Steve Usdin

Credibility is earned by the drop and lost by the bucket. Makary is on the verge of kicking over the bucket. If he doesn't pull back from political review of Novavax vaccine, he'll be remembered as the commissioner who ruined FDA. https://t.co/ba3LmQY50c

RT @PearlF: Massive & poorly planned FDA layoffs are also expected to hit orphan drug development, narrow the accelerated approval pathway…

RT @BioCentury: Unless they are reversed, @US_FDA cuts will hit orphan drug development, narrow use of accelerated approval, and limit repu…

‘Pandemonium’ at FDA Peter Stein pushed out as head of OND; thousands of layoffs. Many staff received lay off notices at 5:15am. Those who didn't check emails arrived at work, can't enter bldgs, sitting in lobbies as colleagues retrieve belongings. https://t.co/zXVGsX1VuX

Long knives at FDA. In addition to mass layoffs, some senior staff were told given choice of demotion or quitting. Peter Stein,longtime director of CDER’s Office of New Drugs was demoted & quit. BioCentury story coming later today.

RT @BioCentury: Peter Marks’ ouster plunges @US_FDA into crisis. BioCentury's @SteveUsdin1 has the insights https://t.co/DNow41gsM7

RT @BioCentury: The two deputy directors of @US_FDA's Oncology Center of Excellence have resigned. The agency is losing decades of experien…

RT @BioCentury: Acting FDA Commissioner Brenner devised plan for cuts that could impair @US_FDA's ability to meet PDUFA goals, protect publ…

FDA has lost two of its most experienced, respected oncology drug reviewers. Paul Kluetz and Marc Theoret, both deputy directors of the Oncology Center of Excellence, announced their resignations from the agency this week. BiocCentury will publish a story tomorrow.

The Senate confirmed Makary, Bhattacharya, now the hard part starts. The FDA commissioner and NIH director are taking charge of agencies in crisis, rocked by arbitrary firings, slash-and-burn management. https://t.co/7URJn3TtOO

RT @BioCentury: Via @IamBiotech survey, biotech industry warns tariffs could have negative consequences for biomedical innovation, patients…

If Trump imposes planned 25% tariffs on pharmaceutical imports, drug companies would incur tens of billions of dollars in added costs. Consumers would face both higher prices and shortages of essential medicines. And it won't increase domestic mfg. https://t.co/vzWpp63wrk

Incoming FDA Commissioner Makary's job 1 will be plugging a brain drain caused by denigration of civil servants, revoked telework policies upending lives, concerns about political interference in regulatory decisions, uncertainty over job security. https://t.co/wNq4XOzewn

Wuxi stocks bounce back as Biosecure threat fades Shares of Wuxi Apptec and Wuxi Biologics are closing in on pre-Biosecure levels. https://t.co/cmIr0RAU2J

NIH seems to be preparing to curtail or abandon research involving mRNA vaccines. https://t.co/jU1FXeBRgX

Interview w/@Iambiotec BIO CEO John Crowley: MFN threat real, trying to head off pharma tariffs, Biosecure is dead, opty to reform FDA, ‘fix’ IRA, restore PRVs. More ($): https://t.co/VS391vJrzp

Facing a Friday deadline to avoid a shutdown, the Senate is considering a House bill passed that does omits reauthorization of pediatric PRVs, slashes funding for biomedical research, and gives RFK Jr authority a free hand to implement his agenda. https://t.co/te1f97bTyU