19:11 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Lundbeck, Takeda planning Japanese regulatory submission for vortioxetine

H. Lundbeck A/S (CSE:LUN) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) plan to submit a regulatory application in Japan this year for Brintellix vortioxetine (Trintellix) to treat major depressive disorder (MDD) after the drug met...
01:23 , Mar 31, 2018 |  BioCentury  |  Strategy

Refashioning Takeda

Takeda Pharmaceutical Co. Ltd.’s potential acquisition of Shire plc appears to be timed to take advantage of the chance to acquire products and a global footprint on the cheap. The combination would create a global biopharma...
20:05 , Aug 16, 2017 |  BC Week In Review  |  Clinical News

Takeda, Lundbeck get second CRL for Trintellix in MDD

In June, H. Lundbeck A/S (CSE:LUN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said FDA issued a second complete response letter to an sNDA for Trintellix vortioxetine (Brintellix) to treat cognitive dysfunction in adults with major...
07:00 , May 30, 2016 |  BioCentury  |  Strategy

Taking Takeda global

Two years after joining Takeda Pharmaceutical Co. Ltd., Christophe Weber has narrowed the company's therapeutic focus, expanded the executive team and reorganized its approach to market with the aim of transforming the company into a...
01:31 , Mar 30, 2016 |  BC Extra  |  Company News

FDA rejects Brintellix cognitive dysfunction claim

H. Lundbeck A/S (CSE:LUN) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said FDA issued a complete response letter for an sNDA in which the partners sought to add an efficacy claim for Brintellix vortioxetine to treat...
08:00 , Feb 8, 2016 |  BC Week In Review  |  Clinical News

Brintellix vortioxetine regulatory update

FDA’s Psychopharmacologic Drugs Advisory Committee voted 8-2 that Brintellix vortioxetine from Takeda and H. Lundbeck provided substantial evidence to support an efficacy claim for Brintellix vortioxetine to treat cognitive dysfunction in adults with major depressive...
04:12 , Feb 5, 2016 |  BC Extra  |  Company News

FDA panel backs cognitive dysfunction claim for Brintellix

FDA's Psychopharmacologic Drugs Advisory Committee voted 8-2 on Wednesday that H. Lundbeck A/S (CSE:LUN) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) provided substantial evidence to support an efficacy claim for Brintellix vortioxetine to treat cognitive...
08:00 , Feb 1, 2016 |  BC Week In Review  |  Company News

Lundbeck, Takeda sales and marketing update

Late last year, the U.K.’s NICE issued final guidance recommending Brintellix vortioxetine from H. Lundbeck to treat major depressive disorder (MDD) in adults whose condition has not adequately responded to two prior treatments with...
07:00 , Oct 26, 2015 |  BC Week In Review  |  Company News

Lundbeck, Takeda sales and marketing update

The U.K.’s NICE issued final draft guidance recommending Brintellix vortioxetine from H. Lundbeck to treat major depressive disorder (MDD) in adults whose condition has not adequately responded to two prior treatments with antidepressants. The...
07:00 , Sep 14, 2015 |  BC Week In Review  |  Company News

Lundbeck sales and marketing update

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) said in an early benefit assessment that Brintellix vortioxetine from H. Lundbeck has no added benefit in patients with major depressive disorder (MDD) --...