Keytruda’s Catch-22 Situation In India Amid Compliance Questions
Merck & Co’s immuno-oncology therapy Keytruda appears be facing a rather paradoxical situation in India, after an expert panel noted that the US multinational had failed to comply with Phase IV study requirements pertaining to the product in the country.
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Eisai’s request to forego Phase IV studies for its anticancer, Halaven, has been turned down by an Indian expert panel, which has reminded the Japanese company of the conditional marketing authorization previously granted for the product. Eisai, for its part, now says it will follow the “necessary requirements” set out by the Indian regulator.
Boehringer Navigates ‘Impractical’ Nintedanib Surveillance Plan In India
Boehringer seeks tweaks in the surveillance plan for nintedanib in India amid disinclination among some physicians to participate in the study. Some experts though believe that the Indian regulatory apparatus should, in general, specify “strict guidance” on all protocol review requests.
Will Keytruda Price Differential Really Count In India?
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