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The FDA approved Shire’s amphetamine-based attention-deficit/hyperactivity disorder (ADHD) drug Vyvanse, which has a lower risk of abuse than similar drugs, the company announced.
Roche sent a letter notifying cardiac transplant healthcare practitioners that it brought an early halt to a clinical trial of its drug CellCept after four heart transplant patients suffered acute rejection.
The European Medicines Agency (EMEA) has granted Roche an accelerated review of its flu drug Tamiflu. The company said it “is optimistic that EMEA will complete their evaluation by midyear.”
An FDA advisory committee is recommending that the agency fundamentally change standards for testing new contraceptives to focus on comparative drug studies.
Although adaptive seamless design (ASD) in clinical trials offers many benefits, "there is no free lunch," said Sue-Jane Wang, associate director at the FDA's Office of Biostatistics.
Adaptive clinical trials make it possible for sponsors to enroll smaller numbers of patients, put a quick stop to treatment approaches that aren’t working and save time and money overall, say experts.
The FDA is promoting adaptive clinical trials, with plans to issue five new guidances. The agency said it is also setting up special teams to provide designers of adaptive clinical trials with consulting advice.
The FDA denied Public Citizen’s request to remove Roche’s prescription weight loss drug Xenical from the market over concerns it could contribute to colon cancer.