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FDA Delays and Drug Approvals Shake Rare Disease and Gene Therapy Landscape
Regulatory shifts are impacting the rare disease and gene therapy sectors. The FDA has delayed its decision on Regenxbio’s gene therapy for Hunter syndrome by three months, prolonging uncertainty...
Merck KGaA and Skyhawk Team Up for $2B RNA Neurological Drug Program
Merck KGaA partnered with RNA-focused biotech Skyhawk Therapeutics in a collaboration potentially worth up to $2 billion targeting neurological diseases. Skyhawk will leverage its SkySTAR platform...
Novo Nordisk’s Wegovy Gains FDA Label Expansion for Fatty Liver Disease MASH
Novo Nordisk's GLP-1 agonist Wegovy received accelerated FDA approval for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), expanding its label to a patient population...
Viking Therapeutics’ Oral Obesity Drug Shows Mixed Phase 2 Results, Stock Falls
Viking Therapeutics reported Phase 2 data for VK2735, an oral obesity drug demonstrating up to 12.2% weight loss after 13 weeks at the highest dose. While efficacy met statistical benchmarks, high...
AI Advances Propel Drug Delivery and Protein Design Innovations
Researchers harnessed artificial intelligence to revolutionize RNA vaccine and drug delivery design, using machine learning to accelerate lipid nanoparticle (LNP) formulation, yielding candidates...
Breakthroughs in Plant Biology and Sustainable Biomaterials
Multiple studies are advancing plant science and biomaterials. Researchers at University of Missouri revealed how poplar trees dynamically regulate lignin composition in response to environmental...
New Therapeutic Strategies and Diagnostics in Oncology and Neurodegeneration
Recent oncology and neurodegenerative disease research unveiled promising findings. Moffitt Cancer Center discovered a combination therapy to overcome immunotherapy resistance in melanoma. In...
Innovations in Medical Devices and Regenerative Medicine
Innovations in medical technology and regenerative therapies are progressing. Ochsner Children’s conducted the first robotic-assisted pediatric spine surgery in Louisiana enhancing precision and...
Biotech Financing and Market Trends Reflect Sector Challenges and Opportunities
Financing activities and market analyses reveal sector dynamics. Gene therapy company Kriya Therapeutics raised $313 million to support clinical advancement amid waning investor enthusiasm in the...
Novo Nordisk Expands Wegovy Indication to Fatty Liver Disease MASH
Novo Nordisk has secured FDA accelerated approval for Wegovy, its GLP-1 drug, to treat metabolic dysfunction-associated steatohepatitis (MASH), a common variant of fatty liver disease. The new...
Kriya Therapeutics Raises $313M to Advance Gene Therapy Pipeline
Kriya Therapeutics, a U.S.-based gene therapy company, has completed a $313 million Series financing, one of the largest private biotech fundraises of the year. The company focuses on developing...
Adaptive Biotechnologies and Genentech End $2B Cancer Cell Therapy Collaboration
After over six years of partnership, Adaptive Biotechnologies and Genentech are winding down their $2 billion strategic collaboration focused on personalized cancer cell therapies using T cell...
Skyhawk Therapeutics Inks $2B Neurology RNA Splicing Deal with Merck KGaA
Skyhawk Therapeutics announced a newly formed RNA splicing-focused collaboration with Merck KGaA valued at up to $2 billion. The partnership targets neurological diseases, with Skyhawk deploying...
Stealth BioTherapeutics Resubmits FDA Application for Rare Barth Syndrome Drug
Stealth BioTherapeutics has resubmitted its regulatory application for an investigational therapy targeting Barth syndrome, an ultra-rare genetic disorder, following an FDA rejection earlier in...
Anocca Secures $46M to Advance TCR Cell Therapy for Pancreatic Cancer
Swedish biotech Anocca AB has raised $46 million to fund a phase I clinical trial testing its CRISPR-edited T-cell receptor (TCR) immunotherapy targeting KRAS mutations in pancreatic cancer. The...
Breakthrough in Lipid Nanoparticle Design via AI Accelerates RNA Therapies
Researchers at MIT have developed an AI-driven approach using a transformer-based neural network named Composite Material Transformer (COMET) to design optimized lipid nanoparticles (LNPs) for RNA...
Neuralink Files as Small Disadvantaged Business Despite $9B Valuation
Elon Musk’s brain-computer interface company, Neuralink, has labeled itself a “small disadvantaged business” (SDB) in an April federal filing, despite recently raising $650 million at a $9 billion...
Clinical Progress in Novel Immunotherapies and Cancer Targets
Recent clinical developments highlight advances in oncology therapeutics. A Moffitt Cancer Center study identifies combination therapies to overcome immunotherapy resistance in melanoma, while...
Advances in Prenatal Diagnostics and Pediatric Disease Insights
Innovations in prenatal and pediatric medicine continue to emerge. The discovery of the “tulip sign” as an acoustic marker aids hypospadias detection in prenatal ultrasounds. Studies link prenatal...
Novo Nordisk’s Wegovy Expands FDA Label to Fatty Liver Disease MASH
The U.S. Food and Drug Administration has granted accelerated approval for Novo Nordisk’s GLP-1 agonist Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH), a prevalent form of...