Author: webdev
9th Annual Neurodegenerative Drug Development Summit
2021 Gastrointestinal Cancers Symposium
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).
VIVD: Virtual in vitro distribution model for the mechanistic prediction of intracellular concentrations of chemicals in in vitro toxicity assays
Certara Broadens and Increases Regulatory Strength with Two Executive Hires
PRINCETON, N.J.—May 21, 2020 — New executives bring strategic and cross-disciplinary expertise to navigate changing regulatory environments
COVID-19 Therapeutic Considerations for Children and Pregnant Women
Watch this webinar to learn about tools & processes to help tailor COVID-19 therapies for special populations, including children and pregnant women
Certara & DMTC Announce Collaboration to Study Using Chloroquine in Healthcare Workers at Risk for COVID-19
Certara applying expertise in clinical pharmacology, innovation and collaboration to accelerate potential prophylaxis for COVID-19
Certara Launches New Version of Simcyp® Simulator for Population-Based Pharmacokinetic Modeling and Simulation
Version 19 offers mechanistic models for assessing maternal-fetal drug risk, developing drug formulations, and optimizing dermal and transdermal drug development
Regulatory and Medical Writing
High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.