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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...
Press Releases
Sandoz Biosimilar Etanercept Recommended By US FDA For Approval To Treat Multiple Inflammatory Diseases
Sandoz, a Novartis division and leader in biosimilars, announced that the US FDA Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously (20-0), in support of biosimilar etanercept for all five indications of the reference...
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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...
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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...
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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....
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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...
Press Releases
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...
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