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CHMP backs Moderna’s flu–COVID combo: EU path clears
The European Medicines Agency’s human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID‑19 mRNA vaccine for adults aged 50 and over. The CHMP...
FDA to pay bonuses for faster reviews – Pilot ties time savings to awards
FDA Commissioner Marty Makary announced a pilot program to provide bonus payments to agency drug reviewers who complete work ahead of schedule, with the first quarterly payouts expected around...
Atrium launches from Avidity buyout – Cardiac RNA franchise moves forward
Atrium Therapeutics debuted as a spinout after Novartis closed its $12 billion acquisition of Avidity Biosciences. Led by former Avidity executives including Kathleen Gallagher and Sarah Boyce,...
BioNTech pushes B7‑H3 ADC into phase 3 – MCRPC program accelerates
BioNTech and partner DualityBio advanced their B7‑H3–targeting antibody‑drug conjugate into a Phase III trial for metastatic castration‑resistant prostate cancer (mCRPC), moving faster than a...
Iza‑bren hits Phase III goals in China – Survival improved in TNBC
Systimmune reported that izalontamab brengitecan (iza‑bren) met both progression‑free survival and overall survival endpoints in a Phase III trial of Chinese patients with advanced triple‑negative...
ctDNA guides bladder preservation – RETAIN‑2 shows surgical avoidance possible
Fox Chase Cancer Center investigators reported phase 2 RETAIN‑2 results showing that a blood‑based circulating tumor DNA (ctDNA) test can identify muscle‑invasive bladder cancer patients at low...
US launches probe into Chinese biotech support – Trade review could shift deals
U.S. authorities have opened investigations into Chinese state support and pricing practices in the biotech sector, with the International Trade Commission and related agencies examining whether...
Ultra‑sensitive CAR T cells target solid tumors – HIT receptors broaden scope
Columbia University researchers led by Michel Sadelain reported development of HLA‑independent T cell (HIT) receptors that confer extreme sensitivity to low‑density tumor antigens. Preclinical...
Generate’s $400M IPO: AI drug designer backs late‑stage asthma push
Generate Biomedicines priced a $400 million IPO to fund pivotal trials of its TSLP‑targeting antibody GB‑0895 and expand its AI‑driven protein design platform. The Flagship Pioneering‑backed...
EMA recommends Moderna’s mCombriax — first flu/COVID combo on the table
The European Medicines Agency’s CHMP recommended Moderna’s mCombriax, a combined mRNA influenza and COVID‑19 vaccine for adults 50 and older. Moderna said the opinion reflects trial data showing...
Atrium rises from Avidity deal: RNA heart programs keep going
Atrium Therapeutics launched after Novartis closed its acquisition of Avidity Biosciences, taking on Avidity’s cardiac RNA delivery programs and a public listing. The new company started...
Earendil and WuXi XDC ink up to $885M ADC pact
AI‑driven biologics developer Earendil Labs secured an exclusive license to WuXi XDC’s WuXiTecan‑2 payload‑linker technology and CRDMO services in a deal worth up to $885 million in upfront and...
Systimmune’s iza‑bren clears phase III goals in China — survival endpoints met
Systimmune reported that izalontamab brengitecan (iza‑bren), its next‑generation antibody‑drug conjugate, met both progression‑free survival and overall survival endpoints in a phase III trial of...
Mutant p53 reactivation: rezatapopt shows clinical activity in NEJM report
PMV Pharmaceuticals published Phase I results for rezatapopt, a small molecule p53 reactivator selective for the TP53 Y220C mutation, reporting objective responses across multiple tumor types in...
Next‑gen CAR‑T: ultra‑sensitive HIT receptors and receptor knockouts advance solid‑tumor work
Two preclinical advances aim to extend CAR‑T efficacy to solid tumors. Columbia University researchers engineered HLA‑independent T (HIT) receptors that detect vanishingly low CD70 expression and...
ctDNA steers care: blood tests predict bladder outcomes and guide FGFR therapy
Two multicenter studies reinforced circulating tumor DNA’s clinical utility. Fox Chase Cancer Center’s phase 2 RETAIN‑2 trial showed that a ctDNA blood test identified muscle‑invasive bladder...
FDA trial rules shift: one‑trial default and rare‑disease framework spark debate
Regulatory changes at the U.S. Food and Drug Administration are drawing industry scrutiny. The agency’s move toward a one‑adequate‑trial default for marketing authorization has raised questions...
U.S. probe targets Chinese state support and pricing in biotech
The U.S. International Trade Commission opened investigations into Chinese government support and pricing practices in the biotech sector to assess whether state aid and pricing distortions...
Generate Biomedicines prices $400M IPO — AI drug design bet
Generate Biomedicines completed a $400 million initial public offering to fund pivotal trials and platform work. The Flagship Pioneering‑backed company will direct roughly $300 million toward two...
EMA endorses Moderna’s flu–COVID combo — EU clearance likely
European regulators’ human medicines committee recommended approval of Moderna’s mCombriax (mRNA‑1083), a combined influenza and COVID‑19 vaccine for people 50 and older. The CHMP concluded the...