International – Efficacité et tolérance des vaccins contre la COVID‐19
Nous avons inclus et analysé 41 ECR évaluant 12 vaccins différents, y compris les schémas vaccinaux homologues et hétérologues et l'effet des doses de...
USA – Industry asks FDA to harmonize pediatric study pharmacology guidance with ICH
Industry groups have asked the US Food and Drug Administration (FDA) to align its recently re-drafted guidance on pediatric clinical pharmacology studies with international...
UK – Kidney Research UK concerned by NICE process
Kidney Research UK has responded to the National Institute for Health and Care Excellence (NICE) draft guidance on therapeutics for patients with COVID-19.
It follows...
International – Contre le Covid-19, l’exécutif mise aussi sur le Paxlovid, l’antiviral de Pfizer
En cette période de vague ascendante de Covid-19 et de fêtes qui approchent, les pouvoirs publics misent sur la responsabilisation des Français, en leur...
Europe – ETF warns that monoclonal antibodies may not be effective against emerging strains...
EMA’s Emergency Task Force (ETF) has cautioned that monoclonal antibodies currently authorised for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2.
These monoclonal antibodies...
USA – FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors
The US Food and Drug Administration (FDA) this week finalized guidance detailing how sponsors of programmed cell death receptor-1 (PD-1) and programmed cell death-ligand...
Europe – ECDC and EMA collaborate on vaccine safety and effectiveness monitoring studies
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) convened on 6 and 7 December in Amsterdam the first meeting...
Europe – ETF statement on the loss of activity of anti-spike protein monoclonal antibodies...
Since the declaration of the COVID-19 public health emergency in early 2020, four monoclonal antibody products have been approved in the European Union for...
France – Fiche bon usage des médicaments antiémétiques dans le traitement symptomatique des nausées...
Les médicaments à base de dompéridone (Motilium®, Peridys®, Oroperidys®), métoclopramide (Anausin Metoclopramide®, Primperan®, Prokynil L.P) ou métopimazine (Vogalène®, Vogalib®)et leurs génériques ont une...
USA – Using mRNA technology for a universal flu vaccine
Influenza, the virus that causes the flu, can be deadly. Twenty different types of the virus have been identified. Many of these circulate between animals...
