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Gilead acquires Sprint’s TREX1 preclinical program — >$400m oncology buy
Gilead Sciences paid in excess of $400 million to acquire a preclinical oncology program from Sprint Bioscience that targets TREX1, an enzyme involved in nucleic acid sensing and tumor immune...
FDA proposes reclassifying companion diagnostics to Class II — 510(k) review pathway eyed
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostic assays from Class III to Class II devices, which would allow manufacturers to seek clearance via the 510(k) pathway...
Phrontline raises $60m pre‑A+ to back bispecific ADC pipeline
Phrontline Biopharma Suzhou closed a $60 million pre‑A+ financing round led by Lapam Investment to support development of next‑generation bispecific antibody‑drug conjugates (ADCs) and dual‑linker...
Otsuka’s Voyxact cleared by FDA: first APRIL blocker for IgAN
The U.S. Food and Drug Administration granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) for adults with primary immunoglobulin A nephropathy (IgAN). The approval is...
CMS sets 2027 Medicare prices: Wegovy, Ozempic among cuts
The Centers for Medicare & Medicaid Services finalized negotiated Medicare prices for 15 drugs under the Inflation Reduction Act, including semaglutide — the active ingredient in Novo Nordisk’s...
Novo files high‑dose Wegovy voucher: regulator review accelerated
Novo Nordisk submitted a higher‑dose formulation of its GLP‑1 obesity drug Wegovy to the FDA and used a priority review voucher to expedite regulatory review. The filing indicates Novo’s push to...
iPSC‑derived iNKT cells show promise in recurrent head‑and‑neck trial
A first‑in‑human phase I trial tested allogeneic induced pluripotent stem cell–derived invariant natural killer T (iNKT) cells in patients with recurrent head and neck cancer. Investigators...
USP issues viral‑vector guidance: standards to steady gene‑therapy scale‑up
The U.S. Pharmacopeia (USP) released new standards aimed at viral vectors and plasmid DNA to improve quality and consistency for cell and gene therapy manufacturing. The guidance includes...
mRNA peptibodies clear drug‑resistant pneumonia in mice: new delivery model
Nature Biotechnology published work showing that antimicrobial peptides delivered as mRNA‑encoded peptibodies in lipid formulations eradicated multidrug‑resistant bacterial pneumonia in mouse...
BoltzGen model debuts: generative AI for molecule design
Researchers at MIT introduced BoltzGen, a generative AI model designed to create candidate molecules for hard‑to‑treat diseases, and presented early demonstrations at a crowded seminar that drew...
Big pharma dealmaking: J&J buys Halda; Abbott’s Exact Sciences bet scrutinized
Johnson & Johnson agreed to acquire Halda Therapeutics for about $3.05 billion to gain access to its RIPTAC platform and lead prostate cancer program, signaling J&J’s continued appetite for...
FDA delays Ascendis’ dwarfism drug decision: three‑month review window
The FDA extended its review of Ascendis Pharma’s TransCon CNP (a once‑weekly treatment for achondroplasia) by three months to allow additional evaluation of the company’s post‑marketing study...
FDA proposes reclassifying companion diagnostics: 510(k) pathway eyed
The FDA proposed reclassifying certain nucleic acid‑based companion diagnostic assays from Class III (PMA) to Class II (special controls), which would allow manufacturers to seek clearance through...
Novartis expands SMA access: Itvisma approved for patients 2 and older
Novartis’ Itvisma (onasemnogene abeparvovec), a re‑formulated gene therapy for spinal muscular atrophy, received FDA approval for patients aged two years and older, expanding a one‑time gene...
Otsuka wins FDA approval for first APRIL inhibitor in IgA nephropathy
The U.S. Food and Drug Administration granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary IgA nephropathy after a late-stage trial showed a large reduction in...
Medicare finalizes deep cuts: CMS posts second-round negotiated drug prices
The Centers for Medicare & Medicaid Services published final maximum fair prices for the second cohort of 15 drugs negotiated under the Inflation Reduction Act, including semaglutide products used...
Novartis expands SMA gene therapy use — Itvisma cleared for older patients
Novartis secured FDA approval for Itvisma (onasemnogene abeparvovec) to treat spinal muscular atrophy in patients aged 2 and older, extending access to a gene‑replacement option beyond infants....
Novo’s amycretin posts strong weight, glycemic data — program moves to pivotal
Novo Nordisk reported phase II results showing its dual amylin/GLP‑1 agonist amycretin produced a mean 14.5% body‑weight reduction in type 2 diabetes patients over 36 weeks with substantial HbA1c...
In vivo editing inches forward: locus‑specific repair restores adrenal function in model
Laboratory teams reported locus‑specific editing of the 21‑hydroxylase gene restored adrenal function in a congenital adrenal hyperplasia (CAH) model, illustrating a tangible therapeutic effect...
Cell therapy clinical momentum — iPSC‑derived iNKT trial reports human data; Vigencell hits Phase II goal
Two separate cell‑therapy advances surfaced: a first‑in‑human phase I study tested allogeneic iPSC‑derived invariant natural killer T (iNKT) cells in recurrent head and neck cancer, and Vigencell...