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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...
AML MRD surrogate gains traction — could speed approvals by years
Data presented at ASH support measurable residual disease (MRD) as a surrogate endpoint in acute myeloid leukemia (AML), potentially enabling faster regulatory pathways. Researchers pooled 1,858...
Kallyope advances elismetrep to Phase 3 after Phase 2b win
Kallyope announced that its acute migraine drug elismetrep succeeded in a Phase 2b study and is moving into a Phase 3 program. The mid‑stage result demonstrated the primary efficacy endpoint in...
Gilead's anito‑cel posts deep responses — Kite prepares commercial push
Gilead and partner Arcellx reported pivotal‑stage CAR‑T data for anito‑cel showing deep and durable responses in multiple myeloma: tumor response in 96% of 117 patients and complete remission in...
Cogent's mastocytosis drug meets Phase 3 endpoint — 2026 filing in view
Cogent Biosciences reported a Phase 3 success for bezuclastinib in advanced systemic mastocytosis, meeting its primary endpoint and demonstrating benefit in sicker patient cohorts. The company...
CDMO and diagnostics deals: Fortrea pairs with SCTbio — Pillar, AstraZeneca expand into China
Fortrea signed a collaboration with Prague‑based SCTbio to offer combined clinical study and cell‑and‑gene therapy (CGT) manufacturing services, targeting developers that need integrated trial...
BioNTech’s CTLA‑4 wins survival — tolerability in question
BioNTech and OncoC4 reported a late‑stage win for their anti‑CTLA‑4 antibody, with the Phase 3 trial showing a greater than 50% reduction in risk of death. The lead dataset marks a major efficacy...
Mirum buys Bluejay for $620M — hepatitis D antibody joins rare‑disease portfolio
Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics for $620 million in cash and stock to secure brelovitug, a monoclonal antibody in late‑stage development for chronic hepatitis D (HDV)....
Dyne prepares FDA push after strong dystrophin gains in DMD
Dyne Therapeutics said its exon‑51 targeting candidate produced unprecedented dystrophin increases in a registrational cohort, prompting plans to seek accelerated FDA approval next year. The...
Structure’s oral GLP‑1 posts rival weight loss — nausea clouds outlook
Structure Therapeutics reported mid‑stage results showing its oral GLP‑1 candidate produced substantial weight loss—placebo‑adjusted averages in double‑digits at extended timepoints—putting the...
Pillar, AstraZeneca expand liquid‑biopsy rollout to China
Pillar Biosciences and AstraZeneca announced an expansion of their liquid‑biopsy collaboration into China to increase availability of plasma‑based tumor profiling kits at major clinical labs. The...
MRD advances as potential surrogate — lymphoma and AML data strengthen case
New data presented at ASH highlighted circulating tumor DNA (ctDNA)‑based and flow cytometry‑based minimal residual disease (MRD) assays as prognostic tools across blood cancers and as candidate...
Anito‑cel deep responses at ASH — Gilead, Kite position CAR‑T for broader launch
Gilead and partners reported deep and durable responses with anito‑cel in a pivotal multiple myeloma trial, with a high overall response rate and a substantial complete remission fraction in the...