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Biohaven achieves FDA approval with Nurtec™

In February 2020, Biohaven announced that the U.S. Food and Drug Administration (FDA) approved Nurtec™ ODT (rimegepant) for the acute treatment of migraines in adults. It is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting, orally disintegrating tablet (ODT).

Salvaging CNS Clinical Trials Halted Due to COVID‐19

The coronavirus disease 2019 (COVID‐19) pandemic has halted many ongoing central nervous system (CNS) clinical trials, especially in Alzheimer’s disease. These long‐duration trials involve many stakeholders, especially the patients and their family members, who have demonstrated their commitment to developing new therapeutic interventions for this devastating disease. We certainly do not want to lose all … Continued

Certara 2019年のベストブログ

A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.

Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems

PRINCETON, NJ – 2019年3月5日 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.
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