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Clinical Trial News

UK Payers Show Flexibility in Nebulizer Access Despite Limited Clinical Evidence in Asthma Treatment

  • Despite higher costs and lack of clinical superiority over metered dose inhalers, UK payers generally maintain open access to nebulizers for asthma treatment due to their minimal budget impact.
  • Research involving 12 payers and KOLs reveals that nebulizer reimbursement faces few restrictions, particularly when requested for severe asthma patients who could benefit from reduced future healthcare costs.
  • Healthcare providers prioritize real-world evidence and cost-effectiveness data, with particular emphasis on reducing unplanned hospital admissions and systemic corticosteroid use.

Temozolomide's Effectiveness in Treating High Grade Glioma

A comprehensive review of randomized controlled trials (RCTs) reveals that temozolomide, when used in both concomitant and adjuvant phases, significantly improves overall survival (OS) and progression-free survival (PFS) in patients with glioblastoma multiforme (GBM), a form of high grade glioma (HGG), compared to radiotherapy alone. However, it is associated with an increased risk of early adverse events. In elderly patients, temozolomide alone shows comparable survival benefits to hypofractionated radiotherapy but with a higher incidence of adverse events. In recurrent HGG, temozolomide improves PFS but does not enhance OS.

Pharma's Evolution in Social Media: From Listening to Collaboration in Rare Disease Communities

  • Social media platforms have transformed from basic forums in the 1990s to sophisticated engagement channels, revolutionizing how pharmaceutical companies interact with rare disease patient communities.
  • Lundbeck's Huntington's disease Facebook page demonstrates successful pharma-patient engagement, providing support to 25,000 affected individuals and their caregivers through disease awareness and community building.
  • The pharmaceutical industry is transitioning from passive social listening to active collaboration, with companies now utilizing crowdsourcing for clinical trial design and patient support program development.

Home Healthcare Services Emerge as Strategic Priority for Pharmaceutical Companies

  • Healthcare at Home Ltd demonstrates significant improvements in patient outcomes across 30 disease areas, with evidence showing reduced side effects and improved quality of life for patients receiving home-based care.
  • Home healthcare services show potential for £3.4bn in NHS savings through reduced hospital admissions and improved care pathways, while delivering 20% better medication persistence rates at 6 months post-initiation.
  • Pharmaceutical companies are increasingly integrating homecare services into their core strategies to enhance real-world data collection, improve patient support, and create sustainable competitive advantages.

FDA Issues New Draft Guidance for Early-Stage Alzheimer's Drug Development

  • The FDA has released draft guidance to help pharmaceutical companies develop treatments for early-stage Alzheimer's disease, focusing on patient selection criteria for clinical trials.
  • The guidance emphasizes identifying and studying patients before significant brain damage occurs, as researchers believe new drugs may be most effective during early disease stages.
  • Dr. Russell Katz, FDA's Division of Neurology Products director, commits to expediting development of new treatments through collaboration with industry, academia, and advocacy groups.

Global Push for Clinical Trial Transparency Gains Momentum with EMA and AllTrials Campaign

  • The European Medicines Agency has committed to proactive publication of clinical trial data starting January 2014, enabling independent analysis of evidence used for drug approvals.
  • The AllTrials campaign has gathered over 10,000 signatures and support from major organizations like the Medical Research Council and Cochrane Collaboration, advocating for registration and full reporting of all clinical trials.
  • New initiatives including the SPIRIT checklist and BMJ's data sharing requirements are establishing stronger standards for clinical trial transparency and protocol development.

GSK and Biological E Form Joint Venture to Develop Novel Six-in-One Pediatric Vaccine

  • GSK and Biological E have established a 50/50 joint venture to develop a first-of-its-kind combination vaccine that would protect children against polio and five other infectious diseases.
  • The innovative vaccine combines GSK's injectable polio vaccine with Biological E's pentavalent vaccine, potentially reducing the number of required injections and improving immunization compliance.
  • The development costs will be shared equally between both companies, with phase 1 trials expected to begin within the next two years.

Cook Medical's Zilver PTX Becomes First FDA-Approved Drug-Eluting Peripheral Stent in U.S. Market

FDA Approval
  • Cook Medical's Zilver PTX drug-eluting peripheral stent achieved FDA approval as the first device of its kind approved for peripheral artery use in the United States.
  • The device combines mechanical stenting with paclitaxel drug coating to reduce follow-up procedures by more than 50 percent in femoropopliteal artery treatment.
  • OhioHealth Riverside Methodist Hospital became the first U.S. institution to commercially implant the Zilver PTX stent following FDA approval.
  • The stent maintains arterial blood flow in seven out of ten patients through 24 months after implantation in the superficial femoral artery.

Biotech Spin-outs Emerge as Critical Bridge Between Academia and Pharma R&D

  • Big Pharma's traditional R&D model is shifting towards external innovation, with universities and biotech spin-outs becoming essential players in drug development ecosystem.
  • Early-stage biotech spin-outs require careful timing, substantial proof-of-principle data, and experienced management to successfully bridge academic research and commercial development.
  • New funding initiatives from MRC/TSB Biomedical Catalyst and Wellcome Trust's Syncona Fund are helping address the financing challenges faced by UK biotech spin-outs.

EMA Recommends Approval of Selincro for Alcohol Dependency Treatment

  • The European Medicines Agency's CHMP has recommended marketing authorization for Selincro (nalmefene), developed by Lundbeck and Biotie, for reducing alcohol consumption in alcohol-dependent adults.
  • Clinical trials involving 2,000 patients demonstrated Selincro's efficacy, with two-thirds of participants being first-time treatment seekers for alcohol dependency.
  • Lundbeck plans to launch Selincro in European markets by mid-2013, offering it as part of a comprehensive treatment program that includes psychosocial support.

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