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. “We really are very satisfied that with a strong partner on board, we can unfold the potential of Gubamy. It really can accelerate development to the market,” said Henrik Blou, CEO of Gubra.

Lexicon hails Progress in neuropathic pain despite stock sag

Executives of Lexicon Pharmaceuticals Inc. said findings from the phase IIb Progress study testing pilavapadin in adults with moderate to severe diabetic peripheral neuropathic pain hit all of the company’s objectives, clearly identifying an effective dosing regimen of the oral, non-opioid candidate to move into phase III development. Investors, however, seemed focused on the trial’s primary endpoint, which measured a dose-response signal using the mean average daily pain score across all treatment arms vs. placebo and fell short of statistical significance, sending shares of Lexicon (NASDAQ:LXRX) down 49% at midday trading.

NIH changes set industry up for dearth of workforce, ideas

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.” They are – but not voluntarily, and not in the way Biden envisioned. The NIH has laid off more than 1,000 employees since January, and further layoffs as well as budget cuts are coming down the pike.

Pallone, DeGette push back on FDA, other HHS dismissals

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. Some of those at the FDA who were terminated, and in some instances rehired, were reviewers tracking a premarket application by Neuralink Corp., a company owned by Elon Musk, the White House adviser who is taking part in the Trump administration’s effort to trim the size of the federal workforce.

Vaxcyte PCV data due soon; Pfizer face-off ahead?

Excitement is growing around Vaxcyte Inc.’s planned readout of phase II infant data by the end of this quarter with VAX-24, the 24-valent pneumococcal conjugate vaccine. 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. Leerink analyst David Risinger said in a Feb. 10 report that he expects positive findings and predicts the trial will show non-inferiority to Pfizer Inc.’s Prevnar 20, first approved by the U.S. FDA in June 2021 for subjects 18 and older. Clearance for infants and children followed in April 2023.

US PTO peels back 2022 memo on discretionary denials of IPRs

The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews (IPRs). The effect of this decision is to grant the Patent Trial and Appeal Board broader discretion in denying institution of IPRs when parallel litigation is in play, the result of which may be to force litigants to rely more heavily on district court litigation to settle their disputes.

Also in the news

Abbvie, ALK, Alumis, Astrazeneca, Bioarctic, Biond, Bridgebio, Delta-Fly, Eisai, Eli Lilly, Garuda, Immunitybio, Innocan, Johnson & Johnson, Krystal, Mustang, Novartis, Nxera, Outlook, Ovid, Pacira, Praxis, Regeneron, Roche, Sanofi, Sciclone, Sparingvision, Vertex, Virpax