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Clinical Trial News

FDA Approves Lialda for Maintenance of Remission in Ulcerative Colitis Patients

The U.S. Food and Drug Administration (FDA) has approved Shire plc's Lialda (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis, following a six-month study demonstrating its safety and effectiveness. This approval adds to Lialda's previous indication for inducing remission in patients with active, mild to moderate ulcerative colitis.

Metallic Copper as an Antimicrobial Surface: A Comprehensive Review

This article reviews the antimicrobial properties of metallic copper surfaces, highlighting their effectiveness in killing bacteria, yeasts, and viruses. It discusses the historical use of copper, its mechanism of action, and recent clinical trials demonstrating its potential in reducing hospital-acquired infections.

Global Pharmaceutical R&D Outsourcing Trends: Industry Shifts Toward Strategic Partnerships and Offshore Operations

  • Pharmaceutical companies are increasingly outsourcing R&D activities upstream in the value chain, including basic chemistry research and preclinical studies, driven by cost pressures and CRO capability expansion.
  • Clinical trials are becoming more globally distributed, with emerging markets in Asia and Eastern Europe gaining prominence alongside traditional US and European research centers.
  • IT-enabled R&D services face growing competition from global IT outsourcing and BPO providers, challenging traditional CROs in data management and programming services.

Urovant Sciences Launches GEMTESA® (vibegron) for Overactive Bladder Treatment in the U.S.

  • Urovant Sciences has commercially launched GEMTESA® (vibegron) 75 mg tablets in the U.S. for treating overactive bladder (OAB) symptoms in adults.
  • GEMTESA, a beta-3 adrenergic receptor agonist, is the first new oral branded OAB medication in nearly a decade, offering a novel treatment option.
  • Clinical studies demonstrated that GEMTESA significantly reduces key OAB symptoms compared to placebo, without association to cognitive decline.
  • Approximately 30 million Americans suffer from OAB, highlighting the importance of new treatments like GEMTESA to improve daily activities.

Global Economic Pressures Force Pharmaceutical Industry to Confront Radical Transformation

  • The pharmaceutical industry faces unprecedented challenges due to patent cliffs, pricing pressures, and a shift from blockbuster drugs to niche products, necessitating fundamental industry restructuring.
  • Healthcare systems, particularly in the UK and US, are implementing severe cost-cutting measures, with the NHS targeting £20bn in annual savings and US healthcare requiring $80bn reduction over 10 years.
  • Industry experts call for urgent reform of regulatory frameworks, including Good Clinical Practice guidelines and EU Clinical Trials directive, to maintain pharmaceutical innovation while managing rising development costs.

FDA Expands Access to Investigational Drugs for Treatment Use

The FDA has finalized a rule to expand access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy. This rule aims to increase awareness and knowledge of expanded access programs, detailing criteria, submission requirements, and safeguards for different types of expanded access.

FDA Approves Sanofi's Multaq for Atrial Fibrillation Patients, Marking First New Treatment in Two Decades

Drug Approval
  • The FDA has approved Sanofi's Multaq (dronedarone) to reduce cardiovascular hospitalization risk in patients with atrial fibrillation or atrial flutter, representing the first new treatment option in this therapeutic area in twenty years.
  • The approval is based on five clinical studies involving 6,300 patients, with the landmark ATHENA trial demonstrating a 24% reduction in cardiovascular hospitalization or death from any cause compared to placebo.
  • Multaq showed significant clinical benefits including a 28% reduction in total hospital days and 35% decrease in heart-related hospitalization time in atrial fibrillation patients.
  • The drug is contraindicated in patients with severe heart failure, following results from the ANDROMEDA trial that showed increased mortality risk in this population.

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