Get the Daily Brief
Latest Biotech News
FDA rolls out reviewer bonus pilot — payments tied to faster approvals
The Food and Drug Administration announced a pilot program to pay bonus awards to drug review staff who complete reviews ahead of schedule, according to internal slides and a staff presentation by...
US opens trade probe into Chinese biotech: ITC examines state support, pricing
The U.S. International Trade Commission launched an investigation into Chinese state support and pricing practices in the biotech sector, probing whether government intervention and subsidies have...
Abbott lines up $20B debt package to fund Exact Sciences buyout
Abbott filed to sell $20 billion of senior notes to help finance its planned $23 billion acquisition of Exact Sciences. The multi-tranche offering spans floating-rate and fixed‑rate maturities...
Merck seeks Welireg label expansion after combo readouts — kidney cancer push
Merck announced plans to pursue regulatory approval for two new combination regimens pairing its HIF-2α inhibitor Welireg with pembrolizumab (Keytruda) and with lenvatinib (Lenvima) in kidney...
Atrium launches from Avidity spinoff — $270M to pursue RNA cardio programs
Atrium Therapeutics launched as a spinout from assets left out of Novartis’s $12 billion acquisition of Avidity Biosciences, taking on preclinical RNA programs for rare cardiomyopathies and...
Disc Medicine cuts staff after FDA rejection — company files layoffs
Disc Medicine disclosed layoffs affecting roughly 30 employees after the FDA declined approval of the company’s experimental drug, according to a public filing. Management said the reductions...
Two CAR T advances aim at solid tumors: receptor edits and ultra‑sensitive HIT cells
Two independent preclinical programs reported strategies that may expand CAR T utility in solid tumors. One group engineered CAR T cells with a dual receptor knockout to blunt prostaglandin E2...
ctDNA steers care: RETAIN‑2 and multicenter studies refine precision treatment
Two studies underlined circulating tumor DNA’s growing clinical role. The phase 2 RETAIN‑2 trial from Fox Chase Cancer Center showed a blood‑based ctDNA assay can stratify muscle‑invasive bladder...
Moderna’s flu–COVID combo gets CHMP nod — EU clearance nears
European regulators’ human medicines committee (CHMP) recommended Moderna’s mCombriax (mRNA‑1083) for approval in people aged 50 and older. The CHMP opinion moves the vaccine to the European...
Generate prices $400M IPO — betting on AI‑designed TSLP antibody
Generate Biomedicines priced a $400 million IPO to fund pivotal trials of its TSLP‑targeting program and expanded R&D into AI‑driven protein therapeutics. The Flagship Pioneering‑backed company...
Atrium launches with $270M — takes Avidity’s cardiac RNA work
Atrium Therapeutics debuted as a standalone company with approximately $270 million in cash, inheriting cardiac RNA delivery programs spun out of Avidity Biosciences after Novartis closed its...
Earendil inks up to $885M deal for WuXi XDC linker‑payload tech
Earendil Labs signed an exclusive licensing and development agreement with WuXi XDC granting access to the WuXiTecan‑2 payload‑linker technology for next‑generation antibody‑drug conjugates...
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...