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FDA insists on sham surgery for uniQure’s Huntington’s gene therapy
The U.S. Food and Drug Administration told uniQure it requires a prospective, randomized, double‑blind, sham surgery‑controlled study to support marketing approval for AMT‑130, the company’s...
Roche halts emugrobart program — patients notified
Roche said it will stop development of emugrobart, an experimental treatment for spinal muscular atrophy (SMA), after a key study failed to show consistent improvements in muscle growth and motor...
Tumor WGS shows broad real‑world utility — 888‑patient study
A real‑world series of 888 patients published in Nature Medicine demonstrates that paired tumor‑normal whole‑genome sequencing (WGS) succeeds in 89% of cases with a median turnaround of six...
Lab‑grown esophagus restores swallowing in growing pig model
Researchers at Great Ormond Street Hospital and UCL reported in Nature Biotechnology that an autologous engineered esophageal segment successfully integrated and restored swallowing in growing...
AI decision support improves stroke care — cluster RCT in BMJ
A cluster‑randomized clinical trial published in The BMJ found that an AI‑driven clinical decision support system (CDSS) improved care quality and long‑term outcomes for patients with acute...
Automation push aims to make cell therapy a scalable medicine
Cellares executives outlined how automation, closed manufacturing systems, and global manufacturing networks could convert individualized cell therapies into broadly available medicines. The...
CytomX, Alto raise cash to support clinical programs
Public markets activity included CytomX’s $250 million follow‑on offering, executed after positive Phase I data for its EpCAM ADC varsetatug masetecan showing a 32% objective response rate in...
FDA clears four NMEs — approvals hit 26 in first two months
The U.S. Food and Drug Administration cleared four new molecular entities (NMEs) in the opening months of 2026, bringing the total to 26 approvals across January and February. The newly approved...
Novartis pays $2B for Synnovation’s next‑gen PI3Kα
Novartis agreed to acquire Pikavation Therapeutics, a Synnovation subsidiary, for $2 billion upfront to secure SNV4818, a mutant‑selective PI3Kα inhibitor now in early clinical testing. The deal...
Earendil raises $787M to scale AI‑driven biologics
Earendil Labs closed a $787 million financing to accelerate an AI‑powered biologics pipeline spanning autoimmune diseases and oncology. Lead investors include Dimension and Luminous Ventures;...
FDA wants sham‑surgery control for uniQure’s Huntington program
The FDA told uniQure it requires a prospective, randomized, double‑blind, sham surgery–controlled trial to support marketing of AMT‑130, the company’s one‑time AAV‑based Huntington’s disease...
Roche halts muscle‑growth drug after mixed trial results
Roche said it will stop development of emugrobart after the drug failed to consistently improve muscle growth and motor function in a key study. The Swiss pharma notified European patients in a...
Abbott set to close $23B Exact Sciences takeover
Abbott said it will close its $23 billion acquisition of Exact Sciences after receiving all regulatory clearances, a deal that expands Abbott’s presence in oncology diagnostics. Exact shareholders...
Engineered esophagus restores swallowing in growing pig model
Scientists at Great Ormond Street Hospital and University College London reported a lab‑grown esophageal graft that replaced a full segment in growing pigs and restored coordinated swallowing...
Tumor whole‑genome sequencing changes care for 41% of patients
A real‑world study of 888 solid‑tumor patients demonstrated clinical utility for routine paired tumor‑normal whole‑genome sequencing (WGS). The diagnostics succeeded in 89% of cases with a median...
FDA expands Imcivree for acquired hypothalamic obesity
The FDA broadened approval of Rhythm Pharmaceuticals’ Imcivree to include adults and children aged 4 and older with acquired hypothalamic obesity, a condition caused by hypothalamic injury and...
FDA clears four NMEs as approvals pace holds in 2026
The U.S. FDA cleared four new molecular entities (NMEs) in the first two months of 2026, part of a 26‑approval run through February. The tally—eight approvals in January and 18 in February—keeps...
Ohio to build $30M life‑science training center in New Albany
The Ohio Life Sciences Association and JobsOhio selected New Albany International Business Park as the site for a new Ohio Life Science Training Center, part of a statewide $30 million workforce...
Novartis buys next‑gen PI3Kα: $2B upfront in Synnovation pact
Novartis agreed to acquire a Synnovation unit for an upfront payment of $2 billion to secure a next‑generation PI3Kα inhibitor program aimed at HR+/HER2‑ breast cancer. The asset, SNV4818, is...
Earendil hauls in $787M: AI drugmaker scales biologics pipeline
Earendil Labs raised $787 million in a financing round to accelerate an AI‑driven biologics pipeline spanning autoimmune and oncology indications. The round included strategic investors and pharma...