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Novartis pays $2B upfront — buys Synnovation’s PI3Kα program
Novartis agreed to acquire Pikavation Therapeutics, a Synnovation subsidiary, in a deal that pays $2 billion up front for SNV4818, a mutant‑selective PI3Kα inhibitor. The deal adds a...
Earendil Labs raises $787M — AI biotech scales toward clinic
Earendil Labs closed a $787 million financing to accelerate an AI‑driven biologics pipeline spanning autoimmune disease and oncology. Founder and CEO Jian Peng said the funding will let the...
Retatrutide hits phase III goals — Lilly posts weight and A1C wins
Eli Lilly reported positive top‑line results from a phase III trial of retatrutide, a first‑in‑class triple‑agonist targeting GLP‑1, GIP and glucagon receptors. In Transcend‑T2D‑1 the drug...
FDA clears high‑dose Wegovy fast — approval under commissioner’s voucher
The FDA cleared a higher‑dose Wegovy (7.2 mg) injection after an accelerated review under the commissioner's voucher program, granting approval about 54 days from filing. Novo Nordisk’s high‑dose...
FDA asks uniQure for sham‑surgery control in Huntington’s trial — ethical debate erupts
The U.S. Food and Drug Administration told uniQure that it expects a prospective, randomized, double‑blind, sham surgery‑controlled trial to support approval of AMT‑130, an AAV‑delivered gene...
Roche halts experimental SMA drug — development stopped after inconsistent benefit
Roche announced it is stopping development of emugrobart, an experimental therapy for spinal muscular atrophy (SMA), after a key study failed to show consistent muscle growth and motor‑function...
Cell therapy at scale: automation, closed systems and commercialization hurdles
Industry leaders laid out practical steps to scale autologous and other cell therapies, focusing on automation, closed‑process manufacturing and global networks to cut cost and increase...
Lab‑grown esophagus restores feeding in pigs — step toward pediatric grafts
Researchers at Great Ormond Street Hospital and University College London reported functional integration of an autologous engineered esophagus in a growing large‑animal model. The Nature...
Nautilus Voyager debuts — Baylor first customer for single‑molecule proteomics
Nautilus Biotechnology announced Baylor College of Medicine as the inaugural customer for its Voyager single‑molecule proteomics platform, marking an early access deployment ahead of commercial...
CSL reports global stockout of hemophilia B gene therapy — patient access risk
CSL Behring disclosed a temporary global stockout of its hemophilia B gene therapy, warning that supply constraints could delay treatment for some patients. The company communicated the shortage...
Novartis shells out $2B — buys Synnovation’s next‑gen PI3Kα program
Novartis agreed to acquire Synnovation Therapeutics’ PI3Kα inhibitor portfolio via a deal that pays $2 billion upfront, plus up to $1 billion in milestones, the companies announced. The purchase...
Lilly’s triple‑agonist retatrutide hits Phase III goals — diabetes A1C and weight fall
Eli Lilly reported positive top‑line Phase III results for retatrutide (a GIP/GLP‑1/glucagon triple agonist) in patients with type‑2 diabetes, showing marked A1C reductions and substantial weight...
FDA clears high‑dose Wegovy fast — Novo leverages commissioner’s voucher
The U.S. Food and Drug Administration approved a higher‑dose formulation of Novo Nordisk’s Wegovy (7.2 mg) under an expedited voucher program, granting clearance roughly 54 days after the filing....
Earendil Labs pulls in $787M — AI‑driven biologics startup scales pipeline
Earendil Labs announced a $787 million financing to accelerate an AI‑driven biologics R&D engine and advance a broad pipeline of antibodies, bispecifics and ADCs across autoimmune and oncology...
Engineered esophagus integrates and functions in growing pigs — path to paediatric grafts
Researchers from Great Ormond Street Hospital and UCL reported successful replacement of a circumferential esophageal segment in growing pig models using a decellularized donor scaffold...
Oncolytic virus pelareorep wins FDA fast‑track — targets KRAS‑mutant metastatic CRC
Oncolytics Biotech secured FDA Fast Track designation for pelareorep (Reolysin) combined with bevacizumab and FOLFIRI as second‑line therapy for KRAS‑mutant, microsatellite‑stable metastatic...
Roche shelves emugrobart — Genentech halts muscle‑preserving antibody after failure
Roche notified European patients that it is terminating development of emugrobart—a Genentech‑originated antibody—for spinal muscular atrophy and facioscapulohumeral muscular dystrophy after...
FDA asks uniQure for sham‑surgery‑controlled study — Huntington’s gene therapy path clouded
The U.S. Food and Drug Administration told uniQure it requires a prospective, randomized, double‑blind, sham surgery‑controlled study to support a marketing application for AMT‑130, an AAV‑based...
ACIP turmoil deepens after injunction — committee membership and future in flux
Tension erupted around the CDC’s vaccine advisory committee after a federal judge issued a temporary injunction challenging recent appointments; an ACIP member publicly claimed the panel had been...
Abbott completes Exact Sciences buy — diagnostics leader expands cancer‑testing footprint
Abbott announced the closing of its $23 billion acquisition of Exact Sciences after securing regulatory approvals and shareholder consent, moving the company deeper into cancer screening and...