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Clinical Trial News

US Universities Drive 87% of Academic Patents Supporting FDA Drug Approvals from 2020-2024

Drug Approval
  • US universities contributed patents supporting half of all FDA-approved drugs between 2020 and 2024, demonstrating their critical role in pharmaceutical innovation.
  • American academic institutions accounted for 87% of all university-based patents linked to FDA drug approvals during this four-year period.
  • The analysis examined patent data from the FDA's Orange Book, revealing the substantial impact of US-based research on global pharmaceutical development.
  • These findings underscore the prominence of American universities in driving medical treatment advances and pharmaceutical research efforts worldwide.

Semaglutide Demonstrates Safety and Efficacy for Weight Loss in Schizophrenia Patients

  • University of Queensland researchers conducted a 36-week trial showing semaglutide is safe and effective for weight loss in people with schizophrenia without affecting psychotic symptoms.
  • Study participants on semaglutide lost almost 14 percent of their bodyweight compared to placebo, with improved lean mass to fat mass ratio indicating preferential fat loss.
  • The findings provide world-first evidence addressing weight gain from antipsychotic medications, which contributes to a 16-year life expectancy gap in schizophrenia patients.
  • Researchers advocate for PBS listing of semaglutide for this population, as many patients cannot afford out-of-pocket costs for this treatment.

Nicoya Lifesciences Acquires Applied Photophysics to Create Integrated Biologics Characterization Platform

Drug Discovery
  • Nicoya Lifesciences has acquired UK-based Applied Photophysics, a 50-year-old provider of biophysical characterization instrumentation, to create a comprehensive biologics analysis platform.
  • The acquisition is expected to immediately double Nicoya's annual revenue, triple its customer base, and establish a foundation for 25% projected organic growth.
  • The combined platform integrates Surface Plasmon Resonance systems with Circular Dichroism, nanoDSF, and stopped-flow technologies to provide complete characterization of complex biologics from a single provider.
  • Applied Photophysics' UK headquarters will become Nicoya's European operational hub, significantly expanding the company's global reach and customer support capabilities.

Bexorg Partners with Biohaven to Advance CNS Drug Development Using AI-Driven Whole-Brain Discovery Platform

AI
  • Bexorg announced a multi-program research collaboration with Biohaven to identify and advance next-generation therapies for central nervous system disorders using its novel whole-brain discovery platform.
  • The platform represents the only technology capable of perfusing isolated human and pig brains with artificial blood to restore metabolic activity for prolonged periods, enabling unprecedented preclinical testing.
  • Bexorg's technology will support two preclinical development programs at Biohaven by demonstrating target engagement and generating biomarkers, pharmacokinetic data, and mechanistic insights.
  • The collaboration aims to overcome traditional translational gaps in CNS drug discovery by providing detailed insights into pharmacology and efficacy before advancing to clinical trials.

Green Valley Pharmaceutical Suspends Production of Controversial Alzheimer's Drug GV-971 Amid License Renewal

Drug Approval
  • Green Valley Pharmaceutical has suspended production and sales of GV-971, China's first indigenous Alzheimer's therapy, after its license expired and entered regulatory review.
  • The seaweed-derived compound sodium oligomannate received conditional approval in 2019 but faced criticism from medical experts over inconsistent clinical trial results and short study duration.
  • Hospital and retail sales of GV-971 reached $45.4 million in 2022, while China's dementia patient population represents 17 million people, about 30% of the global total.
  • The company's global clinical trial launched in 2020 was terminated in 2022 due to funding shortages and COVID-19 pandemic disruptions.

US Small Molecule API CDMO Market Projected to Reach $12.49 Billion by 2030 Driven by FDA Approvals and HPAPI Demand

FDA Approval
  • The US Small Molecule Innovator API CDMO Market is valued at $8.78 billion in 2024 and expected to reach $12.49 billion by 2030, growing at a 6.03% CAGR.
  • Rising demand for highly potent active pharmaceutical ingredients (HPAPIs) across oncology, cardiovascular, and neurological disorders is driving market expansion.
  • In 2024, 50 novel drug approvals by the FDA, including new molecular entities and biologics, are boosting demand for specialized CDMO services.
  • CDMOs are evolving into strategic partners offering integrated end-to-end solutions, from early research to commercial-scale production, to support faster drug development timelines.

Nuevocor Receives FDA IND Clearance for Gene Therapy Targeting Rare Genetic Heart Disease

Rare Disease
  • Nuevocor announced FDA clearance of its Investigational New Drug application for NVC-001, an AAV-based gene therapy designed to treat LMNA-related dilated cardiomyopathy.
  • The therapy targets approximately 100,000 patients in the U.S. and Europe with this aggressive form of genetic heart disease that rapidly progresses to end-stage heart failure.
  • NVC-001 demonstrated significant benefits in survival and cardiac function in preclinical studies by addressing the mechanobiological root cause of disease.
  • The company plans to initiate a first-in-human Phase 1/2 clinical trial in early 2026 to evaluate safety, tolerability, and preliminary efficacy.

FDA Manufacturing Issues Delay Unicycive's Kidney Disease Drug Approval Process

Drug Approval
  • The FDA has identified manufacturing deficiencies at a third-party vendor for Unicycive Therapeutics' oxylanthanum carbonate, an investigational oral phosphate binder for kidney disease patients on dialysis.
  • The manufacturing issues have precluded FDA label discussions with the company, though a final decision is still expected by the June 28 PDUFA action date.
  • Oxylanthanum carbonate uses proprietary nanoparticle technology to deliver high phosphate binding potency while reducing pill burden for patients with hyperphosphatemia.
  • Unicycive's stock fell 27% in premarket trading following the announcement, as the company works with partners to resolve the FDA's cGMP compliance concerns.

AbbVie's Skyrizi and Rinvoq Drive Recovery as Humira Sales Plummet 50% Following Patent Loss

Drug Approval
  • AbbVie expects robust revenue growth in 2025, just two years after losing U.S. exclusivity for Humira in January 2023, with the flagship drug's sales declining nearly 50% to $1.12 billion in Q1 2025.
  • The company's ex-Humira platform grew over 21% year-over-year in Q1 2025, driven by newer immunology drugs Skyrizi and Rinvoq, which showed strong performance across inflammatory bowel disease indications.
  • AbbVie raised its guidance by $900 million and now expects $24.7 billion in combined sales from Skyrizi and Rinvoq this year, with potential for five new Rinvoq indications.
  • The immunology market remains highly competitive with Johnson & Johnson's Stelara and Tremfya, and Eli Lilly's recently approved Omvoh for ulcerative colitis and Crohn's disease.

AIML Innovations Secures Provisional Patents for AI-Powered ECG Signal Processing Technology

AI
  • AI/ML Innovations Inc. has filed comprehensive provisional patent applications with the USPTO through its subsidiary Neural Cloud Solutions, covering advanced neural network architectures and cloud-based ECG signal optimization workflows.
  • The patent filings protect key innovations within AIML's proprietary AI signal-processing platforms MaxYield™ and CardioYield™, including a dynamic ECG reporting engine that supports clinical workflows with customizable components.
  • These patents strengthen AIML's position in AI-assisted cardiology by protecting both algorithmic foundations and deployment infrastructure, supporting the company's global commercialization strategy.
  • The company maintains a growing regulatory portfolio including a 510(k) premarket notification and registered FDA Device Master File, demonstrating commitment to rigorous validation and broad interoperability.

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