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Sarepta gene therapy standoff: shipments paused amid FDA safety probe
Sarepta Therapeutics has temporarily halted all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following mounting safety concerns and an FDA request. The pause follows...
Sanofi secures early vaccine tech with $1.15 billion Vicebio acquisition
Sanofi has agreed to acquire the vaccine-focused biotech Vicebio for $1.15 billion upfront, plus $450 million in milestone payments, expanding its respiratory syncytial virus (RSV) vaccine...
Prime editing reverses rare childhood brain disorder in mice, opens therapeutic avenues
Researchers from the Broad Institute and Jackson Laboratory have successfully applied prime genome editing to correct multiple mutations underlying alternating hemiplegia of childhood (AHC), a...
Biogen commits $2 billion to expand North Carolina manufacturing campuses
Biogen announced a $2 billion investment over the next three years to expand and modernize its manufacturing facilities in North Carolina’s Research Triangle Park. The expansion will enhance...
AstraZeneca pledges $50 billion toward US manufacturing and R&D growth
AstraZeneca confirmed plans to invest $50 billion in the United States by 2030, focusing on manufacturing and research facilities expansion. The commitment includes a $4 billion new factory in...
Alkermes advances narcolepsy treatment with positive mid-stage trial results
Alkermes reported favorable Phase 2 data for alixorexton, an orexin receptor agonist aimed at treating narcolepsy type 1, showing significant improvements in wakefulness and reductions in daytime...
FDA appoints former biotech exec George Tidmarsh as new drug review chief
The FDA has named George Tidmarsh, a Stanford-trained oncologist and experienced biopharma CEO, as the director of the Center for Drug Evaluation and Research (CDER). Tidmarsh brings extensive...
New polygenic risk scores enable childhood prediction of adult obesity
Scientists have developed multi-ancestry polygenic risk scores (PRS) that predict an individual’s likelihood of developing adult obesity based on genetic variants present early in life. An...
Radiotherapy induces genomic and immune shifts in breast cancer tumors
A Phase 2 clinical trial reversing standard breast cancer treatment order has revealed how radiotherapy alone impacts tumor biology. Delivering radiation before surgery allowed researchers at MD...
Orbital Therapeutics enters CAR-T field with circular RNA preclinical data
Orbital Therapeutics, a secretive startup pioneering circular RNA technology, released its first preclinical data demonstrating in vivo CAR-T cell therapy potential in non-human primates. The...
Sanofi Pays $1.15B Upfront for Vaccine Biotech Vicebio Acquisition
Sanofi is advancing its respiratory vaccine pipeline by acquiring London-based Vicebio for $1.15 billion upfront, with additional payments possible based on clinical milestones. Vicebio's lead...
Sarepta’s Duchenne Gene Therapy Shipments Paused Amid FDA Dispute
Sarepta Therapeutics reversed its previous refusal and agreed to temporarily pause shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD), following a request from the FDA....
FDA Names Biotech Veteran George Tidmarsh as New CDER Director
The FDA has appointed George Tidmarsh, a Stanford professor and former biotech executive, as the new director of its Center for Drug Evaluation and Research (CDER). Tidmarsh brings extensive...
Alkermes Advances Narcolepsy Program with Positive Phase 2 Wakefulness Data
Alkermes reported positive Phase 2 trial results for its orexin receptor agonist alixorexton in narcolepsy type 1 patients, showing statistically significant improvements in wakefulness and...
Prime Editing Corrects Genetic Mutations in Rare Childhood Brain Disorder
Researchers at the Broad Institute and Jackson Laboratory used prime editing in mouse models to correct genetic mutations causing alternating hemiplegia of childhood (AHC), a rare...
Biogen Commits $2 Billion for Manufacturing Expansion in North Carolina
Biogen announced a $2 billion investment to expand its manufacturing capabilities across multiple modalities at its Research Triangle Park campuses. The expansion strengthens antisense...
FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma
The FDA declined approval of Roche’s Columvi in combination therapy for second-line diffuse large B-cell lymphoma (DLBCL) patients ineligible for stem cell transplant, citing insufficient evidence...
Omega Funds Closes $647 Million Life Sciences Investment Fund
Boston-based Omega Funds raised $647 million for its eighth biotech venture fund, supporting innovative life sciences companies in the U.S. and Europe. The fund aims to back company creation,...
AstraZeneca Plans $50 Billion US Investment in Manufacturing and R&D
AstraZeneca plans to spend $50 billion on U.S. manufacturing and research through 2030, including a new $4 billion facility in Virginia, aiming to expand drug production, R&D, and cell therapy...
Breast cancer radiotherapy shifts genomic landscape pre-surgery
A Phase 2 clinical trial at the University of Texas MD Anderson Cancer Center has revealed that delivering radiotherapy prior to surgical removal in estrogen receptor-positive breast cancer...