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Sanjiv Navangul, managing director and CEO, Bharat Serums and Vaccines, in a wide-ranging interview with Scrip, outlines the firm’s game plan to establish itself as a “force to reckon with” in women’s health - it goes beyond drugs and encompasses devices and potentially digital therapeutics as well. The former Janssen India chief also weighs in on the worrying industry-wide input cost escalation scenario and supply chain turbulence.
The agency’s existing technical standards are better-suited to clinical trial data, and mapping RWD to these formats will result in the loss of granularity and introduce new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.
Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The Takeda spinout got FDA approval of its acid blocker as combination therapy for H. pylori infections, but the bigger opportunities await in erosive esophagitis and non-erosive reflux disorder.
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