Get the Daily Brief
Latest Biotech News
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...
ADC and bispecific race accelerates — sac‑TMT plus Keytruda shows first‑line PFS gain; funding follows
Kelun‑Biotech and Merck reported positive late‑stage data for sac‑TMT (a TROP2‑targeting ADC) combined with Keytruda as first‑line therapy in PD‑L1 positive non‑small cell lung cancer, showing...
Standards and automation: USP issues viral‑vector guidance; Bracco and Limula partner on cell‑therapy scale‑up
USP launched standards aimed at viral vectors and plasmid DNA raw materials to support cell and gene therapy manufacturing, addressing measurement variability such as empty‑to‑full AAV ratios and...
AI powers discovery and diagnostics: MIT’s BoltzGen debuts generative molecule model; popEVE maps proteome risk
Researchers at MIT introduced BoltzGen, a generative AI model designed to propose candidate molecules for hard‑to‑drug targets, showcasing a push to speed early discovery by integrating advanced...
Big manufacturing bets: AstraZeneca pledges $2B in Maryland; Thermo Fisher prices €2.1B notes
AstraZeneca announced a $2 billion U.S. investment to expand biologics manufacturing in Maryland, nearly doubling capacity at Frederick and building a new clinical facility in Gaithersburg to...
FDA clears first APRIL blocker for IgAN — Otsuka wins accelerated approval
The FDA granted accelerated approval to Otsuka Pharmaceutical’s sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The decision, announced ahead of the...
Novartis expands SMA gene therapy to older patients — Itvisma wins FDA nod
Novartis secured FDA approval for Itvisma (onasemnogene abeparvovec), a revised formulation of its SMN1 gene-replacement therapy, for patients aged 2 years and older with spinal muscular atrophy...
Medicare finalizes second-round IRA prices — Wegovy, Ozempic among heavy cuts
The Centers for Medicare & Medicaid Services published final negotiated Medicare Part D prices for 15 drugs under the Inflation Reduction Act, including semaglutide-containing products (Wegovy,...
FDA proposes reclassifying companion diagnostics — 510(k) route eyed for oncology tests
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 pursue the 510(k)...
AstraZeneca to invest $2B in U.S. biologics — Maryland manufacturing expansion announced
AstraZeneca unveiled plans to invest $2 billion to expand biologics manufacturing in Maryland, nearly doubling commercial capacity in Frederick and building a new clinical supply facility in...
Abbott to buy Exact Sciences for $23B — big bet on diagnostics and oncology testing
Abbott Laboratories announced a $23 billion acquisition of Exact Sciences, signaling a major strategic move into centralized precision oncology diagnostics. The deal gives Abbott a leading...
Toolgen and Geneditbio cross-license to advance in vivo editing therapeutics
Toolgen Inc. and Geneditbio Ltd. struck a strategic cross-license to jointly advance next-generation in vivo genome-editing therapeutics. The deal covers development of editing platforms intended...
CrisprBits raises $3M to scale CRISPR diagnostics and editing platforms
Indian startup CrisprBits closed $3 million in pre-Series A funding led by Spectrum Impact to commercialize its PathCrisp CRISPR-based diagnostic platform and to accelerate development of...