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

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

Biosecure is Back! Sens. Hagerty, Peters trying to revive Biosecure Act as NDAA amendment. Their bill has been modified to address reasons it failed in '24 -- doesn't specify co's, has appeals process. 5 yr grandfather. biocentury.com/article/656707

Third death from a Sarepta gene therapy, patient was in phase 1 trial of limb-girdle muscular dystrophy Type 2. Cause was acute liver injury. Regulators, patient advocates have been informed. www.biocentury.com/article/656520

FDA’s @FDACBER “hiring many new people (lots of reviewers) to support our mission,” its director Vinay Prasad told staff. The hires will include former staff, he said. Prasad also urged staff to come to him w/safety concerns. More ($) www.biocentury.com/article/656389

Leaked memo on BIO strategy energizes anti-vaxxers. It describes BIO's investment in pro-vaccine comms, plans to engage on vaccine policy w/ conservatives in and outside Trump administration. Anti-vax groups claim BIO is plotting removal of RFK Jr. www.biocentury.com/article/656351

.@US_FDA's Makary, Prasad balance vows to speed reviews with industry criticism. Promise “massive” changes in biosimilars regulation and a new rolling submissions pathway, express support for Trump’s ‘most favored nation’ drug pricing policies. buff.ly/4ao452N

To safeguard sound decision-making at FDA, political interference must be kept out of product reviews, argue Phil Krause and Luciana Borio (@llborio ) in a BioCentury Guest Commentary buff.ly/2GoPU60

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. www.biocentury.com/article/655776

FDA Commissioner Makary said he was “shocked” to learn that non-voting industry reps are on advisory committees. Maybe he’s never watched one? Congress put them there – in 1997. Adcoms should be improved, but there are other places to start. www.biocentury.com/article/655684

The leaked Trump administration 2026 HHS budget is sickening. If enacted, it will destroy American science. NIH budget slashed by 40%. The 15% overhead for universities baked into law. Ill-conceived reorganization of NIH institutes.

The Continuing Crisis, Part XII: Behold RFK Jr.'s FDA | Science | AAAS www.science.org/content/blog...

HHS Sec talked to FDA about MKULTRA & Stanley Milgram’s obedience experiments (he got the details wrong), said deep state is real, capitalism inevitably turns to authoritarianism, FDA is pharma’s sock puppet. Msg seemed to be: disobey, inform on superiors. www.biocentury.com/article/655612

RFK Jr cited pseudo-science to justify holding up of Novavax COVID vaccine. He said single-antigen vaccines don’t protect against respiratory diseases. There are 2 FDA-approved sgl antigen vaccines for RSV. And data on Novavax solid, FDA reviewers said. www.biocentury.com/article/655591

Must read: How reductions in force and a planned reorganization of #FDA could dramatically reduce the agency's ability to perform essential functions -- from my colleague @steveusdin.bsky.social www.biocentury.com/article/655559

HHS has circulated an FDA reorganization plan to congressional offices that former FDA officials say is ‘nonsensical,’ unworkable. biocentury.com/article/655559

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. www.biocentury.com/article/655541

‘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. www.biocentury.com/article/655495

In the wake of the ousting of Peter Marks from FDA, I am re-posting the commentary I wrote the day President Trump announced his intention to nominate Robert F. Kennedy Jr. as HHS Secretary. www.biocentury.com/article/654203

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. www.biocentury.com/article/655455

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. www.biocentury.com/article/655428

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. www.biocentury.com/article/655391

Wuxi stocks bounce back as Biosecure threat fades Shares of Wuxi Apptec and Wuxi Biologics are closing in on pre-Biosecure levels. www.biocentury.com/article/655397

Interview w/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 ($): www.biocentury.com/article/655360

Review of my paper about Vladimir Pravdin, "“The Face of Soviet Espionage in the United States during the Stalin Era." networks.h-net.org/group/discus...

The Continuing Crisis, Part VI: Rare Diseases at the FDA and More | Science | AAAS www.science.org/content/blog...

A cry for help from FDA rare disease reviewers. Firings, politicization, denigration of civil servants and an impending back-to-office will cause exodus of experienced staff, lower quality, slower product reviews. Open access story w/free registration: www.biocentury.com/article/655243

A relentless six-week assault on the civil service, with more upheaval planned, has set off a “five-alarm fire for rare disease,” an FDA reviewer told BioCentury. www.biocentury.com/article/655243

The Trump administration hasn’t paid a price for undermining its promises to enforce strict conflict-of-interest policies. DOGE staff have financial interests in health agencies they police. Now, RFK Jr has decided to make a mockery of transparency vows. www.biocentury.com/article/655235

NIH 2025 summer internships cancelled. This really sucks. NIH internships have launched many scientific careers. At a time when the U.S. is discouraging foreign students, how can it make sense to kill a program that costs pennies and is critical to building homegrown scientists?

Bipartisan House bill (EPIC Act) introduced to extend IRA price negotiation window for small molecules to 13 years. Enacting it will be an uphill battle. www.biocentury.com/article/655185

Pres Trump reiterated demands for Rx drugs to cost less in U.S. than overseas, and for domestic drug mfg in meeting last week w/pharma CEOs. Pill penalty fix may not make it into reconciliation.https://www.biocentury.com/article/655181

5 things the Trump administration did to public health last week: Postponed CDC’s vaccine advisory committee meeting Postponed FDA-NIH Rare Disease Day Continued to block reviews of NIH grants Fired ARPA-H Dir. Renee Wegrzyn Told civil servants to list 5 things they did last week

Trump admin is defending the Medicare drug negotiation program in court w/same arguments Biden DOJ used to defeat challenges to the program. Trump DOJ's brief in Novartis case contradicts GOP claims it is unconstitutional. www.biocentury.com/article/655169

FDA, NIH postpone Rare Disease Day without explanation. The move comes a week after the agencies told advocates the event would be held as planned. Hundreds of families have made plans to travel to DC for a week of activities, the FDA/NIH event wld have been a highlight. www.fda.gov/news-events/...

CDC vaccine meeting postponement raises red flags Concerns mount that Trump's vaccine policies will harm public health, disincentivize vaccine R&D. RFK Jr reneging on promises to Cassidy? www.biocentury.com/article/655161

Interesting history website, Bunk history (www.bunkhistory.org). The Soviet/U.S. relations section includes a "Secrecy & Spies" category. www.bunkhistory.org/exhibits/us-...

PhRMA and BIO have prioritized maintaining cordial relations with Trump and RFK Jr over speaking out on FDA, NIH, CDC firings. AdvaMed is calling for reversing the cuts, warns of safety lapses, slowed reviews. www.biocentury.com/article/655131

Morale at @US_FDA 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. www.biocentury.com/article/655114

‘Valentine’s Day massacre’ degrades FDA's ability to regulate AI, personalized medicine. First wave of firings aimed at device regulators. More cuts coming. So far, FDA drug reviewers protected. www.biocentury.com/article/655114

Jay Bhattacharya, Trump’s NIH Director nominee wrote a paper published 1/30 that distorts data on COVID vaccines, calls for policies that would have sharply reduced access to vaccines during the worst days of the pandemic. Raises ?s about how he'll lead NIH. www.biocentury.com/article/655064

Ex-COVID ‘testing czar’ Brett Giroir rejoins HHS as unpaid adviser, will report to RFK Jr. Two weeks ago Giroir warned of RFK's reliance on "pseudoscience." www.biocentury.com/article/6550...

Vik Bajaj, Managing Dir Foresite Capital, interim President Xaira, discusses AI & predictive biology, present, future of AI/ machine learning to accelerate progress in life sciences. Podcast: open.spotify.com/episode/3Dk2... , www.youtube.com/watch?v=n_sC... Video: www.youtube.com/watch?v=jlRo...

Draft Exec Order wld halve FDA staffing, slash NIH, eliminate CDC. WH being warned of impact on public health, biopharma industry, science. OPM back to work starts at FDA March 17. www.biocentury.com/article/655011

“Silence implies tacit acceptance.” A call to defend science from Luke Evnin, chair, Scleroderma Research Foundation and co-founder of MPM Capital; Peter Rubin, No Patient Left Behind, Peter Kolchinsky, RA Capital. No paywall: www.biocentury.com/article/654982

ORPHAN Cures Act reintroduced, seeks to exempt drugs from #IRA price negotiations regardless of number of orphan indications. It could be incorporated into reconciliation legislation. www.biocentury.com/article/654985

The Trump administration's personnel policies could cripple FDA's ability to meet user fee goals for drug reviews and compromise its ability to keep pace with scientific advances. There is a narrow window to avert crisis. More: www.biocentury.com/article/654941

FDA Oncology Center of Excellence initiatives scrubbed from web: Project Community (engagement w/cancer patients), Project Silver (65+ partic in clin trials), Project Equity. DEIA (accessibility)staff to be fired. Clinical trials diversity policy in limbo. More: www.biocentury.com/article/654847

Trump’s communications freeze, DEI policies cld impact drug development. New validated trial endpoint delayed. Staff sidelined, trial diversity guidance pulled, OCE Project Equity shuttered. Ironically, DEI policies started under Trump's first admin. www.biocentury.com/article/654795