Jeff Cranmer

12 former FDA commissioners sound alarm over FDA vaccine policies A dozen former FDA commissioners have sounded the alarm about radical changes to vaccine policy announced in an internal memo last week by CBER Director Vi...

Ex-FDA commissioners sound alarm on radical changes to vaccine policy by CBER Director Prasad. They have accused current FDA leadership of threatening the integrity and effectiveness of U.S. vaccine regulation. @steveusdin.bsky.social www.biocentury.com/article/657756

Prasad’s memo, Makary’s vouchers trigger Pazdur’s exit from FDA Richard Pazdur’s decision to resign as CDER director and retire from FDA was precipitated by a memo CBER Director Vinay Prasad sent to his staff Fri...

Richard Pazdur’s decision to resign as CDER director and retire from FDA was precipitated by a memo CBER Director Vinay Prasad sent to his staff Friday.

Washington Editor Steve Usdin has the inside story in BioCentury: www.biocentury.com/article/657751

FDA’s Vinay Prasad, in his own words CBER Director Vinay Prasad announced radial changes to FDA’s regulatory framework for vaccines in a memo sent to FDA staff on Friday, Nov. 28. As Bi...

FDA's Vinay Prasad, in his own words -- CBER director’s ‘Black Friday memo’ has broad implications for public health, vaccine manufacturers in BioCentury
biocentury.com/article/657740

China biopharma — enter the Oktagon China observers call it the world’s “toughest fitness center.” Get fit here, they say, and you can take on any challenge globally.I li...

In a BioCentury Guest Column, McKinsey alum Franck Le Deu asks, will the world's toughest arena for drug innovation go the way of EVs? & asks MNCs: Are you ready to enter the China Oktagon? Can you afford not to? Read now in front of BioCentury's paywall: www.biocentury.com/article/657621

In his own words: Pazdur’s letter to CDER staff On his first day as director of FDA’s Center for Drug Evaluation and Research, Richard Pazdur sent a letter to staff articulating his management phi...

Richard Pazdur letter to FDA CDER staff details his management philosophy: “I will do my best to open doors for you. Let’s walk through those doorways together.” Read Pazdur's letter in full in BioCentury: www.biocentury.com/article/657570

Pazdur takes CDER job after Kennedy pledges to shield center from political pressure In a stunning reversal, Richard Pazdur, who turned down the job last week, has agreed to serve as director of FDA’s Center for Drug Evaluation and R...

Rick Pazdur takes FDA's CDER job after Kennedy pledges to shield center from political pressure. Washington Editor @steveusdin.bsky.social Usdin explores how Pazdur's past regulatory innovations and policies may read through to the new look FDA in BioCentury: www.biocentury.com/article/657564

With second deal, MFN comes into focus With a second “most favored nation” pricing deal, elements of the Trump administration’s drug pricing strategy came into focus last we...

w/2nd MFN deal, Trump admin's drug pricing strategy coming into focus, but many critical parameters remain murky. The biggest unanswered Q: whether the deals are end or beginning of admin's attempts to remake the U.S. pharma market. via @steveusdin.bsky.social www.biocentury.com/article/657266

Senate passes Biosecure legislation The Senate passed the Biosecure Act Thursday evening as an amendment to the National Defense Authorization Act. Although the amendment was not included in ...

Senate passed Biosecure Act Thursday evening as amendment to the National Defense Authorization Act. It's not in House version, but BioCentury's @steveusdin.bsky.social says it's likely to be included in the final version that President Trump will sign by year-end: biocentury.com/article/657251

David Baltimore’s enduring legacy: Remembering ‘a giant of science’ Molecular biologist David Baltimore, a Nobel laureate whose work bridged the worlds of science, medicine and public health, embodied the values that made U...

The biotech industry lost a giant last month, when David Baltimore passed away. I spoke to some of his closest friends and colleagues and wrote this remembrance (in front of our paywall).

David Baltimore's enduring legacy: Remembering 'a giant of science’: www.biocentury.com/article/656970

Peter Marks has joined Eli Lilly as SVP for molecule discovery and head of infectious diseases, marking his return to industry after nearly a decade at FDA, per BioCentury's @steveusdin.bsky.social

Seeing opportunities among headwinds, TCG X closes $1.3B third fund Despite headwinds facing the biotech industry, TCG Crossover’s Chen Yu believes the firm will deploy its new $1.3 billion fund during “a...

Seeing opportunities among headwinds, TCG X closes $1.3B 3rd fund: BioCentury's @biobonanos.bsky.social speaks with Chen Yu, who sees attractive valuations in private and public equities that could turn into strong returns and draw LPs back into biotech. www.biocentury.com/article/657171

By pursuing a personal agenda, Tidmarsh risks losing public trust: A Perspective George Tidmarsh, director of FDA’s Center for Drug Evaluation and Research, argues FDA should be run like a biotech company, but a biotech CEO who p...

Tidmarsh seems 2 be pursuing a personal agenda at FDA, with LI posts like the 1 that drove $AUPH down 16%. Under previous administrations, a CDER director who behaved this way would have been ordered to pack up and leave, writes BioCentury's @steveusdin.bsky.social www.biocentury.com/article/657149

CMS to propose MFN pricing benchmark model The Trump administration is laying the groundwork for an international reference pricing, or “most favored nation,” system for innovative med...

CMS to propose 'most favored nation' pricing benchmark model. White House reviewing proposed international reference pricing model. Scoop via my BioCentury colleague @steveusdin.bsky.social www.biocentury.com/article/657090

Gottlieb warns against restricting in-licensing drugs from China Former FDA Commissioner Scott Gottlieb warned Friday that restrictions on in-licensing medicines from China could trigger an international IP “arms ...

Former FDA Commish, current NEA Partner Scott Gottlieb warns U.S. against restricting in-licensing drugs from China, saying restrictions could spark 'IP arms race' that would hurt U.S. patients, industry, writes BioCentury Washington Editor @steveusdin.bsky.social: www.biocentury.com/article/657051

$LBRX's IPO 1st to raise >$25M by a pure-play biopharma on
NASDAQ since $AARD in February & at $285M it's 2nd largest of '25 after $MTSR. LB finishes the day up 12%. Another win for CEO Heather Turner, who captained Carmot through its takeout by Roche

House passes bill that would end most U.S.-China academic research collaborations Last week, Cell published a study by researchers at the National Cancer Institute and Chinese universities who analyzed 90 datasets from 8,575 tumors to i...

House passes bill seeking to end most U.S.-China academic research collabs. @steveusdin.bsky.social says like Biosecure, the SAFE Research Act is part of a trend in DC to re-define nat security to include basic, applied research on topics such as cancer www.biocentury.com/article/656978

@giger1964.bsky.social

How Tallon plans to make MHRA a pillar of U.K. life sciences competitiveness The U.K. government will have to find common ground with pharmas on reimbursement if it wants to win the competition for life sciences investments. Fortuna...

U.K. nds to find common ground with pharma on reimbursement if it wants to win the comp for life sciences investments. Fortunately for
MHRA CEO Tallon creating a world-class reg environment is less contentious. via BioCentury's @steveusdin.bsky.social www.biocentury.com/article/656960

👇🏽

A leaked memo on BIO's strategy is energizing anti-vaxxers, writes BioCentury's @steveusdin.bsky.social. The document describes BIO's investment in pro-vaccine communications, plans to engage with conservatives in and outside the Trump administration

Amarin, Merck alum Karim Mikhail emerges as possible head of FDA’s CDER, reports @steveusdin.bsky.social

Industry races to counter Trump MFN threat Biopharma leaders view President Donald Trump’s push for “most favored nation” drug pricing as a serious, urgent threat. While there i...

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 @steveusdin.bsky.social in BioCentury www.biocentury.com/article/656077

Stealth CRL raises questions about FDA’s implementation of rare disease policies FDA has issued a complete response letter for elamipretide, sending patients with Barth syndrome, along with the drug’s developer, Stealth Biotherap...

Setback for Stealth raises questions about FDA’s implementation of rare disease policies. The biotech’s regulatory odyssey in Barth syndrome exemplifies the problems Makary has vowed to fix. @steveusdin.bsky.social Usdin takes a closer look in BioCentury: www.biocentury.com/article/656066

In biggest licensing deal yet for a China asset, Pfizer takes rights to 3SBio’s bispecific In the latest and largest deal between a China-based biotech and a larger biopharma for a bispecific with broad potential in oncology, Pfizer is paying 3SB...

Biggest licensing deal yet for a China biotech asset-PFE taking rights to 3SBio bispecific-is also tied for 3rd largest asset deal ever in biotech.

This latest deal in the PD-(L)1 x VEGF space has PFE paying $1.25B u/f. Here's @biobonanos.bsky.social take www.biocentury.com/article/655979

FDA misses PDUFA goal for Stealth’s Barth syndrome treatment FDA has missed another PDUFA review deadline, this time for a treatment that a small biotech is developing for an ultrarare disease. Stealth Biotherapeutic...

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

Dear Canada-
Please accept our deepest apologies from all decent Americans embarrassed by the obnoxious trolling from our man-baby-in-chief who is lacking in both intelligence & any impulse-control whatsoever.

❤️ from your neighbors below, 🇺🇸

#MakeAmericaNormalAgain

And now, a note on Bill Owens who, until this past week, was the executive producer of 60 Minutes.

We’ll be back next week with another edition of 60 Minutes.

At last, a biotech buy that crosses $1B

Eight-year-run for Pfizer spinout Springworks culminates in Merck KGaA buyout The takeout of Springworks by Merck KGaA will fortify the German company’s oncology business with a pair of approved drugs for rare tumors, while al...

A few words on this morning's Merck KGaA/SpringWorks deal: Two rare tumor treatments, a takeout consummated after months of rumors, and relief from an M&A drought: www.biocentury.com/article/6557...

Hong Kong exchange seizes the moment: a Perspective Growing momentum at the Hong Kong stock exchange and chaotic policies from the White House may upend the longstanding IPO calculus for Asia’s biotec...

Hong Kong exchange seizes the moment: Growing momentum at the Hong Kong stock exchange and chaotic policies from the White House may upend the longstanding IPO calculus for Asia’s biotechs. Here's my take in BioCentury: www.biocentury.com/article/655670