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Sarepta Therapeutics halts Duchenne gene therapy amid FDA standoff
Gene therapy developer Sarepta Therapeutics has reversed course by temporarily pausing all shipments of Elevidys®, its treatment for Duchenne muscular dystrophy (DMD), following significant...
Biogen commits $2 billion to expand North Carolina manufacturing hub
Biogen announced an additional $2 billion investment over the next three years to expand its extensive manufacturing operations within North Carolina’s Research Triangle Park (RTP), reinforcing...
AstraZeneca’s $50 billion U.S. manufacturing and R&D expansion plan
AstraZeneca CEO Pascal Soriot announced a sweeping plan to invest $50 billion in the United States through 2030, including a $4 billion new drug manufacturing site in Virginia. The initiative...
Prime editing corrects mutations in rare childhood brain disorder
Researchers at the Broad Institute and Jackson Laboratory used prime editing to successfully correct multiple genetic mutations responsible for alternating hemiplegia of childhood (AHC) in mouse...
Polygenic risk scores predict childhood obesity and intervention outcomes
An international consortium involving over five million individuals developed multi-ancestry polygenic risk scores (PRS) that predict body mass index (BMI) and adult obesity risk from early...
FDA names biotech veteran George Tidmarsh to lead drug review office
The U.S. Food and Drug Administration appointed George Tidmarsh, an oncologist and biotech executive with leadership roles at Horizon Pharma and La Jolla Pharma, as director of the Center for Drug...
FDA denies Roche’s Columvi approval for diffuse large B-cell lymphoma
Roche reported that the FDA declined approval for Columvi (a CD20xCD3 T-cell engager) in combination with chemotherapy for patients with diffuse large B-cell lymphoma (DLBCL) ineligible for stem...
Sanner inaugurates U.S. production facility to serve pharma and MedTech
German-based Sanner has officially opened its first U.S. production plant in Greensboro, North Carolina, marking a milestone in its 134-year history. The 60,500-square-foot GMP-certified site...
FDA expands Boston Scientific’s Watchman device label to post-ablation patients
The FDA has broadened approval for Boston Scientific’s Watchman Flx and Flx Pro left atrial appendage closure devices to include patients following atrial fibrillation ablation procedures. This...
FDA Names Biotech Veteran Tidmarsh as New CDER Director
The FDA has appointed George Tidmarsh, a physician-scientist and seasoned biotech executive with experience at Horizon Pharma and La Jolla Pharma, as the director of its Center for Drug Evaluation...
Sarepta Standoff with FDA Over Duchenne Gene Therapy
Sarepta Therapeutics is embroiled in a regulatory crisis after the FDA requested a halt on its Duchenne muscular dystrophy gene therapy, Elevidys, following a third patient death, this time linked...
Polygenic Risk Scores Predict Childhood Obesity
An international study published in Nature Medicine demonstrates that polygenic risk scores (PRS) for body mass index (BMI) can predict childhood risk of adult obesity across multiple ancestries....
Alkermes Narcolepsy Drug Advances with Positive Phase 2 Results
Alkermes reported positive mid-stage clinical trial results for its oral orexin receptor agonist, alixorexton, in narcolepsy type 1 patients. The drug improved wakefulness across all doses and...
Roche’s COPD Biologic Faces Setbacks in Phase 3 Trials
Roche’s investigational IL-33-targeting antibody, astegolimab, failed to meet primary endpoints in a pivotal Phase 3 COPD trial, mirroring similar failures by Regeneron and Sanofi's biologics in...
Prime Editing Reverses Childhood Brain Disorder in Mice
Researchers at the Broad Institute and Jackson Laboratory successfully applied prime editing to correct five genetic mutations causing alternating hemiplegia of childhood (AHC) in mice. Treated...
Biotech Investment Remains Robust Amid Funding Challenges
Omega Funds closed its eighth life sciences investment fund at $647 million, sustaining its commitment to backing innovative biotech companies despite broader declines in venture capital funding....
Sanner Launches U.S. Production Facility to Boost Pharma Packaging
Sanner inaugurated its first U.S.-based manufacturing site in Greensboro, North Carolina, featuring advanced GMP-certified cleanrooms and high-speed production capabilities. This move enhances...
UCLA and Dongwoon Anatech Collaborate on Saliva-Based Cancer Diagnostics
UCLA's School of Dentistry and South Korean firm Dongwoon Anatech have forged a $2.4 million collaboration to develop saliva-based liquid biopsy technologies. The partnership aims to create a...
New Sensor Detects Plant Stress for Agriculture Advancement
Researchers developed a minimally invasive sensor capable of measuring hormone levels in plants in real-time with precision and minimal damage. This technology aims to deepen understanding of...
Sarepta Faces FDA Scrutiny After Gene Therapy Patient Deaths
Sarepta Therapeutics is under intensified regulatory scrutiny following the deaths of three patients linked to its gene therapies. The most recent fatality involved a 51-year-old man with limb...