) and Roche (SIX:ROG; OTCQX:RHHBY).

Advertising (PDF file) (March 19, 2012)
FDA guidance on how the agency will implement the requirement for pre-dissemination review of direct-to-consumer television advertisements for prescription drugs and biologics.

Biosimilars (PDF file) (March 19, 2012)
FDA estimate that said the agency expects to receive two applications for new biosimilars and one biosimilar supplemental application annually (see BioCentury Extra, Monday, March 12).

Cervical cancer (March 19, 2012)
— U.S. Preventive Services Task Force (USPSTF) final cervical cancer screening guideline that recommends HPV screening as an option for women ages 30-65 in combination with cytology testing (see BioCentury Extra, Thursday, March 15).
Joint guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology Screening on the prevention and early detection of cervical cancer (see BioCentury Extra, Thursday, March 15). (PDF file)

Conditional approval (PDF file) (March 19, 2012)
Report from a working group co-chaired by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) and British Pharmaceutical Industry (ABPI) on a proposed conditional approval pathway for new products in the U.K. for life threatening, chronic or seriously debilitating conditions without adequate treatment options (see BioCentury Extra, Friday, March 16).

Electronic applications (PDF file) (March 19, 2012)
EMA guidance for its electronic applications forms (eAF) pilot program that allows applicants to apply for new marketing authorization or for its renewal, and to make changes to the marketing authorization.

HIV (PDF file) (March 19, 2012)
EMA reflection paper that contains draft recommendations for the preclinical and clinical development of oral and topical products for HIV pre-exposure prophylaxis (PrEP) (see BioCentury Extra, Thursday, March 15).

Innovation (PDF file) (March 19, 2012)
Welsh government Science for Wales strategic agenda to facilitate growth in scientific research, which includes a commitment of L50 million ($78.4 million) for its Welsh Life Sciences Fund (see BioCentury Extra, Thursday, March 15).

Tuberculosis (PDF file) (March 19, 2012)
FDA draft guidance that would lower the risk classification for nucleic acid-based in vitro tuberculosis (TB) tests to encourage development and reduce regulatory burden for manufacturers (see BioCentury Extra, Friday, March 16).

Product documentation (March 19, 2012)
Eliquis: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Eliquis apixaban provides a "small degree" of additional benefit over enoxaparin in preventing venous thromboembolic events (VTEs) in patients who have undergone hip replacement surgery, but not in patients who received knee replacement surgery; from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, March 15). (PDF file)
Esbriet: Germany's Federal Joint Committee (G-BA) final benefit assessment that said Esbriet pirfenidone provides an additional benefit over best supportive care, but the benefit is not quantifiable; from InterMune Inc. (NASDAQ:ITMN) (see BioCentury Extra, Thursday, March 15). (PDF file)
Esmya: CHMP EPAR for Esmya ulipristal acetate to treat moderate to severe uterine fibroids in women of reproductive age; from Gedeon Richter Ltd. (Budapest:RICHTER).
Gilenya: NICE final appraisal determination (FAD) recommending the use of Gilenya fingolimod in a subset of patients that have highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, March 15). (PDF file)
Incivo: NICE final appraisal determination (FAD) recommending the use of Incivo telaprevir in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infection in adults with compensated liver disease; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Friday, March 16). (PDF file)
Nexavar: Indian Patent Office order granting Natco Pharma Ltd. (BSE:NATCOPHAR) a compulsory license in India to manufacture a generic version of Nexavar sorafenib to treat kidney and liver cancer; from Bayer AG (Xetra:BAYN) (see BioCentury Extra, Monday, March 12). (PDF file)
Pradaxa: NICE final guidance recommending Pradaxa dabigatran etexilate to prevent stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF); from Boehringer Ingelheim GmbH. (PDF file)
Rasilamlo: CHMP revised EPAR updating SPC to include increased creatinine in blood as an adverse reaction for Rasilamlo aliskiren/amlodipene to treat hypertension; from Novartis AG (NYSE:NVS; SIX:NOVN).
Taltorvic: Briefing documents for the March 20 meeting of FDA's Oncologic Drugs Advisory Committee to discuss an NDA for Taltorvic ridaforolimus as maintenance therapy for metastatic soft tissue or bone sarcoma; from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Friday, March 16).
Vepacel: CHMP EPAR for Vepacel pre-pandemic influenza A (H5N1) vaccine; from Baxter International Inc. (NYSE:BAX).
Votrient: Briefing documents for the March 20 meeting of FDA's Oncologic Drugs Advisory Committee to discuss an sNDA for Votrient pazopanib to treat advanced soft tissue sarcoma (STS); from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Friday, March 16).
Vyndaqel: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Vyndaqel tafamidis plus best supportive care provides a "small degree" of additional benefit compared with best supportive care in the treatment of transthyretin (TTR) familial amyloid polyneuropathy (FAP); from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Thursday, March 15). (PDF file)
Xarelto: NICE draft guidance requesting additional information before it can recommend the use of Xarelto rivaroxaban to treat deep vein thrombosis (DVT) and prevent recurrent DVT and pulmonary embolism following an acute DVT; from Bayer AG (Xetra:BAYN) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, March 12).

Accelerated approval (PDF file) (March 12, 2012)
Text of the Faster Access to Specialized Treatments (FAST) Act (H.R. 4132), which seeks to expand FDA's use of accelerated approvals (see Cover Story).

Antibiotics (PDF files) (March 12, 2012)
— FDA draft guidance on the clinical development of treatments for complicated urinary tract infections (cUTI).
— Infectious Diseases Society of America proposal to create a new pathway for review and approval of drugs to treat infections that are not susceptible to existing drugs.

Anti-NGF (March 12, 2012)
Briefing documents and draft questions (PDF file) for the March 12 meeting of FDA's Arthritis Advisory Committee to discuss the development of anti-nerve growth factor (NGF) pain products (see BioCentury Extra, Thursday, March 8).

Asthma (PDF file) (March 12, 2012)
Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing asthma medicines in clinical trials or under FDA review.

Capital formation (PDF file) (March 12, 2012)
Text of the Jumpstart Our Business Startups Act (H.R. 3606) designed to promote capital formation for small companies that was passed by the U.S. House of Representatives (see "Rolling Back SOX").

Counterfeit drugs (PDF file) (March 12, 2012)
Text of the Counterfeit Drug Penalty Enhancement Act (S. 1886) designed to increase penalties for counterfeit drug trafficking that was passed by the U.S. Senate (see BioCentury Extra, Friday, March 9.

Drug labeling (PDF file) (March 12, 2012)
EMA draft concept paper on the need to revise the guideline on excipients in the label and package leaflet of medicinal products for human use.

Drug pricing (PDF file) (March 12, 2012)
AARP Public Policy Institute report on retail prices of prescription drugs widely used by Medicare beneficiaries from 2005-09.

FDA (PDF file) (March 12, 2012)
FDA list of guidance documents to be released by CDER in 2012, which includes draft guidance on submission of clinical pharmacology data as evidence of biosimilarity (see BioCentury Extra, Wednesday, March 7).

Hyperbilirubinemia (PDF file) (March 12, 2012)
Briefing documents for the March 13 meeting of FDA's Gastroenterology Drugs Advisory Committee to evaluate potential new drug therapies to manage hyperbilirubinemia in newborn infants.

Medical countermeasures (PDF file) (March 12, 2012)
Text of the Pandemic and All-Hazards Preparedness Act Reauthorization of 2011 (S. 1855) that proposes to create an independent entity to provide venture capital investment in companies with products and technologies that may be used as medical countermeasures and which was passed by the U.S. Senate (see BioCentury Extra, Thursday, March 8).

PAD (PDF file) (March 12, 2012)
NICE draft clinical guideline on the diagnosis and management of lower limb peripheral arterial disease (PAD).

PCORI (PDF file) (March 12, 2012)
Patient Centered Outcomes Research Institute (PCORI) adopted definition of patient-centered outcomes research that begins with a broad summary followed by a list of characteristics (see BioCentury Extra, Monday, March 5).

PDUFA (March 12, 2012)
Prepared testimony submitted by biotech executives for the March 8 House Energy and Commerce Committee's health subcommittee hearing on PDUFA reauthorization (see Cover Story).

Research safeguards (PDF file) (March 12, 2012)
Letter from Rep. F. James Sensenbrenner (R-Wis.) to the White House requesting information on the administration's safeguards for potentially dangerous research, including two recent studies on the transmissibility of high pathogenic avian influenza A (H5N1) in mammals (see BioCentury Extra, Monday, March 5).

Safety (PDF files) (March 12, 2012)
— FDA draft guidance describing the framework CDER intends to use to classify postmarketing drug safety issues as priority, standard or emergency.
— FDA draft guidance on the agency's development and communication of drug safety information.

Product documentation (March 12, 2012)
Colobreathe: CHMP EPAR for Colobreathe colistimethate sodium to treat chronic lung infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients ages 6 years and older; from Forest Laboratories Inc. (NYSE:FRX).
Simponi: CHMP revised EPAR updating SPC to include nausea as an adverse event for Simponi golimumab to treat active rheumatoid arthritis (RA), active and progressive psoriatic arthritis, and severe ankylosing spondylitis; from Johnson & Johnson (NYSE:JNJ).
— Victrelis: NICE final draft guidance (PDF file) recommending Victrelis boceprevir in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infection in adults with compensated liver disease; Germany's Federal Joint Committee (G-BA) final benefit assessment (PDF file) and documentation that said HCV drug Victrelis provides benefit in a population larger than the one included in a preliminary assessment from the Institute for Quality and Efficiency in Health Care (IQWiG); from Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Thursday, March 8).

Biologics (PDF file) (March 5, 2012)
EMA draft reflection paper on the use of starting materials and intermediates collected from different sources to manufacture biological medicinal products.

EMA (PDF files) (March 5, 2012)
— EMA Joint CHMP/CVMP Quality Working Party work plan for 2012.
— EMA list of applications for human medicines under CHMP review.

EU economic strategy (PDF file) (March 5, 2012)
European Council review of the EU economic strategy for 2020, which recommends that member states come to a final agreement in June regarding the adoption of a single EU patent system.

Genetic testing (March 5, 2012)
NIH's Genetic Testing Registry, a free searchable database of information on a genetic test's purpose, methodology, validity and evidence of usefulness (see BioCentury Extra, Wednesday, Feb. 29).

Medicare (March 5, 2012)
Text of the Health Care Bureaucrats Elimination Act (S. 2118) that would eliminate the Independent Payment Advisory Board (IPAB), which has the authority to recommend steps to cut Medicare costs, if spending exceeds specific triggers (see BioCentury Extra, Monday, Feb. 27). (PDF file)
Text of the Medicare Decisions Accountability Act (H.R. 452) that would repeal the IPAB and which was passed by the House Energy and Commerce Committee's health subcommittee 17-5 (see BioCentury Extra, Wednesday, Feb. 29). (PDF file)
White House blog post in which Assistant to the President and Deputy Chief of Staff for Policy Nancy-Ann DeParle defended IPAB, saying it is "legally prohibited from making recommendations that would ration health care" (see BioCentury Extra, Wednesday, Feb. 29).

OTC (PDF file) (March 5, 2012)
FDA notice of a March 22-23 public hearing to discuss a potential pathway for OTC approval of products that would otherwise be available only by prescription (see BioCentury Extra, Tuesday, Feb. 28).

Pediatric studies (March 5, 2012)
Institute of Medicine report that said two laws intended to motivate and require companies to conduct pediatric studies have led to improvements in the availability of data in children (see BioCentury Extra, Wednesday, Feb. 29).

Pricing (PDF file) (March 5, 2012)
European Commission proposed Transparency Directive that would reduce the time limits for member states to make pricing and reimbursement decisions for medicinal products (see BioCentury Extra, Thursday, March 1).

Product documentation (March 5, 2012)
Bydureon: NICE final guidance recommending the use of once-weekly Bydureon exenatide to treat Type II diabetes in triple and dual therapy regimens; from Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) and Alkermes plc (NASDAQ:ALKS). (PDF file)
Glivec: CHMP revised EPAR updating SPC to include a warning on a higher risk of developing edema and fluid retention in patients with a history of renal failure for Glivec imatinib, which is approved to treat gastrointestinal stromal tumors (GIST), Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and myeloproliferative diseases; from Novartis AG (NYSE:NVS; SIX:NOVN).
Kalydeco: FDA video of an interview with Deputy Commissioner for Medical Products and Tobacco Stephen Spielberg on personalized medicine and the approval of Kalydeco ivacaftor to treat cystic fibrosis (CF) in patients aged six and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator (CFTR) gene; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) (see Cover Story).
Pharmalgen: NICE final guidance recommending Pharmalgen to treat IgE-mediated bee and wasp venom allergy; from ALK-Abello A/S (CSE:ALK-B). (PDF file)

Adverse events (PDF file) (February 27, 2012)
FDA guidance on intended approach to enforce adverse events reporting for medical products and dietary supplements during an influenza pandemic.

CIRM (PDF file) (February 27, 2012)
The California Institute for Regenerative Medicine (CIRM) transition plan outlining ideas for continued funding after the expiration of the $3 billion in original funding authorized by Prop. 71 in 2004 (see BioCentury Extra, Thursday, Feb. 23).

cUTI (PDF file) (February 27, 2012)
FDA draft guidance on the clinical development of treatments for complicated urinary tract infections (cUTI) (see BioCentury Extra, Thursday, Feb. 23).

Drug pricing (PDF file) (February 27, 2012)
U.K. Department of Health's 11th report to Parliament on the Pharmaceutical Price Regulation Scheme (PPRS) that found the U.K. has the lowest drug prices compared with several developed countries.

Drug shortages (PDF file) (February 27, 2012)
FDA draft guidance on reporting drug shortages, which notes manufacturers would be required to notify FDA at least six months prior to any interruption of manufacturing that could lead to a potential disruption in supply (see BioCentury Extra, Tuesday, Feb. 21).

PET drugs (PDF file) (February 27, 2012)
FDA draft Q&A on the drug approval process for PET drugs.

Pharmacovigilance (PDF files) (February 27, 2012)
EMA modules on good pharmacovigilance practices: Module I: pharmacovigilance systems and their quality systems; Module II: pharmacovigilance systems master file; Module V: risk management systems; Module VI: management and reporting of adverse reactions to medicinal products; Module VII: safety update reports; Module VIII: post-authorization safety studies; Module IX: signal management.

R&D (PDF files) (February 27, 2012)
Letters from Reps. Henry Waxman (D-Calif.), Edward Markey (D-Mass.) and (D-Colo.) to NIH Director Francis Collins and FDA Commissioner Margaret Hamburg expressing concern and requesting information regarding the "underreporting" of results of clinical drug trials by researchers and companies.

Product documentation (February 27, 2012)
Aclidinium bromide: Briefing documents for the Feb. 23 meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted 12-2 that the benefit-risk profile for aclidinium bromide supports approval to treat bronchospasm associated with chronic obstructive pulmonary disease (COPD); from Forest Laboratories Inc. (NYSE:FRX) and Almirall S.A. (Madrid:ALM) (see BioCentury Extra, Thursday, Feb. 23).
Northera: Briefing documents for the Feb. 23 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee, which voted 7-4, with one abstention and one non-vote, to recommend approval of Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH); from Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) (see BioCentury Extra, Thursday, Feb. 23).
Qnexa: Briefing documents for the Feb. 22 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 20-2 that the benefit-risk profile for Qnexa phentermine/topiramate supports approval to treat obesity; from Vivus Inc. (NASDAQ:VVUS) (see Cover Story).
RoActemra: NICE final guidance recommending use of RoActemra tocilizumab in combination with methotrexate to treat rheumatoid arthritis after failure with DMARDs; from Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Synflorix: CHMP revised EPAR updating SPC to include hypotonic hyporesponsive episodes as an undesirable effect for Synflorix pneumococcal vaccine; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Votubia: CHMP revised EPAR updating SPC to include deep vein thrombosis (DVT) as an adverse drug reaction for Votubia everolimus to treat subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC); from Novartis AG (NYSE:NVS; SIX:NOVN).

Accelerated approval (PDF file) (February 20, 2012)
Text of the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act (S. 2113), which encourages FDA to use its Fast Track authority more broadly to expedite drug development and clarifies the agency's authority to grant accelerated approval based on clinical endpoints in addition to surrogate markers (see "Name of Story," AX).

Biosimilars (PDF file) (February 20, 2012)
Text of a bill (HB5581) introduced in Illinois' General Assembly that would limit the substitution of a biosimilar for a prescribed product by the state's pharmacies (see BioCentury Extra, Thursday, Feb. 16).

Budget (February 20, 2012)
Documentation for President Obama's FY13 budget request, which would fund FDA and NIH at roughly the same levels as in FY12 and proposes to cut the length of exclusivity for biologics to seven years from 12 years (see BioCentury Extra, Monday, Feb. 13 & Tuesday, Feb. 14).

Drug development (PDF files) (February 20, 2012)
— FDA draft guidance on design of pharmacokinetic drug interaction studies.
— FDA draft guidance on standards for electronic submission of clinical trial data.
— FDA Q&A on International Conference on Harmonisation (ICH) guidance that provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines likely to have significant use in the elderly.

PET (PDF file) (February 20, 2012)
FDA draft guidance on the IND application process for PET drugs.

Pharmacogenomics (PDF file) (February 20, 2012)
EMA concept paper on the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products.

Safety data (PDF file) (February 20, 2012)
FDA draft guidance outlining situations when it is appropriate to limit the collection of safety data during late-stage clinical trials or postmarketing studies (see BioCentury Extra, Monday, Feb. 13).

Sepsis (PDF file) (February 20, 2012)
NICE draft clinical guideline on prevention and management of neutropenic sepsis in cancer patients.

Product documentation (February 20, 2012)
Botox: NICE draft guidance requesting additional information prior to recommending Botox onabotulinumtoxinA to treat chronic migraine; from Allergan Inc. (NYSE:AGN) (see BioCentury Extra, Wednesday, Feb. 15).
Herceptin: NICE draft guidance recommending against Herceptin trastuzumab in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from the Genentech Inc. unit of Roche (SIX:ROG; OTCQ:RHHBY) (see BioCentury Extra, Monday, Feb. 13).
Qnexa: Briefing documents for the Feb. 22 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss Qnexa phentermine/topiramate to treat obesity; from Vivus Inc. (NASDAQ:VVUS) (see BioCentury Extra, Friday, Feb. 17).
Rasilamlo: Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that found Rasilamlo aliskiren/amlodipine provides "no additional benefit" for patients with hypertension for whom therapy with aliskiren or amlodipine alone is not sufficient; from Novartis AG (NYSE:NVS; SIX:NOVN). (PDF file)
Tarceva: NICE draft guidance requesting additional information prior to recommending Tarceva erlotinib as first-line treatment for locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer (NSCLC); from Roche (SIX:ROG; OTCQX:RHHBY) (see BioCentury Extra, Thursday, Feb. 16).
Trobalt: Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that found adjunctive epilepsy drug Trobalt retigabine provides "no additional benefit" over comparators; from Meda AB (SSE:MEDAA), Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Wednesday, Feb. 15). (PDF file)
Tykerb: NICE draft guidance recommending against Tykerb lapatinib in combination with an aromatase inhibitor as a first-line treatment of metastatic, hormone-receptor and HER2-positive breast cancer; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury Extra, Monday, Feb. 13).

Antimicrobial resistance (PDF file) (February 13, 2012)
U.K. Department of Health report on the emergence and spread of extended-spectrum beta lactamase-producing bacteria.

Biosimilars (PDF files) (February 13, 2012)
FDA biosimilars guidance documentation, including a Q&A about the implementation of the biosimilars pathway and draft guidances covering the scientific and quality considerations in demonstrating biosimilarity to a reference product (see Cover Story).


Gene therapy (PDF file) (February 13, 2012)
EMA reflection paper on design modifications of gene therapy medicinal products during development.

Heparin (PDF file) (February 13, 2012)
FDA draft guidance providing recommendations to ensure the heparin supply chain is not contaminated with oversulfated chondroitin sulfate or non-porcine material.

Osteoporosis (PDF file) (February 13, 2012)
NICE draft guideline on the selection and use of risk assessment tools for osteoporosis patients at risk for fragility fractures.

Partnering (February 13, 2012)
Association of University Technology Managers website to facilitate partnership and licensing deals among corporations and universities (see BioCentury Extra, Monday, Feb. 6).

Patents (February 13, 2012)
— U.S. Patent and Trademark Office's Patents For Humanity pilot competition that is designed to encourage the development of patented technologies that address humanitarian issues (see BioCentury Extra, Thursday, Feb. 9).
— PTO's proposed fee adjustments that would provide the agency with a 10% increase in fee collections in FY13 compared to the current schedule and a further 5% bump in FY14 (see BioCentury Extra, Wednesday, Feb. 8).

Pharmacogenetics (PDF file) (February 13, 2012)
EMA final guideline covering the use of pharmacogenetic studies in the pharmacokinetic evaluation of drug candidates (see BioCentury Extra, Friday, Feb. 10).

Sickle cell (PDF file) (February 13, 2012)
NICE draft guidance on the management of acute painful sickle cell episodes in the hospital setting.

Synthetic biology (February 13, 2012)
Woodrow Wilson International Center for Scholars' Synthetic Biology Scorecard that is designed to track federal and non-federal efforts to improve the governance of synthetic biology R&D.

Product documentation (February 13, 2012)
Dacogen: Briefing documents for the Feb. 9 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 10-3, with one abstention, that Dacogen decitabine did not demonstrate a favorable benefit-risk profile to treat newly diagnosed acute myelogenous leukemia (AML) in patients 65 years and older; from Astex Pharmaceuticals Inc.(NASDAQ:ASTX) and Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Thursday, Feb. 9).
Qutenza: Briefing documents for the Feb. 9 meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-0, with one abstention, that a 30-minute application of Qutenza capsaicin does not have an acceptable risk-benefit profile to support its approval to treat HIV-associated peripheral neuropathy (HIV-PN); from NeurogesX Inc. (NASDAQ:NGSX) (see BioCentury Extra, Thursday, Feb. 9).
Xgeva: Briefing documents for the Feb. 8 meeting of FDA's Oncologic Drugs Advisory Committee, which voted 12-1 that Xgeva has not demonstrated a favorable benefit-risk profile for treating pre-metastatic castration-resistant prostate cancer (CRPC); from Amgen Inc. (NASDAQ:AMGN) (see “Waiting for Xgeva”).

CMS (PDF file) (February 6, 2012)
Centers for Medicare & Medicaid Services proposed rule to implement changes to Medicaid in the Patient Protection and Affordable Care Act, including increasing rebates paid by drug manufacturers (see BioCentury Extra, Monday, Jan. 30).

COPD (PDF file) (February 6, 2012)
Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing chronic obstructive pulmonary disease medicines in clinical trials or under FDA review.

Drug development (February 6, 2012)
Transparency Life Sciences LLC clinical trial protocols for three repurposed compounds being developed by the company that are available for stakeholder input (see BioCentury Extra, Tuesday, Jan. 31).

Medical devices (PDF files) (February 6, 2012)
— Internal Revenue Service proposed rule that would implement a 2.3% excise tax mandated by the Patient Protection and Affordable Care Act on the sales of certain medical devices sold after Dec. 31, 2012 (see BioCentury Extra, Friday, Feb. 3).
— U.S. Government Accountability Office (GAO) report that found substantial variation in the amounts that surveyed hospitals paid for implantable medical devices.

PET drugs (PDF file) (February 6, 2012)
FDA draft guidance providing a Q&A on the regulatory process for PET drugs.

Pharmacovigilance (PDF file) (February 6, 2012)
EMA plan to implement pharmacovigilance legislation that aims to strengthen the EU-wide system for monitoring the safety and benefit-risk balance of medicines.

Transparency (PDF file) (February 6, 2012)
FDA report on transparency initiatives the agency will explore to increase public access to information on regulatory compliance and enforcement (see BioCentury Extra, Tuesday, Jan. 31).

Venture funding (February 6, 2012)
PricewaterhouseCoopers and National Venture Capital Association (NVCA) report that found life sciences VC funding, which includes biotech and medical device industries, increased 21% during 2011, with a total of $7.5 billion invested in 785 deals.

Product documentation (February 6, 2012)
Halaven: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Halaven eribulin mesylate provides "no additional benefit" over chemotherapy to treat breast cancer; from Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) (see BioCentury Extra, Wednesday, Feb. 1). (PDF file)
IHC4 immunohistochemistry test: NICE draft guidance that requested additional information on the IHC4 immunohistochemistry test before it can recommend widespread use to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer; from Royal Marsden Hospital and Queen Mary University London (see BioCentury Extra, Friday, Feb. 3). (PDF file)
MammaPrint: NICE draft guidance recommending against MammaPrint to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer; from Agendia B.V. (see BioCentury Extra, Friday, Feb. 3). (PDF file)
Mammostrat: NICE draft guidance recommending against Mammostrat to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer; from the Clarient Inc. subsidiary of General Electric Co. (NYSE:GE) (see BioCentury Extra, Friday, Feb. 3). (PDF file)
Oncotype DX: NICE draft guidance recommending against Oncotype DX to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer; from Genomic Health Inc. (NASDAQ:GHDX) (see BioCentury Extra, Friday, Feb. 3). (PDF file)
Xiapex: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment that said Xiapex collagenase clostridium histolyticum demonstrated "no additional benefit" over comparators to treat Dupuytren's contracture; from Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL), BioSpecifics Technologies Corp. (NASDAQ:BSTC) and Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Wednesday, Feb. 1). (PDF file)
Zytiga: NICE preliminary appraisal recommending against Zytiga abiraterone acetate in combination with prednisone or prednisolone for metastatic, castration-resistant prostate cancer (CRPC) that has progressed on or after docetaxel-containing therapy; from BTG plc (LSE:BGC) and Johnson & Johnson (NYSE:JNJ) (see Small Does Have A Price).

Advanced therapies (PDF file) (January 30, 2012)
EMA's Committee for Advanced Therapies (CAT) draft guideline on the methodology for identification of risks and associated risk factors of advanced therapy medicinal products.

Advertising (PDF file) (January 30, 2012)
FDA guidance on requirements for product name placement, size and prominence in advertising and promotional labeling for human and animal prescription drugs.

Alzheimer's disease (PDF file) (January 30, 2012)
EMA's CHMP final qualification opinion concluding that low hippocampal volume is predictive of Alzheimer's disease-type dementia in patients with cognitive impairment (see BioCentury Extra, Monday, Jan. 23).

Comparative effectiveness (PDF file) (January 30, 2012)
Patient-Centered Outcomes Research Institute (PCORI) draft research priorities and agenda that proposes to allocate funding through grants and contracts to research programs across five areas; PCORI was established by the Patient Protection and Affordable Care Act to conduct comparative effectiveness research (see BioCentury Extra, Monday, Jan. 23).

Drug development (PDF file) (January 30, 2012)
EMA guidance on the process for qualification of novel methodologies for drug development.

Gates Foundation (PDF file) (January 30, 2012)
Bill & Melinda Gates Foundation annual letter.

Genomics (PDF file) (January 30, 2012)
U.K.'s Human Genomics Strategy Group (HGSG) report recommending that the government produce a strategic document or white paper outlining a policy for the adoption of genomic technology in the NHS (see BioCentury Extra, Wednesday, Jan. 25).

Pharmacovigilance (January 30, 2012)
— EMA concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products. (PDF file)
Summary of actions taken at the Jan. 16-18 plenary meeting of EMA's Pharmacovigilance Working Party (PhVWP). (PDF file)

Prescription drug plans (PDF file) (January 30, 2012)
Avalere Health LLC study on the variation in formulary drugs covered in essential health benefit (EHB) plan options; states are required to chose one of several existing plans to use as the "benchmark" for the EHBs package that insurers would be required to cover under the Patient Protection and Affordable Care Act (see BioCentury Extra, Monday, Dec. 19, 2011).

Psoriasis (January 30, 2012)
National Psoriasis Foundation guideline on treating chronic plaque psoriasis that clarifies when to use systemic drugs for the disease.

Product documentation (January 30, 2012)
Arzerra: CHMP revised EPAR updating SPC to include anaphylactic shock as an uncommon adverse drug reaction for Arzerra ofatumumab to treat chronic lymphocytic leukemia (CLL); from Genmab A/S (CSE:GEN) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
Avastin: NICE final guidance 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)
Daxas: NICE final guidance recommending a clinical trial be conducted to assess 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), Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502). (PDF file)
Eliquis: NICE final guidance recommending Eliquis apixaban to prevent venous thromboembolism (VTE) in adults who have undergone elective hip or knee replacement surgery; from Bristol-Myers Squibb Co. (NYSE:BMY) and Pfizer Inc. (NYSE:PFE). (PDF file)
Erbitux: NICE final guidance recommending against Erbitux cetuximab as second-line therapy for metastatic colorectal cancer (mCRC); from Bristol-Myers Squibb Co. (NYSE:BMY), Eli Lilly and Co. (NYSE:LLY) and Merck KGaA (Xetra:MRK). (PDF file)
Exjade: CHMP revised EPAR updating SPC to include a recommendation against use of Exjade deferasirox, which is approved to treat chronic iron overload due to blood transfusions in patients with severe hepatic impairment; from Novartis AG (NYSE:NVS; SIX:NOVN).
MabThera: U.K.'s NICE final guidance recommending MabThera rituximab as first-line treatment for follicular non-Hodgkin's lymphoma (NHL) in combination with chlorambucil, clophosphamide, vincristine and prednisolone; from Biogen Idec Inc. (NASDAQ:BIIB) and Roche (SIX:ROG; OTCQX:RHHBY). (PDF file)
Ozurdex: CHMP revised EPAR updating SPC to include a warning concerning the risk of implant migration for Ozurdex dexamethasone intravitreal implant to treat macular edema associated with retinal vein occlusion (RVO) and non-infectious uveitis; from Allergan Inc. (NYSE:AGN).
Vectibix: NICE final guidance recommending against Vectibix panitumumab as second-line therapy for metastatic colorectal cancer (mCRC); from Amgen Inc. (NASDAQ:AMGN). (PDF file)

Biosimilars (PDF file) (January 23, 2012)
EMA draft guidance on the development of biosimilar versions of multiple sclerosis (MS) drug interferon beta (see BioCentury Extra, Thursday, Jan. 19).

CNS (PDF file) (January 23, 2012)
EMA Central Nervous System Working Party work plan for 2012.

Knee cartilage (PDF file) (January 23, 2012)
FDA guidance on the preparation of IDEs and INDs for products to repair or replace knee cartilage.

MDUFA (January 23, 2012)
Minutes from the Nov. 29 and Dec. 6 meetings between industry and FDA to discuss MDUFA reauthorization (see BioCentury Extra, Wednesday, Jan. 18).

Medicare (PDF file) (January 23, 2012)
Congressional Budget Office (CBO) report that found three of four value-based payment experiments reviewed produced little or no savings for Medicare (see BioCentury Extra, Thursday, Jan. 19).

Product documentation (January 23, 2012)
Gardasil: CHMP revised EPAR updating SPC to include cellulitis as an undesirable effect for Gardasil HPV vaccine; from Merck & Co. Inc. (NYSE:MRK) and Sanofi (Euronext:SAN; NYSE:SNY).
Gilenya: Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that said Gilenya fingolimod provides an additional benefit over interferon beta-1a for patients with rapidly progressing, severe relapsing-remitting multiple sclerosis (RRMS); from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Tuesday, Jan. 17). (PDF file)
Incivo: Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that said Incivo telaprevir plus standard of care with peginterferon and ribavirin provides an "additional benefit" compared with SOC alone in three HCV subgroups, but no additional benefit for four others; from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Tuesday, Jan. 17). (PDF file)
Jevtana: Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) preliminary benefit assessment report that said Jevtana cabazitaxel has significant additional benefit over palliative care and best supportive care for castration-resistant prostate cancer (CRPC) patients under 65 who can no longer be treated with docetaxel; from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Tuesday, Jan. 17). (PDF file)
Norvir: CHMP revised EPAR updating SPC to include severe skin disorders as a rare adverse event for Norvir ritonavir to treat HIV infection; from Abbott Laboratories (NYSE:ABT).
Prochieve: Briefing documents for the Jan. 20 meeting of FDA's Reproductive Health Drugs Advisory Committee, which voted 13-4 that the benefit-risk profile of Prochieve vaginal progesterone gel does not support its approval in reducing the risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy; from Columbia Laboratories Inc. (NASDAQ:CBRX) and Watson Pharmaceuticals Inc. (NYSE:WPI) (see BioCentury Extra, Friday, Jan. 20). (PDF file)
Sutent: CHMP revised EPAR updating SPC to include tumor hemorrhage, tumor necrosis and infections as adverse reactions for Sutent sunitinib to treat gastrointestinal stromal tumors (GIST), advanced pancreatic neuroendocrine tumors and metastatic renal cell carcinoma (RCC); from Pfizer Inc. (NYSE:PFE).

Antibiotics (PDF file) (January 16, 2012)
EMA final guideline on the development of therapeutics to treat bacterial infections (see BioCentury Extra, Tuesday, Jan. 10).

Blood products (PDF file) (January 16, 2012)
EMA's Blood Products Working Party work plan for 2012.

Epilepsy (PDF file) (January 16, 2012)
NICE final clinical guideline for the diagnosis and management of epilepsy.

Pediatric drugs (PDF file) (January 16, 2012)
Pharmaceutical Research and Manufacturers of America (PhRMA) report detailing medicines for children and adolescents in clinical trials or under FDA review in the U.S.

Pharmacovigilance (PDF file) (January 16, 2012)
Summary of actions taken at the Dec. 12-14 plenary meeting of EMA's Pharmacovigilance Working Party.

Product documentation (January 16, 2012)
Afinitor: CHMP revised EPAR updating SPC to include deep vein thrombosis (DVT) as an adverse reaction for Afinitor everolimus to treat advanced renal cell carcinoma and advanced pancreatic neuroendocrine tumors; from Novartis AG (NYSE:NVS; SIX:NOVN).
Ameluz: CHMP EPAR for Ameluz to treat actinic keratosis; from Biofrontera AG (Xetra:B8F).
Bydureon: NICE final appraisal determination (FAD) recommending once-weekly Bydureon exenatide to treat Type II diabetes in triple and dual therapy regimens; from Alkermes plc (NASDAQ:ALKS), Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Thursday, Jan. 12). (PDF file)
Glivec/Gleevec: NICE final guidance recommending against the use of the 800 mg dose of Glivec imatinib to treat chronic myelogenous leukemia (CML) in patients resistant or intolerant to the standard 400 mg dose; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Jan. 12).
Jevtana: NICE final draft guidance recommending against Jevtana cabazitaxel as a second-line treatment for prostate cancer in combination with prednisone or prednisolone; from Sanofi (Euronext:SAN; NYSE:SNY) (see BioCentury Extra, Wednesday, Jan. 11). (PDF file)
Sprycel: NICE final guidance recommending against Sprycel dasatinib to treat chronic myelogenous leukemia (CML) in patients who are resistant or intolerant to the standard 400 mg dose of Glivec imatinib; from Bristol-Myers Squibb Co. (NYSE:BMY) and Otsuka Pharmaceutical Co. Ltd. (see BioCentury Extra, Thursday, Jan. 12).
Tasigna: NICE final guidance recommending Tasigna nilotinib to treat chronic myelogenous leukemia (CML) in patients resistant or intolerant to the standard 400 mg dose of Glivec imatinib; from Novartis AG (NYSE:NVS; SIX:NOVN) (see BioCentury Extra, Thursday, Jan. 12).
Xarelto: NICE preliminary appraisal requesting additional information before it can recommend the use of Xarelto rivaroxaban to prevent stroke and systemic embolism in patients with atrial fibrillation (AF); from Bayer AG (Xetra:BAY) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, Jan. 9).

Antibiotics (PDF file) (January 9, 2012)
NICE draft guidance on the use of antibiotics to treat and prevent early onset neonatal infection.

Infectious disease (PDF file) (January 9, 2012)
EMA Infectious Diseases Working Party plan for 2012.

Patents (January 9, 2012)
World Intellectual Property Organization's PATENTSCOPE website that will allow patent applicants to list information of their international applications, if they are interested in making them available for licensing (see BioCentury Extra, Thursday, Jan. 5).

Safety (PDF file) (January 9, 2012)
FDA draft guidance to implement International Conference of Harmonization (ICH) requirements on the electronic transmission of individual case safety reports for medicinal products and biologics.

Product documentation (January 9, 2012)
Levemir: CHMP revised EPAR updating SPC to include data from a clinical trial evaluating Levemir insulin detemir to treat Type I diabetes in pregnant women; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO).
Trajenta: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary assessment benefit that said diabetes drug Trajenta linagliptin provided "no additional benefit" over comparable therapy in three different settings; from Boehringer Ingelheim GmbH and Eli Lilly and Co. (NYSE:LLY) (see BioCentury Extra, Tuesday, Jan. 3). (PDF file)
Zytiga: Germany's Institute for Quality and Efficiency in Health Care (IQWiG) preliminary assessment benefit that said Zytiga abiraterone provided "important additional benefit" in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate cancer (CRPC) for whom docetaxel is no longer an option, but provided no additional benefit compared with docetaxel in combination with prednisone in patients for whom treatment with docetaxel is still an option; from BTG plc (LSE:BGC) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Tuesday, Jan. 3). (PDF file)

Advanced therapies (PDF file) (January 2, 2012)
Summary of actions taken at the Dec. 8-9 meeting of EMA's Committee for Advanced Therapies (CAT).

Biomarkers (PDF file) (January 2, 2012)
FDA draft guidance on processes to ensure the quality and integrity of histology data in biomarker qualification studies, and the scientific standards that should be used in biomarker characterization and qualification.

Cancer (PDF file) (January 2, 2012)
EMA draft guidance on clinical development of cancer treatments, including disease-specific guidance for non-small cell lung cancer (NSCLC), prostate cancer, chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS) and hematopoietic stem cell transplantation (see BioCentury Extra, Thursday, Dec. 22, 2011).

CHMP (January 2, 2012)
Summary of actions taken at the Dec. 12-15 meeting of EMA's CHMP.

Chronic fatigue syndrome (PDF file) (January 2, 2012)
Proceeding of the National Academy of Sciences retraction of an August 2010 paper that suggested a link between chronic fatigue syndrome and viruses related to murine leukemia virus (MLV) (see BioCentury Extra, Tuesday, Dec. 27, 2011).

Devices (PDF file) (January 2, 2012)
FDA draft guidance on the use of classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and research (CBER).

EMA (PDF files) (January 2, 2012)
— EMA framework for interaction between the agency and healthcare professionals related to medicines for human use.
— Work plans for 2011 for EMA's Gastroenterology Drafting Group; Urology Drafting Group; Rheumatology-Immunology Working Party (RIWP); Pharmacokinetics Working Party (PKWP); Respiratory Drafting Group (RDG); Oncology Working Party; CHMP Biologics Working Party (BWP) and EMA/CHMP Working Group with Healthcare Professionals' Organizations (HCP WG).

Fentanyl (PDF file) (January 2, 2012)
FDA REMS for the class of transmucosal immediate-release fentanyl pain drugs to reduce the risk of misuse, abuse, addiction and overdose (see BioCentury Extra, Thursday, Dec. 29, 2011).

Genotoxicity (PDF file) (January 2, 2012)
EMA revised guideline on genotoxicity testing of medicines.

Health benefits (PDF file) (January 2, 2012)
HHS proposal that would allow states to choose one of several existing plans to use as the "benchmark" for the essential health benefits package that insurers would be required to cover under the Patient Protection and Affordable Care Act (see BioCentury Extra, Monday, Dec. 19, 2011).

Malaria (January 2, 2012)
Medicines for Malaria Venture and Scynexis Inc. website offering 400 compounds with anti-malarial activity for free to researchers (see BioCentury Extra, Tuesday, Dec. 20, 2011).

Medical devices (PDF file) (January 2, 2012)
FDA draft guidance to identify, explain and clarify the critical decision points in the agency's decision-making process to determine substantial equivalence for 510(k) applications.

Patents (January 2, 2012)
European Patent Office (EPO) website to collect public comments on proposed amendments to European patent law and practice (see BioCentury Extra, Monday, Dec. 19, 2011).

Pediatric drugs (PDF file) (January 2, 2012)
Summary of actions taken at the Dec. 7-9 meeting of EMA's Pediatric Committee (PDCO).

Rheumatoid arthritis (PDF file) (January 2, 2012)
EMA draft guideline on clinical investigation of medicinal products other than NSAIDs to treat rheumatoid arthritis (RA).

Product documentation (January 2, 2012)
Dificlir: CHMP EPAR for Dificlir fidaxomicin to treat Clostridium difficile-associated diarrhea; from Optimer Pharmaceuticals Inc. (NASDAQ:OPTR) and Astellas Pharma Inc. (Tokyo:4503).
Pharmalgen: NICE final appraisal determination recommending Pharmalgen to treat IgE-mediated bee and wasp venom allergy; from ALK-Abello A/S (CSE:ALK-B). (PDF file)
Rasitrio: CHMP EPAR for Rasitrio aliskiren/amlodipine/hydrochlorothiazide to treat high blood pressure; from Novartis AG (NYSE:NVS; SIX:NOVN).