We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A new Tufts University report praises the FDA’s breakthrough therapy program for its potential to advance new drugs and biologics targeting unmet needs. Read More
FDA reviewers have unveiled the top five reasons for drug approval delays and denials over a twelve-year period, noting that many could be avoided if drugmakers submitted more accurate and useful information. Read More
Boehringer Ingelheim is halting development of deleobuvir-containing hepatitis C (HCV) drugs after Phase III clinical trial data showed the candidate lacked therapeutic value, clearing away one more candidate from the crowded field of new HCV treatments. Read More
Brand drugmakers are denying accusations they’re behind a covert campaign to block proposed patent law changes that would improve access to generics in South Africa. Read More
The European Medicines Agency (EMA) says it is no longer acceptable for sponsors to conduct placebo-controlled clinical trials when developing monotherapy drugs for lipid disorders. Read More
At least 75 percent of clinical trials are extended by six weeks or more because of failure to enroll enough patients, a new study finds, but help may be on the way in the form of “big data.” Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More