BioCentury | Apr 11, 2020
Emerging Company Profile

Clover: trimerizing fusion proteins

Clover is developing trimerized fusion proteins to target cancer and infectious disease pathways that depend on trimer formation. The company has exclusive, worldwide rights to its Trimer-Tag platform from GenHunter Corp., which was co-founded by...
BioCentury | Sep 6, 2019
Regulation

Lackluster U.S. biosimilars market sparks radical recommendations

The lackluster U.S. biosimilars market has led to calls for a new regulatory paradigm that could slash the cost of development. Biosimilars developers and critics of the sector agree on one thing: as it has...
BC Extra | Jan 7, 2019
Politics & Policy

FDA launching new digital health regulatory framework

FDA Monday announced the launch of a new streamlined regulatory framework for digital health devices. The framework will initially be used only for products FDA classifies as software as a medical device (SaMD), which includes...
BC Week In Review | Aug 10, 2018
Company News

Samsung planned $22B investment includes biopharma, AI

Samsung Group (Seoul, South Korea) said it would invest W25 trillion ($22.2 billion) over the next three years in biopharmaceuticals and artificial intelligence, among other sectors. While Samsung did not disclose details of the plans,...
BC Extra | Aug 8, 2018
Company News

Samsung planned $22B investment includes biopharma, AI

Samsung Group (Seoul, South Korea) said it would invest W25 trillion ($22.2 billion) over the next three years in biopharmaceuticals and artificial intelligence, among other sectors. While Samsung did not disclose details of the plans,...
BC Extra | Mar 9, 2018
Company News

Coherus gains on plans to resubmit BLA for Neulasta biosimilar

Coherus BioSciences Inc. (NASDAQ:CHRS) rose $2.75 (30%) to $11.85 on Friday after announcing in its earnings that it will resubmit a BLA for CHS-1701, with plans to launch the product in the U.S. next half....
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
BC Week In Review | Jul 7, 2017
Clinical News

Daiichi ends Japanese development of Coherus' Enbrel biosimilar

Daiichi Sankyo Co. Ltd. (Tokyo:4568) discontinued development in Japan of CHS-0214 (BAX 2200), a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN), to treat rheumatoid arthritis. Coherus BioSciences Inc. (NASDAQ:CHRS) said it regained territorial rights...
BC Extra | Jul 5, 2017
Company News

Daiichi ends development of Coherus' biosimilar of Enbrel

Coherus Biosciences Inc. (NASDAQ:CHRS) slipped $0.25 to $14.40 on Wednesday after partner Daiichi Sankyo Co. Ltd. (Tokyo:4568) discontinued development in Japan of CHS-0214 , a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN), to treat rheumatoid...
BC Week In Review | Jul 3, 2017
Clinical News

CHMP recommends Imraldi biosimilar adalimumab

EMA’s CHMP recommended approval of Imraldi biosimilar adalimumab (SB5) from Samsung Bioepis Co. Ltd. to treat psoriasis and Crohn's disease (CD) in both adults and children, rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic...
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