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AbbVie Receives U.S. FDA Rare Pediatric Disease Designation for Investigational ABT-414

AbbVie a global biopharmaceutical company, announced that the U.S. FDA granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse...

EC Grants Marketing Authorization for Gilead’s Epclusa for the Treatment of All Genotypes of Chronic Hepatitis C

Gilead Sciences, Inc announced that the European Commission has granted marketing authorization for Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection....

Sanofi and WRAIR sign research agreement to co-develop Zika vaccine candidate

Sanofi and its vaccines global business unit Sanofi Pasteur Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate.    According to the terms of...

FDA Approves Gilead’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...

Novartis’ 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. ...

FDA accepted Teva’s Fluticasone Propionate and Fluticasone Propionate RespiClick Inhalers

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

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