Antimicrobial resistance (PDF file)
EMA report summarizing the outcomes of a Nov. 8 workshop on regulatory options in the fight against antimicrobial resistance.
The Cancer Prevention and Research Institute of Texas request for applications for grant awards and list of new members appointed to its scientific review council (see BioCentury Extra, Wednesday, Dec. 11).
Drug reimbursement (PDF files)
Express Scripts and CVS Caremark 2014 lists of excluded drugs by class along with preferred alternatives (see BioCentury, December 16, 2013).
Healthcare exchanges (PDF files)
— HHS interim final rule intended to alleviate coverage gaps that are likely to occur as consumers attempt to use insurance purchased on federal and state healthcare exchanges in January (see BioCentury Extra, Friday, Dec. 13).
— HHS report stating that 258,497 people selected a qualified health plan in the healthcare exchanges in November, bringing the total number to 364,682 since the exchanges opened on Oct. 1 (see BioCentury, Wednesday, Dec. 11).
Malaria (PDF file)
Policy Cures report on funding trends for malaria, which projects a need for up to $8.3 billion in funding over the next decade for malaria research.
Text of legislation passed by the Senate Finance Committee and the House Ways and Means Committee (PDF file) that would repeal the Medicare physician sustainable growth rate (SGR) formula but would also give the HHS secretary unprecedented power to control the practice of medicine (see BioCentury Extra, Friday, Dec. 13).
NICE (PDF file)
The U.K.'s NICE interim process and methods statement explaining the development of Medtech Innovation Briefings, which provide objective information on medical technologies as an aid to medical decision-making but do not constitute a guidance recommendation.
— European Commission first calls for proposals under Horizon 2020, the EU research and innovation program for 2014-20; the first calls have a budget of more than EUR 15 billion ($20.6 billion) and cover funding opportunities for 2014-15 (see BioCentury Extra, Thursday, Dec. 12).
— EU's Innovative Medicines Initiative eleventh call for proposals covering R&D for eight topics, including Alzheimer's disease (AD), antimicrobial resistance, osteoarthritis and cancer (see BioCentury Extra, Thursday, Dec. 12). (PDF file)
— Dapagliflozin: Briefing documents for the Dec. 12 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 13-1 that the benefit-risk profile of dapagliflozin supported approval as an adjunct to diet and exercise to treat Type II diabetes; from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol Myers Squibb Co. (NYSE:BMY) (see BioCentury Extra, Thursday, Dec. 12).
— Grastek: Briefing documents for the Dec. 12 meeting of FDA's Allergenic Products Advisory Committee, which unanimously voted that available data support the efficacy of Grastek grass Allergy Immunotherapy Tablet (AIT) to treat Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals five years of age and older; from ALK-Abello A/S (CSE:ALK-B) and Merck & Co. Inc. (NYSE:MRK) (see BioCentury Extra, Thursday, Dec. 12). (PDF file)
— Myalept: Briefing documents for the Dec. 11 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which voted 11-1 that there was substantial evidence that the benefits of Myalept metreleptin exceed the risks in patients with generalized lipodystrophy; from Bristol-Myers Squibb Co. (NYSE:BMY) (see BioCentury, Wednesday, Dec. 11). (PDF file)
— Oralair: Briefing documents for the Dec. 11 meeting of FDA's Allergenic Products Advisory Committee, which voted 9-1 that available data support the efficacy of Oralair to treat grass pollen-induced allergic rhinoconjunctivitis in individuals five years of age and older when administered prior to and during the grass pollen season; from Stallergenes S.A. (Euronext:GENP) (see BioCentury Extra, Thursday, Dec. 12). (PDF file)
— Relvar Ellipta: EMA's CHMP EPAR for Relvar Ellipta fluticasone furoate/vilanterol to treat asthma and chronic obstructive pulmonary disease (COPD) in adults with a history of exacerbations; from Theravance Inc. (NASDAQ:THRX) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). (PDF file)
— Vascepa: Citizen's Petition from the EPA Drug Initiative to FDA asking FDA Commissioner Margaret Hamburg to overturn the agency's October decision to rescind an SPA for the Phase III ANCHOR trial of Vascepa icosapent ethyl to treat high triglycerides, defined as triglyceride levels 200 mg/dL or greater and less than 500 mg/dL, in patients with mixed dyslipidemia; from Amarin Corp. plc (NASDAQ:AMRN) (see BioCentury Extra, Friday, Dec. 13).