Novartis will likely have to conduct another clinical trial of its dipeptidyl peptidase-4 inhibitor Galvus (vildagliptin) following a Feb. 23 "approvable" letter. FDA had earlier requested a three-month extension of the initial November 2006 user fee date due to concerns about necrotoxicity seen in preclinical studies. Novartis said FDA remains concerned about the skin toxicity and that some patients may be predisposed to achieving high plasma levels with standard doses. FDA requested that all manufacturers developing DPP-4 agents characterize their compounds' dermatologic safety profiles. Cleared in October, FDA did not see skin toxicity in Merck's Januvia (sitagliptin), which was the first DPP-4 inhibitor to be approved (1Pharmaceutical Approvals Monthly January 2007, p. 29)...

The leadership of top Indian firms recounted at the IPA Forum how they got together on a joint 45-minute call daily in the early phase of the pandemic to collaborate and ensure uninterrupted supplies of medicines both in India and globally. The executives also shared views on telemedicine and digitalization trends at the event.

Medtech Insight spoke to attorney Greg Dadika about mass tort litigation, including industry trends, how to find the right law firm, and when it’s the right time to settle a suit. See what Dadika, an attorney at the law firm Greenberg Traurig LLP, said about it here.