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Lupin Partners with Takeda to Launch Novel Acid Blocker Vonoprazan in India

  • Lupin has secured a non-exclusive patent license agreement with Takeda Pharmaceutical to commercialize Vonoprazan, a potassium-competitive acid blocker (P-CAB), in India under the brand name Lupivon.
  • The Drug Controller General of India has approved Vonoprazan for treating gastric ulcers, reflux esophagitis, duodenal ulcers, and Helicobacter pylori eradication, addressing a significant medical need in the country.
  • The launch addresses a substantial patient population in India, where gastroesophageal reflux disease affects 5-28.5% of people and peptic ulcer disease impacts approximately 8% of the population.

Three Major Trends Reshaping Precision Medicine: AI, CRISPR, and mRNA Technologies Lead Innovation

  • Precision medicine deals reached $97.39 million in 2023, with cell therapies projected to generate over $52 billion by 2029, marking significant growth in personalized treatment approaches.
  • AI is revolutionizing precision medicine by accelerating genomic data analysis, drug discovery, and enabling personalized treatment predictions through platforms like Tempus and Foundation Medicine.
  • CRISPR gene editing achieved a milestone with FDA approval of Casgevy for sickle cell disease, while mRNA technology expands beyond COVID-19 with Moderna's mRESVIA approval for RSV.

Osemitamab Plus Nivolumab and CAPOX Shows Encouraging Efficacy in G/GEJ Cancer

  • Updated data from the TranStar102 trial shows Osemitamab, Nivolumab, and CAPOX combination yields a 68% confirmed objective response rate.
  • The median progression-free survival reached 14.2 months in patients with high/medium CLDN18.2 expression and known PD-L1 status.
  • The triple combination therapy demonstrates a manageable safety profile, with most treatment-related adverse events being grade 1 or 2.
  • These results suggest Osemitamab's potential in improving outcomes for patients with advanced gastric/gastroesophageal junction cancer.

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

NCT04495296RecruitingPhase 1
Suzhou Transcenta Therapeutics Co., Ltd.
Posted 8/13/2020

A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

NCT04396821Active, Not RecruitingPhase 1
Suzhou Transcenta Therapeutics Co., Ltd.
Posted 5/28/2020

Sidra Medicine Launches Clinical Trials Program for Rare Pediatric Diseases in the Arab Region

  • Sidra Medicine initiates a clinical trials program focusing on rare and complex diseases affecting children in the Arab region, addressing a significant data gap.
  • The program aims to provide personalized treatment options, particularly for children with genetic ancestries unique to the Middle East, who are often overlooked in drug development.
  • Sidra Medicine's trials will cover conditions like Congenital Hyperinsulinism, Spinal Muscular Atrophy, and pediatric cancers, utilizing medicines and procedures approved for adults but not yet for children.
  • The initiative includes rigorous ethical reviews and partnerships with global institutions and pharmaceutical companies, positioning Sidra Medicine as a regional leader in pediatric clinical research.

Study Finds No Short-Term Benefit of Adding Revascularization to Medical Therapy for Carotid Stenosis

  • A multicenter randomized trial reveals no advantage in adding revascularization to optimized medical therapy for patients with carotid stenosis in the first two years of treatment.
  • The study included patients with both asymptomatic and symptomatic carotid stenosis of 50% or greater who had a five-year predicted ipsilateral stroke risk below 20%.
  • Researchers are continuing follow-up to five years after randomization to determine if revascularization might provide benefits over a longer timeframe.

SciSparc Advances Cannabinoid-Based Therapies for CNS Disorders, Including Autism

  • SciSparc has enrolled the first patient in its clinical trial for SCI-210, a cannabinoid-based treatment for Autism Spectrum Disorder (ASD) in children.
  • The company's pipeline includes SCI-110 for Tourette Syndrome and Alzheimer's agitation, and SCI-160 for pain management, all leveraging cannabinoid pharmaceuticals.
  • SciSparc has expanded its intellectual property portfolio with recent patents in the U.S., Canada, and Europe, enhancing its competitive position.
  • Through MitoCareX Bio, SciSparc is also involved in cancer drug discovery, targeting mitochondrial SLC25 proteins.

Organon Expands Dermatology Portfolio with $1.2 Billion Acquisition of Dermavant

  • Organon is set to acquire Dermavant for up to $1.2 billion, gaining Vtama (tapinarof) cream, a commercialized plaque psoriasis drug.
  • Vtama, a non-steroidal topical cream, is under FDA review for atopic dermatitis, with a decision expected in Q4, potentially triggering a $75 million milestone payment.
  • Organon aims to leverage its global reach to maximize Vtama's commercial potential, combining Dermavant's U.S. presence with Organon's market access and regulatory expertise.
  • Roivant's sale of Dermavant aligns with its strategy to focus on specialty drug candidates with blockbuster potential, following previous sales and new subsidiary launches.

Subclinical HSV-1 Reactivation Common in Solid Organ Transplant Recipients

  • A study of solid organ transplant (SOT) recipients found frequent subclinical Herpes Simplex Virus-1 (HSV-1) reactivation, highlighting potential risks.
  • Researchers observed that 80% of SOT recipients experienced HSV-1 shedding, with most episodes occurring without visible lesions.
  • Longer shedding episodes correlated with higher viral titers, suggesting a potential link to adverse patient outcomes post-transplantation.
  • The findings underscore the need for further investigation into the impact of subclinical HSV-1 reactivation in immunocompromised individuals.

Stirred-Tank Bioreactors Enhance CAR-T Cell Efficacy in Tumor Microenvironments

  • A novel CAR-T cell manufacturing process using stirred-tank bioreactors (STBs) demonstrates improved efficacy in simulated tumor microenvironments.
  • STB-produced CAR-T cells exhibit a higher proportion of CD8 T cells, crucial for directly killing tumor cells, compared to static cultures.
  • Lower CD4/CD8 ratios in STB-manufactured CAR-T cells correlate with enhanced patient responsiveness to CAR-T cell treatment.
  • The optimized bioprocessing method shows potential for improving CAR-T cell therapies targeting HER2-positive breast cancer.

FDA to Decide on Govorestat for Classic Galactosemia by November 28 After Advisory Committee Not Required

  • The FDA has completed its late-cycle review meeting for govorestat, a treatment for Classic Galactosemia, and an advisory committee meeting will not be required.
  • The Prescription Drug User Fee Act (PDUFA) target action date for govorestat remains on track for November 28, 2024, indicating a decision is expected by then.
  • Govorestat, a CNS penetrant Aldose Reductase Inhibitor, has shown clinical benefits in children with Galactosemia, improving daily living activities and reducing plasma galactitol levels.
  • Applied Therapeutics is preparing for the potential approval of govorestat with a focus on patient access, physician awareness, and payor engagement.

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