35 documents

Read All
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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...
Read More
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),...
Read More
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
Read More
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...
Read More