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...
07:00 , Aug 15, 2016 |  BioCentury  |  Finance

Serving returns

China's Ally Bridge Group hit the investment world's radar in 2015 with its audacious move to take CRO WuXi PharmaTech Inc. private. If the firm and its partners can engineer the first fruits of that...
07:00 , Jul 25, 2016 |  BioCentury  |  Strategy

Eurosimilars

The complex European biosimilars landscape makes it hard to extrapolate pricing, market share and switching trends to the U.S. Across Europe, price reductions following biosimilar introduction vary widely. For example, according to IMS Health...
07:00 , Jun 20, 2016 |  BC Week In Review  |  Clinical News

Biosimilar infliximab: Additional Phase III data

Data from 396 patients with moderate to severe RA despite methotrexate therapy who were re-randomized at week 54 to either transition from Remicade infliximab to Flixabi (n=94) or remain on treatment with Flixabi...
07:00 , Jun 6, 2016 |  BC Week In Review  |  Clinical News

Biosimilar infliximab regulatory update

The European Commission approved an MAA from Samsung Bioepis Co. Ltd. for Flixabi infliximab, a biosimilar of autoimmune drug Remicade infliximab. Flixabi, a chimeric mAb against tumor necrosis factor (TNF) alpha, is indicated to...