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...
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...
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...
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...
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...
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...
18:04 , Sep 1, 2017 |  BC Week In Review  |  Clinical News

FDA approves Chemo's Chagas treatment

FDA granted accelerated approval to benznidazole from the Chemo Research S.L. unit of Chemo Group (Barcelona, Spain) to treat Chagas disease caused by Trypanosoma cruzi in children ages 2-12. FDA said the nitroimidazole antimicrobial is...
00:04 , Aug 30, 2017 |  BC Extra  |  Company News

FDA approves first Chagas treatment

FDA granted accelerated approval to benznidazole from the Chemo Research S.L. unit of Chemo Group (Madrid, Spain) to treat Chagas disease in children ages two to 12 years. FDA said the oral small molecule antiprotozoal...
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),...