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Widespread use of electronic data capture (EDC) technology is helping Novartis Pharmaceuticals cut down on errors during the clinical trial process and achieve research savings approaching $100 million annually.
The FDA has ordered GlaxoSmithKline (GSK) to halt a clinical trial of a drug candidate in the same class of drugs as Biogen Idec’s and Elan’s multiple sclerosis (MS) treatment Tysabri, which was recently withdrawn for safety reasons.
Middle-age women can significantly reduce their risk of stroke by regularly taking low doses of aspirin, according to a new study that healthcare experts say will have major public health implications
The proliferation of clinical trial registries has started raising red flags among drug companies, some of which are starting to express concerns that making all clinical data publicly available will leave valuable trade secrets exposed.
As clinical trial registries proliferate, some drug companies are raising concerns that making all clinical data publicly available will leave valuable trade secrets exposed.
While the pharmaceutical industry has taken a hit for its lackluster pipeline in recent years, there are a number of promising products -- either newly approved or soon-to-be-approved -- that could give big pharma firms a boost in 2005 and beyond, according to a new research report from Standard & Poor's (S&P).
As expected, two influential senators have introduced bipartisan legislation that would create an electronic clinical trials registry to which drugmakers must submit the results of their drug studies or face monetary penalties.
The FDA is preparing to release a draft guidance that will contain details about a new investigational new drug (IND) application process that it hopes will enhance post-discovery drug development, according to a top agency official.
A Democratic-backed bill from last year that would have required drug sponsors to report all clinical trial results to a government registry could be reintroduced soon, this time with the backing of a powerful Republican senator.
The FDA has announced the availability of final guidance for industry on how to conduct a safety review of a new drug application (NDA) and a biologics license application (BLA).