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Sarepta Shares Plunge After Third Gene Therapy Patient Dies
Sarepta Therapeutics faced a 36% stock drop following the death of a third patient treated with its gene therapies for muscular dystrophies. The latest fatality involved a 51-year-old man with...
FDA Panelists’ Anti-Antidepressant Bias Surfaces Ahead of Review
A recent Food and Drug Administration panel on antidepressant use during pregnancy featured several members with longstanding skepticism toward SSRIs. These experts have published work linking the...
Hookipa Pharma Announces Liquidation After Asset Sales to Gilead
Hookipa Pharma declared plans to delist from Nasdaq and liquidate following the sale of its vaccine assets to Gilead Sciences. The immunotherapy biotech cited lack of revenue-generating products...
Advanced PCR Automation Targets Diagnostic Workflow Bottlenecks
Seegene introduced its CURECA system, a fully automated, end-to-end PCR platform designed to eliminate manual workflow interruptions in molecular diagnostics. CURECA integrates all steps from...
Biosimilar Competition Sharpens as Stelara Faces Multiple Challengers
Johnson & Johnson’s autoimmune drug Stelara (ustekinumab) is encountering biosimilar competition from seven approved products with deep price discounts. Unlike the Humira biosimilar market,...
Gene Therapy Manufacturing Faces Scale-Up Challenges and Solutions
The market for adeno-associated virus (AAV) gene therapies is expanding toward treatments for common diseases like Alzheimer’s and cardiovascular conditions. This growth demands scalable,...
Click Chemistry Enables Targeted, Safer Cancer Therapy in Humans
For the first time, click chemistry — a Nobel-recognized technology — has been used clinically to direct chemotherapy agents specifically to tumors, minimizing systemic toxicity. This...
New Phylogenetic Analysis Redraws Transposon Regulatory Landscape
Researchers from Kyoto University and McGill University employed phylogenetic methods to better classify endogenous retrovirus subfamilies within transposable elements (TEs), which comprise nearly...
Researchers Engineer Bacteria to Produce Animal-Free Milk Proteins
Scientists have successfully genetically modified E. coli bacteria to synthesize key milk proteins essential for cheese and yogurt production, enabling dairy-free products with molecular...
AAV Gene Therapy Manufacturing Scale-Up: De-Risking Production Challenges
The AAV gene therapy field is scaling beyond rare genetic diseases to address larger patient populations including cardiovascular and neurological conditions like Alzheimer’s and Parkinson’s....
Stelara Biosimilars Race: Pricing and Interchangeability Factors
With 88 biologics facing exclusivity loss, Stelara biosimilars are under scrutiny as manufacturers compete for market share in autoimmune diseases. Stelara, J&J's top seller in 2024 with $10.4...
CMS Medicare Proposal Sparks Provider Concerns Over Physician Payments
CMS proposed a 2.4% payment boost for outpatient hospital departments and ambulatory surgery centers in 2026 alongside a two-tiered physician reimbursement framework tied to value-based care...
Roche’s Astegolimab Fails Phase 3 in COPD, Delaying Approval Prospects
Roche announced its anti-ST2 monoclonal antibody astegolimab failed to reduce flare-ups in a pivotal Phase 3 study for chronic obstructive pulmonary disease (COPD). The setback significantly dims...
Cloudbreak Pharma Eyes Phase 3 After Positive Phase 2 Eye Drop Trial
Cloudbreak Pharma achieved its primary endpoint in Phase 2 for eye disease candidate CBT-004, an eye drop formulation. Encouraged by this mid-stage success, the company plans to advance CBT-004...
Seegene’s CURECA System: Toward Fully Unattended PCR Automation
Seegene is developing CURECA, the world’s first fully unattended PCR automation platform designed for continuous, 24/7 operation without human intervention. Addressing critical workflow gaps like...
Click Chemistry Used Safely in Humans to Target Tumors
Researchers have applied click chemistry, a Nobel Prize-winning technique, for the first time in human cancer patients to selectively deliver chemotherapy directly to tumors. This approach...
Phylogenetic Approach Uncovers Regulatory Roles of Transposons in Primate Genomes
A new study published in Science Advances by Kyoto University and McGill University researchers used phylogenetic analysis and cross-species conservation to annotate transposable element...
Hookipa Pharma to Liquidate After Asset Sales and Merger Collapse
Hookipa Pharma announced plans to delist from Nasdaq and fully liquidate following the sale of its key vaccine assets to Gilead and the cancellation of a merger with Poolbeg Pharma. With no...
Sarepta Shares Dive Post Patient Death in LGMD Gene Therapy Trial
Sarepta Therapeutics’ shares plummeted 36% after a third patient treated with its LGMD gene therapy SRP-9004 died from acute liver failure in a Phase 1 trial. This follows two earlier patient...
Seegene Launches CURECA: Fully Automated PCR System
Seegene is pioneering an end-to-end PCR automation platform named CURECA intended to revolutionize molecular diagnostics workflows. Unlike conventional automation that addresses isolated steps,...