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IDEAYA Biosciences to Present Phase 2 Darovasertib Data for Uveal Melanoma at ESMO 2025

Precision MedicineOncology
  • IDEAYA Biosciences will present Phase 2 clinical data on neoadjuvant darovasertib in primary uveal melanoma at the 2025 ESMO meeting in Berlin.
  • The presentation will include data from over 90 patients across both plaque brachytherapy and enucleation-eligible cohorts, focusing on enucleation prevention and vision preservation.
  • Darovasertib has received FDA Breakthrough Therapy Designation for neoadjuvant uveal melanoma in subjects requiring enucleation.
  • The company has initiated a multi-site, global randomized Phase 3 neoadjuvant registrational trial (OptimUM-10) in primary uveal melanoma in Q3 2025.

Roche Explores Direct-to-Consumer Drug Sales Model to Reduce US Patient Costs

  • Roche is considering selling prescription medicines directly to US consumers to lower patient costs, following government pressure to reduce drug prices.
  • The direct-to-consumer model would bypass pharmacy benefit managers, which CEO Thomas Schinecker says would help reduce costs quickly.
  • This follows similar moves by Bristol Myers and Pfizer with their blood thinner Eliquis, and existing programs by Eli Lilly and Novo Nordisk for weight-loss drugs.
  • Industry sources suggest small-molecule drugs for diabetes, cardiovascular conditions, and respiratory diseases are most viable for direct-to-consumer distribution.

Sanner Opens First U.S. Manufacturing Facility in North Carolina, Expanding Global CDMO Operations

  • Sanner Group has launched its first North American manufacturing facility in Greensboro, North Carolina, featuring a 60,500 square foot GMP-certified site with cleanrooms and advanced injection molding capabilities.
  • The facility is designed to produce critical injection-molded components for medical devices and pharmaceutical packaging, along with desiccant solutions for the North American pharmaceutical and nutraceutical industries.
  • The new facility strengthens Sanner's position as a Contract Development and Manufacturing Organization (CDMO) for the healthcare industry, combining global quality standards with local responsiveness.
  • The investment includes 20,000 square feet of expansion space and represents part of Sanner's broader global expansion strategy following recent facility openings in Germany and China.

Mass General Brigham Study Links Glipizide to 13% Higher Cardiovascular Risk in Type 2 Diabetes Patients

Real World Evidence
  • Mass General Brigham researchers analyzed data from nearly 50,000 type 2 diabetes patients and found glipizide associated with a 13% increase in cardiovascular risk compared to DPP-4 inhibitors.
  • The five-year study examined patients with moderate cardiovascular risk treated with different sulfonylureas or DPP-4 inhibitors alongside metformin across 10 study sites nationwide.
  • Glipizide showed higher incidence of heart failure, related hospitalization and death, while glimepiride and glyburide demonstrated relatively smaller and less clear cardiovascular effects.
  • The findings highlight the importance of evaluating individual drugs within pharmaceutical classes separately rather than treating them as equivalent therapeutic options.

ASTRA Therapeutics Secures CHF 7.75 Million to Develop Novel Anti-Parasitic Drugs for Veterinary Medicine

Precision Medicine
  • ASTRA Therapeutics raised CHF 7.75 million in seed funding led by MIG Capital and Digitalis Ventures to advance its proprietary ParaX® platform for developing precision anti-parasitic drugs.
  • The Swiss biotech company targets the growing veterinary parasiticide market worth over $10 billion, addressing critical drug resistance issues where up to 98% of heartworm cases resist standard therapies in some regions.
  • ASTRA's pipeline includes over 15 patentable chemical classes of Parabulins® targeting tubulin in parasites, with initial proof-of-concept demonstrated for treating coccidia in farm animals and heartworm in pets.

Novartis Partners with Matchpoint Therapeutics in $1 Billion Anti-Inflammatory Drug Development Deal

  • Swiss pharmaceutical giant Novartis has entered into a collaboration agreement with U.S. biotech Matchpoint Therapeutics worth up to $1 billion to develop oral anti-inflammatory therapies.
  • Matchpoint will lead the research and development process using its proprietary technology to create drugs that block specific protein activity and reduce inflammation-causing signals.
  • The deal includes $60 million in upfront payments and research funding, with potential milestone payments reaching $1 billion if Novartis exercises its licensing option.
  • Upon exercising the option, Novartis would gain exclusive global rights to develop and commercialize all products resulting from the collaboration.

Stanford Study Shows Ibogaine Dramatically Reduces PTSD and Depression in Veterans with Traumatic Brain Injury

  • Stanford Medicine researchers found that ibogaine treatment led to an 88% reduction in PTSD symptoms and 87% reduction in depression symptoms in 30 special operations veterans with traumatic brain injury.
  • Brain scans revealed that ibogaine alters neural activity by increasing theta rhythms associated with neuroplasticity and reducing cortical complexity linked to stress responses.
  • The psychedelic compound, derived from African iboga shrub roots, showed no serious side effects and improved veterans' cognitive function, memory, and concentration within one month of treatment.
  • Based on these findings, Texas approved a $50 million initiative to fund clinical trials of ibogaine, representing one of the largest government investments in psychedelic therapy.

FDA Grants Priority Review for Flibanserin Expansion to Postmenopausal Women with HSDD

Drug Approval
  • The FDA has granted Priority Review to a supplemental new drug application seeking to expand flibanserin 100 mg (Addyi) indication to include postmenopausal women with hypoactive sexual desire disorder.
  • Flibanserin is currently the only FDA-approved, non-hormonal oral therapy for low sexual desire in premenopausal women, and this expansion would address an unmet need for postmenopausal women.
  • The application is supported by robust clinical trial data from the largest clinical trials in women's sexual health, with Health Canada already approving the drug for postmenopausal women based on the same evidence.
  • If approved, this would represent the first FDA-approved pharmacologic therapy for HSDD in postmenopausal women, potentially benefiting the estimated 40% of women who experience low sexual desire at some point in their lives.

Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

NCT01057901TerminatedPhase 3
Sprout Pharmaceuticals, Inc
Posted 1/1/2010

Intranasal Insulin Successfully Reaches Memory Centers in Alzheimer's Brain Imaging Study

  • A first-in-human imaging study demonstrates that intranasal insulin can safely reach 11 key brain regions involved in memory and cognition in older adults, including the hippocampus and amygdala.
  • The study enrolled 16 participants with a mean age of 72 years and used radiolabeled insulin with PET brain scans to measure real-time uptake across memory-related brain areas.
  • Cognitively normal adults showed higher insulin uptake compared to those with mild cognitive impairment, who demonstrated faster clearance and lower cumulative insulin delivery.
  • The findings provide critical validation for intranasal drug delivery systems and establish a foundation for future therapeutic trials targeting Alzheimer's disease and mild cognitive impairment.

Incyte Reports Strong Q2 2025 Results with Jakafi Growth and New Drug Approvals

Drug ApprovalMonoclonal AntibodyOncology
  • Incyte reported strong second quarter 2025 financial results with Jakafi net revenues of $764 million, representing 8% year-over-year growth driven by increased demand across all indications.
  • The company achieved two significant regulatory milestones with FDA approvals of Zynyz for squamous cell anal carcinoma and Monjuvi for follicular lymphoma, expanding treatment options for cancer patients.
  • Niktimvo, launched in Q1 2025, demonstrated continued strong commercial uptake with $13.6 million in sales, while Opzelura revenues grew 35% to $164 million driven by increased patient demand in both atopic dermatitis and vitiligo.
  • The company raised its 2025 revenue guidance for Jakafi and other oncology products, reflecting strong first-half performance and successful product launches.

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

NCT06388564RecruitingPhase 2
Incyte Corporation
Posted 10/11/2024

MAXPIRe: Study to Evaluate Axatilimab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT06132256RecruitingPhase 2
Syndax Pharmaceuticals
Posted 12/11/2023

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

NCT06585774RecruitingPhase 3
Incyte Corporation
Posted 1/21/2025

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