BioCentury | Mar 11, 2020
Product Development

Biocon, Mylan look ahead to U.S. launch of insulin glargine as last Lantus patent falls for Sanofi

A district court decision in favor of Biocon and Mylan sets the partners up to launch their version of insulin glargine in the U.S. midyear should the candidate get FDA approval in June. The partners...
BC Extra | Jan 28, 2020
Company News

Jan. 27 Company Quick Takes: Enhertu meets in pivotal gastric cancer study; plus Biocon-Mylan, CMS, Lilly-Boehringer, Ningbo-Genentech

Japan submission on horizon for AZ, Daiichi’s ADC  Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...
BC Week In Review | Jun 8, 2018
Clinical News

Mylan, Biocon get CRL for insulin glargine follow-on

Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said they recently received a complete response letter from FDA for their follow-on of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). The partners said...
BC Extra | Jun 5, 2018
Company News

Mylan, Biocon get CRL for insulin glargine follow-on

Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said they recently received a complete response letter from FDA for their follow-on of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). The partners said...
BC Week In Review | Mar 30, 2018
Clinical News

Mylan, Biocon insulin glargine biosimiliar approved in EU and Australia

Mylan N.V. (NASDAQ:MYL) said the European Commission and Australia's Therapeutic Goods Administration each approved Semglee, a biosimilar of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). Mylan co-developed Semglee with Biocon Ltd. (NSE:BIOCON; BSE:BIOCON)....
BC Week In Review | Nov 18, 2016
Clinical News

Biosimilar insulin glargine regulatory update

EMA accepted for review an MAA from Mylan for biosimilar insulin glargine to treat Type I and II diabetes. Mylan and Biocon said the MAA includes data showing bioequivalence to Lantus insulin glargine from Sanofi...
BC Week In Review | Nov 17, 2016
Clinical News

Lusduna regulatory update

EMA's CHMP recommended approval of Lusduna from Merck to treat diabetes in patients ages ≥2. The product is a biosimilar of Lantus insulin glargine, a synthetic sustained-release subcutaneous insulin analog from Sanofi (Euronext:SAN; NYSE:SNY, Paris,...
BC Extra | Nov 4, 2016
Company News

EMA reviewing Lantus biosimilar

Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for the partners’ biosimilar insulin glargine to treat Type I and Type II diabetes. The companies said the MAA includes...
BC Week In Review | Aug 8, 2016
Clinical News

Biosimilar insulin glargine regulatory update

Merck is partnered with Samsung Bioepis Co. Ltd., a JV between Biogen and Samsung Biologics, to develop and commercialize multiple biosimilars, including MK-1293 (see BioCentury, Feb. 17, 2014). Samsung Biologics is a JV between Samsung...
BC Week In Review | Jul 25, 2016
Clinical News

Biosimilar insulin glargine: Phase III data

Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass.   Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J.   Samsung Group , Seoul, South Korea   Product: Biosimilar insulin glargine ( MK-1293 )   Business: Endocrine/Metabolic   Molecular target: Insulin receptor (INSR)  ...
Items per page:
1 - 10 of 16