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Clinical Trial News

Reappraisal of US Clinical Trials on Post-Treatment Lyme Disease Syndrome

  • Two out of four U.S. treatment trials demonstrated the efficacy of IV ceftriaxone on primary and/or secondary outcome measures for post-treatment Lyme fatigue.
  • Treatment guidelines should clarify that IV ceftriaxone for post-treatment Lyme fatigue was demonstrated effective in one RCT and supported by a second RCT.
  • Repeated IV antibiotic therapy can be effective, but safer modes of delivery are needed due to adverse events stemming from the IV route of treatment.
  • Future studies must also begin to address non-antibiotic strategies to help improve persistent symptoms.

Sanofi and Bristol-Myers Squibb Restructure Alliance Following Patent Expirations

  • Sanofi gains worldwide rights to Plavix and Avapro/Avalide from Bristol-Myers Squibb, except for Plavix in the US and Puerto Rico, effective January 2013.
  • Bristol-Myers Squibb will receive royalty payments on Sanofi's global Plavix sales through 2018, culminating in a $200 million terminal payment.
  • The restructuring follows patent expiration of both drugs and aims to streamline operations, with Sanofi expecting a $1.85 billion impact on net income due to generic competition.

Study Confirms Efficacy of Ulipristal Acetate as Emergency Contraception

A comprehensive study across multiple clinics in the U.S. and Europe has confirmed the efficacy of ulipristal acetate as an emergency contraceptive, showing a significant reduction in pregnancy rates when administered within 48 to 120 hours after unprotected intercourse. The study also compared its effectiveness and safety profile with levonorgestrel, another emergency contraceptive, finding ulipristal acetate to be non-inferior and well-tolerated.

Pharma Giants Embrace Open Science: Pfizer, Merck Lead Industry Transformation

  • Major pharmaceutical companies are adopting innovative open science initiatives, with Pfizer exploring social media for clinical trials and Merck funding CALIBR with significant investment for biomedical research.
  • The open science movement is gaining momentum through three key pillars: open access to scientific data, easy access to research tools, and community collaboration, paralleling the successful open source software model.
  • Janssen has established a groundbreaking research innovation center in San Diego, offering fully equipped laboratories and expertise access to 20 small drug discovery companies, marking a significant shift in pharmaceutical R&D approach.

NIH Expert Outlines Critical Challenges and Solutions in Rare Disease Clinical Trials

  • The Office of Rare Diseases Research (ORDR) at NIH has launched the Global Rare Disease Patient Registry and Data Repository (GRDR) to facilitate research and clinical trials across 6,800+ known rare diseases.
  • Patient identification and recruitment remain major challenges in rare disease trials, with affected populations often small and geographically dispersed, requiring new clinical study models.
  • The ORDR is implementing solutions through standardized data collection, biospecimen linking, and increased collaboration between patient advocacy groups, researchers, and pharmaceutical companies.

Strategic Clinical Trial Outsourcing Could Save Pharma Industry Billions, Experts Say

  • Clinical trial outsourcing could help address the $5 billion annual cost of unnecessary trial procedures in the pharmaceutical industry, offering potential savings in time and resources.
  • Key outsourcing challenges include contracting delays, vendor comparison difficulties, and interest alignment, with preferred vendor systems emerging as a potential solution.
  • Emerging markets present unique opportunities for clinical trial outsourcing but require careful navigation of cultural differences, data standards, and regulatory requirements.

Global Clinical Trials: Navigating Challenges and Opportunities in Modern Drug Development

  • Global clinical trials offer significant advantages including lower development costs and faster timelines, with ClinicalTrials.gov now hosting over 100,000 trials across 180 countries.
  • Conducting multinational trials presents complex challenges in trial design, execution, and analysis, requiring careful consideration of ethnic diversity, regulatory requirements, and regional healthcare differences.
  • Strategic collaboration between government, industry, and academia is crucial for advancing global trial methodologies, particularly in areas like rare disease research and patient registries.

Global Biosimilars Market Set to Reach $2-3 Billion by 2015 as Industry Faces Development Challenges

  • The biosimilars market is projected to experience significant growth over the next 10-15 years, driven by patent expirations of branded biologics and healthcare cost reduction pressures.
  • Unlike generic drugs, biosimilar development requires a complex, integrated approach combining regulatory compliance, strategic clinical development, and targeted commercialization planning.
  • Companies must navigate varying regulatory frameworks across markets, with the FDA adopting a stepwise approach aligned with EMA guidelines while offering unique considerations for interchangeability.

Global Biosimilars Market Set to Reach $3.99 Billion by 2017 as Industry Embraces Complex Biologics

  • The biosimilars market is experiencing rapid growth, with projections showing an expansion from $172 million in 2010 to $3.99 billion by 2017, driven by patent expirations of major biologics.
  • Over 90 companies are actively developing monoclonal antibodies (MAbs) across 200 indications, with current market sales exceeding $40 billion and significant growth potential.
  • European regulatory environment remains favorable for biosimilar development, while the US market is opening up with new FDA draft guidance aligned with EU standards.

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