20:14 , Dec 21, 2018 |  BC Week In Review  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Dec. 14 to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab...
00:06 , Dec 15, 2018 |  BC Extra  |  Financial News

Shanghai Henlius up for Hong Kong IPO

Biosimilars company Shanghai Henlius Biotech Inc. (Shanghai, China) proposed on Friday to list on the Hong Kong stock exchange. Shanghai Henlius' lead compound is HLX01, a biosimilar of cancer and autoimmune drug MabThera rituximab from...
18:24 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin...
21:41 , Nov 28, 2018 |  BC Extra  |  Company News

FDA approves first biosimilar for NHL

FDA approved a resubmitted BLA for Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA). The agency said Truxima is the first biosimilar approved in the U.S. to treat non-Hodgkin...
18:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). The unit of Novartis AG (NYSE:NVS;...
20:18 , Nov 5, 2018 |  BC Extra  |  Company News

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). The unit of Novartis AG (NYSE:NVS;...
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...
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...