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Takeda Oncology
Division of Takeda Pharmaceutical Co. Ltd.
www.takedaoncology.com
Latest From Takeda Oncology
We Need To Talk – When To Get Early Scientific Advice
Hearing direct from HTA agencies on what evidence they want to see is now an option through early dialogue. With many options for early dialogue available, it is hard for companies to know whether to get advice, from which agency and how to get the most out of the dialogue.
Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases
Generic and brand firms both seem to want ‘very black and white lines’ on orphan exclusivity, but FDA isn't so sure how to distinguish biomarker-targeted disease from histologically-defined disease.
Indication 'Carve In' Allowed Under Generic Labeling 'Carve-Out' Authority, US FDA Says
In citizen petition response involving Takeda's Velcade, agency says ANDA and 505(b)(2) applicants may add more words to the indication statement in order to carve-out protected uses from the reference product's broadly written indication.
Indication 'Carve In' Allowed Under Generic Labeling 'Carve-Out' Authority, US FDA Says
In citizen petition response involving Takeda's Velcade, agency says ANDA and 505(b)(2) applicants may add more words to the indication statement in order to carve-out protected uses from the reference product's broadly written indication.
Company Information
- Industry
-
Biotechnology
- Large Molecule
- Pharmaceuticals
- Therapeutic Areas
- Cancer
- Alias(es)
- Millennium Pharmaceuticals Inc.
- Millennium: The Takeda Oncology Co.
- Ownership
- Private
- Headquarters
-
Worldwide
-
North America
-
USA
-
USA
-
North America
- Parent & Subsidiaries
- Takeda Pharmaceutical Co. Ltd.
- Senior Management
-
Christophe Bianchi, MD, Pres.
Fabien Dubois, Head, Fin.
Ryan Cohlhepp, VP, US Mktg.
Joe Regan, VP, US Sales - Contact Info
-
Takeda Oncology
Phone: (617) 679-7000
40 Lansdowne St.
Cambridge, MA 02139
USA
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