22:57 , May 16, 2018 |  BC Extra  |  Company News

Management tracks: Novartis, Aileron

Novartis AG (NYSE:NVS; SIX:NOVN) said General Counsel Felix Ehrat will retire, effective June 1, in light of Novartis' payments to a consultancy owned by Michael Cohen. "As a co-signatory with our former CEO, I take...
20:27 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Adello's BLA for Neupogen biosimilar

FDA accepted for review a BLA from Adello Biologics LLC (Piscataway, N.J.) for its biosimilar candidate of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). Adello did not disclose the user fee action goal date....
23:37 , Sep 12, 2017 |  BC Extra  |  Company News

Regulatory round-up: Array, Sandoz, Sorrento, Adello

FDA accepted for review a number of applications, including NDAs from Array BioPharma Inc. (NASDAQ:ARRY) and BLAs for two biosimilar candidates. FDA assigned a June 30, 2018 PDUFA date to a pair of NDAs from Array...
01:15 , Nov 3, 2015 |  BC Extra  |  Company News

Management tracks

Biosimilar company Therapeutic Proteins International LLC (Chicago, Ill.) named Peter Moesta CEO. Moesta was SVP of biologics development and operations at Bristol-Myers Squibb Co. (NYSE:BMY). Diagnostic play Exosome Diagnostics Inc. (Cambridge, Mass.) named John Boyce...