Pharmaceuticals, Biotechnology and Life Sciences
Valneva on Monday said that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15.
Belgian company Ablynx said Monday that it has issued an additional 19.833 common shares, in exchange for €121.444.
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.