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BioNTech pushes B7‑H3 ADC into phase 3 with a trimmed trial
BioNTech and partner DualityBio advanced their B7‑H3 antibody‑drug conjugate into a phase‑3 program for metastatic castration‑resistant prostate cancer (mCRPC). The companies plan a trial...
Padcev–Keytruda combo posts fresh positive bladder cancer data
New clinical data showed that enfortumab vedotin (Padcev) combined with pembrolizumab delivered additional positive results as a frontline option in a form of bladder cancer, adding to earlier...
Systimmune’s iza‑bren meets phase‑III PFS and OS targets in China
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...
FDA will pilot bonus pay to speed drug reviews — critics raise flags
FDA Commissioner Marty Makary unveiled a pilot to offer bonus payments to reviewers who complete drug reviews ahead of schedule, with the first quarterly payments slated for around August. The...
FDA shifts trial expectations — one‑trial default and rare‑disease pathway proposed
Two regulatory moves this week signaled a broader rejiggering of FDA expectations for approvals. First, FDA leadership articulated a new default that could allow marketing authorization based on a...
Abbott proposes $20B debt sale to fund Exact Sciences acquisition
Abbott filed agreements to issue $20 billion in senior notes to help finance its pending $23 billion acquisition of Exact Sciences. The multi‑maturity offering ranges from floating‑rate notes due...
p53 reactivation shows clinical activity – Rezatapopt posts Phase I data
PMV Pharmaceuticals reported first‑in‑human data showing that rezatapopt, a small molecule designed to reactivate mutant p53, produced objective responses in heavily pretreated patients with TP53...
Generate prices $400M IPO – Market backs AI‑designed TSLP program
Generate Biomedicines completed a $400 million IPO, selling 25 million shares at $16 apiece, to fund pivotal Phase III tests of its AI‑designed anti‑TSLP antibody GB‑0895 and other platform...
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...