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Clinical Trial News

Disease Rarity and Clinical Benefits Drive Rare Disease Drug Pricing in Germany's AMNOG System

  • Germany's AMNOG system evaluates rare disease drugs based on multiple factors, with drugs treating ultra-rare conditions generally commanding higher prices while staying below €50 million annual sales threshold.
  • Analysis of over 20 rare disease drugs reveals that G-BA benefit ratings significantly influence pricing, with treatments like Spinraza and Orkambi securing higher reimbursements due to demonstrated clinical benefits.
  • Clinical trial design and comparator choice show less impact on pricing decisions, with German payers focusing more on data robustness and incremental benefits regardless of trial methodology.

Medtronic's DiamondTemp Ablation System Receives FDA Approval for Atrial Fibrillation Treatment

  • Medtronic's DiamondTemp Ablation (DTA) system has gained FDA approval for treating recurrent, symptomatic paroxysmal atrial fibrillation (AF) in patients unresponsive to drug therapy.
  • The DTA system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds, offering real-time feedback for precise lesion creation.
  • Clinical trials demonstrated the DTA system's safety and effectiveness, with improved procedural efficiencies like shorter RF ablation times and reduced saline infusion volumes.
  • The DIAMOND-AF trial showed a 96.7% freedom from patient complication rate in the DTA group, compared to 93.4% in the control group (P<0.0001).

Sangamo Therapeutics Charts Pragmatic Course in Gene Editing Evolution, Balancing Innovation with Viability

• Sangamo Therapeutics has strategically diversified beyond pure gene editing, building a three-pillar approach across gene therapy, ex vivo editing, and in vivo genome engineering to ensure financial sustainability.
• Under CEO Sandy Macrae's leadership, Sangamo has secured $1.6 billion in funding, established six big pharma partnerships, and developed proprietary zinc finger technology for precise genetic manipulation.
• The company emphasizes cautious progression in genome editing, focusing initially on rare diseases while building evidence for broader applications, with manufacturing capability seen as critical for long-term success.

US Biosimilar Market Set for $100 Billion Cost Reduction as Adoption Accelerates

  • The US biosimilar market has shown significant growth with 20 approved products, projected to reduce drug costs by $100 billion over the next five years through increased competition and adoption.
  • Recent oncology biosimilars in bevacizumab, trastuzumab, and rituximab markets are achieving record market share, expected to reach 60% combined volume share within two years of launch.
  • Regulatory changes have expanded biosimilar categories to include 90 new molecules, with insulin biosimilars poised to enter the market and potentially transform diabetes care costs.

A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

NCT06348199RecruitingPhase 3
Samsung Bioepis Co., Ltd.
Posted 3/12/2024

Addressing the Trust Crisis in Clinical Trials: Lessons from Historical Cases to Modern Solutions

  • The COVID-19 pandemic has intensified public scrutiny of clinical trials, revealing widespread misconceptions and distrust in medical research processes and vaccine development.
  • Historical cases like Thalidomide have shaped modern clinical trial regulations and safety protocols, though public awareness of these improvements remains limited.
  • The Good Clinical Trials Collaborative (GCTC) is working to streamline complex trial guidelines, while initiatives like the MT Pharmacy campaign aim to educate the public about the necessity of clinical research.

Alleviant Medical's Transcatheter Technology Receives FDA Breakthrough Device Designation for Heart Failure

• Alleviant Medical's transcatheter technology, a no-implant interatrial shunt, has received FDA Breakthrough Device designation for treating heart failure (HFpEF/HFmrEF). • The technology aims to alleviate elevated left atrial pressure in HFpEF/HFmrEF patients without requiring a permanent cardiac implant. • The FDA program expedites the development and review of innovative medical devices, potentially offering quicker access to new treatments for patients. • Clinical evidence for the Alleviant Medical technology is under development, with initial patient series outcomes expected later this year.

Leading Biotech Companies Converge at Mitochondria-Targeted Drug Development Summit to Advance Therapeutic Pipeline

• Industry leaders from Stealth BioTherapeutics, Cohbar, and GenSight Biologics will gather at the exclusive Mitochondria-Targeted Drug Development Digital Summit to share breakthrough research developments.
• The summit will showcase innovative approaches including Mitokinin's PINK1 activation for Parkinson's disease and Larimar Therapeutics' CTI-1601 protein replacement therapy for Friedreich's Ataxia.
• Over 80 key industry experts will participate in 20+ hours of content and workshops, focusing on advancing therapeutics for mitochondrial and age-related diseases.

Five-Year Outcomes From the Randomized, Phase III Trials: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

A comprehensive analysis of 5-year outcomes from the CheckMate 017 and 057 trials demonstrates that nivolumab significantly improves overall survival and progression-free survival rates compared to docetaxel in patients with previously treated, advanced non-small-cell lung cancer (NSCLC). The study highlights the long-term survival benefits and durable responses with nivolumab, alongside a favorable safety profile.

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

NCT01673867CompletedPhase 3
Bristol-Myers Squibb
Posted 11/2/2012

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017)

NCT01642004CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2012

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