Pharmaceutical Industry news, analysis and insights
GSK has announced that ViiV healthcare has received a positive opinion from the EMA's CHMP, recommending marketing authorisation for cabotegravir long-acting (LA) injectable and tablets for HIV prevention.
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+).
AbbVie has announced that it has received positive feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (rinvoq) for the treatment of adult patients with moderate to severe crohn’s disease who have had an inadequate response, lost response or were intolerant to conventional therapies or biologic agents.
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.