17:30 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 on Oct. 10 that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a monotherapy...
22:55 , Oct 11, 2018 |  BC Week In Review  |  Financial News

JHL raises financing at $750M valuation

Biosimilars company JHL Biotech Inc. (Zhubei, Taiwan) raised an undisclosed amount in a private financing at a valuation of $750 million. Participating in the financing were Sanofi (Euronext:SAN; NYSE:SNY) and other undisclosed investors, according to...
22:09 , Oct 10, 2018 |  BC Extra  |  Company News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 Wednesday that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab. The panel backed the biosimilar's approval as a monotherapy to...
18:22 , Oct 5, 2018 |  BC Extra  |  Financial News

JHL raises financing at $750M valuation

Biosimilars company JHL Biotech Inc. (Zhubei, Taiwan) raised an undisclosed amount in a private financing at a valuation of $750 million. Participating in the financing were Sanofi (Euronext:SAN; NYSE:SNY) and other undisclosed investors, according to...
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...
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...