Pharmaceutical Industry news, analysis and insights
The European Commission (EC) has again delayed the release of its new proposal for changes to Europe’s pharma legislation. The decision was previously expected on 29 March 2023, but has been announced to be “slightly later”.
Pharma giant AstraZeneca has been given a recommendation by the EU's Committee for Medicinal Products (CHMP) for marketing authorisation for ultomiris (ravulizumab), a treatment for adult patients with neuromyelitis optica spectrum disorder (NMSOD) who are anti-aquaporin-4 (AQP4) antibody positive (ab+).
CSL, a biotech company, has announced that it has received conditional marketing authorisation (CMA) from the European Commission (EC) for its haemophilia b drug hemgenix.
Life sciences giant Merck & Co has announced that it will appeal the EU's committee for Medicinal Products for Human Use’s (CHMP) decision to not recommend approval for its COVID-19 drug lagevrio.
Following the increase in respiratory infections, the continuing cost of living crisis and the Russia-Ukraine conflict, Europe is planning countermeasures for further antibiotic shortages