Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Astellas, Basilea, Gosun, Bristol Myers Squibb, Lipocine, Sarepta, Sedor, Senhwa.
The U.S. Court of Appeals for the Federal Circuit narrowed the landscape for filing Hatch-Waxman infringement suits against U.S.-based companies, as it answered yet another question raised by the Supreme Court’s unanimous decision in TC Heartland v. Kraft Foods, which dramatically changed venue parameters in 2017 for all patent infringement cases.
Shares of Bluebird Bio Inc. (NASDAQ:BLUE) sank 16.6%, or $9.72, to close at $48.83 as Wall Street reacted to news that the U.S. regulatory filing for Lentiglobin in sickle cell disease (SCD) will be delayed. Previously expected in the second half of next year, the filing won’t happen until late 2022.
The latest global regulatory news, changes and updates affecting biopharma, including: Price not so NICE for routine use of Opdivo in melanoma; MHRA updates EAMS guidance; HHS plans retrospective regulatory review; USPTO sees spike in AI-related patent applications.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amnio Technology, Asieris, Astrazeneca, Bluebird, Genmab, Janssen, Vertex.
The FDA posted briefing documents related to the Nov. 6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, and Wall Street’s opinion turned out decidedly mixed regarding the odds for aducanumab, the anti-amyloid beta monoclonal antibody for Alzheimer’s disease from Cambridge, Mass.-based Biogen Inc. and Eisai Co. Ltd., of Tokyo.
It didn’t take long for a U.S. district judge to grant Gilead Sciences Inc.’s request for a temporary restraining order to stop two interconnected health care networks in Florida from defrauding the company’s Advancing Access Medication Assistance Program that provides free HIV pre-exposure prophylaxis drugs to eligible, uninsured people.
The latest global regulatory news, changes and updates affecting biopharma, including: PhRMA: Broader response to trade barriers needed; Russia setting up drug purchasing center.
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