USA – Moderna chairman says COVID-19 vaccine could begin phase 2 trials in spring

Moderna’s chairman Noubar Afeyan has said that phase 2 human trials of the company’s coronavirus vaccine could begin in spring, as pressure mounts for...
FDA: 2019 Continues Uptick in Orphan Drug Approvals

USA – Why FDA’s Issuance of EUAs are Not ‘Approvals’ and Why That Matters

You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US Food and...

Europe – EMA provides recommendations on compassionate use of remdesivir for COVID-19

During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be...

France – Hydroxychloroquine : un essai clinique français bien conçu est conduit dans 37...

L’essai clinique HYCOVID, randomisé versus placebo, en double aveugle,  a pour objectif d’évaluer l’efficacité de l’hydroxychloroquine chez 1300 patients porteurs de la  forme non...
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...
As coronavirus roils region, EU device body adamant about steps to hit MDR deadline

Europe – EU Regulatory Roundup

MHRA Approves Adapted CPAP Device for COVID-19, Shares Design Specifications The United Kingdom’s Medicines and Healthcare and products Regulatory Agency (MHRA) has approved an adapted...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – Products and extemporaneous preparation of paediatric formulations that may be useful in...

During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication...
Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA regulatory flexibilities resulting from coronavirus (COVID-19)

We are working closely with the Department of Health and Social Care (DHSC) and other healthcare partners and stakeholders to rapidly develop a package...
NICE pushes Doptelet for pre-surgery liver disease treatment

UK – NICE publishes second set of rapid COVID-19 guidelines

The National Institute for Health and Care Excellence (NICE) has published its second set of rapid guidelines to cover the provision of radiotherapy services...
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....