17:51 , Aug 3, 2018 |  BC Week In Review  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled July 30 that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion...
22:04 , Aug 1, 2018 |  BC Extra  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled Monday that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion victory...
21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
15:39 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Amgen's biosimilar non-inferior to Remicade in Phase III for RA

Amgen Inc. (NASDAQ:AMGN) said 3 mg/kg ABP 710, a biosimilar of Remicade infliximab, was non-inferior to Remicade on the primary endpoint of the proportion of patients with a 20% improvement in American College of Rheumatology...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
18:50 , Feb 9, 2018 |  BC Week In Review  |  Clinical News

FDA warns Celltrion of GMP violations at Inflectra facility

FDA issued a warning letter to Celltrion Inc. (KOSDAQ:068270) on Jan. 26 identifying "significant violations" of GMP regulations regarding production of Inflectra biosimilar infliximab-dyyb (CT-P13) at its manufacturing facility in Incheon, South Korea. According to the...
19:18 , Jun 2, 2017 |  BC Week In Review  |  Clinical News

Celltrion to begin clinical trials of Remsima in China

Celltrion Inc. (KOSDAQ:068270) said it has received clearance from China FDA to begin clinical trials of Remsima biosimilar infliximab. The company said it will become the first non-Chinese company to begin clinical studies of a...
20:58 , May 30, 2017 |  BC Extra  |  Clinical News

Celltrion to begin China studies of Remsima

Celltrion Inc. (KOSDAQ:068270) has received clearance from China FDA to begin clinical trials of Remsima biosimilar infliximab, spokesperson Gunn Lee told BioCentury. Lee said Celltrion will become the first non-Chinese company to begin clinical studies...
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....
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...