Pharmaceuticals, Biotechnology and Life Sciences
Novartis has confirmed positive 5 year efficacy and safety results for Cosentyx from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis.
The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Mylan’s and Biocon’s proposed biosimilar trastuzumab.
European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for CTI BioPharma’s pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia.
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Eli Lilly has entered into a settlement agreement with generic companies to resolve pending patent litigation in the U.S. District Court for the Eastern District of Virginia regarding the Cialis (tadalafil) unit dose patent.
Boehringer Ingelheim has reported that final results from RE-VERSE AD study showed that idarucizumab, marketed in the U.S. as Praxbind, was able to immediately reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients in emergency situations.
Sanofi announced today it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States.
Guerbet, the global specialist in contrast products and solutions for medical imaging, will phase out sales throughout the world of two products: Hexabrix (meglumine and sodium ioxaglate) and Optimark (gadoversetamide).
BioInvent International and ThromboGenics have agreed to amend their long-standing agreement, which covers the co-development of the novel anti-PlGF monoclonal antibody products TB-403 and THR-317.