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FDA Approves Gileadโ€™s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C

Gilead Sciences, Inc. announced that the U.S. FDA has approved Epclusa , the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also...

Novartisโ€™ midostaurin achieves 60% response rate in advanced systemic mastocytosis

Novartis announced that The New England Journal of Medicine published data for PKC412 demonstrating an overall response rate, defined as a major or partial response, of 60% (95% confidence interval , 49-70%; P<0.001) in patients with advanced systemic mastocytosis...

Merck, Premier Inc collaborate to improve care for osteoporosis patients

Merck and Premier Inc , a leading healthcare improvement company, have agreed to collaborate on the co-development of solutions to help improve population health. Initially, the companies will focus on reducing fracture rates for at-risk osteoporosis patients. ...

Pfizer says Two additional late stage studies of cholesterol drug met goals

Pfizer Inc. announced two additional Phase 3 bococizumab trials, SPIRE-HR and SPIRE-FH , met their primary endpoint, demonstrating a significant reduction in the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at 12 weeks compared to placebo among...

EU approves Astrazeneca Plcโ€™s New Antibiotic Zavicefta

AstraZeneca announced that the EC has granted marketing authorisation for Zavicefta , a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation. The approval includes intravenous use of Zavicefta for...

FDA accepted Tevaโ€™s Fluticasone Propionate and Fluticasone Propionate RespiClick Inhalers

Teva Pharmaceutical Industries Ltd. announced that the U.S. FDA has accepted for review the companyโ€™s new drug applications (NDAs) for two products for adolescent and adult patients with asthma. The first, fluticasone propionate/salmeterol, is a fixed-dose...

Novo Nordisk receives the EMA marketing approval of the mylife YpsoPump insulin pump

Novo Nordisk announces the EMA marketing approval of the mylife(TM) YpsoPumpยฎ insulin pump for use with prefilled pump cartridge NovoRapidยฎPumpCartยฎ. The approval is a key milestone for the collaboration between Novo Nordisk and Ypsomed and their goal to deliver...

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