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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.

BioPharmaceutical Europe

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.

Rare Diseases Review Pathway

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.

Drug Approval Standards Generic Drugs

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.

Drug Approval Standards Generic Drugs
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