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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...
Myrio cracks binder challenge — higher affinity and specificity achieved
Myrio Therapeutics announced it has developed binders in which both affinity and specificity can be increased simultaneously — a capability the company says rivals have not achieved. The advance...
Phrontline raises $60M to fund bispecific ADC pipeline — Series pre-A+ round closed
Phrontline Biopharma Suzhou closed a $60 million pre-A+ financing round led by Lapam Investment to advance its bispecific antibody-drug conjugate (ADC) programs built on dual-linker payload and...
Otsuka’s anti-APRIL antibody clears FDA: first-in-class IgAN approval
The FDA granted accelerated approval to Otsuka’s sibeprenlimab (Voyxact) for adults with primary immunoglobulin A nephropathy (IgAN), based on positive interim results from the phase III Visionary...
Novartis wins FDA nod for Itvisma – gene therapy now cleared for older SMA patients
Novartis received FDA approval for Itvisma (onasemnogene abeparvovec) to treat spinal muscular atrophy (SMA) patients aged two years and older with biallelic SMN1 mutations. The intrathecal,...
Bayer’s asundexian nails Phase III goal: stroke prevention win for FXIa inhibitors
Bayer reported that asundexian met the primary endpoint in a Phase III trial, reducing ischemic stroke recurrence when added to standard antiplatelet therapy in a large secondary‑prevention...
Novo’s Alzheimer gambit fails: oral semaglutide misses against cognitive decline
Novo Nordisk disclosed negative topline results from two Phase III trials testing oral semaglutide in Alzheimer’s disease; the drug did not slow clinical progression versus placebo. The company...
Abbott bets $23B on diagnostics: Exact Sciences deal remakes lab testing landscape
Abbott Laboratories agreed to acquire Exact Sciences for $23 billion, a transformative move that expands Abbott into cancer diagnostics and substantially increases its addressable diagnostics...
Standards and partnerships to unclog cell & gene bottlenecks: USP guidance and Bracco–Limula tie-up
USP launched new standards aimed at viral vectors and plasmid DNA to improve quality and consistency for cell and gene therapy manufacturing. The guidance covers best practices for raw materials...