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Sanofi Expands Respiratory Vaccine Pipeline: $1.15B Vicebio Buyout
Sanofi is set to acquire Vicebio Ltd., a privately held UK biotech specializing in respiratory virus vaccines, for $1.15 billion upfront with up to $450 million in potential milestone payments....
Sarepta Therapeutics Faces FDA Safety Crisis Over Duchenne Gene Therapy
Sarepta Therapeutics has temporarily halted shipments of its Duchenne muscular dystrophy gene therapy Elevidys following safety concerns tied to three patient deaths linked to acute liver failure....
FDA Names George Tidmarsh to Lead CDER Amid Drug Review Challenges
The FDA appointed George Tidmarsh, an accomplished biotech executive and Stanford professor with expertise spanning oncology and pediatrics, as director of its Center for Drug Evaluation and...
Replimune’s Melanoma Virus Therapy Gets FDA Rejection, Shares Drop 75%
Replimune Group’s application for approval of RP1, a viral-based treatment for advanced melanoma, was rejected by the FDA for inadequate and uncontrolled clinical investigation and trial design...
Omega Funds Closes $647 Million Biotech Venture Capital Fund
Omega Funds closed its eighth investment fund, raising $647 million targeted at U.S. and European life sciences companies addressing unmet medical needs. The fund nearly matched the size of the...
Neuralink Hits Double Brain Implant Milestone, Eyes 20 Procedures by Year-End
Neuralink has performed two brain-computer interface implants in a single day for the first time, advancing its total human implants to nine and pushing toward a goal of 20 procedures by the end...
Pancreatic Cancer Stress Pathway Identified for Early Detection Opportunities
Researchers discovered a molecular pathway used by pancreatic cancer cells to adapt to stress and inflammatory conditions, which could serve as an early warning system for aggressive pancreatic...
Asia-Pacific Biotechs Drive Innovation in Extracellular Vesicle Drug Delivery
Biotech startups in the Asia-Pacific region are pioneering the use of extracellular vesicles (EVs) for drug delivery, leveraging their low immunogenicity, natural tissue targeting, and ability to...
Single-Cell Study Reveals Mechanisms of Nasopharyngeal Cancer Radioresistance and Immune Escape
A Chinese research team applied integrated single-cell and spatial transcriptomic techniques to characterize molecular features of recurrent nasopharyngeal carcinoma (rNPC), uncovering key...
Sanofi Bolsters Respiratory Vaccine Pipeline With $1.15 Billion Vicebio Buy
Sanofi announced a $1.15 billion acquisition of London-based biotechnology company Vicebio, including potential milestone payments up to $450 million, to expand its respiratory virus vaccine...
Sarepta Faces FDA Scrutiny, Halts Duchenne Therapy Shipments Amid Safety Concerns
Sarepta Therapeutics has temporarily paused shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy (DMD), following an escalating standoff with the FDA. The FDA requested a halt...
FDA Rejects Replimune’s Melanoma Oncolytic Virus Therapy Amid Regulatory Shift
The FDA issued a complete response letter rejecting Replimune Group’s oncolytic virus drug for advanced melanoma, citing inadequate single-arm trial design and patient heterogeneity. The agency...
Neuralink Hits Milestone with Two Brain-Computer Interface Implants in a Day
Neuralink, Elon Musk’s neurotechnology company, successfully performed two brain-computer interface (BCI) implants within 24 hours, marking a significant operational milestone. With nine human...
Prime Editing Advances for Rare Neurodevelopmental Disorder in Animal Models
Researchers at the Broad Institute and Jackson Laboratory demonstrated that prime editing can successfully correct five genetic mutations causing alternating hemiplegia of childhood (AHC), a...
Largest Four-Day Workweek Trial Shows Improved Employee Wellbeing Without Productivity Loss
A multinational study spanning six countries found that transitioning to a four-day workweek, without pay reduction, enhances employee happiness, mental and physical health, and job satisfaction...
Genetic Signatures Partners with Tecan and Repado to Automate Infectious Disease Testing
Australian molecular diagnostics firm Genetic Signatures announced a strategic partnership with automation provider Tecan and IVD software developer Repado to create fully integrated syndromic...
Danaher Reports 4% Revenue Growth With Continued China Market Headwinds
Danaher reported second quarter revenues of $5.94 billion, up 4% year-over-year, driven primarily by robust growth in its bioprocessing division despite challenges in China’s diagnostics business....
FDA Panel Questions Safety and Efficacy of Antidepressants in Pregnancy, Calls for Stricter Labeling
A Food and Drug Administration advisory panel expressed concerns over the use of selective serotonin reuptake inhibitors (SSRIs) during pregnancy, discussing potential risks to fetal...
Sarepta and FDA Face Off Over Duchenne Gene Therapy
Sarepta Therapeutics is embroiled in a regulatory crisis as the FDA has requested a voluntary halt to shipments of Elevidys, Sarepta's gene therapy for Duchenne muscular dystrophy (DMD), following...
Sanofi Expands Respiratory Vaccine Portfolio with Vicebio Acquisition
Sanofi announced a $1.15 billion upfront acquisition of UK-based biotech Vicebio, gaining early-stage combination vaccine candidates targeting respiratory syncytial virus (RSV) and human...