Although the U.S. CDC considers myocarditis to be a rare event linked to mRNA COVID-19 vaccines, the FDA is adding a warning about the adverse event to its doctor and patient fact sheets for the vaccines.
More than two weeks after the FDA gave its go-ahead to Biogen Inc.’s Aduhelm (aducanumab), controversy still rages over the accelerated approval as well as the price for the anti-amyloid beta monoclonal antibody for Alzheimer’s disease (AD). Embattled U.S. regulators made the uncommon move of releasing documents – with more due to be made public later – that show the internal deliberations that led to Aduhelm’s clearance.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algenex, Antares, Astrazeneca, Boehringer Ingelheim, Caladrius, Fennec, Grace, Xentria.
With the July 25 PDUFA priority review date looming for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic anal cancer, the FDA has one voting question for its Oncologic Drugs Advisory Committee (ODAC): Should it hold off on its approval decision until more data are in from a phase III study?
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Bayer, Beigene, Bioheng, BMS, Boehringer, Day One, Eli Lilly, Hope Biosciences, Hutchmed, Prestige, Vertex.
In denying cert to Abbvie Inc. v. FTC June 21, the U.S. Supreme Court may have strengthened an FTC tool for going after biopharma companies that try to protect their patents. The high court’s refusal to hear the case reinforces a September decision by the U.S. Court of Appeals for the Third Circuit that the biopharma industry has said will make it more difficult for drug companies to pursue patent infringement cases in keeping with Hatch-Waxman.
The U.S. Supreme Court will not take up Amarin Corp. plc’s appeal of a September Federal Circuit decision that opened the door for generics of the company’s fish oil-derived cardiovascular drug, Vascepa (icosapent ethyl), to enter the U.S. market.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Merck, Orphazyme, Sanofi.
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