The casual observer may think that physician speaker programs sponsored by makers of drugs and medical devices have drawn less attention from U.S. federal attorneys, but reality has failed to meet that expectation. Mark Gardner, managing attorney of Gardner Law of Stillwater, Minn., said on a Nov. 19 webinar that “there’s a lot coming through right now in terms of settlements,” including a settlement with a drug maker that sent the company into bankruptcy.
If the FDA’s opening meeting Nov. 19 on the reauthorization of BsUFA is anything to go by, interchangeability could be a key part of the next round of U.S. biosimilar user fee negotiations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Alvotech, Aquestive, Asklepios, Day One, Orchard, Seelos, Selecta, Teva, Zymeworks.
With the FDA’s required safety milestone notched in their phase III study of COVID-19 vaccine candidate BNT-162b2, Pfizer Inc. and Biontech SE said they will request emergency use authorization “within days.”
Concerns about biopharma executives profiting from stock sales aligned with releases of promising COVID-19 vaccine results could result in Congress requiring a cooling-off period for executives’ 10b5-1 plans that provide a safe harbor to insider trading.
The latest global regulatory news, changes and updates affecting biopharma, including: SEC: electronic signatures OK; FDA releases more PSGs; HHS sees AI, NLP as regulatory clean-up service providers; MHRA gives ups and downs of reclassifying drugs; TGA: Diabetes risks greater than NDMA risks.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Phage, Biogen, Bioventus, Cellectis, Cormedix, Janssen, Nanobiotix, Omeros, Pfizer, PTC, Samsung, Sanofi, Vivet.
Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.
The latest global regulatory news, changes and updates affecting biopharma, including CDER, CBER promise EUA transparency; FDA plasma guidance updated, again; WHO targets cervical cancer; Draft guidance to help FDA respond to 2012 citizen petition; More time to comment on instituting PTAB trials.
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