BioCentury | Sep 20, 2019
Company News

Sept. 20 Company Quick Takes: Three Japanese approvals, plus AZ-Ironwood, Boehringer-Inflammasome, China Biologics and a Sino-Russian JV

...Tokyo:4519) to include PD-L1-positive triple-negative breast cancer. MHLW also approved serotonin modulator and stimulator Trintellix vortioxetine...
...Brand), RG7446 (Compound #), MPDL3280A (Compound #), atezolizumab (Generic), Tecentriq (Other), Anti-PDL1 (Other) Brintellix, Trintellix, vortioxetine (lu aa21004) roxadustat...
BioCentury | Sep 16, 2019
Company News

Lundbeck enters migraine race with $2B takeout of Alder

...focused on neurology and psychiatric indications. In 1H19, the company's best selling drug was Trintellix/Brintellix vortioxetine...
BioCentury | Jul 13, 2018
Clinical News

Lundbeck, Takeda planning Japanese regulatory submission for vortioxetine

...Ltd. (Tokyo:4502) plan to submit a regulatory application in Japan this year for Brintellix vortioxetine (Trintellix...
...Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Brintellix vortioxetine (Trintellix...
...Deficits Questionnaire (PDQ-5) Status: Phase III data Milestone: Submit regulatory application (2H18) Jennie Walters Brintellix, Trintellix, vortioxetine (lu aa21004) H...
BioCentury | Mar 31, 2018
Strategy

Refashioning Takeda

...were $2.3 billion in the period. Takeda discloses sales for just one CNS product: Trintellix vortioxetine...
...of FY17 for the serotonin modulator and stimulator were ¥37.6 billion ($333.7 million). Takeda co-commercializes Trintellix...
BioCentury | Aug 16, 2017
Clinical News

Takeda, Lundbeck get second CRL for Trintellix in MDD

...Tokyo:4502) said FDA issued a second complete response letter to an sNDA for Trintellix vortioxetine (Brintellix...
...with major depressive disorder (MDD). FDA issued the first CRL in 2016. The companies market Trintellix...
...Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Trintellix vortioxetine (Brintellix) (formerly Lu AA21004) Business: Neurology Chris Lieu Brintellix Trintellix vortioxetine H...
BioCentury | May 30, 2016
Strategy

Taking Takeda global

...for Trintellix ( Brintellix ) vortioxetine, up 80% from ¥13.6 billion in FY14. Takeda launched Trintellix...
BioCentury | Mar 30, 2016
Company News

FDA rejects Brintellix cognitive dysfunction claim

...for an sNDA in which the partners sought to add an efficacy claim for Brintellix vortioxetine...
...vortioxetine to treat cognitive dysfunction in adults with major depressive disorder (MDD). The partners market Brintellix...
BioCentury | Feb 8, 2016
Clinical News

Brintellix vortioxetine regulatory update

...FDA’s Psychopharmacologic Drugs Advisory Committee voted 8-2 that Brintellix vortioxetine from Takeda and H. Lundbeck provided...
...vortioxetine from Takeda and H. Lundbeck provided substantial evidence to support an efficacy claim for Brintellix...
...Denmark Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Brintellix vortioxetine ( Trintellix ) (formerly Lu AA21004...
BioCentury | Feb 5, 2016
Company News

FDA panel backs cognitive dysfunction claim for Brintellix

...Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) provided substantial evidence to support an efficacy claim for Brintellix vortioxetine...
...vortioxetine to treat cognitive dysfunction in adults with major depressive disorder (MDD). The companies market Brintellix...
...adults. The committee was discussing an sNDA from Takeda seeking to add the claim to Brintellix's...
BioCentury | Feb 1, 2016
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...
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