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Amgen And Daiichi Sankyo Announce Agreement To Commercialize Biosimilars In Japan

Amgen and Daiichi Sankyo Company, Limited announced the execution of an exclusive agreement to commercialize nine biosimilars in Japan. The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab. Under the...

Mylan NV Launches Generic Temodar Capsules

Mylan N.V. announced the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, which is a generic version of Merck's Temodar®. Mylan received final approval from the U.S. Food and...

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...

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