EMA Management Board – highlights of March 2020 meeting

International – International regulators discuss available knowledge supporting COVID-19 medicine development

On 2 April, regulators from around the world joined the second workshop on COVID-19 organised by the European Medicines Agency (EMA) under the umbrella...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH: MedDRA existing and supplemental codes for Coronavirus

The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue....

International – Clinical Trials During COVID-19: Updates From FDA, MHRA and TGA

The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.   The...

International – Predicting the angiotensin converting enzyme 2 (ACE 2) utilizing capability as the...

Prédire les espèces animales qui possèdent des récepteurs ACE 2 auxquels le SRAS-CoV-19 est capable de se lier. I Phase - valuation de l'homologie des...
WHO drafts guidance for pharma supply chain tracking

International – Coronavirus : l’OMS réfute l’utilisation de médicaments sans preuve d’efficacité

« Ces morts et ces contaminations sont des chiffres tragiques, mais n’oublions pas que dans le monde entier, il y a des centaines de...

International – COVID-19: Daily Report for Life Sciences and Health Care Companies

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in...
Safety testing for coronavirus vaccine begins

International – ICMRA Plots Data Requirements for Phase I COVID-19 Vaccine Studies

After meeting last week to discuss vaccine development for the coronavirus disease (COVID-19), the International Coalition of Medicines Regulatory Authorities (ICMRA) on Tuesday released...
The Essential List of Regulatory Authorities in Europe

International – COVID-19 Vaccine Tracker

On 11 March, the World Health Organization classified the COVID-19 outbreak as a pandemic. The disease has reached nearly every country, infecting hundreds of...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials...

To properly inform decision making by pharmaceutical companies, regulators, patients, physicians and other stakeholders, clear descriptions of the benefits and risks of a treatment...
Orphan drugs face “uphill battle” in 2020

International – Orphan drugs face “uphill battle” in 2020

The company has revealed that over the last six years, the numbers have slowed down despite the visible benefits of such designations in speeding...