Access to investigational drugs
Information about Johnson & Johnson's Janssen Pharmaceuticals division's policies on access to investigational medicines April 21).
Comparative effectiveness trials
The New England Journal of Medicine perspective article from researchers at NIH's NCI on proposals on how to fund comparative effectiveness trials for expensive new cancer drugs vs. cheaper drugs (see BioCentury Extra, Friday, April 18).
— Text of HCR 2005 passed by the Arizona Senate, which would allow physicians to prescribe investigational products to eligible terminally ill patients who have no "comparable or satisfactory" FDA-approved treatment options (see Cover Story).
— Text of the Compassion Freedom of Choice Act (H.R. 4475) introduced in the U.S. House of Representatives, which would allow manufacture, importation, distribution and sale of investigational products outside of a clinical trial for terminally ill patients without restriction by or reporting to FDA (see BioCentury Extra, Wednesday, April 16).
Joint statement from the American College of Cardiology and American Heart Association on integrating value assessments for treatments into clinical practice guidelines and performance measures (see BioCentury Extra, Friday, April 18).
Endotoxin testing (PDF file)
FDA draft guidance for endotoxin testing in single-use intraocular ophthalmic devices.
The U.K.'s NICE draft guidance recommending the use of erythropoietin-stimulating agents epoetin and darbepoetin to treat cancer treatment-associated anemia (see BioCentury Extra, Tuesday, April 15).
HCV (PDF file)
The U.S. Department of Veteran Affairs treatment guidelines recommending regimens containing Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) and Olysio simeprevir from Johnson & Johnson (NYSE:JNJ) and Medivir AB (SSE:MVIR B) for most HCV patients, but says it would be "reasonable" for doctors to defer treatment for some patients until newer therapies are available (see BioCentury Extra, Friday, April 18).
Figures released by the White House showing that 8 million people have enrolled in health plans offered on state and federal health insurance exchanges (see BioCentury Extra, Thursday, April 17).
Orphan drugs (PDF file)
Summary of actions taken at the April 8-9 meeting of EMA's Committee for Orphan Medical Products (COMP).
Seasonal influenza vaccines (PDF file)
EMA's interim guidance on safety surveillance for seasonal influenza vaccines.
Analysis from Express Scripts Holding Co. (NASDAQ:ESRX) that said use of specialty drugs was greater in January and February among enrollees on health exchanges compared with patients in commercial health plans (see BioCentury Extra, Monday, April 14).
— MoxDuo: Briefing documents for the April 22 meeting of FDA's Anesthetic and Analgesic Drug Products Advisory Committee to discuss MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain; from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) (see BioCentury Extra, Friday, April 18).
— NovoEight: Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) preliminary benefit assessment that concluded NovoEight turoctocog alfa has "no additional benefit" vs. other Factor VIIIs (FVIIIs) to treat and prevent bleeding in hemophilia A patients; from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) (see BioCentury Extra, Tuesday, April 15). (PDF file)
—Trobalt: Germany's Federal Joint Committee (G-BA) preliminary benefit assessment that again concluded that Trobalt retigabine for epilepsy has "no additional benefit" vs. individualized antiepileptic therapy; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) (see BioCentury, Tuesday, April 15). (PDF file)