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Celcuity’s Breast Cancer Combo Wins Phase 3 — FDA Filing Next
Celcuity has reported positive Phase 3 clinical trial data for its breast cancer combination therapy, achieving primary endpoints with a significant reduction in mortality risk in certain patient...
FDA Investigates Safety of Sarepta’s Elevidys Gene Therapy
The FDA has initiated an investigation into the death of an 8-year-old Brazilian boy following treatment with Elevidys, Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy. In...
Replimune’s $900M Oncolytic Virus Faces FDA Setback
Replimune's RP1 oncolytic virus therapy, designed for anti-PD-1 refractory melanoma, received a complete response letter from the FDA, signaling a significant regulatory hurdle despite encouraging...
Abivax Shares Rally on Phase III Ulcerative Colitis Data, $747M Raise
French biotech Abivax surged after its oral ulcerative colitis drug obefazimod exceeded Phase III expectations. The company raised $747.5 million through a Nasdaq offering, oversubscribed five...
Ivermectin Mass Administration Cuts Malaria Transmission in Kenya
A large cluster-randomized trial in Kwale, Kenya, demonstrated that monthly mass administration of ivermectin reduced malaria infections by 26% in children aged 5–15. Published in The New England...
Mitophagy Pathways Uncovered: New Therapy Avenue for Parkinson’s
Researchers at the University of Vienna detailed molecular mechanisms initiating mitophagy through transmembrane cargo receptors, offering insights into selective mitochondrial degradation....
GenAI and Real-World Data: 4 Keys to Pharma Insights
Pharma companies deploying AI-powered real-world data analytics must prioritize platform usability, data agnosticism, transparency, and flexibility to generate actionable insights. Effective GenAI...
Theta-Frequency DBS Enhances Cognitive Control in Parkinson’s
Neuroscientists have demonstrated that theta-frequency deep brain stimulation targeting basal ganglia areas can improve conflict resolution and cognitive functions in Parkinson’s disease patients....
Cancer Immunity: Microbiota’s Role Post-Radiotherapy
New research highlights how the gut microbiota modulates immune responses following radiotherapy, influencing cancer treatment outcomes. This evolving understanding reveals that microbiome...
GSK's Major Licensing Deal With Hengrui Pharma Expands COPD Pipeline
GlaxoSmithKline has entered a landmark agreement with Jiangsu Hengrui Pharmaceuticals, paying $500 million upfront for rights to the experimental COPD drug HRS-9821 along with options on 11...
Abivax Surge on Phase III Ulcerative Colitis Data and $747M Offering
Abivax's shares soared after reporting positive Phase III trial results for its oral ulcerative colitis drug obefazimod, triggering massive investor demand that expanded its offering to nearly...
FDA Rejects Replimune’s RP1 Oncolytic Virus, Signaling Regulatory Shift
The FDA issued a complete response letter for Replimune’s RP1 oncolytic virus therapy, causing its stock to plunge by 75%. Despite promising Phase II data showing response rates surpassing...
FDA Investigates Death Linked to Sarepta’s Elevidys Duchenne Therapy
The FDA is probing the death of an 8-year-old Brazilian boy who had received Sarepta Therapeutics’ Elevidys gene therapy for Duchenne muscular dystrophy. Shipment of Elevidys has been voluntarily...
Mass Ivermectin Use Reduces Malaria Transmission in Kenya Trial
A large-scale cluster-randomized trial in Kwale, Kenya, demonstrated that mass administration of ivermectin to children aged 5–15 reduced new malaria infections by 26% beyond standard bed net use....
Mitophagy Pathways Uncovered: New Therapeutic Avenues for Parkinson’s
Researchers at the University of Vienna have delineated molecular mechanisms by which transmembrane cargo receptors initiate mitophagy, a selective autophagy process important in Parkinson’s...
AI's Role in Pharma Real-World Data Insights Faces Regulatory and Usability Tests
Although generative AI (GenAI) generates excitement in healthcare analytics, life sciences companies require platforms that offer data agnosticism, transparency, and regulatory compliance to...
Neuromodulation and Microbiome Therapies Show Promise in Parkinson’s
Recent advances in Parkinson’s disease research include theta-frequency deep brain stimulation (DBS) enhancing conflict resolution and a pilot study demonstrating the safety of fecal microbiota...
Emerging Guidelines and Therapeutic Targets Revamp Hematology and Oncology
New clinical guidelines from the European Hematology Association and European Myeloma Network are transforming care for smoldering multiple myeloma, emphasizing risk stratification and early...
Microbial and Plant Immunity Mechanisms Drive Agricultural and Biological Innovations
Frontline research has unveiled mechanisms such as a root-based N-hydroxypipecolic acid circuit regulating Arabidopsis immunity and growth, and complex genetic bases of sorghum mold resistance...
FDA Rejection Rocks Replimune’s Oncolytic Virus Program
The FDA’s recent complete response letter to Replimune’s RP1 oncolytic virus therapy marks a pivotal regulatory setback, signaling a stricter era for oncology drug approvals. RP1, engineered with...