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Lyell launches head‑to‑head CAR‑T trial — first test against marketed therapies
Lyell Immunopharma initiated a first‑of‑its‑kind clinical trial testing its experimental CAR‑T therapy directly against marketed counterparts, setting up a comparative study of efficacy and...
Quantx raises $85M — funds oral STAT6 and IL‑17 programs
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two oral immunology candidates: a STAT6 inhibitor and an IL‑17 inhibitor. The financing will support IND‑enabling work...
Anterior grabs $40M — AI to speed care approvals for payers
Anterior secured $40 million to scale an AI platform that automates administrative clinical work for health plans, aiming to compress care‑approval timelines from weeks to minutes. MedCity News...
FDA trims boxed warnings on menopausal HRTs — risk statements narrowed
The FDA removed boxed warnings tying menopausal hormone replacement therapies to increased risks of cardiovascular disease, breast cancer and probable dementia for six HRT products. The agency...
FDA rejects Disc’s therapy: voucher fast-track falters
The FDA formally rejected Disc Medicine’s bitopertin for porphyria after questioning the link between the blood biomarker used in trials and clear clinical benefit. Disc, an early recipient of the...
BridgeBio’s oral drug clears Phase 3 — oral rival to Voxzogo
BridgeBio reported positive top‑line results from Propel 3: oral infigratinib achieved statistically significant gains in annualized height velocity in children with achondroplasia versus placebo....
FDA refuses to file Moderna’s flu vaccine — company blindsided
The FDA issued a refusal‑to‑file letter for Moderna’s next‑generation mRNA influenza vaccine, a move the company says came unexpectedly after years of engagement with regulators. Moderna...
Ultragenyx trims staff 10% as FDA stalls gene‑therapy plans
Ultragenyx announced a programmatic restructuring that will eliminate roughly 130 jobs—about 10% of its workforce—after a year of clinical setbacks and regulatory friction. Management tied the...
FDA drops boxed warnings for six HRTs — labels narrowed
The FDA removed the most severe boxed warnings relating to breast cancer, cardiovascular disease and probable dementia from six menopausal hormone replacement therapies after an agency review and...
Lyell launches head‑to‑head CAR‑T trial against marketed therapies
Lyell Immunopharma has initiated a first‑of‑its‑kind trial that directly compares its experimental CAR‑T therapy with existing marketed CAR‑T products. The study design pits Lyell’s engineered...
CareDx plans AlloHeme launch after validation shows 41‑day relapse lead
CareDx said validation data from the ACROBAT observational study support commercialization plans for AlloHeme, its cell‑free DNA assay for allogeneic hematopoietic cell transplant surveillance....
Quantx secures $85M to advance oral immunology pipeline
Quantx Biosciences closed an $85 million Series B to advance two oral immunology candidates: a STAT6 small‑molecule inhibitor and an IL‑17 oral inhibitor. The oversubscribed financing funds...
PacBio posts 14% Q4 growth — clinical and European demand climbs
Pacific Biosciences reported a 14% year‑over‑year revenue increase in Q4, driven by stronger demand in Europe and rising clinical adoption of its long‑read platforms. The company shipped multiple...
Gilead buys Genhouse cancer drug — $80M upfront
Gilead acquired global rights to an oral oncology candidate from China‑based Genhouse Bio in a deal that includes an $80 million upfront payment. Genhouse, which recently filed for an IPO in Hong...
BridgeBio’s oral dwarfism pill wins Phase 3 — regulatory filing planned
BridgeBio reported positive top-line results from Propel 3, its global Phase 3 study of oral infigratinib in children with achondroplasia. The trial met its primary endpoint, showing statistically...
FDA rejects Disc Medicine’s bitopertin — voucher fast-track fails
The FDA issued a rejection letter for Disc Medicine’s bitopertin, a candidate for a rare porphyria, citing uncertainties about the blood-based biomarker used as the trial’s efficacy endpoint. Disc...
Moderna’s flu program stalled: FDA refuse-to-file sparks industry alarm
Moderna received a refusal-to-file letter from the FDA for its mRNA influenza vaccine application, and company executives expressed surprise at the agency’s decision. Moderna said it had submitted...
NIAID told to deprioritize pandemic work: agency pivots under NIH directive
Internal emails obtained by Nature indicate that the National Institute of Allergy and Infectious Diseases has been instructed to remove references to "pandemic preparedness" and "biodefense" from...
FDA removes boxed warnings for six menopausal HRTs — label overhaul takes effect
The FDA finalized label changes removing the boxed warnings about cardiovascular disease, breast cancer and probable dementia from six menopausal hormone replacement therapies (HRTs). The agency...
Lyell launches first head‑to‑head CAR‑T trial — challengers to market incumbents
Cell therapy developer Lyell Immunopharma initiated a head‑to‑head CAR‑T trial that will compare its experimental product directly against marketed CAR‑T therapies. The trial structure is novel...