FDA Approves Kidney Drug Despite No Functional Benefit
This week's Biotech Scorecard newsletter: $TVTX Travere Therapeutics' drug for a rare kidney disease doesn’t improve kidney function. The FDA approved it anyway. https://t.co/63hDsPfOcT
Roche Initiates New Elevidys Trial Targeting EU Approval
Roche to launch another Elevidys trial, with eyes on European approval https://t.co/eAANNiihpt via @DrewQJoseph $SRPT
FDA Panel to Consider Expanding Peptide Access
FDA panel will meet to discuss allowing broader access to certain peptides https://t.co/PDWKvmvvUH via @LizzyLaw_
Dan Rosenblum's Twitter Hacked; Follow SharkAlertsBio for Updates
Hey folks - For those who follow Dan Rosenblum @sharkbiotech -- his account was hacked and he's currently locked out of it. @nikitabier -- any help here? There doesn't seem to be an @X person to contact about regaining control...
Rigorous Trials, Not Hype, Prove Cancer Drug Value
Today's $RVMD study outcome in pancreatic cancer is a good lesson for all the $IBRX @DrPatrick fans. Stop with all the hand-waving "cancer cure" podcasting social media nonsense. Shut up and run well-designed clinical trials with definitive endpoints. If you have...
Second‑line RVMD Improves Pancreatic Cancer Survival over First
As noted by others, the $RVMD dara mOS in 2nd line PDAC is better than mOS for current first-line regimens.
Daraxonrasib Halves Pancreatic Cancer Mortality, Doubles Survival
Finally, best news of the morning (and something you didn't expect so soon)... Revolution Medicines $RVMD daraxonrasib Ph3 results in second-line pancreatic cancer. Median overall survival in ITT patients (KRAS mutants + wild type combined) Dara 13.2 months vs chemo 6.7...
Allogeneic CAR‑T Achieves 42% MRD Boost, Safe Profile
Allogene $ALLO cema-cel interim ALPHA3 results just reported: B-cell lymphoma MRD negativity: cema-cel 58% vs observation 16% A 42% absolute difference in MRD clearance is better than expected. Clean safety profile, too. Allogeneic CAR-T may have found its role. Nice...
Spyre's SPY001 Achieves 40% Remission in UC Trial
Spyre $SYRE just reported SPY001 (long-acting alpha4beta7 antibody) ulcerative colitis induction data. Here's the efficacy chart, notable for a 40% clinical remission rate at week 12, albeit with small number of patients. https://t.co/aEoLWPRjEL
OCE's Objections Caused Rejection, Not Vinay Prasad
$REPL my read of the RP1 CRL suggests OCE (CDER) took the lead in the review. Their objections led to the first rejection, as I previously reported, and nothing Replimune submitted for the second review was enough to support...
Replimune's FDA‑targeted Skin Cancer Drug Faces Another Rejection
Replimune $REPL skin cancer drug that became FDA flashpoint is rejected again https://t.co/7aOfKy8vC7 via @Jasonmmast
Patients Favor Peptides over Statins, Exposing Medical Bias
My patient would rather take a peptide than a statin. That reveals an uncomfortable truth in medicine https://t.co/vCtJj2O6vq via @statnews
FDA's Future: New CBER Chief & Rare Disease Flexibility
On this week’s pod, we chatted with @docrodwong about the FDA, the next CBER chief and regulatory flexibility for rare diseases https://t.co/f6L7gwcNsr via @statnews
Paragon Launches Korsana Biosciences, Targeting Alzheimer's
Paragon launched its 7th company today -- Korsana Biosciences, merging into the $CYCN public shell. New ticker will be $KRSA. Lead drug candidate is a shuttled anti-amyloid beta antibody for Alzheimer's disease in early studies. https://t.co/RcJ8adMakm
FDA Hurdles Stall Academic Scaling of Custom Gene Editor
Baby KJ scientists hit speed bump in quest to scale custom gene editor. Stringent FDA requirements could prove stumbling block for academics https://t.co/HsaK7lSuh1 via @Jasonmmast
