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The COVID-19 pandemic has spurred the World Health Organization (WHO) to release new draft guidelines on good manufacturing practices (GMPs) for investigational therapeutics. Read More
Axsome Therapeutics has received a deficiency letter from the FDA for its investigational neurological drug AXS-05 (dextromethorphan-bupropion) for major depressive disorder. Read More
The Biden administration proposes to rescind the controversial ‘most favored nation’ drug pricing final rule that required Medicare to buy some Part B drugs at the lowest price paid by a list of developed nations. Read More
In a significant policy shift, the FDA is going to reclassify some medical products as devices rather than drugs, in accordance with an April 16 ruling by the U.S. Court of Appeals for the District of Columbia Circuit, the agency says in a Federal Register notice published today. Read More
The FDA has finalized a guidance on one aspect of drug quality assessment: “Development and Submission of Near Infrared Analytical Procedures,” abbreviated NIR. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed an earlier judgment that Teva Pharmaceuticals has to pay $235.5 million in damages to GlaxoSmithKline (GSK) for patent infringement. Read More
To address concerns of federal regulators, vaccine maker Novavax said it will pause production of its COVID-19 vaccine lest it lose its government funding. Read More
HHS said this week that its Office of the Inspector General (OIG) is beginning an investigation into how the FDA determines who gets an accelerated approval pathway and how those prized designations are implemented. Read More
In the latest in a series of acquisitions aimed at quickly ramping up its portfolio of new drugs, Bayer is acquiring San Diego, Calif.-based biopharmaceutical firm Vividion Therapeutics in a deal worth up to $2 billion. Read More
Two industry groups and an opioid maker and distributor have asked the Supreme Court to reject a tax New York state is imposing on opioid manufacturers. Read More