Get the Daily Brief
Latest Biotech News
Biogen Announces $2B Expansion of Manufacturing Capacity in North Carolina
Biogen plans to invest an additional $2 billion over the next three years to expand operations at its Research Triangle Park campuses in North Carolina. The expansion will enhance multiple...
Sarepta Duchenne Gene Therapy Shipment Paused amid Safety Concerns
Sarepta Therapeutics has voluntarily paused shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following FDA requests amid safety concerns linked to acute liver failure and...
Sanofi Buys Vicebio for $1.15 Billion to Expand Respiratory Vaccine Portfolio
Sanofi has agreed to acquire UK-based respiratory vaccine specialist Vicebio for $1.15 billion upfront plus up to $450 million in development and regulatory milestones. The acquisition brings...
AstraZeneca Pledges $50 Billion U.S. Investment for Manufacturing and R&D
AstraZeneca unveiled plans to invest $50 billion in U.S. manufacturing and research operations through 2030, over a 14-fold increase from previous commitments. Key components include constructing...
FDA Leadership Change: George Tidmarsh Named CDER Director
FDA Commissioner Marty Makary named George Tidmarsh, an accomplished physician-scientist and biotech executive with oncology and pediatrics expertise, as the new director of the Center for Drug...
FDA Rejects Replimune’s Oncolytic Virus Therapy for Melanoma
The FDA issued a complete response letter rejecting Replimune's melanoma drug candidate RP1, an oncolytic virus therapy combined with nivolumab, citing inadequate and uncontrolled clinical trial...
Breakthrough: Prime Editing Corrects Mutations in Rare Neurological Disorder
Researchers from the Broad Institute and Jackson Laboratory demonstrated in a mouse model that prime editing can correct five genetic mutations causing alternating hemiplegia of childhood (AHC), a...
Novel Therapies and Clinical Advances in Immunotherapy and Neurology
Multiple studies highlight progress in immunotherapy and neurological diseases. Engineered IL-18 variants with improved pharmacological properties show promise for cancer treatments. Myogenic...
Gene Editing for Conservation and Wheat Biofortification Advances
Emerging applications of gene editing reach biodiversity conservation and agriculture. Scientists propose using genome engineering to restore genetic diversity in endangered species, such as the...
Biotech Financing and Industry Funding Trends in 2025
Despite market challenges, biotech sector sees significant financing activities. Omega Funds closed a $647 million fund aimed at investing in U.S. and European life sciences startups, matching its...
AstraZeneca's $50 Billion U.S. Expansion Plan
AstraZeneca has amplified its investment in the U.S. with a commitment of $50 billion for manufacturing and R&D projects over the next five years. The centerpiece is a major manufacturing facility...
Sanofi Acquires Vicebio to Expand Respiratory Vaccine Portfolio
Sanofi announced the acquisition of London-based biotechnology Vicebio for $1.15 billion upfront with up to $450 million in milestone payments. Vicebio's pipeline includes an experimental bivalent...
Sarepta's Duchenne Gene Therapy Under Regulatory Scrutiny and Shipment Pause
Sarepta Therapeutics is facing mounting challenges surrounding its Duchenne muscular dystrophy (DMD) gene therapy, Elevidys. After three patient deaths linked to liver failure, including a case...
FDA and Biotech Leadership Changes Amid Increasing Regulatory Challenges
The FDA has appointed George Tidmarsh, a seasoned biotech executive and Stanford professor, as director of the Center for Drug Evaluation and Research (CDER), a key leadership role during a period...
Replimune’s Melanoma Therapy Faces FDA Rejection
The FDA has issued a complete response letter rejecting Replimune Group’s oncolytic virus therapy RP1 for advanced melanoma, citing inadequate and poorly controlled clinical studies that failed to...
Advances in Cancer and Immunotherapy Research
Recent studies and clinical trials are shedding new light on cancer biology and immunotherapy. Key findings include the identification of transfer RNA-derived small RNAs impairing NK cell function...
Neuralink Hits Milestone with Two Brain Implants in One Day
Neuralink announced it has successfully performed two brain-computer interface implant surgeries in a single day, bringing the total number of human participants to nine. This achievement advances...
Genomic Editing and Conservation Biology
An international scientific team proposed using gene editing to restore genetic diversity in endangered species by leveraging historical DNA samples from museum specimens, biobanks, and related...
Innovations in AI and Bioinformatics for Drug Discovery
Jura Bio introduced VISTA, an AI data loop system for large-scale de novo antibody design, addressing gaps in functional annotation crucial for drug discovery. The system synergizes genomic...
Alkermes Advances Narcolepsy Treatment with Positive Phase 2 Data
Alkermes reported positive Phase 2 trial results for its orexin receptor agonist, alixorexton, in patients with narcolepsy type 1, demonstrating statistically significant improvements in...