19:32 , Sep 14, 2018 |  BC Week In Review  |  Clinical News

Celltrion NDA for rituxan biosimilar awaits FDA panel discussion

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab. Celltrion resubmitted the BLA in May, two months after...
19:59 , Sep 11, 2018 |  BC Extra  |  Company News

FDA panel to discuss Celltrion biosimilar

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab. Celltrion resubmitted the BLA in May, two months after...
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...