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;...
19:29 , Oct 26, 2018 |  BC Week In Review  |  Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks...
23:38 , Oct 19, 2018 |  BC Extra  |  Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

EMA’s CHMP recommended several approvals Friday, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri. CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE....
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...
22:09 , 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...
17:36 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

FDA approves Teva's Ajovy, second CGRP inhibitor to prevent migraine

FDA approved Ajovy fremanezumab-vfrm from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) on Sept. 14 to prevent migraine in adults. The mAb targeting the calcitonin gene-related peptide ligand is the second in its class approved...
00:20 , Sep 15, 2018 |  BC Extra  |  Company News

FDA approves Teva's Ajovy, second CGRP inhibitor to prevent migraine

FDA approved Ajovy fremanezumab-vfrm from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) to prevent migraine in adults. The mAb targeting the calcitonin gene-related peptide ligand is the second in its class approved in the indication....