Express Scripts Holding Co. (NASDAQ:ESRX) drug trend report for 2013, which said the pharmacy benefit manager expects U.S. specialty drug spending to grow 63% by 2016 compared to 2013, driven primarily by a predicted 1,800% increase in spending on HCV drugs (see BioCentury Extra, Tuesday, April 8).
The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) Early Access to Medicines Scheme, which will allow limited access to unapproved or off-label products based on quality, safety and efficacy data from Phase II or III testing (see BioCentury Extra, Monday, April 7).
GMO labeling (PDF file)
Text of Safe and Accurate Food Labeling Act (H.R. 443) introduced in the U.S. House of Representatives, which would give FDA sole authority to require mandatory labeling on foods with genetically modified ingredients if there is a "material difference" compared to foods without genetically modified ingredients (see BioCentury Extra, Wednesday, April 9).
Heparin (PDF file)
FDA draft guidance for immunogenicity-related considerations for the approval of NDAs and ANDAs for low molecular weight heparin.
Opioid abuse (PDF file)
FDA notice soliciting comments on how product packaging, storage and disposal systems could be used to prevent or deter opioid abuse and misuse (see BioCentury Extra, Thursday, April 10).
PhRMA (PDF file)
Report from the Pharmaceutical Research and Manufacturers of America (PhRMA) that outlines two potential growth trajectories for the U.S. biopharma sector and the top policy factors that enable innovation.
European Commission delegated act that specifies circumstances under which EMA can require a postmarketing efficacy trial (see BioCentury Extra, Friday, April 11).
Research funding (PDF file)
Text of the America HEALS Act (H.R. 4384) introduced in the U.S. House of Representatives, which would create a mandatory trust fund for biomedical research to increase funding for NIH, CDC, the Department of Defense Health Program (DHP) and the medical and prosthetics research program at the Department of Veteran Affairs (see BioCentury Extra, Monday, April 7).
Stability testing (PDF file)
EMA guideline on stability data for active substances and/or finished products required for variations to MAAs.
Sterilization processes (PDF file)
EMA concept paper on the need to revise the guidance on the selection of sterilization processes for drugs.
— Adempas: EMA's CHMP EPAR for Adempas riociguat to treat pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH); from Bayer AG (Xetra:BAYN).
— Eperzan: EMA's CHMP EPAR for Eperzan albiglutide to treat Type II diabetes as monotherapy or as add-on therapy; from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK).
— Latuda: EMA's CHMP EPAR for Latuda lurasidone to treat schizophrenia in adults; from Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).
— Niox Mino: The U.K.'s NICE final guidance recommending Niox Mino to help diagnose eosinophilic asthma; from Aerocrine AB (SSE:AERO). (PDF file)
— Niox Vero: The U.K.'s final guidance recommending Niox Vero to help diagnose eosinophilic asthma; from Aerocrine AB (SSE:AERO). (PDF file)
— NObreath: The U.K.'s final guidance recommending NObreath to help diagnose eosinophilic asthma; from Bedfont Scientific Ltd. (PDF file)