00:19 , Jul 31, 2019 |  BC Extra  |  Clinical News

July 30 Clinical Quick Takes: Biogen, Alkermes MS candidate superior to Tecfidera; plus Amgen, Lilly and more

Biogen, Alkermes Phase III MS candidate beats Tecfidera  Biogen Inc. (NASDAQ:BIIB) and Alkermes plc (NASDAQ:ALKS) said diroximel fumarate (BIIB098) met the primary endpoint in the Phase III EVOLVE-MS-2 trial: superiority to Biogen’s Tecfidera dimethyl fumarate...
00:33 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

FDA approves Lilly's Verzenio as first-line endocrine therapy

Eli Lilly and Co. (NYSE:LLY) said FDA approved Verzenio abemaciclib as first-line endocrine therapy in combination with an aromatase inhibitor to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. The approval...
00:08 , Feb 27, 2018 |  BC Extra  |  Company News

FDA approves Lilly's Verzenio as first-line endocrine therapy

Eli Lilly and Co. (NYSE:LLY) said FDA approved Verzenio abemaciclib as first-line endocrine therapy in combination with an aromatase inhibitor to treat hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women. The approval...
20:32 , Oct 12, 2017 |  BC Extra  |  Company News

Lilly's Verzenio gets Priority Review for label expansion

Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to an NDA for Verzenio abemaciclib as a first-line endocrine therapy in combination with an aromatase inhibitor to treat hormone receptor-positive, HER2-negative advanced...
20:17 , Sep 22, 2017 |  BC Week In Review  |  Clinical News

Lilly reports additional Phase III breast cancer data for abemaciclib

Eli Lilly and Co. (NYSE:LLY) reported additional data from the Phase III MONARCH 3 trial in 493 postmenopausal women with hormone receptor-positive, HER2-negative, locoregionally recurrent or metastatic breast cancer showing that median progression-free survival, the...
02:29 , Jul 13, 2017 |  BC Week In Review  |  Clinical News

Lilly's abemaciclib gets Priority Review for breast cancer

Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to an NDA for abemaciclib (LY2835219) to treat advanced breast cancer. Its PDUFA date is in 1Q18. Specifically, abemaciclib is under review as...
00:04 , Jul 11, 2017 |  BC Extra  |  Company News

Lilly's abemaciclib gets Priority Review

Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to an NDA for abemaciclib (LY2835219) to treat advanced breast cancer. Its PDUFA date is in 1Q18. Specifically, abemaciclib is under review as...
03:09 , Jun 9, 2017 |  BC Week In Review  |  Clinical News

Lilly reports detailed MONARCH 2 data of abemaciclib in breast cancer

Eli Lilly and Co. (NYSE:LLY) reported additional data from Phase III MONARCH 2 trial in 669 postmenopausal women with hormone receptor-positive, HER2-negative breast cancer showing that twice-daily 150 mg oral abemaciclib (LY2835219) plus Faslodex fulvestrant...
21:05 , Apr 27, 2017 |  BC Week In Review  |  Clinical News

Abemaciclib: Interim Ph III MONARCH 3 data

Interim data from the double-blind, placebo-controlled, international Phase III MONARCH 3 trial in 493 postmenopausal women with hormone receptor-positive, HER2-negative, locoregionally recurrent or metastatic breast cancer showed that twice-daily 150 mg oral abemaciclib plus anastrozole...
20:30 , Apr 24, 2017 |  BC Extra  |  Clinical News

Lilly's abemaciclib passes latest MONARCH test

Eli Lilly and Co. (NYSE:LLY) said abemaciclib (LY2835219) significantly improved progression-free survival (PFS) in the Phase III MONARCH 3 trial to treat hormone receptor-positive, HER2-negative advanced breast cancer, meeting the study's primary endpoint. The company...