Abbvie Inc. is buying into the obesity fray in a potential $1.875 billion development and commercialization agreement with Danish peptide drug discovery specialist Gubra A/S. In addition, there will be a $350 million up-front payment as Abbvie takes over the reins of GUB-014295 (referred to as Gubamy), a long-acting analog of the satiety hormone amylin, currently in phase I development. Read More
For executives of Lexicon Pharmaceuticals Inc., the missed primary endpoint in the phase IIb Progress study testing pilavapadin, its non-opioid candidate, in adults with moderate to severe diabetic peripheral neuropathic pain seemed merely a footnote for what CEO Mike Exton called an “exciting and long-awaited day for the Lexicon team, collaborators and patients.” Read More
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.” Read More
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. Read More
As U.S. regulatory uncertainty swirls around the vaccine space and health care in general, Vaxcyte Inc. stands poised for a readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine (PCV). The San Carlos, Calif.-based firm will offer top-line safety, tolerability, and immunogenicity data, to be followed by top-line data with the booster dose by the end of this year. Read More
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alumis, Delta-Fly, Nanomerics, Praxis, Virpax. Read More
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. Read More
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. Read More
