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...
22:43 , Sep 13, 2018 |  BC Week In Review  |  Company News

Gottlieb rebukes Nostrum's 300% price hike for generic antibiotic

A price hike of more than 300% by Nostrum Pharmaceuticals LLC (New Brunswick, N.J.) for a 65-year-old antibiotic met swift condemnation by FDA Commissioner Scott Gottlieb on Sept. 11. Gottlieb said in a tweet that FDA...
23:55 , Sep 11, 2018 |  BC Extra  |  Company News

Gottlieb rebukes Nostrum’s 300% price hike for generic antibiotic

A price hike of more than 300% by Nostrum Pharmaceuticals LLC (New Brunswick, N.J.) for a 65-year-old antibiotic met swift condemnation by FDA Commissioner Scott Gottlieb on Tuesday. Gottlieb said in a tweet that FDA...
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...
23:20 , Sep 7, 2018 |  BC Extra  |  Financial News

Opko's Frost among those charged in ‘pump-and-dump’ schemes

The SEC filed charges against biotech investor and former Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) Chairman Phillip Frost alleging that he participated in “pump-and-dump” schemes involving penny stock companies. Frost, who is chairman and CEO at...
23:15 , Sep 5, 2018 |  BC Extra  |  Company News

Management tracks: Sihuan launches U.S. unit

Sihuan Pharmaceutical Holdings Group Ltd. (HKSE:460) established a global business development unit in the U.S., through which it is seeking to expand and speed its international projects. The unit will be led by CBO Frank...
17:57 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Teva wins first FDA approval for generic EpiPen

FDA approved an ANDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) for the first generic version of EpiPen epinephrine auto-injector for the emergency treatment of allergic reactions including anaphylaxis. Mylan N.V. (NASDAQ:MYL) markets the...
17:52 , Aug 29, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Cancer; cervical cancer; head and neck cancer; lung cancer; ovarian cancer Patient sample, cell culture and mouse studies suggest inhibiting MAST1 could help treat cisplatin-resistant cancer. In tumor samples from squamous cell carcinoma of...