Biopeutics
Co. Ltd. is a medical
therapeutic company that has existing registered pharmaceutical products & a
pipeline of new and emerging products, in particular for the cardiovascular
markets. Biopeutics has a main focus on new indication development for
pre-existing tested and regulatory approved drugs, so as to fasttrack to
market and to generate revenue. Biopeutics also has an interest in the development
of medical
devices,
in
particular for new generation of vascular stenting. The Biopeutics
team is
working on new indications for existing drugs and preparing to bring
these expeditiously to the
approval stage by the regulatory authorities . |
News and Events
U.S. Food and Drug Administration(FDA):
September 9th 2022
Pre-IND Brief Package Type C
December 9th 2022
Pre-IND Teleconference
December 22th 2022
FDA meeting minutes
European Medicines Agency (EMA):
Submission of European clinical trial review documents to EMA on March 13, 2023
March 15, 2023 EMA has accepted applications for European clinical trials
April 14, 2023 EMA has replied as following: Following the SAWP first report discussion of your case EMA/SA/0000129062 (Follow up Scientific Advice - Human), the SAWP has decided that there is no need for a discussion meeting (40-day procedure). Therefore you should expect to receive the final advice letter by the end of the week following the next CHMP plenary.
We are expecting the written letter from 04/26-05/05.
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