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Sarepta Therapeutics’ Duchenne Gene Therapy Resumes Shipments for Ambulatory Patients
Following FDA investigation clearing the recent death as unrelated, the agency lifted the voluntary hold on Sarepta Therapeutics’ Elevidys gene therapy shipments for ambulatory patients with...
Merck Plans $3 Billion Cost Cuts by 2027 to Redirect Investment to New Drug Launches
Pharma giant Merck announced a comprehensive cost-cutting initiative aiming to save $3 billion annually by the end of 2027. This includes reductions in administrative, sales, and R&D positions,...
Apellis Pharmaceuticals Gains FDA Approval for Rare Kidney Diseases with Empaveli
Apellis Pharmaceuticals secured FDA approval to expand the label of its complement C3 inhibitor, Empaveli (pegcetacoplan), to treat patients aged 12 and older with complement 3 glomerulopathy...
Novo Nordisk Faces Sales Downgrade and CEO Transition Amid Obesity Drug Challenges
Novo Nordisk downgraded its 2025 sales growth forecast to 8%-14% from 13%-21%, citing competition from low-cost semaglutide generics affecting blockbuster obesity drug Wegovy. Operating profit...
Novel Oncolytic Virus Shows Promise in Pediatric Brain Tumors with Early Clinical Data
Engineered oncolytic adenovirus Ad-TD-nsIL12 is demonstrating encouraging results in two early-phase clinical trials targeting diffuse intrinsic pontine glioma (DIPG), a pediatric brain tumor with...
Multiomics and Machine Learning Enhance Cancer and Neonatal Disease Diagnostics
Integrating multiomics approaches with AI and machine learning is transforming disease detection and prognosis. Studies include a plasma synuclein test offering sensitive Parkinson’s diagnosis,...
FDA Shakeup: Vinay Prasad Departs Amid Sarepta Gene Therapy Controversy
The abrupt departure of Dr. Vinay Prasad, former head of the FDA's Center for Biologics Evaluation and Research (CBER), has spurred significant market reactions and raised questions about the...
Advances in Neonatal Care and Therapies
Several studies highlight critical innovations in neonatal care. New research published in the Journal of Perinatology explores rapid team deployment strategies to accelerate urgent neonatal...
Cancer Biology: Tumor Microenvironment and Metastasis Mechanisms
Groundbreaking research is unraveling complex interactions within the tumor microenvironment. The protein SPON2 has been identified as a driver of osteosarcoma progression via M2 macrophage...
Breakthroughs in Epigenetics and Immune Dysregulation in Disease
Recent proteomic and epigenomic studies are redefining pathophysiological understanding in cancer and neurodegeneration. A Nature Communications paper reveals autocrine interferon signaling...
Gene Editing Advances Powered by AI: CRISPR Automation and AI-Designed Therapeutics
Artificial intelligence is increasingly integrated into gene editing technologies. The innovative CRISPR-GPT system automates design and conduct of gene-editing experiments through large language...
Regulatory and Market Trends: Biotech Financial Moves and Leadership Changes
The biotech industry is witnessing significant financial and leadership developments. Novo Nordisk named Mike Doustdar as incoming CEO amid a sharp downgrade of sales forecasts for its obesity...
Cancer Diagnostic and Therapeutic Innovations
Several companies have reported advancements in cancer diagnostics and treatments. Saga Diagnostics achieved Medicare coverage for its Pathlight molecular residual disease test for breast cancer...
Innovations in Rare Disease and Genetic Therapeutics
Recent advances in gene and cell therapies include FDA approvals and promising trial results. PTC Therapeutics obtained FDA approval for Sephience, an oral therapy for phenylketonuria, expanding...
Environmental and Agricultural Innovations
Research teams have developed transformative technologies for environmental and agricultural applications. Carnegie Mellon University scientists employed AI-generated synthetic images to enhance...
FDA Reverses Course on Sarepta’s Duchenne Therapy Amid Safety Review
The FDA has permitted Sarepta Therapeutics to resume shipments of its gene therapy Elevidys for ambulatory patients with Duchenne muscular dystrophy (DMD) following an investigation that concluded...
Novo Nordisk Cuts Sales Forecast, Names New CEO amid Obesity Drug Pressure
Novo Nordisk has substantially lowered its 2025 sales growth expectations for its obesity and diabetes treatment portfolio, including GLP-1 agonists Ozempic and Wegovy, citing increased...
Apellis Pharmaceuticals Expands Empaveli Approval for Rare Kidney Diseases
Apellis Pharmaceuticals received FDA approval to broaden the labeling of its complement C3 inhibitor, Empaveli (pegcetacoplan), for treatment of complement 3 glomerulopathy (C3G) and primary...
Bristol Myers Squibb Spins Off Immunology Drugs in $300M Bain-Backed Startup
Bristol Myers Squibb is divesting five immune-modulating drug candidates, including three already in clinical development, to a newly formed biotech company financed with $300 million led by Bain...
Merck Plans $3 Billion Cost Cuts with Strategic Focus Shift to New Drugs
Facing declining revenue from blockbuster products like Keytruda and Gardasil, Merck announced an ambitious $3 billion annual cost-saving program to be completed by 2027. The initiative includes...