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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,...
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...