FDA misses PDUFA goal for Stealth’s Barth syndrome treatment It isn’t clear whether staffing cuts or loss of FDA champions have caused FDA to miss the PDUFA goal for an ultrarare disease therapy. biocentury.com/article/655776

Another missed deadline by RFK Jr. & Makary's U.S. FDA -- this time for a treatment for a very rare disease: biocentury.com/article/655776

The biggest licensing deal yet for a China biotech asset -- @Pfizer taking rights to a 3SBio bispecific -- is also tied for 3rd largest biotech asset deal ever. The deal for a PD-(L)1 x VEGF has $PFE paying $1.25B u/f Here's Paul Bonanos in @biocentury biocentury.com/article/655979

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Setback for Stealth raises questions about U.S. FDA’s implementation of rare disease policies. The biotech’s regulatory odyssey in Barth syndrome exemplifies the problems Makary has vowed to fix. via @SteveUsdin1 in BioCentury biocentury.com/article/656066

The biopharma industry is racing to counter the Trump MFN threat: With White House demanding 85% across-the-board drug price cuts, the biopharma industry hopes to avoid catastrophic policies via alternative concessions, writes BioCentury's steve usdin biocentury.com/article/656077

Amarin, Merck alum Karim Mikhail emerges as possible head of U.S. FDA’s CDER, reports BioCentury's steve usdin

hmm the possible next head of CDER. A marketing and management degree vs the acting head dr corrigan-coray

A leaked memo on Biotechnology Innovation Organization strategy is energizing anti-vaxxers, writes BioCentury's steve usdin. Document describes BIO's investment in pro-vaccine communications, plans to engage with conservatives in and outside the Trump administration biocentury.com/article/656351

First clinical evidence spurs Sanofi takeout of @Medicxi best in class vax play Vicebio for $1.15B up front. via Paul Bonanos: biocentury.com/article/656546

Always knew Ozzy had a sweet tooth but thought it was for the leaf. h/t Paul Bonanos

Leads Biolabs' offering is the 16th biotech IPO on an East Asian exchange this year, 9 of which have been on the HKSE. 7 of those nine have come since mid-April. That compares with 11 biotech IPOs on NASDAQ in 2025.

Sunday's deal between GSK and Hengrui for up to 12 assets is 1 of the clearest signs yet that cross-border, East-West deals have been undergoing a foundational shift. Josh Berlin and I take a look at why this deal is so important in BioCentury: biocentury.com/article/656602

Prasad's ouster from U.S. FDA raises prospect of CBER reset: Uncertainty fueled by ideology, politics is increasing, but when dust settles industry and advocates may be happier, says steve usdin in BioCentury: biocentury.com/article/656627

Prasad’s downfall signals a shift to libertarian regulation: The challenge for industry and patients is to couple misplaced enthusiasm for right-to-try with science-based approaches to generating evidence. A Perspective from BioCentury's steve usdin: biocentury.com/article/656645

I knew it! Dan for Warwick was right.

It will take U.S. FDA 24 mo to review data from 12 #BarthSyndrome pts. StealthBT doesn’t know if it can stay in business that long. Will another patient group be able to sway Donald J. Trump's #FDA to make good on rare dis. promises? steve usdin reports: biocentury.com/article/656691

Just when u thought it was safe to go back in the water - it's baaack. Sens. reviving Biosecure via an amendment in must-pass Defense bill that seeks disengagement with Chinese biotechs, attempts to address concerns that killed Biosecure. via steve usdin biocentury.com/article/656707

After delays & an about-face on reconsidering a CRL, U.S. FDA will now conduct exceptionally quick review of Stealth BioTherapeutics' treatment for #Barthsyndrome. Does the move signal the agency's changing stance on rare disease therapies? via Paul Bonanos biocentury.com/article/656827