Clinical Trial News

FDA Issues New Draft Guidance for Early-Stage Alzheimer's Drug Development

12 years ago

The FDA has released draft guidance to help pharmaceutical companies develop treatments for early-stage Alzheimer's disease, focusing on patient selection criteria for clinical trials.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.

12 years ago

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.

12 years ago

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.

12 years ago

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.

13 years ago

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.

13 years ago

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.

13 years ago

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.

13 years ago

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.

13 years ago

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.

13 years ago

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.