No Trial Waiver Sail-Through For Lilly’s Taltz In India?
Eli Lilly's Taltz (ixekizumab) may be staring at stretched launch timelines in India where competitor secukinumab already has a head start, after the US company's request for a local trial waiver for the product was turned down twice.
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India plans pivotal tweaks to its three-layered review process for clinical trial-related clearances – a move that is expected to pare approval timelines significantly and improve predictability for sponsors who have been generally cautious, over the recent past, about placing studies in the country.
India has proposed expanding its clinical trial waiver clause to permit such exemption for drugs already approved in ICH countries, subject to certain conditions – a move which potentially augurs well for applicant firms and could improve patient access to some critical medicines.
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