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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...
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...