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.
The European Medicines Agency has backed off of several controversial limitations it was considering imposing on sponsors of trials for treatments for chronic primary immune thrombocytopenia. Read More
Sponsors of BLAs, NDAs, and ANDAs should justify the amount of excess medication for injectable drug products they plan to pack in vials and ampules, according to an FDA draft guidance. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
Drugmakers decried the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
Merck, Ferring Pharmaceuticals and the World Health Organization have partnered up to study a drug aimed at preventing excess bleeding during childbirth — the leading cause of maternal deaths during childbirth in developing countries. Read More
The FDA should create incentives to encourage manufacturers to include minorities and other underrepresented groups in clinical trials and delay approvals of products whose sponsors conducted less-inclusive trials, advocacy groups say. Read More
GlaxoSmithKline has joined a list of drugmakers whose non-small cell lung cancer (NSCLC) drug candidates have failed in Phase III trials in the past year. Read More
Advocates for minorities and other patient groups that are underrepresented in clinical trials want the FDA to create incentives for drugmakers that include those groups in studies and become more aggressive in delaying drugs that don’t include them. Read More
The European Medicines Agency has backed off of several controversial limitations that it was contemplating imposing on sponsors designing trials for treatments for chronic primary immune thrombocytopenia (ITP). Read More