Roche Calls For Harmonized Regulations As Subcutaneous Herceptin Declined Trial Waiver In India
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.
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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.
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.
The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.