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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
Because nanosized solubilizers known as block copolymer micelles (BCM) contain highly functional polymers, drugmakers that use them are recommended to apply quality-by-design (QbD) principles within a “well-defined manufacturing process” to ensure consistent quality. Read More
Santaris Pharma and GlaxoSmithKline have signed a deal giving GSK access to Santaris’ locked nucleic acid technology in order to develop RNA-targeted medicines. Read More