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Dailies Total1 Multifocal contact lenses launched for presbyopia- Alcon

Alcon, the global leader in eye care and a division of Novartis, introduces Dailies Total1 Multifocal contact lenses for people with presbyopia. This innovative multifocal lens provides both seamless distant, intermediate and near vision, and the outstanding comfort of...

U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets

Janssen Pharmaceuticals, Inc announced that the U.S. FDA has granted Priority Review designation for the NDA for a 500mg chewable tablet formulation of mebendazole.  If approved, the chewable mebendazole tablet will provide a treatment and prevention alternative for adults...

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...

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...

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...

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...

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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