03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
17:09 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing GMP...
23:21 , Apr 5, 2018 |  BC Extra  |  Company News

FDA issues CRLs for Celltrion biosimilars

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10). Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing GMP...
23:01 , Jan 24, 2018 |  BC Extra  |  Clinical News

Pfizer's biosimilar equivalent to rituximab in Phase III test

Pfizer Inc. (NYSE:PFE) said biosimilar candidate PF-05280586 met the primary endpoint of equivalence to rituximab on overall response rate (ORR) in the Phase III REFLECTIONS B3281006 trial to treat CD20-positive, low tumor burden follicular lymphoma...
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...
20:43 , Jul 7, 2017 |  BC Week In Review  |  Clinical News

FDA to review Celltrion's biosimilar rituximab

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) and Celltrion Inc. (KOSDAQ:068270) said FDA accepted for review a BLA for CT-P10, their proposed biosimilar of rituximab. Teva spokesperson Michelle Larkin told BioCentury the candidate's user fee...
21:37 , Jun 29, 2017 |  BC Extra  |  Company News

FDA reviewing Celltrion's Rituxan biosimilar

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) and Celltrion Inc. (KOSDAQ:068270) said FDA accepted for review a BLA for CT-P10, their proposed biosimilar of rituximab. Teva spokesperson Michelle Larkin told BioCentury the candidate's user fee...
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...
22:39 , Apr 7, 2017 |  BioCentury  |  Finance

Fade to black

At the end of 2016, investors argued that equity values had nowhere to go but up. This proved to be the case in 1Q as all market cap bands finished in the black. Sector specialists,...
21:34 , Mar 17, 2017 |  BioCentury  |  Finance

Mirae’s Western expansion

Mirae Asset Financial Group is tapping the Western market experience of biosimilar company Celltrion Inc. (KOSDAQ:068270) to expand its VC investments outside of Asia. The partners will jointly launch a healthcare fund this month. Each will...