03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
15:27 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

FDA approves AbbVie's Orilissa for endometriosis pain

FDA approved Orilissa elagolix from AbbVie Inc. (NYSE:ABBV) for the management of moderate to severe pain associated with endometriosis. AbbVie expects to launch the drug early next month at a wholesale acquisition cost (WAC) of...
20:44 , Jun 22, 2018 |  BC Week In Review  |  Clinical News

ObsEva's linzagolix meets in Phase IIb for endometriosis-associated pain

ObsEva S.A. (NASDAQ:OBSV) said three of four doses of linzagolix (OBE2109, KLH-2109) met the primary endpoint in the Phase IIb EDELWEISS trial to treat moderate to severe endometriosis-associated pain. The company plans to present additional...
20:13 , Jun 20, 2018 |  BC Extra  |  Financial News

ObsEva raises $73M on heels of linzagolix data

ObsEva S.A. (NASDAQ:OBSV) raised $73.1 million through the sale of 4.8 million shares at $15.39 in a follow-on underwritten by J.P. Morgan, Credit Suisse Securities (USA), Jefferies, Wedbush Securities and H.C. Wainwright. The price is...
16:32 , Mar 16, 2018 |  BC Week In Review  |  Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the non-peptide small molecule...
18:08 , Mar 13, 2018 |  BC Extra  |  Clinical News

AbbVie's elagolix meets in second Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-II (M12-817) trial, the second of two replicate Phase III trials of the candidate to treat...
20:34 , Feb 23, 2018 |  BC Week In Review  |  Clinical News

AbbVie's elagolix meets in Phase III for uterine fibroids

AbbVie Inc. (NYSE:ABBV) said elagolix (ABT-620) met the primary and all ranked secondary endpoints in the Phase III ELARIS UF-I (M12-815) trial to treat uterine fibroids. The trial is the first of two replicate Phase...
21:12 , Jan 23, 2018 |  BC Innovations  |  Distillery Therapeutics

Other; hematology

INDICATION: Poisoning; hematology Mouse studies suggest GnRH/LHRH receptor antagonists could help treat radiation poisoning and chemotherapy-induced myelosuppression. In mice exposed to lethal whole-body radiation, the GnRH/LHRH receptor antagonist Firmagon degarelix increased counts of red blood...
21:26 , Nov 10, 2017 |  BC Week In Review  |  Clinical News

Myovant and Takeda's relugolix meets in Phase III for uterine fibroid pain

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and partner Myovant Sciences GmbH (NYSE:MYOV) reported top-line data from the Phase III TAK-385-3008 trial in 65 women with pain associated with uterine fibroids showing that once-daily 40 mg oral...
04:52 , Nov 3, 2017 |  BC Week In Review  |  Clinical News

Priority Review for AbbVie endometriosis therapy elagolix

FDA accepted and granted Priority Review to an NDA for elagolix (ABT-620, NBI-56418) from AbbVie Inc. (NYSE:ABBV) for the management of endometriosis with associated pain. Its PDUFA date is in 2Q18. Elagolix is a non-peptide...