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Clinical Trial News

UK Issues Class 2 Recall for Zaditen Eye Drops Batch Due to Potential Microbial Contamination Risk

Drug Recall
  • The UK's MHRA has issued a class 2 medicines recall for batch 4V64 of Zaditen 0.25 mg/ml eye drops solution due to a manufacturing event that may increase microbial contamination risk.
  • Approximately 11,360 packs of the affected batch were distributed starting January 27, 2025, with an expiration date of September 30, 2026.
  • Healthcare professionals must immediately stop supplying the batch and quarantine all remaining stock for return to suppliers.
  • No adverse events or product quality complaints have been reported to date, and the recall is being conducted as a precautionary measure.

Cingulate Appoints Chief Legal Officer as Company Prepares FDA Filing for Novel ADHD Treatment

  • Cingulate Inc. has appointed Nilay Patel as Chief Legal Officer ahead of submitting a new drug application to the FDA for CTx-1301, an innovative ADHD treatment.
  • The company's lead candidate CTx-1301 utilizes proprietary Precision Timed Release technology to deliver three precisely timed medication releases in a single tablet.
  • ADHD affects over 20 million diagnosed patients in the U.S., with current treatments failing to provide full active-day duration of action.
  • CTx-1301 is designed to address the long-standing challenge of providing entire active-day efficacy with rapid onset and extended duration coverage.

Suvoda and Greenphire Complete Merger to Create Integrated Clinical Trial Technology Platform

  • Suvoda and Greenphire have successfully completed their merger, creating a unified clinical trial technology company under the Suvoda name with expanded capabilities for trial management and patient support.
  • The combined company will offer an integrated platform that unifies randomization, trial supply management, patient payments, and financial management solutions to streamline clinical trial workflows.
  • Led by CEO Jagath Wanninayake, the merged entity is backed by Thoma Bravo as lead investor, with support from Bain Capital Tech Opportunities Fund and LLR Partners.
  • The company now supports over 1,800 trials across 95 countries and serves more than one million active trial participants through 25,000 investigative research teams worldwide.

Salarius Pharmaceuticals' Seclidemstat Gains Validation as LSD1 Inhibitor in New Studies While Phase 1/2 Trial Advances

  • Two recently published animal studies provide additional validation for seclidemstat's mechanism of action as an LSD1 inhibitor, supporting its potential role in cancer treatment.
  • Salarius' Phase 1/2 clinical study at MD Anderson Cancer Center is actively enrolling patients with MDS and CMML, with study updates expected later this year.
  • The company continues to advance its planned merger with Decoy Therapeutics, which would create a combined entity focused on peptide conjugate therapeutics for respiratory viruses and cancer.

Nature Study Validates LIXTE's PP2A Inhibitor LB-100 for Enhanced Cancer Immunotherapy

  • A Nature study led by MD Anderson researchers found that ovarian cancer patients with PPP2R1A mutations had significantly better overall survival when treated with immune checkpoint blockade therapy.
  • The findings validate LIXTE's approach with LB-100, a PP2A inhibitor that targets the same pathway affected by PPP2R1A mutations and enhances interferon gamma response.
  • LIXTE is currently testing LB-100 in combination with checkpoint immunotherapy in two clinical trials for ovarian clear cell carcinoma and colorectal cancer.
  • The company expects first clinical results from these studies in the second half of 2025.

Durvalumab and Tremelimumab in Treating Participants With Recurrent or Refractory Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

NCT03026062Active, Not RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 5/18/2017

Alvotech Acquires Swiss Packaging Specialist Ivers-Lee to Expand Biosimilar Manufacturing Capacity

  • Alvotech has acquired Ivers-Lee Group, a Swiss family-owned pharmaceutical packaging company founded in 1947, to expand its assembly and packaging capabilities ahead of three new biosimilar launches in 2025.
  • The acquisition integrates Ivers-Lee's GMP-licensed and FDA-approved facilities in Switzerland and Germany into Alvotech's Technical Operations division while maintaining the company as a separate legal entity.
  • Ivers-Lee brings specialized capabilities in autoinjector assembly, pre-filled syringe packaging, and safety device manufacturing to support Alvotech's growing global demand for biosimilar medicines.
  • The strategic move strengthens Alvotech's manufacturing infrastructure as the company prepares for increased sales growth in global markets with existing approved biosimilars to Humira and Stelara.

Phesi CEO Warns of Impending Phase 3 Trial Failures Due to Site Oversaturation and Complex Design

AI
  • Phesi analysis reveals Phase 3 trials across multiple indications face avoidable failure due to overly complex design and lack of real-world data integration.
  • Atopic dermatitis trials exemplify the crisis, with recruiting sites surging 205% in four years while one California investigator manages 14 concurrent AD studies.
  • AI-powered data analytics could simplify trial metrics and improve site selection, with EASI and %BSA showing near-perfect correlation in AD patient populations.
  • The company's Digital Patient Profile analysis suggests opportunities to reduce patient burden without compromising scientific rigor through smarter endpoint selection.

Centivax Secures $45 Million Series A to Advance Universal Flu Vaccine into Phase I Clinical Trial

  • Centivax raised an oversubscribed $45 million Series A round led by Future Ventures to advance its universal flu vaccine through Phase I clinical trials beginning within eight months.
  • The company's epitope-focusing platform technology demonstrated universal immunity against all tested influenza viruses in preclinical studies across multiple animal models and human immune organoids.
  • Former Pfizer and Merck vaccine executive Dr. Emilio Emini joined the board of directors, bringing extensive experience in vaccine development including contributions to Prevnar.
  • The Phase I trial will test the vaccine's efficacy against over twenty flu strains using the gold-standard hemagglutination inhibition assay in direct comparison with existing seasonal flu vaccines.

Lupin Secures $50 Million Licensing Deal with Zentiva for Global Certolizumab Pegol Biosimilar Rollout

  • Lupin has entered into a strategic licensing and supply agreement with Czech-based Zentiva to commercialize its biosimilar version of Certolizumab Pegol across multiple global markets.
  • Under the agreement, Zentiva will handle marketing and distribution in Europe and CIS countries while Lupin retains commercialization rights in the United States, Canada, and other regions.
  • Zentiva will make milestone-based payments of up to $50 million to Lupin, including a $10 million upfront payment, with both companies jointly investing in biosimilar development.
  • The partnership aims to expand Lupin's market reach and provide cost-effective biosimilar alternatives to patients worldwide through Zentiva's extensive European commercial infrastructure.

Johnson & Johnson Seeks European Approval to Expand AKEEGA for Metastatic Prostate Cancer with Genetic Alterations

Drug ApprovalPrecision Medicine
  • Janssen-Cilag applied to the European Medicines Agency to expand AKEEGA usage for adults with metastatic hormone-sensitive prostate cancer who have homologous recombination repair gene alterations.
  • Over 20% of mHSPC patients have HRR gene alterations, including BRCA1/2 genes, and these patients often experience worse outcomes with limited treatment options.
  • The application is supported by Phase 3 AMPLITUDE study results showing the niraparib and abiraterone acetate combination significantly delayed cancer progression and symptom worsening.
  • AKEEGA combines niraparib and abiraterone acetate, targeting a specific patient population with genetic changes that affect DNA repair mechanisms.

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