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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,...
Caris Detect interim validation—sensitivity climbs with cancer stage
Caris Life Sciences released interim Achieve 1 validation results for its Caris Detect multicancer early detection (MCED) assay. The test showed stage‑dependent sensitivity—~57% for stage I, ~70%...
Systimmune’s iza‑bren clears phase III goals in China—survival gains reported
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...
FDA clears Ascendis’ once‑weekly achondroplasia drug—new option for rare growth disorder
The FDA approved Ascendis Pharma’s once‑weekly TransCon CNP (navepegritide) for achondroplasia, marking a new injectable option for the genetic short‑limb growth disorder. Ascendis and competitors...
U.S. opens probe of Chinese biotech support—trade stakes rise
U.S. authorities initiated a closer look at Chinese state support and pricing in the biotech sector, with the International Trade Commission (ITC) set to examine whether Chinese subsidies and...
Abbott files $20B note offering to fund Exact Sciences takeover
Abbott filed to issue $20 billion of senior notes to help finance its pending $23 billion acquisition of Exact Sciences. The debt package spans maturities from 2029 through 2066 and names major...
ctDNA blood test may spare bladder surgery—RETAIN‑2 phase 2 shows promise
Fox Chase Cancer Center released phase 2 RETAIN‑2 results showing a circulating tumor DNA (ctDNA) blood test can identify muscle‑invasive bladder cancer patients with low metastatic risk who might...
Moderna’s mCombriax wins CHMP backing — EU path cleared
European regulators’ human medicines committee recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID-19 mRNA vaccine. The EMA’s positive CHMP opinion covers people...
Belzutifan plus pembrolizumab improves disease-free survival in high‑risk kidney cancer
The phase 3 LITESPARK-022 trial reported that combining belzutifan, a HIF-2α inhibitor, with pembrolizumab extends disease-free survival in patients with high‑risk clear cell renal cell carcinoma...
FDA to pilot bonuses for faster drug reviews — internal pay shakeup
FDA Commissioner Marty Makary announced a pilot program to pay bonuses to reviewers who complete drug evaluations ahead of schedule, with the first quarterly payments slated for August. Agency...
Generate Biomedicines prices $400M IPO to fund pivotal asthma program
Generate Biomedicines raised $400 million in an IPO to finance pivotal trials of its severe asthma candidate and expand its programmable‑biology platform. The Flagship‑spawned company priced 25...
Caris Detect interim validation shows promising MCED sensitivity and specificity
Caris Life Sciences released interim Achieve 1 validation data for its Caris Detect multicancer early detection (MCED) assay showing stage‑dependent sensitivity and high specificity. The diagnosed...
Atrium Therapeutics debuts with Avidity cardio programs and $270M cash
Atrium Therapeutics launched as a spinout carrying preclinical RNA programs for rare cardiac diseases that were not part of Novartis’ acquisition of Avidity Biosciences. The new company assumed...
Ascendis wins FDA approval for once‑weekly achondroplasia therapy
The FDA approved Ascendis Pharma’s once‑weekly TransCon CNP (navepegritide) for achondroplasia, providing an alternative treatment option in a competitive therapeutic area. The approval sets the...
Abbott lines up $20B debt package to finance Exact Sciences buy
Abbott filed to sell $20 billion in senior notes to help fund its pending $23 billion acquisition of Exact Sciences. The debt offering spans maturities from 2029 to 2066 and names Morgan Stanley,...
U.S. probe targets Chinese state support and pricing in biotech — trade scrutiny rises
The U.S. International Trade Commission opened a probe into Chinese state support and pricing practices in the biotech sector, examining whether government actions distorted markets and...
Systimmune’s iza‑bren meets phase III endpoints in Chinese triple‑negative breast cancer study
Systimmune reported that its antibody‑drug conjugate izalontamab brengitecan (iza‑bren) met both progression‑free survival and overall survival endpoints in a phase III trial of Chinese patients...
Generate Biomedicines prices $400M IPO: AI-designed TSLP program funded
Generate Biomedicines completed a $400 million initial public offering to finance pivotal tests of its TSLP-targeting program for severe asthma. The Boston-based firm, built on an AI-driven...
EMA recommends Moderna combo shot: Europe clears path for flu–COVID vaccine
The European Medicines Agency’s CHMP recommended approval of Moderna’s mCombriax, a combined seasonal influenza and COVID-19 mRNA vaccine for older adults. The committee concluded the vaccine...