Pharmaceuticals, Biotechnology and Life Sciences
Sanofi and Regeneron Pharmaceuticals, on Friday announced that the European Medicine Agency`s Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Dupixent.
Novartis on Friday said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive.
GlaxoSmithKline and Innoviva have asked the European Medicines Agency (EMA) to extend the use of Relvar Ellipta, a once-daily fluticasone furoate/vilanterol-based (FF/VI) inhaled corticosteroid (ICS) / combination, in patients already adequately controlled on an ICS/LABA combination.
The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.
Diplomat Pharmacy will distribute Puma Biotechnology’s new product, Nerlynx, a kinase inhibitor approved by the US Food and Drug Administration (FDA).
SillaJen and Lee’s Pharmaceutical Holdings have said that they’ve gotten the approval from the China Food and Drug Administration (CFDA) to get a Phase 3 clinical trial for advanced liver cancer using its oncolytic immunotherapy called Pexa-Vec, the PHOCUS study.
The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.
Novatris has reported net income of $2.9 million for the second quarter of 2017 which is a slight decrease comparing the same period last year.
The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Ablynx has announced that Hilde Windels will be nominated as an Independent Non-Executive Director at the Company`s forthcoming Special General Meeting of its shareholders to be held on 18 August 2017.