U.S. spending law a rebuke to proposed White House biomedical cuts. HHS budget law revives pediatric PRVs, increases PBM transparency, writes Washington Editor @steveusdin.bsky.social in BioCentury : biocentury.com/article/658296

Raising the sun: Japan biotech looks to level up: Can a country rich in Nobel winners and blockbuster drugs grow its biotech culture? I spoke with domestic and Western VCs and Japanese biotech executives to find out. Read the piece in BioCentury: www.biocentury.com/article/657543

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

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’s ‘Black Friday memo’ has broad implications for public health, vaccine manufacturers in BioCentury biocentury.com/article/657740

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

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

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

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 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

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 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

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 '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

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 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

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

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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

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

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

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

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

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: 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

#AACR25 Preview: Bispecific antibodies, targeted protein degraders are front and center at this year’s meeting, driving modality innovation, while post-translational sugar modifications are emerging as a focal point for new target discovery via BioCentury: www.biocentury.com/article/655676

Two key management moves at Galapagos: - CEO Paul Stoffels (ex-JNJ CSO) is retiring this year, but will remain chairman - Ex-Neumora CEO Henry Gosebruch will be CEO of the planned GLPG spinout Release: www.globenewswire.com/news-release... Background ($): www.biocentury.com/article/6546...

I just landed in San Salvador a little while ago, and I look forward to meeting with the team at the U.S. embassy to discuss the release of Mr. Abrego Garcia. I also hope to meet with Salvadoran officials and with Kilmar himself. He was illegally abducted and needs to come home.

Makary filling key #FDA spots with Capitol Hill alum Grace Graham, Washington lawyer Lowell Zeta, BioCentury's @steveusdin.bsky.social has learned. They'll join the agency's Office of the Commissioner

Shanghai ADC play Duality braved one of HK's worst downturns of past 20 yrs to stick its landing on the HKSE, offering hope to China biotechs that have been suffering through a multiyear financing drought. I took a closer look in today's BioCentury www.biocentury.com/article/655632

"Not exactly a pick-me-up" said my BioCentury pal Josh Berlin about this week's BioCentury This Week biotech podcast! But trust him, it's the stuff you know you need to know about what's happening at FDA -- and to the XBI: www.biocentury.com/article/655488

Just after biotech started to see some green shoots, we're back in a bear market. $XBI cratering in the wake of Peter Marks departure from FDA, looming tariff threat. #FAFO

here's a short window left to halt the brain drain at FDA,says BioCentury's @steveusdin.bsky.social Senior managers, office directors, and reviewers with decades of experience have accepted or plan to accept buyout offers. Anxiety is high in White Oaks. www.biocentury.com/article/655391

Shares of WuXi AppTec and WuXi Biologics are closing in on pre-Biosecure Act levels now that the legislation that sought to rein in China CDMOs and genomics companies appears to have faded away. Read my latest in BioCentury: www.biocentury.com/article/655397

Congress is considering a House bill that would eliminate a huge incentive for pediatric drug development, slash funding for innovative biomedical research & give RFK Jr. authority to implement his agenda w/o Congressional consent, writes @steveusdin.bsky.social www.biocentury.com/article/655338

My latest on the #Zealand and #Roche deal for amylin agonist pretrelintide: www.biocentury.com/article/655330

RFK Jr. Vows To Make Measles Deaths So Common They Won’t Be Upsetting Anymore

Morale at FDA is sinking as news of firings, dubbed a Valentine’s Day massacre by agency staff, started ricocheting from Reddit threads and social media posts to group text chats and phone calls Friday evening, writes @steveusdin.bsky.social www.biocentury.com/article/655114

Here is the pre-RFK vaccination schedule for your kids. Please download it before he is confirmed and changes/deletes it. Give it to your pediatrician and say this is the schedule you want your kids on. Making this my pinned post.

Also, while the FDA of the next 4 yrs may not care, the FDA of the future may care once more. And how many pivotal trials being started now will have a PDUFA date within 4 years? Probably not the vast majority

Especially shocking because diversity of clinical trials is squarely a scientific necessity if the results are to be representative of and generalizable to the broader population. It's bad science to test a candidate medicine in a non-representative population.

DISEASES ERADICATED OR DECIMATED BY SCIENCE: 1. Chickenpox 2. Diphtheria 3. Measles 4. Pertussis 5. Pneumococcal Infection 6. Polio 7. Tetanus 8. Typhoid 9. Yellow Fever 10. Smallpox DISEASES ERADICATED OR DECIMATED BY RFK JR. OR PRAYER: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Imagine if @aoc @sanders.senate.gov , every dem, SIMULTANEOUSLY held Town Halls where they allowed grant and contract recipients to explain to the country what it is they do and why it's important Invite all media. Including RW podcasters. @spaces Flood the zone Call it a Day Of Transparency

BREAKING: In response to doctors' lawsuit, Judge John Bates, a George W. Bush appointee, orders CDC, NIH, and FDA to put back up websites and datasets cited by the doctors in their lawsuit as having been relied upon and pulled down without notice. storage.courtlistener.com/recap/gov.us...