Get the Daily Brief
Latest Biotech News
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...
Novartis pays $2 billion — buys mutant‑selective PI3Kα to shore up breast‑cancer franchise
Novartis agreed to acquire Synnovation’s Pikavation unit, paying $2 billion up front for a next‑generation, mutation‑selective PI3Kα inhibitor meant to defend and extend its HR+/HER2‑ breast...
Earendil hauls in $787 million — AI‑powered biologics blitz expands pipeline
Earendil Labs closed a $787 million financing to scale an AI‑driven biologics discovery engine and advance a broad pipeline of antibody, bispecific and ADC candidates across autoimmune disease and...
Retatrutide: Lilly’s triple‑agonist delivers on glucose and weight — phase III win
Eli Lilly reported positive phase III data for retatrutide, a triple‑agonist targeting GLP‑1, GIP and glucagon receptors, showing robust A1C reductions and substantial weight loss in patients with...
FDA clears high‑dose Wegovy under voucher — Novo pushes to reclaim market share
The U.S. Food and Drug Administration approved a higher‑dose Wegovy injectable formulation following an accelerated review under the commissioner’s voucher program, delivering clearance roughly...
Genentech, Roche halt muscle‑growth program — late‑stage failure prompts pipeline cull
Genentech (Roche) announced it has stopped development of an experimental muscle‑building antibody after key studies failed to show consistent improvements in muscle growth and function. The...
FDA asks uniQure for sham‑surgery randomized trial for Huntington’s gene therapy — ethical alarm
The FDA told uniQure that its AMT‑130 gene‑silencing therapy for Huntington’s disease will require a prospective, randomized, double‑blind, sham‑surgery‑controlled study to support marketing...
Tumor whole‑genome sequencing shows real‑world clinical utility — Nature Medicine dataset
A real‑world study of paired tumor‑normal whole‑genome sequencing (WGS) in 888 solid‑tumor patients demonstrated high technical success, rapid turnaround (median 6 working days), and substantial...
NCCN adds genomic profiling recommendation for pancreatic cancer — NGS use expands
The National Comprehensive Cancer Network updated pancreatic adenocarcinoma guidelines to recommend tumor molecular profiling, preferably by DNA and RNA next‑generation sequencing (NGS), to detect...
Excalipoint raises $68.7M — Shanghai startup advances trispecific T‑cell engagers for solid tumors
Excalipoint Therapeutics closed a $68.7 million seed financing to develop masked, co‑stimulating and multispecific T‑cell engager platforms targeting solid tumors. The Shanghai‑based biotech...
Abbott closes $23 billion Exact Sciences acquisition — diagnostics push accelerates
Abbott completed its $23 billion acquisition of Exact Sciences after securing regulatory clearances, bringing the Cologuard multi‑cancer and colorectal screening products, Oncotype DX, and other...
Measles resurgence: U.S. records sustained transmission after vaccination declines
U.S. public-health researchers report that measles has been continuously circulating nationwide for more than a year, with 1,300 confirmed infections already in 2026 and outbreaks spanning...
ACIP upheaval – court injunction fuels claims of panel reshuffle
An outspoken member of the CDC’s Advisory Committee on Immunization Practices (ACIP) claimed the panel had been disbanded following a federal judge’s temporary injunction, then retracted the...