Press Releases

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...

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 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...

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 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...

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 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...