The European Commission said on Aug. 31 that 70 percent of the European Union’s adult population was fully vaccinated against Covid-19, hitting a target the EC set at the beginning of 2021.
U.S.-based Biomarin Pharmaceutical Inc.’s treatment for one of the most common forms of dwarfism received clearance from the European Commission, becoming the first therapy to get an approval in the region for achondroplasia.
The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
The U.S. Food and Drug Administration granted accelerated approval to GlaxoSmithKline’s PD-1 checkpoint inhibitor Jemperli (dostarlimab) for a wider group of indications for adults with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
The European Commission approved Roche’s injectible drug Enspryng, which can be administered at home to treat neuromyelitis optica spectrum disorder.
Regeneron Pharmaceuticals and Sanofi announced that the European Commission approved the PD-1 inhibitor Libtayo (cemiplimab) for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The EC also approved Libtayo in advanced basal cell carcinoma (BCC).
AstraZeneca’s $39 billion acquisition of Alexion is being investigated by the UK’s Competition and Markets Authority (CMA) to determine if the deal is anti-competitive.
The European Union expects to have received more than a billion doses of Covid-19 vaccines by the end of September from four drugmakers, according to a document presented to EU leaders on Tuesday.
The European Commission called on May 7 on the United States and other major Covid-19 vaccine producers to export what they make as the European Union does, rather than talk about waiving intellectual property rights to the shots.
The European Union on May 6 backed a U.S. proposal to discuss waiving patent protections for Covid-19 vaccines, but drugmakers and some other governments opposed the idea, saying it would not solve global inoculation shortages.
