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Sponsors of vaccine trials intended to support a marketing submission in China have seven days to report study-related fatalities and another eight days to file follow up reports, according to a new China Food and Drug Administration guideline. Read More
Pfizer’s lung cancer drug dacomitinib has failed in two Phase III clinical trials and analysts aren’t holding out much hope for results from a third Phase III study expected next year. Read More
To foster discussion on what level of transparency on clinical trials is appropriate, the Institute of Medicine (IOM) is seeking comment on a wide range of proposals that would encourage clinical data sharing. Read More
Devicemakers conducting clinical trials in India must inform patients during videotaped informed consent sessions of potential payments resulting from adverse events, a draft guideline says. Read More
A key panel of the European Parliament on Wednesday advanced draft legislation revising EU clinical trial regulations, setting up a final vote for replacing the current trial directive in April. Read More
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
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
India has created a formula to calculate the compensation clinical trial subjects will receive in the event of death or serious adverse event, stressing that sponsors must fully inform study subjects about the payments during a videotaped informed consent process. Read More
The Canadian government has released a draft guidance aimed at streamlining the approval process for basic clinical trials using positron-emitting radiopharmaceuticals, or PERs. Read More
Doctors and researchers should have full access to clinical trial data on products licensed in the UK to ensure that the cost-benefits, as well as safety and efficacy, are considered in prescribing and coverage decisions, lawmakers say. Read More