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).
The global Alzheimer’s drugs market to grow at a CAGR of 1.90% during the period 2017-2021, according to ResearchandMarkets, with Key vendors being Allergan, Eisai Pharmaceuticals, Johnson & Johnson, and Novartis, with other other prominent vendors Amgen and Pfizer.
Pharming Group N.V. has completed the replacement of its recently announced $100 million bridge finance with OrbiMed Advisors with a $100 million permanent facility agreement with OrbiMed Advisors.
The European Commission has approved patriometer to be marketed as Veltassa in the 28 EU countries for treating hyperkalaemia in adult patients.
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.
GSK on Wednesday set out several announcements made by the company to improve the efficiency and competitiveness of its manufacturing network, including investments for respiratory and HIV medicines manufacturing in the UK and strategic reviews. This includes the sale of several products and a proposal to close a UK manufacturing site.