With a decision by FDA on a new filing for flibanserin possible by the fall, Sprout hopes to gain the first U.S. approval for treating women with low sexual desire. Meanwhile, Palatin forges on to Phase III with its female sexual desire disorder drug bremelanotide after discussing endpoints with FDA.
If successful, a resubmitted filing of flibanserin by Sprout Pharmaceuticals Inc. could provide a roadmap for drug development in female sexual dysfunction, a field that up to now has been marred by regulatory failures.
Flibanserin is an agonist of serotonin 5HT(1A) and an antagonist of 5-HT(2A) receptors. It is also a partial agonist of...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
The news coincides with rumors that Commissioner Martin Makary soon will name a new Center for Drug Evaluation and Research director.
There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
