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U.S. probes Chinese biotech subsidies, pricing — trade scrutiny escalates
The U.S. International Trade Commission and other federal bodies launched investigations into Chinese state support and pricing practices in the biotech sector, examining whether government...
Caris Detect posts strong interim results — MCED launch moves closer
Caris Life Sciences released interim validation data from its Achieve 1 study supporting the launch of Caris Detect, a multicancer early detection (MCED) blood assay. In diagnosed cohorts the...
Reactivating mutant p53: PMV’s rezatapopt shows proof‑of‑concept in NEJM
PMV Pharmaceuticals published Phase I results for rezatapopt, a small molecule p53 reactivator targeting the TP53 Y220C mutation, in the New England Journal of Medicine. Across 77 heavily...
Iza‑bren hits endpoints in China phase III — boost for licensee Bristol Myers
Systimmune reported that izalontamab brengitecan (iza‑bren) met both progression‑free and overall survival endpoints in a Phase III trial of Chinese patients with advanced triple‑negative breast...
Bladder cancer: Padcev–Keytruda wins more data; ctDNA predicts who can skip surgery
Researchers released additional positive data supporting the combination of Padcev (enfortumab vedotin) and Keytruda (pembrolizumab) as a first‑line treatment in a bladder cancer setting,...
Two CAR‑T upgrades expand solid tumor reach — dual receptor knockout and ultra‑sensitive HIT cells
Two preclinical strategies aim to improve CAR‑T efficacy against solid tumors. Columbia University researchers reported HIT (HLA‑independent T cell) receptors engineered for ultra‑sensitive...
Generate prices $400M IPO – AI-designed TSLP push
Generate Biomedicines completed a $400 million IPO to fund pivotal programs and platform growth. The Flagship Pioneering–backed company said proceeds will underwrite two phase 3 trials of its...
EMA recommends Moderna’s flu–COVID combo: European path cleared
The European Medicines Agency’s CHMP recommended approval of Moderna’s mCombriax (mRNA‑1083), a combined influenza and COVID‑19 vaccine for older adults. The endorsement — pending formal European...
Atrium launches with $270M – Avidity cardiac RNA programs continue
Atrium Therapeutics launched as a spinout from Avidity Biosciences after Novartis closed its acquisition, taking on cardiovascular RNA programs and a $270 million cash position. The new company...
Earendil inks up to $885M ADC pact with WuXi XDC
AI‑driven biologics developer Earendil Labs secured an exclusive license to WuXi XDC’s WuXiTecan‑2 payload‑linker technology to develop next‑generation antibody‑drug conjugates (ADCs), in a deal...
CHMP recommends three orphan drugs; rebuffs two FDA‑approved programs
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval for three new orphan medicines and declined to endorse two programs previously cleared by the...
U.S. launches probe into Chinese biotech support – ITC examines pricing
U.S. authorities opened an investigation into Chinese state support and pricing practices in the biotech sector, flagging potential market manipulation that could disadvantage American firms....
Rezatapopt shows clinical activity in TP53 Y220C tumors – NEJM report
PMV Pharmaceuticals published Phase I data in the New England Journal of Medicine showing clinical activity for rezatapopt, a small molecule designed to reactivate mutant p53 in tumors bearing the...
Ultra‑sensitive CAR‑T advances: HIT receptors and NR2F6 deletion boost potency
Two independent preclinical advances aim to tackle the core challenge of applying cell therapy to solid tumors. Columbia University researchers reported in Science that HLA‑independent T (HIT)...
Roche details Axelios sequencer: $150 per human genome claim
At AGBT Roche provided technical and commercial details for its Axelios 1 sequencing platform, touting a $150 list cost to sequence a human genome at 30× coverage in duplex mode. The company...
FDA trial default and political defense collide — one trial standard questioned
The FDA’s move to adopt a default of relying on one adequate, well‑controlled trial for marketing authorization is provoking industry debate about global consequences and payer expectations. A New...
Generate Biomedicines IPO: $400M to fund phase‑3 TSLP push
Generate Biomedicines priced a $400 million IPO to bankroll pivotal trials of its anti‑TSLP antibody and expand its AI‑driven protein design platform. The Flagship Pioneering‑backed company sold...
EMA recommends Moderna’s flu–COVID combo: mCombriax nears EU clearance
European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID‑19 mRNA vaccine for people aged 50 and older. The CHMP concluded...
Atrium Therapeutics rises from Avidity: $270M, cardiac RNA programs
Atrium Therapeutics launched as a spinout carrying Avidity Biosciences’ cardiac RNA programs and the public listing formerly held by Avidity after Novartis completed its $12 billion acquisition....
WuXi XDC licenses ADC linker to Earendil — up to $885M pact
WuXi XDC signed an exclusive licensing and CRDMO agreement with AI‑driven biologics developer Earendil Labs giving Earendil access to the WuXiTecan‑2 payload‑linker technology to build...