India’s Trial Approval Timelines Report Card – Some Red Lines?
India’s streamlined clinical trial approvals process appears to have made some gains, but top industry experts tell Pink Sheet how the non-standardized approach of Subject Expert Committees is a “major handicap” for applicants.
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Roche’s Immuno-Oncology Therapy On Course To Indian Debut?
Roche’s cancer immunotherapy Tecentriq has received conditional marketing authorization under India’s layered approval process, setting the stage for a potential debut in the country. However, it remains to be seen how India’s evolving regulations in the area of clinical trial waivers could play out for such products.
Jardiance's Label Expansion Will Change Diabetes Management
US approval of the first cardiovascular label expansion for an anti-diabetic medicine will mark a shift in disease management, says Datamonitor Healthcare analyst Kevin Shannon.
Five Key Indian Trial Regulation Play-Outs For 2016
India's clinical trial approval numbers may still be well short of the heady years of 2010-12, but the implementation of a set of crucial trial-related regulations and potential tweaks in others are expected to help bring some momentum back to the sector in 2016.