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BioNTech, DualityBio greenlight B7‑H3 ADC into phase 3 — mCRPC race tightens
BioNTech and partner DualityBio advanced their B7‑H3 antibody‑drug conjugate into a phase 3 trial for metastatic castration‑resistant prostate cancer after encouraging phase 1/2 data, the partners...
Atrium spins out with $270M — RNA push for rare heart diseases
Atrium Therapeutics launched with a $270 million financing to advance RNA therapies targeting rare inherited cardiac disorders, MedCity News reported. The spinout emerges from Avidity Biosciences...
Researchers find viral 'kill switch' that locks MurJ: new bacterial target
Researchers discovered that several unrelated viruses produce small proteins that bind and lock the bacterial membrane flippase MurJ into a single conformation, halting peptidoglycan biosynthesis...
Dual receptor knockout enhances CAR‑T activity against solid tumors
Researchers demonstrated that genetically ablating both receptors for prostaglandin E2 (PGE2) in CAR‑T cells markedly enhances their potency against solid tumors in preclinical models. By removing...
GoodRx launches employer program: employers can subsidize GLP‑1s
GoodRx introduced Employer Direct, a program that allows employers to subsidize manufacturer‑sponsored prices for high‑cost brand drugs — explicitly including GLP‑1 weight‑loss therapies — without...
Novartis tests Rhapsido for food allergy...Phase 2 shows dose responses
Novartis presented Phase 2 results testing Rhapsido—an approved drug for chronic hives—in food allergy, reporting that all three doses in the trial produced higher response measures versus...
Moderna wins EU backing: combo flu–COVID vaccine cleared by CHMP
European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined influenza and COVID-19 mRNA vaccine, clearing a major regulatory hurdle for the product in...
BioNTech advances B7-H3 ADC: phase 3 start in prostate cancer
BioNTech and partner DualityBio moved their B7-H3–targeting antibody–drug conjugate into a phase 3 trial for metastatic castration‑resistant prostate cancer (mCRPC) after encouraging phase 1/2...
Atrium spins out RNA cardio programs — $270M bankroll
Atrium Therapeutics launched as a spinout carrying Avidity Biosciences’ cardiac RNA delivery programs, debuting with about $270 million in cash to advance therapies for rare inherited...
Generate raises $400M: AI‑driven protein design firm prices IPO
Generate Biomedicines priced an IPO that raised roughly $400 million to fund pivotal trials for its severe asthma program and further develop its programmable‑biology platform. Founded by Flagship...
Abbott floats $20B notes to fund Exact Sciences buy — debt package unveiled
Abbott disclosed a $20 billion senior notes offering intended to help finance its pending $23 billion acquisition of Exact Sciences. The debt package spans multiple tranches and maturities and...
FDA to pilot bonuses for faster reviews — incentive plan raises questions
FDA Commissioner Marty Makary announced a pilot to pay bonus awards to drug reviewers who complete work ahead of schedule, with the first quarterly payments expected around August. Slides and...
U.S. probes Chinese state support and pricing in biotech — ITC inquiry opened
U.S. authorities opened a formal review into Chinese state support and pricing practices in the biotech sector, with the International Trade Commission and related agencies scrutinizing whether...
Systimmune’s iza‑bren clears phase 3 endpoints in China — survival gains reported
Systimmune reported that izalontamab brengitecan (iza‑bren), its next‑generation ADC licensed to Bristol Myers Squibb for China, met both progression‑free survival and overall survival endpoints...
Ascendis wins FDA approval for achondroplasia drug — weekly TransCon CNP cleared
The FDA approved Ascendis Pharma’s once‑weekly TransCon CNP (navepegritide) for achondroplasia, establishing a new treatment option for the genetic short stature disorder and setting up a...
UniQure stock tumbles after FDA remarks — investor nerves over rare‑disease reviews
UniQure’s market value plunged after FDA Commissioner Marty Makary’s public defense of the agency’s review approach and comments suggesting some recent rare‑disease approvals were pressured....
Atrium launches with $270M—Avidity spinout targets cardiac RNA
Atrium Therapeutics debuted with about $270 million in cash and a pipeline of RNA therapies aimed at rare inherited cardiomyopathies. The San Diego spinout takes programs and leadership from...
Generate prices $400M IPO—AI‑designed TSLP program backed for pivotal tests
Generate Biomedicines raised about $400 million in an IPO to fund pivotal trials of its lead TSLP‑targeting program and expand its AI‑driven protein design platform. The Flagship‑founded company...
EMA backs Moderna’s flu–COVID combo—EU clears path for first‑in‑class shot
European regulators’ CHMP endorsed Moderna’s mCombriax (mRNA‑1083), a combined influenza and COVID‑19 mRNA vaccine, recommending approval for older adults. The CHMP opinion paves the way for...
FDA pilots reviewer bonuses and retools trial default—approval norms shift
The FDA announced two policy moves that could reshape regulatory timelines: a pilot program to pay quarterly bonuses to drug reviewers for time‑savings, and a shift toward treating one adequate,...