Just four products are listed as being up for an opinion on whether they should be approved for sale across the EU at the latest meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), under way this week in London.
The CHMP has already adopted a negative opinion on one of the four marketing authorization applications in question – AB Science’s would-be amyotrophic lateral sclerosis (ALS) treatment, Alsitek (masitinib) – so that leaves three: Gilead Sciences’s fixed-dose combination therapy for HIV, bictegravir/emtricitabine/tenofovir alafenamide (approved in the US in February this year as Biktarvy (Also see "
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?