Get the Daily Brief
Latest Biotech News
Atrium launches with Avidity’s cardiac RNA assets — $270M war chest
Atrium Therapeutics launched as a San Diego‑based spinout taking on preclinical cardiac RNA programs that were not included in Novartis’s acquisition of Avidity Biosciences. The new company...
EMA’s CHMP backs three orphan drugs — rejects two FDA‑cleared programs
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of three new orphan medicines and declined support for two programs previously cleared by the...
US opens probe into China’s biotech support and pricing — ITC inquiry
U.S. authorities launched a fact‑finding probe into Chinese state support and pricing practices in the biotech sector, initiating investigations by the International Trade Commission. The...
CAR‑T advances for solid tumors: receptor edits and ultra‑sensitive HIT cells
Two independent preclinical advances aim to expand CAR‑T impact in solid tumors. One study reported that knocking out dual prostaglandin E2 (PGE2) receptors in engineered T cells neutralizes an...
Rezatapopt shows proof‑of‑concept in TP53 Y220C tumors — NEJM report
PMV Pharmaceuticals reported Phase I data for rezatapopt, a small molecule designed to reactivate mutant p53 in tumors carrying the TP53 Y220C mutation. Published in the New England Journal of...
ctDNA steers bladder preservation and FGFR therapy decisions
Two studies reinforced circulating tumor DNA’s clinical utility in urothelial cancers. Fox Chase’s RETAIN‑2 phase 2 trial reported that ctDNA can stratify muscle‑invasive bladder cancer patients...
FDA floats 'plausible mechanism' pathway; senators press agency on rare approvals
The FDA proposed a faster 'plausible mechanism' framework aimed at accelerating personalized genomic and ultrarare disease drug development by accepting mechanistic evidence in lieu of large...
Earendil inks up to $885M ADC pact with WuXi XDC — linker license
AI‑driven biologics developer Earendil signed an exclusive deal with WuXi XDC for the WuXiTecan‑2 linker‑payload platform to advance next‑generation antibody‑drug conjugates. Financial terms total...
Moderna’s combo shot clears EU — EMA backs mCombriax
European regulators recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID‑19 mRNA vaccine for people aged 50 and older. The European Medicines Agency’s CHMP...
Generate prices $400M IPO — Funds go to phase‑3 asthma push
Generate Biomedicines priced a $400 million IPO, selling 25 million shares at $16 each, to bankroll pivotal phase‑3 trials of its TSLP‑targeting antibody GB‑0895 and additional platform programs....
Avidity spinout Atrium launches — $270M to pursue RNA heart drugs
Atrium Therapeutics formally launched as a spinout from Avidity Biosciences after Novartis completed its $12 billion acquisition of Avidity. The new company, led by former Avidity executives...
FDA’s one‑trial default raises global questions — reviewers, industry push back
The U.S. FDA’s shift toward accepting one adequate, well‑controlled pivotal trial as a default for marketing authorization sparked debate over global consequences. FDA Commissioner Marty Makary...
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...