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...
Europe – ETF concludes that bivalent original/Omicron BA.4-5 mRNA vaccines may be used for...
EMA’s Emergency Task Force (ETF) considers that adapted mRNA bivalent vaccines targeting the original strain and Omicron BA.4-5 subvariants of SARS-CoV-2 may be used for primary...
USA – Uptake of biosimilars on the rise in the US, but number of...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars...
International – ICH adopts Q13 guideline on continuous manufacturing
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing....
USA – FDA updates statistical approaches for assessing bioequivalence
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies...
