23:44 , Mar 9, 2018 |  BC Extra  |  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....
00:38 , Jan 6, 2018 |  BioCentury  |  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 a...
20:40 , Jul 7, 2017 |  BC Week In Review  |  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...
20:30 , Jul 5, 2017 |  BC Extra  |  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...
19:07 , Jul 3, 2017 |  BC Week In Review  |  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...
22:38 , Jun 23, 2017 |  BC Extra  |  Company News

CHMP recommendations include two new HCV combos

On Friday, EMA's CHMP recommended approval of a basket of therapies, including two new combinations to treat HCV infection. The committee recommended approval of Maviret glecaprevir/pibrentasvir from AbbVie Inc. (NYSE:ABBV) to treat chronic HCV infection in...
21:06 , Apr 27, 2017 |  BC Week In Review  |  Clinical News

Renflexis regulatory update

FDA approved a BLA from Samsung Bioepis Co. Ltd. for Renflexis infliximab-abda, a biosimilar of Remicade infliximab, to treat Crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis....
02:10 , Feb 14, 2017 |  BioCentury  |  Regulation

From similar to same

FDA’s draft guidance on demonstrating interchangeability with a reference product cracks open a door into a generics-like marketplace but, in many settings, manufacturers may decide it isn’t worth the expense. The guidance sets a high...
21:54 , Jan 18, 2017 |  BC Extra  |  Company News

Boehringer's biosimilar Humira under FDA, EMA review

Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA and EMA accepted for review regulatory applications for BI 695501, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NASDAQ:ABBV). In October, Boehringer said the biosimilar met...
00:53 , Dec 31, 2016 |  BioCentury  |  Finance

Delivering takeouts

  BioCentury’s 25th annual Buyside View finds biotech investors focusing on mid-cap names with late-stage or marketed products that could become M&A targets. “The main theme playing at the moment is investors like us are looking more...