The FDA has approved Trudhesa (dihydroergotamine mesylate [DHE]; INP-104) from Impel Neuropharma Inc. for treating acute migraine headaches with or without aura in adults. The approval comes as several competitors, including Axsome Therapeutics Inc and Abbvie Inc., have NDAs submitted or approved for new therapies to treat migraine.
While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs).
The European Commission and Astrazeneca plc have ended their legal row over COVID-19 vaccines, while also reaching an agreement over supplies of remaining shots to Europe. The settlement brings to an end an unseemly row over vaccine supply, which further soured relations between the EU and U.K. following Brexit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cstone, Eqrx, Evgen, Kahr, Moderna, Novartis, Orphalan, Pfizer, Polaryx, Relief, TCR2, Tetra.
Rokit Healthcare Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Dfurege, its artificial organ platform to treat diabetic foot ulcers. “We hope that having a South Korean approval for this platform will be a boost for our planned IPO,” Seok Hwan You, CEO at Rokit, told BioWorld.
Aatru Medical LLC has received FDA 510(k) class II clearance for a platform that turns its back on electro-mechanical components in other negative pressure wound therapy (NPWT) systems. Deployed for closed surgical incision applications, the Negative Pressure Surgical Incision Management System (NPSIMS) is a single-use, disposable platform that could help reduce the 20% of hospital infections attributed to surgical site infections (SSI).
Even as the Biden administration pushes for drug imports from Canada as a way to help curb U.S. prescription drug prices, Canada is doubling down on its efforts to protect its supply of drugs and medical devices.
In a precedential opinion, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s conclusion that Belcher Pharmaceuticals LLC’s chief science officer engaged in inequitable conduct by withholding material information from the U.S. Patent and Trademark Office during prosecution of Belcher’s 9,283,197 patent.
Now that the U.S. judge overseeing Purdue Pharma LP’s bankruptcy proceedings has conditionally signed off on a $10 billion settlement intended to resolve 3,000 opioid lawsuits filed by states, tribes and local governments, the privately owned drugmaker can take the first steps to transform itself into a public service company owned mostly by the National Opioid Abatement Trust and governed by a new independent board.
The Biden administration’s plan to roll out COVID-19 boosters by Sept. 20 could get pushed back – pending the outcome of an FDA advisory committee meeting and how quickly the FDA acts on the adcom’s recommendation. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, announced Sept. 1 that the agency will convene its Vaccines and Related Biological Products Advisory Committee for a virtual meeting Sept. 17.
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