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Clinical Trial News

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.

Novel Extended-Release Diphenidol Formulation Reduces Dosing Frequency While Maintaining Therapeutic Plasma Levels

  • A new extended-release diphenidol pharmaceutical composition has been developed that reduces daily dosing from six times to twice daily while maintaining therapeutic plasma concentrations.
  • The formulation contains 15-50% diphenidol hydrochloride with specific excipients including binding agents, diluents, release-modifying agents, lubricants, and gliding agents to achieve sustained drug release over 10 hours.
  • Clinical bioavailability studies in 16 healthy male volunteers demonstrated that the 100mg extended-release tablets administered every 12 hours achieved comparable therapeutic levels to 25mg immediate-release tablets given every 6 hours.
  • The extended-release formulation showed significantly improved patient compliance potential by reducing dosing frequency and minimizing the risk of missed doses or overdosing associated with frequent administration schedules.

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.

Emotional Marketing in Pharma: Evidence Shows Power of Combining Rational and Emotional Appeals

  • Research from IPA dataMINE analysis of 880 case studies reveals that emotional marketing campaigns significantly outperform purely rational messaging in driving business outcomes and brand loyalty.
  • Pharmaceutical brand perception is shaped early in the pre-launch phase, with emotional connections and trust playing crucial roles in physician prescribing behavior and long-term brand adoption.
  • Strategic emotional marketing requires a balanced approach combining rational product features with emotional benefits, as demonstrated by Pfizer's successful 'Rapid Response' OTC campaign.

Roche's Journey: From Vitamin Production Pioneer to Personalized Medicine Leader

• Founded in 1896, Roche transformed from a small Swiss company into a global pharmaceutical powerhouse, pioneering industrial-scale standardized medicine manufacturing and international expansion.
• The company achieved significant breakthroughs including first mass-produced synthetic vitamin C in 1934, development of benzodiazepines in 1957, and strategic acquisition of Genentech in 2009.
• Roche has evolved into a leader in personalized medicine and oncology, with over 60% of its pharmaceutical pipeline projects incorporating companion diagnostics for more effective treatments.

Prucalopride Significantly Improves Bowel Function in Asia-Pacific Patients with Chronic Constipation

  • Prucalopride 2 mg significantly increased spontaneous complete bowel movements (SCBMs) in Asia-Pacific patients with chronic constipation compared to placebo.
  • 33.3% of prucalopride-treated patients experienced ≥3 SCBMs per week versus 10.3% on placebo over a 12-week period.
  • Prucalopride demonstrated improvements in constipation-related symptoms and enhanced quality of life, with a rapid onset of action.
  • The treatment was safe and well-tolerated, with no unexpected safety findings, supporting its use for chronic constipation in this population.

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.

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