Otsuka America Inc.
www.otsuka-america.com
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Latest From Otsuka America Inc.
Otsuka Adds To CNS Pipeline With Mindset Acquisition
After a year of R&D collaboration, Otsuka has made a decision to acquire Canadian venture Mindset to further expand its neurological pipeline with new 5-HT2A agonists.
US FDA’s Fast Track Designation Policy Faces Unusual Legal Challenge
Vanda Pharmaceuticals contends the agency unfairly denied its request for fast track designation for tradipitant. This appears to be the first time the FDA has been sued over a denial. In FY 2021, CDER denied 78 requests for the designation and granted 173.
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