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Replimune’s oncolytic virus melanoma therapy rejected by FDA
The FDA issued a complete response letter rejecting Replimune Group’s Biologics License Application for RP1, an oncolytic virus therapy combined with nivolumab for advanced melanoma. The agency...
Abivax ulcerative colitis drug shows strong Phase 3 results amid funding pressures
French biotech Abivax’s oral drug obefazimod demonstrated statistically significant clinical remission rates in twin Phase 3 trials for moderate to severe ulcerative colitis, surpassing previous...
Automation and AI-driven advances in biomanufacturing and mRNA production
Emerging innovations in biomanufacturing are leveraging automation, AI, and advanced modeling to streamline processes and reduce costs. Notably, new mathematical models for in vitro transcription...
AstraZeneca commits $50 billion to US manufacturing and R&D expansion
AstraZeneca announced a $50 billion investment plan to expand its U.S. manufacturing and research infrastructure through 2030, including the largest facility it has ever built in Virginia focused...
Cancer immunotherapy innovations and biotech fundraising
The cancer immunotherapy sector sees emerging approaches and substantial funding rounds aiming to tackle solid tumors. Dispatch Bio, a startup backed by $216 million from investors including the...
Biotech industry earnings and market outlook for CDMOs and diagnostics
Contract development and manufacturing organizations (CDMOs) including Lonza, Thermo Fisher, and Samsung Biologics reported earnings exceeding expectations despite client funding challenges and...
Breakthrough cancer and neurodegenerative research advances
Novel research highlights promising therapeutic strategies across oncology and neurology. Identification of autoantibodies influencing immunotherapy response offers a route to improved cancer...
Genomic and bioinformatics innovations enhance precision medicine
Advances in human genome sequencing reveal complex gene duplications linked to brain function and evolutionary traits. Bioinformatics collaborations, such as between TileDB and Databricks,...
Innovations in RNA technology and therapeutic development
Orbital Therapeutics’ next-generation circular RNA technology advances in vivo CAR-T cell therapy development, potentially offering improved delivery and gene expression profiles. Concurrently,...
Thermo Fisher Posts Q2 Beat, Sets Leadership Transition
Thermo Fisher Scientific reported a 3% year-over-year revenue increase to $10.86 billion in Q2, surpassing analyst estimates with a 6% rise in life sciences solutions revenue. Net income reached...
Sarepta's Duchenne Gene Therapy Hits Regulatory Roadblocks
Sarepta Therapeutics faced significant setbacks as the FDA demanded a halt of its Duchenne muscular dystrophy gene therapy Elevidys amid safety concerns following multiple patient deaths due to...
Sanofi Expands Respiratory Vaccine Pipeline with Vicebio Acquisition
Sanofi announced a $1.15 billion upfront acquisition of London-based biotech Vicebio, gaining an early-stage vaccine candidate targeting RSV and human metapneumovirus. The deal includes potential...
Dispatch Bio Launches with $216M to Target Solid Tumors via Novel CAR-T
Dispatch Bio debuted with $216 million in funding to develop a universal immunotherapy for solid tumors. The approach uses a dual mechanism with a viral vector tagging cancer cells and CAR-T or...
Abivax’s Ulcerative Colitis Drug Posts Dual Phase 3 Successes
French biotech Abivax reported positive results from two Phase 3 trials of its oral treatment obefazimod for moderate to severe ulcerative colitis. The pooled clinical remission rate was 16.4%...
AstraZeneca Commits $50B to U.S. Manufacturing and R&D Expansion
AstraZeneca announced plans to invest $50 billion in the U.S. over the next five years for manufacturing and research facilities, including the company’s largest-ever plant in Virginia. The...
Gene Editing Brings Hope for Rare Neurodevelopmental Disorder Treatment
Researchers utilized prime editing technology to correct five mutations responsible for alternating hemiplegia of childhood (AHC), a rare neurodevelopmental disorder. The approach demonstrated up...
Danaher Posts Revenue Growth Despite China Headwinds
Danaher’s Q2 revenue rose nearly 4% year-over-year to $5.94 billion, beating estimates driven by robust bioprocessing sales. Despite ongoing headwinds from China’s volume-based procurement and...
New Insights into Brain Aging Acceleration During COVID-19 Pandemic
A study analyzing brain scans from nearly 1,000 individuals revealed accelerated brain aging in healthy people during the COVID-19 pandemic, regardless of infection status. The effect was most...
Advances in Molecular Diagnostic Automation from Genetic Signatures Partnership
Australian molecular diagnostics firm Genetic Signatures formed a partnership with Tecan and Repado to integrate infectious disease testing with automated liquid handling and regulatory compliant...
Sanofi Expands Respiratory Vaccine Pipeline With $1.15B Vicebio Buyout
Sanofi has agreed to acquire UK-based biotech Vicebio in a deal totaling up to $1.6 billion, including $1.15 billion upfront. Vicebio’s lead asset, VXB-241, a bivalent vaccine targeting...