BioNTech's mRNA cancer immunotherapy BNT113 misses primary goal in Phase 2/3 head and neck cancer trial
The failure marks a third mRNA setback for BioNTech and dents analyst confidence in the broader mRNA cancer vaccine field.
Biopharmadive · +14 outlets
Former FDA commissioners blast DOGE cuts as 'one of the biggest disasters in American history'
Three former FDA chiefs say the cuts robbed the agency of institutional knowledge that will take years to restore.
STAT · +1 outlets
Arrowhead RNAi drug hints at Alzheimer's benefit, crossing into the brain via subcutaneous dosing
In a first, a subcutaneously administered RNA interference medicine crossed into the brain and lowered levels of a tau-related protein.
Biopharmadive · +4 outlets
FDA clears ImmunityBio's Anktiva expansion in bladder cancer after prior regulatory setbacks
The approval restores an expansion for the immunotherapy after earlier regulatory whiplash.
Fierce Pharma · +7 outlets
Trump administration delays 90 days a rule that could restrict imported medicines from Canada and overseas
The delay affects Americans who obtain prescription drugs from licensed international pharmacies.
STAT · +14 outlets
Ultragenyx raises about $413M selling FDA priority review vouchers after summer gene therapy approvals
The company monetized rare disease review vouchers quickly, including a $203M Fayuvi voucher sale, to fund pipeline buildout.
Fierce Pharma · +3 outlets
White House shift of research funding toward industry risks basic research drought, science leaders warn
At a Boston summit, US science leaders defended the role of the American university amid a planned funding pivot toward AI, tech, and industry.
STAT · +13 outlets
Study finds nearly 40% of FDA advisory committee meetings included patient or consumer reps with pharma-funded ties
The analysis raises conflict-of-interest questions about patient and consumer representation on FDA advisory panels.
STAT · +9 outlets
Roche extends China deal streak with $1B RNAi obesity drug pact with Rona Therapeutics
The alliance adds to an active stretch of China licensing deals and bets on medicines lowering visceral fat.
Biopharmadive · +3 outlets
Sanofi avoids EU fine as regulators accept offer to end antitrust probe over disparaging rival flu vaccine
EU antitrust regulators settled the probe into an allegedly misleading campaign against a rival flu vaccine.
STAT · +7 outlets
FTC asks court to hold Martin Shkreli in contempt, demands he divest pharma stocks
The FTC says Shkreli flagrantly violated a court order banning him from working in the pharmaceutical industry.
STAT · +11 outlets
BlackRock to buy majority stake in Humana's CenterWell clinics for $2.8 billion
Humana is swapping private equity sponsors for BlackRock at its CenterWell senior primary care clinics.
STAT · +14 outlets
Divergent cancer vaccine trial results leave field grappling with hard questions
Mixed outcomes across studies are prompting debate about the path forward for personalized cancer vaccines.
The Boston Globe · +4 outlets
Verastem cancer drug shows early promise in small pancreatic cancer study
Analysts now view Verastem's G12D-targeted drug as competitive in a crowded oncology research area.
Biopharmadive · +7 outlets
FDA launches rare disease framework initiative to modernize small-cohort trial design
The initiative aims to update how trials are designed for rare disease populations with limited patients.
HIT Consultant
J&J earnings set negative tone for biopharma as Gilead partners with Vir, Syndax bid falls short
A 6% sell-off in J&J shares was seen as emblematic of broader market volatility, while Syndax shares fell on a failed lung fibrosis trial.
Biopharmadive · +3 outlets
Lobbyists and trade groups fight to shape state regulation of autonomous clinical AI
Doctor and hospital lobbying groups are working behind the scenes on how states should regulate AI in medicine.
STAT · +1 outlets
Radical Numerics startup pursues 'general biological intelligence' AI for drug discovery
The company is developing AI intended to reason across biology, part of a wave of biotech AI startups.
STAT