Fibrinogen (PDF file)
EMA guideline on information to be included in the SPC of human fibrinogen products.
CMS's proposed decision memo supporting coverage of screening for HCV infection in people at high risk for infection, as well as one-time screening in baby boomers — the generation born during 1945-65 (see BioCentury Extra, Tuesday, March 4).
Hematopoietic disorders (PDF file)
FDA draft guidance on IND submissions for products using hematopoietic progenitor cells from placental/umbilical cord blood for hematopoietic and immunologic reconstitution in patients with hematopoietic system disorders.
Medicare Part D (PDF file)
Text of a bill introduced in the U.S. House of Representatives that would prevent HHS from implementing changes to Medicare Part D that are contained in a proposed rule issued by CMS in January (see BioCentury Extra, Friday, March 7).
Off-label guidance (PDF file)
FDA draft guidance on recommended practices for how companies can distribute papers, reference texts and clinical guidelines that describe off-label uses of drugs or devices to health care professionals (see BioCentury Extra, Monday, March 3).
Patents (PDF file)
The U.S. Patent and Trademark Office updated guidance to patent examiners on determining whether product claims that involve natural phenomena and natural products are patent eligible (see BioCentury Extra, Thursday, March 6).
Pediatric products (PDF file)
Minutes from the Jan. 15-17 meeting of EMA's Pediatric Committee (PDCO).
Type II diabetes (PDF file)
EMA's CHMP reflection paper proposing to simplify the label for Type II diabetes drugs "as a more relevant way of reflecting the intended use"; comments are due June 3 (see BioCentury Extra, Monday, March 3).
— President Obama's FY15 budget proposal that would slightly increase funding for FDA and NIH over the amount allocated to the agencies by the budget enacted for FY14 (see BioCentury Extra, Tuesday, March 4).
— HHS's summary on the President's FY15 budget proposal, which includes measures that could affect biotech and pharma, such as a proposal to cut the exclusivity period for innovator biologics to seven years from the current 12 years and proposed changes to Medicare payment rates for drugs and diagnostics (see BioCentury Extra, Wednesday, March 5). (PDF file)
— Inlyta: The U.K.'s NICE draft guidance recommending Inlyta axitinib to treat advanced renal cell carcinoma (RCC) in patients who failed treatment with a first-line kinase inhibitor or a cytokine; from Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Tuesday, March 4).
— Soliris: The U.K.'s NICE draft guidance requesting information on the development costs for Soliris eculizumab to treat atypical hemolytic uremic syndrome (aHUS) and an explanation of how those costs related to the proposed price for Soliris for the indication; from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) (March 10).