Pharma News

Results from pivotal Phase III trials presented at the European Respiratory Society (ERS) International Congress demonstrated that adding benralizumab to standard-of-care medicine significantly reduced exacerbations and improved lung function and asthma symptoms in severe asthma patients with an eosinophilic phenotype, as indicated by the presence of eosinophils in their blood.

Amgen and Boehringer Ingelheim announced that Amgen has acquired global development and commercial rights from Boehringer Ingelheim for BI 836909 (AMG 420), a bispecific T cell engager (BiTE^®) that targets B-cell maturation antigen (BCMA), a potential target for multiple myeloma. BI 836909 (AMG 420) is currently in Phase 1 studies. BI 836909 (AMG 420) was originally licensed to Boehringer Ingelheim by Micromet before the company was acquired by Amgen in 2012.

MiMedx Group, Inc., the leading regenerative medicine company, announced its plans for the nationwide launch of AmnioFill, the first product in the MiMedx placental collagen matrix product family to be commercially launched.

Biogen announced that aducanumab, its investigational treatment for early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The FDA’s Fast Track program supports the development of new treatments for serious conditions with an unmet medical need such as Alzheimer’s disease.

Perrigo Company plc announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Epiduo® Gel (adapalene and benzoyl peroxide 0.1%/2.5%).

Neurocrine Biosciences, Inc. has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for once-daily dosing of valbenazine in treating tardive dyskinesia.