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 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

Senators are trying to revive the Biosecure Act Legislation modeled on the Biosecure Act has been introduced in the Senate as an amendment to a must-pass Defense appropriations bill. The measure, sponsor...

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 A third patient has died in a Sarepta gene therapy trial. A 51 year-old patient a Phase 1 study of SRP-9004 for Limb-Girdle muscular dystrophy Type 2E.Like...

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

CBER hiring ‘many’ reviewers, Prasad says Vinay Prasad, director of FDA’s Center for Biologics Evaluation and Research, outlined his leadership philosophy and hiring plans in a memo to staff...

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 vaccine skeptics Anti-vaccine advocates are portraying a leaked memo about BIO’s strategy for communicating about the safety and efficacy of vaccines as evidence tha...

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

Politics intrudes into Trump administration’s regulation of vaccines The Trump administration’s ambiguous and scientifically unsupported statements regarding the Novavax COVID-19 vaccine this weekend represent an unpr...

My story: With ambiguous and scientifically unsupported statements on the Novavax COVID vaccine HHS, FDA have allowed politics to override public health. The consequences won't be limited to vaccines. biocentury.com/article/655774

Safeguarding sound decision-making at FDA Recent delays and confusion surrounding the approval of Novavax’s updated COVID-19 vaccine offer a case study in how missteps at the political level...

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

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

Advisory panels need to be reformed — but not by barring industry voices: a Perspective FDA Commissioner Marty Makary’s announcement that industry representatives will be excluded from advisory committees will have more symbolic than pr...

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

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

Kennedy’s remarks intensify FDA morale crisis The morale crisis at FDA deepened Friday as HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors ov...

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

Former FDA officials call HHS plan for agency ‘nonsensical,’ unworkable The Department of Health and Human Services has developed a plan for reorganizing FDA. Former senior FDA officials told BioCentury the proposal is infeasib...

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

Former FDA officials call HHS plan for agency ‘nonsensical,’ unworkable The Department of Health and Human Services has developed a plan for reorganizing FDA. Former senior FDA officials told BioCentury the proposal is complete...

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

Makary facing key test: a Perspective Credibility is earned by the drop and lost by the bucket. FDA Commissioner Marty Makary is on the verge of kicking over the bucket. In his first days as co...

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 “It’s pandemonium here,” an FDA staffer told BioCentury Tuesday morning from the agency’s headquarters.FDA employees are findin...

‘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

Giving RFK Jr. control of HHS would be disastrous: an Editor’s Commentary The pharma CEOs, lobbyists and hedge fund managers who confidently reassured me and anyone who would listen that they had an inside track to Trumpland, and...

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.

Makary, Bhattacharya confirmed, now the hard part starts Senate confirmation of leaders for FDA and NIH marks an inflection point for agencies that have experienced an extraordinary level of turmoil over the past...

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

PhRMA, BIO fighting tariffs If President Donald Trump imposes planned 25% tariffs on pharmaceutical imports, drug companies would incur tens of billions of dollars in added costs, and...

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

Short window to halt FDA brain drain Marty Makary is on track for Senate confirmation as FDA commissioner as soon as next week, but he’ll have little time for celebration. His immediate...

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 A little more than a year after the introduction of the Biosecure Act, the legislation appears to be dead and shares of the two companies most impacted by ...

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

It’s been a year: BIO CEO Crowley’s plans for Trump 2.0 The last seven weeks in Washington have felt like a year; it seems like a lifetime has passed since last March, when John Crowley joined BIO as its preside...

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

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

Turmoil at FDA puts rare disease review capacity at risk 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 revi...

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

Turmoil at FDA puts rare disease review capacity at risk 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 revi...

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