BioCentury

6 days ago | biocentury.com | Steve Usdin

ARTICLE | Editor's CommentaryThe new FDA commissioner’s push to remove industry reps won’t get far, but it could further erode public trust By Steve Usdin, Washington EditorFDA Commissioner Marty Makary’s announcement that industry representatives will be excluded from advisory committees will have more symbolic than practical effects. That doesn’t mean the announcement is unimportant. In an era when trust in government and science are in short supply, symbols matter.

6 days ago | biocentury.com | Steve Usdin

ARTICLE | RegulationThe FDA commissioner said a new pathway will provide conditional approval based on a plausible mechanism of action in very rare diseases By Steve Usdin, Washington Editor FDA Commissioner Marty Makary has announced his intention to create a new pathway for drugs that treat ultrarare conditions. “We're going to be rolling out a new pathway for drugs, which is a pathway based on a plausible mechanism,” Makary said in an interview Thursday with Megyn Kelly....

6 days ago | biocentury.com | Paul Bonanos

ARTICLE | FinancePlus: Updates from Glycomine, Attovia, Thirtyfivebio, Heparegenix, Duality, Pelthos and Third Harmonic By Paul Bonanos, Director of Biopharma Intelligence, and Meredith Durkin Wolfe, Director of ResearchTwo biotech veterans have set up a new fund to give troubled biotechs a way to return cash to shareholders as they evaluate options such as selling, merging or winding down.

1 week ago | biocentury.com | Selina Koch

ARTICLE | Discovery & TranslationAlzheimer’s research joins list of NIH-funded projects disrupted by terminations, freezes By Selina Koch, Executive EditorAs it terminates NIH grants, the Trump administration has largely targeted politically charged areas such as DEI and COVID research. Yet Alzheimer’s disease research — with no direct ties to these issues — has also been swept up in the purge, with more such projects, in Alzheimer’s and other diseases, almost certain to follow.

1 week ago | biocentury.com | Steve Usdin

ARTICLE | Politics, Policy & LawTrump wants to eliminate the pill penalty — but he isn’t saying how. That presents challenges for industry By Steve Usdin, Washington EditorBiopharma lobbyists, who suffered an epic defeat when the Medicare drug price negotiation provisions were included in the Inflation Reduction Act, celebrated President Donald Trump’s call this week to modify the IRA by creating a level playing field for small molecules and biologics.