REGULATORY

JPO Decides Lipitor Crystal Form “Valid”, Sandoz Calls for Appeal

January 30, 2012
On action brought on by Sandoz in November 2011 seeking the annulment of a patent covering crystalline forms of Lipitor (atorvastatin calcium hydrate; owned by Pfizer Japan and Astellas Pharma), for which generic versions have been launched by market entrants…

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REGULATORY

By Izuru Ando

A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…

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