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Japanese officials launched an investigation Jan. 10 into claims that falsified clinical trial data were used in an Alzheimer’s study involving several major drugmakers, marking an expansion of the country’s scrutiny of trial data misuse. Read More
Videotapes of patients giving informed consent to participate in clinical trials must show the investigator explaining the study protocol in language the subject can understand, according to a draft guideline by India’s Central Drugs Standard Control Organization. Read More
Johnson & Johnson unveiled a first-of-kind clinical trial data-sharing plan that it hopes will become a model for industry transparency initiatives: rather than provide direct access to trial data, sponsors could contract with third parties to serve as gatekeeper and approve data access requests. Read More
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve. Read More
Sponsors of both over-the-counter and prescription point-of-care blood glucose tests should design trials that replicate real-world usage conditions, the FDA says. Read More
Drugmakers are encouraged to work together to get agency qualification for drug development tools, which can be used to aid in development and review of multiple companies’ drugs, according to an FDA final guidance. Read More
Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. Read More
Shire said Thursday it will abandon the development of its blockbuster hyperactivity drug Vyvanse as a treatment for major depressive disorder after two failed Phase III trials. Read More
To help the European Medicines Agency (EMA) meet 90-day deadlines for orphan drug designation reviews, the agency is asking sponsors to give two months’ advance notice of their intent to file. Read More