ODAC backs U.S. approval of Mylan’s and Biocon’s cancer drug
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.
Pharmaceuticals, Biotechnology and Life Sciences
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.
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.
Celgene Corporation and BeiGene have entered into a strategic collaboration to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1…
The Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Novartis’s Cosentyx (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis.
STADA Arzneimittel AG has appointed Engelbert Coster Tjeenk Willink as Chief Executive Officer with immediate effect.
AstraZeneca on Monday reported closing two different agreements for certain commercial rights for its drugs, in Europe and worldwide.