Clinical Trial News

Daily cigarette smokers may qualify for a UAB research study involving online screening, 8 contacts over 6 months, and trying varenicline or nicotine patches/lozenges. Compensation available. More info at https://redcap.musc.edu/surveys/?s=8JWFT9XFY3FYR7Y3.

Johnson & Johnson's Phase II SKIPPirr study of IV RYBREVANT in advanced NSCLC patients with EGFR ex19del or L858R mutations met primary endpoint of reducing infusion-related reactions (IRRs) to 22.5% with dexamethasone prophylaxis, compared to 67.4% historically. No Grade 3 or higher IRRs reported, and all IRRs were Grade 1 or 2.

Europe approves sotatercept (Winrevair; Merck) as a combination treatment for pulmonary arterial hypertension (PAH) in World Health Organization Functional Class II to III patients, following FDA approval. Based on the Phase 3 STELLAR trial, sotatercept improved exercise capacity, reduced risk of death or clinical worsening, and improved functional class. The drug, a first activin signaling inhibitor, is administered subcutaneously every 3 weeks.

Merck announces positive Phase 3 trial results for GARDASIL 9, showing reduced HPV-related anogenital persistent infection in Japanese males ages 16-26. The vaccine met primary and secondary endpoints, with plans to share data with regulatory authorities in Japan and other countries to support licensure for use in males.

Entero Therapeutics to exclusively license Data Vault's QOLPOM and FotoDigm software for GI clinical trials, with plans to secure up to $3 million in strategic investment. The deal aims to improve clinical trial compliance and outcomes, leveraging Data Vault's technology for Entero's phase 3 latiglutenase trial for celiac disease.

The DCGI suspended Entod Pharmaceuticals' approval for PresVu eye drops due to concerns over misuse and overselling of benefits, despite the company's planned October launch. Entod plans to challenge the suspension in court.

Indies Pharma Jamaica is the first Jamaican company to have an ANDA approved by the FDA, unlocking a $400 million market for its generic drug Regadenoson, used for heart disease diagnostics. The company plans to divest its anti-cancer drug due to market shrinkage and aims to secure a distributor for its new drug in the U.S.

A real-world report supports recombinant porcine factor VIII (rpFVIII) for treating bleeding in adults with acquired hemophilia A, with no new safety concerns. The study aligns with Phase 2/3 trial results, showing no hypersensitivity or thromboembolic events. rpFVIII is recommended as first-line treatment in EU, UK, and US guidelines, with 74% of initial bleeding events resolved after treatment.

FDA commissioner Robert Califf defends agency's standards amid criticism for granting full approval to Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys and Travere Therapeutics’ drug Filspari for IgAN, despite failed Phase 3 trials.

MHRA approves Dupixent (dupilumab) as the first targeted biologic for uncontrolled COPD in the UK, based on phase 3 studies showing significant reduction in exacerbations and improved lung function. NICE and SMC to review for reimbursement.