FDA Launches RWE Initiative to Repurpose Drugs for Unmet Needs
Standing-room only session at DIA - FDA on RWE submissions - new initiative coming on using RWE to repurpose drug candidates for unmet medical needs https://t.co/1FaQOHDtkq
FDA to Preserve Makary's Trial and China Priorities
As the jostling over PDUFA VIII riders takes shape, the FDA plans to keep former commissioner Makary's priorities on trials, China, deputy says - https://t.co/55YPdcirm9
FDA Demands Extra Run, Threatens Grace Science’s Gene Therapy
Grace Science (co-founded by Carolyn Bertozzi) is running out of cash and says the FDA didn't let them use the "plausible mechanism" pathway bc, although they're developing an ultra-rare gene therapy, it's not an n-of-1 therapy. The FDA is also...
Makary's 'America First' Provisions Reach White House Review
Makary's 'America First' provisions did make it into the PDUFA VIII user fee draft deal (expected to be made public in July or August) and it's now under review at the White House https://t.co/64GUDv9kmA
FDA Withholds Company Names Unlike Other CNPVs
why is the FDA not releasing the company names? They did for every other CNPV...
Pharma-Backed Petition Urges FDA to Overhaul Rejection Letters
New Pharma-backed petition calls on FDA to reform how it releases drug rejection letters, says current process is unlawful - https://t.co/XLwCxt1FY6
Trump’s “Most‑favored‑nation” Deals Don’t Ensure Cheapest U.S. Drug
One lie worth refuting that @RobertKennedyJr keeps repeating across hours of testimony before Congress from the last week (final Senate Finance/HELP day today): The "most-favored nation" drug pricing deals that Trump crafted with 16 cos. DO NOT by any means guarantee...
RFK Jr
RFK Jr. says China is 'eating our lunch' in biotech advances - but said Makary’s actions so far have been sufficient - also pledged support for Trump’s CDC nominee https://t.co/LMh0dShbYz
RFK Denies Trump Sidelining, Confirms Team Vetted CDC Nominee
RFK says today at @HouseCommerce hearing that it's not true that he's been sidelined by Trump bc of his vaccine views, and that while he didn't talk to Trump about Erica Schwartz's nomination to CDC, his team vetted and...
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