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Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. Read More
Sponsors of new drugs and biologics intended to treat chronic pain should plan on submitting more safety data than they would to support candidates for acute pain, the FDA says. Read More
As the FDA moves to update and standardize data submission standards for NDAs, ANDAs, INDs and BLAs, it’s warning sponsors they will only have two years to come into compliance once guidance is finalized later this year. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
Vertex’s efforts to stretch its drug pipeline took a hit Wednesday as the drugmaker halted development of its experimental hepatitis C treatment VX-135 in the face of lingering safety issues and regulatory delays. Read More
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
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
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
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