Pharmaceuticals, Biotechnology and Life Sciences
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.
Biocartis Group said on Wednesday that on the day before, July 11, 2017 the US FDA published a final list of devices that it has exempted from 510(k) premarket notification requirements in accordance with the US 21st Century Cures Act (signed into US law 13 December 2016).
Omya said Wednesday it will showcase its Omyapharm multifunctional excipient platform based on functionalized calcium carbonate, a highly structured mineral At CPhI in Frankfurt.
Gelesis Inc, a subsidiary of PureTech Health, has completed treatment of the final patient in the pivotal GLOW (Gelesis Loss Of Weight) Study, to assess the long-term efficacy and safety of its Gelesis100.
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.
Evgen Pharma said Tuesday that its lead product, SFX-01, will be tested against triple negative breast cancer (TNBC) in new preclinical research at the Manchester Cancer Research Centre, UK.