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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...
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....