Antiviral products (PDF file)
FDA draft guidance on the format for submitting HIV-1 resistance data.
Chronic constipation (PDF file)
EMA draft guideline on evaluating medicinal products to treat chronic constipation.
CMS (PDF file)
CMS bulletin announcing the agency will provide cost-sharing reductions and tax credits to individuals who were unable to enroll in health plans through the state and federal health insurance exchanges due to technical problems, including glitches with HealthCare.gov, by the March 31 deadline (see BioCentury Extra, Friday, Feb. 28).
Combination products (PDF file)
FDA draft guidance proposing to recognize five-year exclusivity for fixed-dose combination products that have at least one new active moiety (see BioCentury Extra, Monday, Feb. 24).
U.S. Preventive Services Task Force (USPSTF) draft research plan for dyslipidemia screening and use of statins to improve cardiovascular outcomes in adults.
EMA (PDF file)
EMA GCP Inspectors Working Group work plan for 2014.
Fecal transplants (PDF file)
FDA draft guidance saying the agency will "exercise enforcement discretion" on INDs for the use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies as long as three conditions are met (see BioCentury Extra, Wednesday, Feb. 26).
Health research diversity (PDF file)
Letter from Reps. Henry Waxman (D-Calif.) and Frank Pallone Jr. (D-N.J.) requesting that the health subcommittee of the Energy and Commerce Committee hold a hearing to discuss the progress on the inclusion of women and minority groups in health research (see BioCentury Extra, Tuesday, Feb. 25).
Indiana biosimilars (PDF file)
Text of a bill passed by Indiana State House of Representatives and Senate that would allow pharmacists to substitute biosimilars that FDA has approved as interchangeable with an original biologic if the prescriber indicates the biologic may be substituted (see BioCentury Extra, Wednesday, Feb. 26).
Medicare Part D (PDF file)
Letter from the National Community Pharmacists Association sent to CMS Administrator Marilyn Tavenner in support of CMS's proposal to expand preferred pharmacy networks as part of several proposed changes to Medicare Part D (see BioCentury Extra, Wednesday, Feb. 26).
Orphan drugs (PDF files)
— Discussion draft bill of proposed tax reform legislation, which includes a proposal to repeal the 50% tax credit for clinical development costs of Orphan drugs, and an explanation of the draft (see BioCentury Extra, Thursday, Feb. 27).
— EMA guidance for sponsors on the procedure for Orphan Drug designation.
FDA web-based educational resources for patients, advocacy groups, research investigators and drug developers on FDA-related rare disease topics.
U.K. doctors (PDF file)
The U.K. government's consultation on a draft bill that would encourage doctors to use "innovative treatments" by protecting them from clinical negligence claims when the decision to use an innovative, non-standard treatment was "responsible" (see BioCentury Extra, Thursday, Feb. 27).
— Alimta: The U.K.'s NICE final appraisal determination (FAD) recommending against the use of Alimta pemetrexed for maintenance treatment of locally advanced or metastatic, non-squamous non-small-cell lung cancer (NSCLC) in patients whose disease has not immediately progressed following induction therapy with Alimta and cisplatin; from Eli Lilly and Co. (NYSE:LLY). (PDF file)
— Eylea: The U.K.'s NICE final guidance recommending the use of Eylea aflibercept to treat visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO); from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Bayer AG (Xetra:BAYN). (PDF file)
— Invokana: The U.K.'s NICE draft guidance recommending the use of Invokana canagliflozin in combination regimens for Type II diabetes; from Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Monday, Feb. 24).
— Tecfidera: EMA's CHMP EPAR for Tecfidera dimethyl fumarate as first-line treatment for relapsing-remitting multiple sclerosis (RRMS); from Biogen Idec Inc. (NASDAQ:BIIB).
— Yervoy: The U.K.'s NICE preliminary appraisal recommending Yervoy ipilimumab as first-line treatment of advanced malignant melanoma only in the context of research as part of a clinical study; from Bristol-Myers Squibb Co. (NYSE:BMY). (PDF file)