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)  ...
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)  ...
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