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 Pharmaceuticals 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 Pharmaceuticals 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. Teva...
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...
17:51 , Aug 3, 2018 |  BC Week In Review  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled July 30 that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion...
22:04 , Aug 1, 2018 |  BC Extra  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled Monday that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion victory...
03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
18:26 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

Teva discontinues Phase III chronic cluster headache trial of fremanezumab

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) discontinued a Phase III trial of fremanezumab (TEV-48125) to prevent chronic cluster headache based on a prespecified futility analysis. The company said a Phase III trial of the...
19:07 , Jun 15, 2018 |  BC Extra  |  Clinical News

Teva discontinues chronic cluster headache trial of fremanezumab

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) discontinued a Phase III trial of fremanezumab (TEV-48125) to prevent chronic cluster headache based on a prespecified futility analysis. The company said a Phase III trial of the...
18:23 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

FDA rebuffs third biosimilar Herceptin

Amgen Inc. (NASDAQ:AMGN) received a complete response letter from FDA for ABP 980. This marks the third CRL the agency has issued for a biosimilar of Herceptin trastuzumab. Amgen declined to disclose details of the...