Reposted by @steveusdin.bsky.socialJeff Cranmer @jcranmer.bsky.social · 07/10/2025Peter 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 001
Reposted by @steveusdin.bsky.socialJeff Cranmer @jcranmer.bsky.social · 12/09/2025House 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/656978biocentury.comHouse passes bill that would end most U.S.-China academic research collaborationsLast 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... 001
steveusdin.bsky.social @steveusdin.bsky.social · 09/08/2025Biosecure 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/656707biocentury.comSenators are trying to revive the Biosecure ActLegislation modeled on the Biosecure Act has been introduced in the Senate as an amendment to a must-pass Defense appropriations bill. The measure, sponsor... 010
steveusdin.bsky.social @steveusdin.bsky.social · 18/07/2025Third 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/656520biocentury.comThird death from a Sarepta gene therapyA 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... 010
steveusdin.bsky.social @steveusdin.bsky.social · 08/07/2025FDA’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/656389biocentury.comCBER hiring ‘many’ reviewers, Prasad saysVinay Prasad, director of FDA’s Center for Biologics Evaluation and Research, outlined his leadership philosophy and hiring plans in a memo to staff... 020
steveusdin.bsky.social @steveusdin.bsky.social · 02/07/2025Leaked 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/656351biocentury.comLeaked memo on BIO strategy energizes vaccine skepticsAnti-vaccine advocates are portraying a leaked memo about BIO’s strategy for communicating about the safety and efficacy of vaccines as evidence tha... 010
steveusdin.bsky.social @steveusdin.bsky.social · 12/06/2025.@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/4ao452Nbuff.ly 110
steveusdin.bsky.social @steveusdin.bsky.social · 29/04/2025To 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/2GoPU60buff.lySafeguarding sound decision-making at FDARecent delays and confusion surrounding the approval of Novavax’s updated COVID-19 vaccine offer a case study in how missteps at the political level... 294
steveusdin.bsky.social @steveusdin.bsky.social · 29/04/2025FDA 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/655776biocentury.comFDA misses PDUFA goal for Stealth’s Barth syndrome treatmentFDA has missed another PDUFA review deadline, this time for a treatment that a small biotech is developing for an ultrarare disease. Stealth Biotherapeutic... 022
steveusdin.bsky.social @steveusdin.bsky.social · 19/04/2025FDA 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/655684biocentury.comAdvisory panels need to be reformed — but not by barring industry voices: a PerspectiveFDA Commissioner Marty Makary’s announcement that industry representatives will be excluded from advisory committees will have more symbolic than pr... 020
steveusdin.bsky.social @steveusdin.bsky.social · 17/04/2025The 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. 0354
steveusdin.bsky.social @steveusdin.bsky.social · 14/04/2025The Continuing Crisis, Part XII: Behold RFK Jr.'s FDA | Science | AAAS www.science.org/content/blog...science.orgThe Continuing Crisis, Part XII: Behold RFK Jr.'s FDA 010
steveusdin.bsky.social @steveusdin.bsky.social · 12/04/2025HHS 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/655612biocentury.comKennedy’s remarks intensify FDA morale crisisThe morale crisis at FDA deepened Friday as HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to report supervisors ov... 010
steveusdin.bsky.social @steveusdin.bsky.social · 10/04/2025RFK 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 264
Reposted by @steveusdin.bsky.socialStephen Hansen @stephenhansen.bsky.social · 08/04/2025Must 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/655559biocentury.comFormer FDA officials call HHS plan for agency ‘nonsensical,’ unworkableThe Department of Health and Human Services has developed a plan for reorganizing FDA. Former senior FDA officials told BioCentury the proposal is infeasib... 012
steveusdin.bsky.social @steveusdin.bsky.social · 07/04/2025HHS has circulated an FDA reorganization plan to congressional offices that former FDA officials say is ‘nonsensical,’ unworkable. biocentury.com/article/655559biocentury.comFormer FDA officials call HHS plan for agency ‘nonsensical,’ unworkableThe Department of Health and Human Services has developed a plan for reorganizing FDA. Former senior FDA officials told BioCentury the proposal is complete... 010
steveusdin.bsky.social @steveusdin.bsky.social · 05/04/2025Credibility 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/655541biocentury.comMakary facing key test: a PerspectiveCredibility 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... 132
steveusdin.bsky.social @steveusdin.bsky.social · 01/04/2025‘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/655495biocentury.com‘Pandemonium’ at FDA“It’s pandemonium here,” an FDA staffer told BioCentury Tuesday morning from the agency’s headquarters.FDA employees are findin... 010
steveusdin.bsky.social @steveusdin.bsky.social · 30/03/2025In 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/654203biocentury.comGiving RFK Jr. control of HHS would be disastrous: an Editor’s CommentaryThe 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... 040
steveusdin.bsky.social @steveusdin.bsky.social · 27/03/2025FDA 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. 59928
steveusdin.bsky.social @steveusdin.bsky.social · 27/03/2025The 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/655455biocentury.comMakary, Bhattacharya confirmed, now the hard part startsSenate confirmation of leaders for FDA and NIH marks an inflection point for agencies that have experienced an extraordinary level of turmoil over the past... 020
steveusdin.bsky.social @steveusdin.bsky.social · 22/03/2025If 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/655428biocentury.comPhRMA, BIO fighting tariffsIf President Donald Trump imposes planned 25% tariffs on pharmaceutical imports, drug companies would incur tens of billions of dollars in added costs, and... 010
steveusdin.bsky.social @steveusdin.bsky.social · 19/03/2025Incoming 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/655391biocentury.comShort window to halt FDA brain drainMarty 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... 021
steveusdin.bsky.social @steveusdin.bsky.social · 19/03/2025Wuxi 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/655397biocentury.comWuxi stocks bounce back as Biosecure threat fadesA 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 ... 000
steveusdin.bsky.social @steveusdin.bsky.social · 16/03/2025Interview 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/655360biocentury.comIt’s been a year: BIO CEO Crowley’s plans for Trump 2.0The 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... 010
steveusdin.bsky.social @steveusdin.bsky.social · 11/03/2025Review 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...networks.h-net.orgH-Diplo Article Review 1234: Bain on Usdin, "The Face of Soviet Espionage" | H-NetH-Diplo Article Review 1234Steven Usdin, “The Face of Soviet Espionage in the United States during the Stalin Era: Vladimir Pravdin, ‘Man of Truth.’” Journal of Cold War Studies 26:2 (Spring 2024): 78... 010
steveusdin.bsky.social @steveusdin.bsky.social · 06/03/2025The Continuing Crisis, Part VI: Rare Diseases at the FDA and More | Science | AAAS www.science.org/content/blog...science.orgThe Continuing Crisis, Part VI: Rare Diseases at the FDA and More 020
steveusdin.bsky.social @steveusdin.bsky.social · 04/03/2025A 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/655243biocentury.comTurmoil at FDA puts rare disease review capacity at riskA 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... 020
steveusdin.bsky.social @steveusdin.bsky.social · 04/03/2025A 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/655243biocentury.comTurmoil at FDA puts rare disease review capacity at riskA 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... 000
steveusdin.bsky.social @steveusdin.bsky.social · 01/03/2025The 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/655235biocentury.comHHS, DOGE make a mockery of transparency, COI pledges — a PerspectiveThe Trump administration hasn’t paid a price for undermining its promises to enforce strict conflict-of-interest policies. Now, it has decided to ma... 010
steveusdin.bsky.social @steveusdin.bsky.social · 28/02/2025NIH 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? 020
steveusdin.bsky.social @steveusdin.bsky.social · 25/02/2025Bipartisan 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/655185biocentury.comTough path for pill penalty fixThe attempt to mitigate the IRA’s disincentive to invest in small molecule drugs took a small step forward Tuesday with the introduction in the Hous... 011
steveusdin.bsky.social @steveusdin.bsky.social · 25/02/2025Pres 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 000
steveusdin.bsky.social @steveusdin.bsky.social · 25/02/20255 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 010
steveusdin.bsky.social @steveusdin.bsky.social · 22/02/2025Trump 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/655169biocentury.comTrump administration echoes Biden’s defense of IRA drug programThe Trump administration is defending the Medicare drug negotiation program in court, using the same legal arguments the Biden administration employed to d... 010
steveusdin.bsky.social @steveusdin.bsky.social · 22/02/2025FDA, 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/...fda.govPOSTPONED - FDA-NIH Rare Disease DayFDA-NIH Rare Disease Day 2025 Information 2129
steveusdin.bsky.social @steveusdin.bsky.social · 21/02/2025CDC 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/655161biocentury.comCDC vaccine meeting postponement raises red flagsThe Trump administration’s decision to postpone a CDC vaccines advisory committee meeting intensifies concerns that HHS Secretary Robert F. Kennedy ... 020
steveusdin.bsky.social @steveusdin.bsky.social · 20/02/2025Interesting history website, Bunk history (www.bunkhistory.org). The Soviet/U.S. relations section includes a "Secrecy & Spies" category. www.bunkhistory.org/exhibits/us-...bunkhistory.orgThe Soviets and USIn the second half of the 20th century, the relationship between the United States and the Soviet Union structured life for many hundreds of millions of people — not only in those two nations but also... 000
steveusdin.bsky.social @steveusdin.bsky.social · 19/02/2025PhRMA 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/655131biocentury.comPrioritizing relationship with Trump, Kennedy, BIO, PhRMA do not protest firingsPharmaceutical and biotech industry associations, which have embraced the Trump administration, have avoided criticizing the recent mass firings at governm... 110
steveusdin.bsky.social @steveusdin.bsky.social · 18/02/2025Morale 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/655114biocentury.comFirst round of cuts torpedos FDA morale, more firings expectedMorale at FDA is sinking as news of firings, dubbed a Valentine’s Day massacre by agency staff, started ricocheting from Reddit threads and social m... 110
steveusdin.bsky.social @steveusdin.bsky.social · 18/02/2025‘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/655114biocentury.comFirst round of cuts torpedos FDA morale, more firings expectedMorale at FDA is sinking as news of firings, dubbed a Valentine’s Day massacre by agency staff, started ricocheting from Reddit threads and social m... 136
steveusdin.bsky.social @steveusdin.bsky.social · 13/02/2025Jay 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/655064biocentury.comPaper raises concerns about NIH director nominee’s scientific judgment: an Editor’s CommentaryA new paper co-authored by Jay Bhattacharya, President Donald Trump’s nominee for NIH director, distorts data on mRNA COVID-19 vaccine efficacy and ... 011
steveusdin.bsky.social @steveusdin.bsky.social · 13/02/2025Ex-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...biocentury.comEx-COVID ‘testing czar’ Giroir rejoins HHSBrett Giroir, who served in public health leadership positions in the first Trump administration, has joined the Office of the HHS Secretary on a temporary... 130
steveusdin.bsky.social @steveusdin.bsky.social · 09/02/2025Vik 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...open.spotify.comEp. 77 - AI’s Next Leap: Foresite Labs’ Vik Bajaj on Predictive BiologyThe BioCentury Show · Episode 000
steveusdin.bsky.social @steveusdin.bsky.social · 07/02/2025Draft 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/655011biocentury.comWhite House plans to slash FDA, NIH would decimate agenciesWhite House plans to slash FDA and NIH and eliminate CDC could create lasting damage to public health, sink share prices of biotech and pharmaceutical comp... 1010175
steveusdin.bsky.social @steveusdin.bsky.social · 06/02/2025“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/654982biocentury.comCall to action: Defending the NIH, the NSF and the foundation of American science — a Guest CommentaryWhether you consider yourself a patient advocate, investor, innovator, health provider or payer of healthcare services, now is the time to stand up for the... 074
steveusdin.bsky.social @steveusdin.bsky.social · 06/02/2025ORPHAN 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/654985biocentury.comBill expanding IRA orphan exemption introducedLegislation seeking to expand the Medicare drug negotiation program’s orphan drug exemption was introduced in the House of Representatives Tuesday. ... 010
steveusdin.bsky.social @steveusdin.bsky.social · 04/02/2025The 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/654941biocentury.comDownsizing could cause FDA to miss PDUFA goalsCurrent and former FDA officials warn that Trump administration personnel policies could cripple the agency’s ability to meet user fee goals for dru... 010
steveusdin.bsky.social @steveusdin.bsky.social · 28/01/2025FDA 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/654847biocentury.comFDA clinical trial diversity policies in limboThe Trump administration’s campaign against diversity, equity, inclusion and accessibility programs continues to impact FDA and generate uncertainty... 000
steveusdin.bsky.social @steveusdin.bsky.social · 23/01/2025Trump’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/654795biocentury.comTrump’s communications freeze, DEI policies could impact drug developmentFour days into the new administration, FDA’s operations and morale have begun to be affected by a communications freeze imposed by HHS and by new po... 000
