As CEO of Morunda, I had the privilege of interviewing Bill Schuster, Country Manager of Viatris in South Korea. Our conversation delved into the multifaceted nature of leadership in the healthcare industry, exploring challenges, successes, and the power of authenticity.A…
REGULATORY
Exemption from Bioequivalence Studies Adopted as New Topic at ICH Meeting in Lisbon; Could Affect Generics as Well
“Biowaivers” that would allow drug makers to skip conducting bioequivalence studies of oral agents if certain conditions are met was adopted as a new topic (M9) at a meeting of the International Council for Harmonization of Technical Requirements for Registration…
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REGULATORY
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A total of 43 innovative new medicines are anticipated to be approved or listed in Japan this year, according to a survey by Jiho. At the center of attention are some highly innovative, but probably ultra-expensive, gene therapies, as well…
For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…