17:38 , Nov 16, 2018 |  BC Week In Review  |  Company News

Samsung BioLogics trading suspended after accounting violations

Korea’s Securities and Futures Commission (SFC) temporarily suspended trading of Samsung BioLogics Co. Ltd. (KSE:207940) for violating accounting rules. The commission also recommended an W8 billion ($7 million) fine and the dismissal of Samsung BioLogics'...
20:34 , Nov 14, 2018 |  BC Extra  |  Company News

Samsung BioLogics trading suspended after accounting violations

Korea’s Securities and Futures Commission (SFC) temporarily suspended trading of Samsung BioLogics Co. Ltd. (KSE:207940) for violating accounting rules. The commission also recommended an W8 billion ($7 million) fine and the dismissal of Samsung BioLogics'...
20:15 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...
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;...
01:14 , Nov 9, 2018 |  BC Extra  |  Company News

FDA extends review of Samsung Bioepis' trastuzumab biosimilar

A Samsung Bioepis Co. Ltd. spokesperson told BioCentury that FDA extended by three months its review of a BLA for SB3, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech...
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...