37 documents

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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...
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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...
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16:24 , May 4, 2018 |  BC Week In Review  |  Clinical News

CRL for Sandoz's biosimilar rituximab

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said it received a complete response letter from FDA for a BLA for GP2013, the company's biosimilar of Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). Sandoz said it is...
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18:15 , May 3, 2018 |  BC Extra  |  Company News

CRL for Sandoz's biosimilar rituximab

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said it received late Wednesday a complete response letter from FDA for a BLA for GP2013, the company's biosimilar of Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). Sandoz said...
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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...
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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...
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20:24 , Feb 2, 2018 |  BC Week In Review  |  Clinical News

Pfizer's biosimilar equivalent to Rituxan in Phase III for follicular lymphoma

Pfizer Inc. (NYSE:PFE) reported top-line data from the Phase III REFLECTIONS B3281006 trial showing that PF-05280586, a biosimilar of rituximab, as first-line treatment of CD20-positive, low tumor burden follicular lymphoma met the primary endpoint of...
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16:40 , Nov 28, 2017 |  BC Innovations  |  Distillery Techniques

Disease models

TECHNOLOGY: Transgenics and knockouts Mice with humanized immune systems could be used to screen immunotherapies for cancer. The model involved modifying NK cell-deficient mice by knocking in genes encoding human IL-15 and signal regulatory protein α...
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20:28 , Sep 15, 2017 |  BC Week In Review  |  Clinical News

FDA accepts Novartis' BLA for biosimilar rituximab

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA accepted for review a BLA for GP2013, its proposed biosimilar of Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). Sandoz did not disclose the user fee action...
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16:07 , Aug 11, 2017 |  BC Week In Review  |  Clinical News

EC approves Novartis' rituximab biosimilar Rixathon

In June, Novartis AG (NYSE:NVS; SIX:NOVN) said the European Commission approved Rixathon (GP2013), a biosimilar of Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY), for all of MabThera's approved indications. Rixathon is indicated for non-Hodgkin's lymphoma (NHL),...
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