Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Astrazeneca, Bioarctic, Daiichi, Eisai, Eli Lilly, Immunitybio, Janssen Cilag, Johnson & Johnson, Krystal, Novartis, Outlook, Regeneron, Roche, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Biond, Bridgebio, Eisai, GQ Bio Therapeutics, Helix Acquisition, Holling Bio-Pharma, Mustang Bio, Neuren, Nxera, Pacira, Sanofi, Sciclone, Theras.
The rash of firings at agencies of the Department of Health and Human Services has provoked a Feb. 28 letter from Reps. Dianna DeGette (D-Colo.) and Frank Pallone (D-N.J.), blasting the dismissals and insinuating that the dismissals were politically motivated.
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.