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Clinical Trial News

Johnson & Johnson Strengthens Neuroscience Portfolio with $14.6 Billion Intra-Cellular Acquisition

  • Johnson & Johnson completed its $14.6 billion acquisition of Intra-Cellular Therapies on April 2, marking the company's strategic re-entry into the neuroscience field.
  • The acquisition contributed to strong second-quarter performance, with the Neuroscience unit growing 14.4% year-over-year in constant currency, making it the second-fastest growing segment.
  • J&J raised full-year guidance to $93.2-93.6 billion in revenue and $10.80-10.90 adjusted EPS, up from previous projections of $91-91.8 billion and $10.50-10.70 respectively.
  • Second-quarter revenue reached $23.7 billion, representing 5.8% growth and beating analyst expectations despite acquisition-related costs.

OpenEvidence Raises $210 Million Series B to Expand AI-Powered Medical Research Platform for Physicians

AI
  • OpenEvidence, an AI-powered medical search engine for physicians, raised $210 million in Series B funding at a $3.5 billion valuation, co-led by Google Ventures and Kleiner Perkins.
  • The platform is used by over 40% of U.S. physicians daily and supports over 8.5 million clinical consultations per month, demonstrating over 2,000% year-over-year growth.
  • The company launched OpenEvidence DeepConsult, an AI agent that provides physicians with PhD-level medical research capabilities, analyzing hundreds of peer-reviewed studies in parallel.
  • Strategic partnerships with leading medical journals including JAMA and The New England Journal of Medicine enable instant access to evidence-based medical information for clinical decision-making.

Yale Researchers Engineer Novel Antibody-RNA Therapy Platform for Treatment-Resistant Cancers

Targeted Therapy
  • Yale researchers developed TMAB3, a specially engineered antibody that successfully delivers RNA therapies to treatment-resistant "cold" tumors, significantly reducing tumor size and extending survival in animal models of pancreatic, brain, and skin cancers.
  • The therapy demonstrated ability to penetrate the blood-brain barrier and target cancerous cells while avoiding healthy tissue, showing pronounced tumor suppression without severe side effects across multiple cancer types.
  • Computer modeling enabled antibody modification for RNA binding and humanization, laying groundwork for personalized immuno-RNA therapies and potential first-in-human clinical trials.

Eight Healthy Babies Born in Britain Using Three-Person DNA Technique to Prevent Mitochondrial Disease

Rare Disease
  • Eight healthy babies were born in Britain using an experimental technique that combines DNA from three people to prevent mothers from passing devastating mitochondrial diseases to their children.
  • Researchers from Newcastle University and Monash University performed the technique on fertilized embryos from 22 patients, with results published in the New England Journal of Medicine.
  • The method involves transferring genetic material from the mother's egg into a donor egg with healthy mitochondria, creating embryos free from mitochondrial diseases that can cause organ failure and death.
  • One baby showed slightly elevated abnormal mitochondria levels but remains below disease-causing thresholds, requiring ongoing monitoring as the child develops.

CSIR Launches Nationwide Phenome India Health Cohort Study to Develop Personalized Disease Risk Predictions

Precision Medicine
  • The Council of Scientific and Industrial Research has launched Phenome India, a five-year nationwide health cohort study involving over 10,000 CSIR employees to develop personalized risk prediction scores for communicable and non-communicable diseases.
  • Phase II health camps have been completed at multiple CSIR facilities, collecting comprehensive health data including blood biochemistry, molecular assays, imaging assessments, and lifestyle patterns from participants.
  • The study aims to address India's rising cardio-metabolic disorders such as diabetes, obesity, and fatty liver disease by creating precision healthcare interventions tailored to the Indian population.
  • All collected samples will be stored at CSIR Biobank under strict anonymity protocols, with data analysis using AI and machine learning approaches to advance personalized medicine research.

22nd Century Group Expands VLN Reduced-Nicotine Cigarette Partnerships Ahead of FDA Mandate

Drug Approval
  • 22nd Century Group is partnering with multiple tobacco brands including Smoker Friendly and Pinnacle to expand availability of its VLN reduced-nicotine cigarettes containing 95% less nicotine than conventional products.
  • The FDA's proposed nicotine reduction mandate would cap combustible tobacco products at 0.7 mg nicotine per gram of tobacco, with VLN products already meeting this standard at 0.5 mg per gram.
  • Clinical trials demonstrate VLN cigarettes reduce nicotine cravings by 33% and increase cessation success by 50% compared to conventional cigarettes, with no compensatory smoking behavior observed.
  • The FDA estimates the proposed standard could prevent 48 million youth and young adults from initiating smoking by 2100, representing a significant public health intervention.

Overture Orthopaedics Launches OvertureTi Knee Resurfacing System for Early Osteoarthritis Treatment

  • Overture Orthopaedics has launched the OvertureTi Knee Resurfacing System commercially in the U.S., offering a novel approach to treat early osteoarthritis and cartilage defects through partial joint resurfacing.
  • The system bridges the gap between biological repair options and full joint replacement, utilizing 3D-printed titanium implants that preserve healthy cartilage while replacing only damaged areas.
  • Following FDA 510(k) clearance in March 2023 and successful completion of approximately 150 cases during limited market release, the system addresses the growing need for cartilage restoration surgeries that exceed 300,000 annually.
  • The technology offers significant cost advantages over existing biological options, with some procedures like chondrocyte implantation costing up to $83,073 compared to this more affordable alternative.

NeoCast Liquid Embolic Shows Promise for Pain-Free Treatment of Chronic Subdural Hematoma

  • Arsenal Medical's EMBO-02 clinical trial demonstrated that NeoCast, a next-generation liquid embolic agent, achieved 100% target vessel occlusion with no related adverse events in 15 chronic subdural hematoma patients.
  • The study showed 87% of patients underwent embolization without adjunctive surgery, with 60% and 90% achieving complete hematoma resolution at 3 and 6 months respectively.
  • NeoCast was administered painlessly under conscious sedation with no patients reporting injection pain or increased headache 24 hours post-procedure.
  • The treatment represents a significant advancement in middle meningeal artery embolization for chronic subdural hematoma, offering improved controllability and patient comfort compared to existing liquid embolic agents.

Federal Circuit Invalidates Shockwave Medical's Intravascular Lithotripsy Patent in Precedential Ruling

  • The Federal Circuit invalidated all claims of Shockwave Medical's U.S. Patent No. 8,956,371 covering an angioplasty catheter system that uses intravascular lithotripsy to break up hardened plaque in blood vessels.
  • The court clarified that applicant admitted prior art (AAPA) cannot serve as the basis for invalidity grounds in IPR proceedings but can be used as evidence of background knowledge to fill in missing claim limitations.
  • CSI successfully challenged the patent through inter partes review, with the PTAB initially finding all but claim 5 unpatentable, but the Federal Circuit ultimately invalidated the remaining claim on cross-appeal.
  • The decision establishes important precedent for how AAPA can be properly used in patent invalidity proceedings while maintaining compliance with statutory limitations.

OKYO Pharma Secures $1.9M Non-Dilutive Funding Following Positive Phase 2 Results and FDA Fast Track Designation

  • OKYO Pharma has received $1.9 million in non-dilutive funding to support its pharmaceutical development programs.
  • The company has achieved promising Phase 2 trial results that have contributed to positive analyst ratings.
  • FDA has granted Fast Track designation to one of OKYO Pharma's therapeutic candidates, expediting regulatory review.
  • The combination of funding, clinical progress, and regulatory recognition positions the company for accelerated development.

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