RFK Jr. Defends FDA Chief Amid Industry Backlash
RFK Jr. defends FDA, Makary following Republican questions - also defends the $REPL CRL: "Marty made the correct decision to not approve that drug. But everybody goes after him because the industry is so powerful." https://t.co/CuEeNFCYpp
FDA Pushes New
First autism, now low T - FDA continues to do its own literature searches and encourage sponsors to apply for new indications (never saw this in prior admins — with the exception of updating old cancer drug labels to include...
Former FDA Chief Urges Term Limits, Merit‑based Appointments
Former FDA cancer chief/CDER dir. Rick Pazdur told me earlier this week he's concerned w/political appointees injecting themselves into drug reviews - and that this might trickle down past this admin. He's calling for time limits on senior FDA positions...
REPL CEO Skips
$REPL CEO tells me they’re not going to appeal the 2nd CRL but will try to work with FDA - for now, commercial team/other layoffs, cash runway til Q1 of next year, stock price -75% from Fri https://t.co/FLAiOcAAQB
FDA Zeroes in on Houman Hemmati for CBER Lead
FDA narrows in on search for new biologics and vaccines leader - and we’re hearing @houmanhemmati is a top contender for CBER - https://t.co/qMx8wv32fG
FDA Reopens Mifepristone Safety Review Amid Court Pressure
FDA is working on another safety review of abortion drug mifepristone, after a Louisiana court order/pressure from @HawleyMO - FDA in 2021 said it did not find increases in adverse events after allowing remote prescribing https://t.co/FcznZ41p45
GSK’s Leucovorin
what a timeline - Sept. 1999 - $GSK withdraws Wellcovorin (leucovorin) bc it's not selling Sept. 2025 - GSK is told by FDA to apply for a new indication for leucovorin after an FDA review of lit. March 2026 - FDA approves...
Cash‑pay Market for $950 Humira Doubtful vs Cheap Biosimilars
Is there really a cash-pay market for a $950/month brand-name Humira? (...especially w/two adalimumab biosimilars priced at less than $300/mo. already on TrumpRx, and many insured folks paying $0-5/month) https://t.co/taeQUY6Rve
FDA Backs Permanent Re‑authorization of Pediatric PRV Program
FDA calls to permanently re-authorize the rare pediatric disease PRV program in Friday's 2027 budget plan -- far cry from the FDA that complained to the GAO about PRVs as distracting from their public health priorities https://t.co/i79F7X1ECw
FDA Commissioner Seeks Private Partnerships for Collaboration and Regulation
Couple interesting meetings for FDA Commissioner Makary: met with Arnold Ventures on Mar. 3 about "collaboration opportunities" https://t.co/vEyhDu5xaW and with $MNPR on "establishing a regulatory mechanism" on Mar. 13 https://t.co/DHaD6IlvCS
Prasad’s CBER Saw Frequent Overrules, Unlike Rest of FDA
caveat here is that it was routine when Prasad ran CBER (at least 4 overrules in Prasad's 10 mo. tenure) but it didn't/doesn't still seem to be happening elsewhere in FDA
CBER Updates SOPs, Enables RMAT for Held Therapies
CBER changes its standard operating procedures to open the door to RMAT designations for therapies on clinical hold - https://t.co/bZmhga8xxC
FDA Urges IRB Overhaul to Match China's 60‑day Trials
FDA commissioner Makary at a CMS conference today in Baltimore calls for “big and different” IRB reforms to catch China's speedy trial starts - pre-IND phase can run 380 days in the US, he said, while China is pushing for...
Linking U.S. Medicare Payments to Global Benchmarks Matters
CMS' CMMI dir. Abe Sutton at quality conf. in Baltimore today: "tying what we pay to what other countries pay across Medicare Part B, Medicare Part D and Medicaid really matters."
Sen. Markey Admits He Doesn
Sen. Markey (D-Mass.) tells me outside the Capitol he doesn’t know who Vinay Prasad is and would need to be briefed by staff to respond to questions on the FDA
