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BioNTech’s CTLA‑4 antibody improves survival — efficacy offsets tolerability concerns
BioNTech and OncoC4 reported Phase 3 survival data for their anti‑CTLA‑4 candidate that showed a large reduction in death risk in lung cancer, but subsequent analysis highlighted a challenging...
FDA sets higher bar for CAR‑T: superiority now expected — pivotal readouts test the claim
The FDA’s biologics chief argued in a journal article that new CAR‑T therapies will need to demonstrate superiority over existing standards to secure approval, signaling a tougher regulatory path...
KRAS G12D: more than 20 programs launch — companies race to drug common mutation
BioCentury reported an accelerating wave of programs targeting the KRAS G12D mutation, with more than 20 initiatives launched in the past year across biotech and Big Pharma. Companies are...
Medtronic’s Hugo RAS cleared by FDA — a new rival to da Vinci in soft‑tissue surgery
The U.S. FDA cleared Medtronic’s Hugo robotic‑assisted surgery (RAS) system, a regulatory milestone that gives the device maker a direct platform to challenge Intuitive Surgical’s da Vinci...
ASH nudge for AML: MRD surrogate endorsed — targeted therapies outpace chemo
Researchers presented pooled data at ASH supporting measurable residual disease (MRD) as a surrogate endpoint that could accelerate acute myeloid leukemia (AML) drug development, enabling earlier...
Dyne’s Duchenne win — FDA filing in sights
Dyne Therapeutics reported that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study and is preparing a regulatory submission. The company presented registrational...
Mirum buys Bluejay’s hepatitis D asset — $620M deal
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics to secure brelovitug, a monoclonal antibody in late‑stage testing for chronic hepatitis D virus (HDV). The transaction calls for $620...
Terns’ CML candidate pressures Novartis — ASH update
Terns Pharmaceuticals presented early ASH data showing its targeted chronic myeloid leukemia (CML) drug produced high molecular response rates in heavily pretreated patients. An interim readout...
Oral GLP‑1 race heats up — efficacy vs tolerability
Two oral GLP‑1 candidates reported mid‑stage efficacy that keeps the small‑molecule obesity race competitive with injectables. Structure Therapeutics reported placebo‑adjusted weight loss near...
FDA raises the bar for CAR‑T approvals
The FDA signaled a policy shift that will require new CAR‑T therapies to demonstrate superiority over existing treatments to secure approval, according to a journal article by the agency’s...
Gilead’s anito‑cel posts deep myeloma responses at ASH
Gilead and partner Arcellx reported pivotal‑stage results for anito‑cel in multiple myeloma showing high response rates and deep remissions. In a cohort of 117 patients, companies disclosed a 96%...
MRD surrogate could speed AML approvals — Harmony data
Researchers presented pooled Harmony Alliance data at ASH indicating that measurable residual disease (MRD) may serve as a surrogate endpoint to accelerate acute myeloid leukemia (AML) trials. The...
Fortrea links with SCTbio to offer integrated CGT study and manufacturing
Contract development and manufacturing specialist Fortrea struck a partnership with Prague‑based SCTbio to provide combined clinical study support and production services for cell and gene therapy...
Wireless skull implant creates artificial perception in mice
A Northwestern University team published Nature Neuroscience data on a soft, wireless implant that delivers patterned transcranial optogenetic stimulation through the skull to activate genetically...
BioNTech’s CTLA‑4 antibody extends survival — tolerability caveat
Phase 3 data from BioNTech and partner OncoC4 showed a CTLA‑4–targeting antibody improved overall survival in a lung cancer study but raised tolerability concerns that could complicate use. The...
Dyne Duchenne win — readies accelerated FDA bid
Dyne Therapeutics reported pivotal-study success for its exon‑51 skipping Duchenne muscular dystrophy candidate and signaled plans to seek accelerated FDA approval. In a registrational expansion...
Mirum shells out $620M: snaps up Bluejay's HDV antibody
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $620 million in cash and stock to gain brelovitug, a monoclonal antibody in Phase 3 targeting hepatitis D virus (HDV). Bluejay’s...
FDA heightens CAR‑T bar: new therapies must prove superiority
The FDA’s biologics chief signaled a policy shift requiring new CAR‑T cancer therapies to demonstrate superiority over existing treatments to secure approval. The position, articulated in a recent...
BioNTech CTLA‑4 shows survival gain — tolerability concerns linger
BioNTech and partner OncoC4 reported Phase 3 survival data for an anti‑CTLA‑4 antibody in lung cancer that more than halved the risk of death, delivering a significant efficacy signal. Subsequent...
Structure posts competitive weight loss — nausea rates raise flags
Structure Therapeutics disclosed mid‑stage results for its oral GLP‑1 candidate showing substantial placebo‑adjusted weight loss that rivals injectable competitors. In one trial, a 120‑mg dose...