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Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
The FDA has granted Catabasis Pharmaceuticals a rare pediatric disease designation for an investigational drug used to treat Duchenne Muscular Dystrophy, paving the way for priority review, the company said Monday. Read More
Raptor Pharmaceuticals says it does not plan to develop its liver drug, RP103, after it missed the primary endpoint in a Phase 2b study for nonalcoholic steatohepatitis in children. Read More
Sanofi’s LixiLan met the primary endpoint in a pivotal Phase 3 trial showing a greater drop in average blood glucose in diabetes patients when combined with Lantus (insulin glargine). Read More
Drugmakers are seeking clarification on the use of in vitro studies to assess the effects of active pharmaceutical ingredients taken by men on their potential offspring. Read More
A new study looking at large-scale clinical trials funded by NIH shows the number reporting positive results dropped precipitously in the years since they were required to preregister on the clinicaltrials.gov website. Read More
Drugmakers and patient groups are pressing the FDA for more leeway on approaches to developing drugs for Duchenne Muscular Dystrophy, saying a June draft guidance doesn’t go far enough. Read More
HHS on Sept. 2 proposed an overhaul of human research subject protections, including simpler informed consent forms, informed consent for secondary research using biospecimens and using a single IRB for all domestic sites in multisite clinical trials. Read More
A decline in spending on clinical research following implementation of the Physician Payment Sunshine Act could change the clinical trial landscape if it becomes an ongoing trend, an expert warns. Read More
GlaxoSmithKline’s Breo Ellipta failed to meet its primary goal in a pivotal clinical trial of curbing death risk in patients suffering from chronic pulmonary obstructive disease. Read More