The European Commission (EC) granted marketing authorization for Biogen Inc.’s Vumerity (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
AstraZeneca Plc’s Imfinzi was approved in the European Union to treat an aggressive form of lung cancer in previously untreated adult patients.
BioSpace Global Roundup: Jan. 30, 2020Alopecia, Anti-GBM Antibody Disease (Goodpasture´s Disease), Approvals, Bacteria, Business, Cancer, Clinical Trials, Deals, Diagnostics, Drug Discovery, European Commission, FDA/Regulatory, Hair Loss, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), New Indications, PD-1/PD-L1 inhibitors, Product Pipelines, R&D, Tumors
Pharma companies from across the globe provide updates on their pipelines and business.
The European Commission granted marketing authorization to Amgen and UCB for Evenity (romosozumab) for treating severe osteoporosis in postmenopausal women at high risk of fracture.
The European Commission approved Astellas Pharma’s oral once-daily therapy Xospata as a monotherapy for treating adults with relapsed or refractory acute myeloid leukemia with a FLT3 mutation.
Roche’s Tecentriq won European approval for use against a tough-to-treat breast cancer, helping the Swiss drugmaker to widen use of an immunotherapy that has so far been eclipsed in revenue terms by more-established rival medicines.
The Dupixent product developed by Sanofi and the French company’s U.S. partner Regeneron won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents.
GlaxoSmithKline’s ViiV Healthcare received European Commission approval for Dovato to treat advanced-stage HIV infections in adults and adolescents above the age of 12 and weighing at least 40 kg.
The European Commission granted conditional marketing authorization for Libtayo (cemiplimab) for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
The European Commission approved Pfizer Inc.’s Talzenna (talazoparib), an oral polypolymerase inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer.