Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India
Executive Summary
Roche has sought a harmonized regulatory approach for approval of innovative medicines and formulations in India, after its request for a trial waiver for subcutaneous Herceptin was turned down by an expert panel.
You may also be interested in...
Products Roundup - 19 December 2018: European Commission Approves Mylan/Biocon’s Ogivri Biosimilar, Amgen Files Infliximab With The FDA And Hikma Debuts Dalfampridine
The latest generic, biosimilar and value-added drug development news and highlights from across the globe.
Roche India Mandate 'Completely Different' Says New Head Bezzera
Lara Bezerra, Roche’s new managing director in India, outlines in an interview with Scrip how the Swiss multinational is now looking at the Indian market through a different lens and beyond short-term gains.
Piramal Dreams Big, Wants To Be In Top Five India-Listed Pharma
Nandini Piramal, executive director of Piramal Enterprises, discusses how things have shaped the group's pharma business, its continuing appetite for acquisitions, efforts to de-risk the supply chain for key starting materials and the outsourcing “framework” deployed by industry.