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...
22:19 , Mar 16, 2018 |  BioCentury  |  Finance

Hong Kong’s new chapter

Introducing a biotech chapter to the Hong Kong stock exchange fills a massive void in the region’s innovation ecosystem, but won’t come without risks. It promises to create a long sought public capital market for biotechs...
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...
20:49 , Jan 5, 2018 |  BC Week In Review  |  Financial News

Fosun's biosimilar unit to raise $190M

Shanghai Henlius Biotech Inc. (Shanghai, China) said on Dec. 21, 2017, it will raise RMB1.3 billion ($192.5 million) through the sale of 55.4 million shares at RMB22.71, including 14.6 million shares to its parent company...
23:59 , Dec 28, 2017 |  BC Extra  |  Financial News

Fosun's biosimilar unit to raise $190M

On Dec. 20, Shanghai Henlius Biotech Inc. (Shanghai, China) said it will raise RMB1.3 billion ($192.5 million) through the sale of 55.4 million shares at RMB22.71, including 14.6 million shares to its parent company Fosun...
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...
20:12 , Sep 22, 2017 |  BC Week In Review  |  Financial News

AbClon raises W6.8B in IPO

On Sept. 18, AbClon Inc. (KOSDAQ:174900) raised W6.8 billion ($6.1 million) through the sale of 680,741 shares at W10,000 in an IPO. Director Kyu-Tae Kim told BioCentury that AbClon's lead candidate is AC101, a mAb targeting...