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Latest From Recordati SpA

How Ex-Janssen India Chief Is Steering Bharat Serums’ Ambitions In Women’s Health

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.

Commercial India

US FDA’s Current Technical Standards Not A Good Fit For Real-World Data, Stakeholders Say

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new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.

Real-World Evidence Guidance Documents

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

US FDA Performance Tracker Approvals

Phathom’s First Approval Of Voquezna Expected To Lay Ground For Larger Indications

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.

Approvals Business Strategies
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