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On February 10 , 2022 , Biohaven Pharmaceutical Holding Company Ltd.
On February 10 , 2022 , Biohaven Pharmaceutical Holding Company Ltd.
This is the fourth positive Phase 3 study of NURTEC ODT for the acute treatment of migraine and the first to be conducted in the Asia Pacific region .
NURTEC ODT (Rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist with a rapidly dissolving orally disintegrating tablet form, regulated by the U.
NURTEC ODT is a CGRP receptor antagonist that inhibits the biological activity of CGRP neuropeptides by reversibly blocking the CGRP receptor .
BioShin President and Executive Chairman Donnie McGrath, MD, said : " We would like to express our sincere gratitude to the patients, institutions and investigators in China and South Korea who have contributed greatly to the success of this large study
More than one billion people worldwide suffer from migraine, and the World Health Organization ranks migraine as one of the ten most serious disabling medical conditions
Professor Yu Shengyuan , director of the Department of Neurology at the Chinese People's Liberation Army General Hospital, who led the BHV3000-310 research project, said: " According to the results of the World Health Organization ( WHO ) Global Burden of Disease Survey published in The Lancet in 2013 , Migraine is the third most common disease in humans and the number one cause of disability in the Lancet under- 50s , and we need new, effective, and safe treatment options to help improve patients' lives .
Karl Lintel, MD, CEO of BioShin , said: " The results of this study demonstrate the efficacy of NURTEC ODT and underscore the importance of the impact it may have on patients in the Asia Pacific region once approved .
The successful completion of the study and the high-quality results also underscore our global expertise in running complex neuroscience clinical trials .
I am proud of the BioShin R&D team that provided these results and look forward to submitting our NDA to China and the Korean regulatory agency for approval .
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