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Takeda Oncology

Division of Takeda Pharmaceutical Co. Ltd.
www.takedaoncology.com

Latest From Takeda Oncology

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

Supplemental Oncology Approvals: 'Reverse Accelerated Approval,' Not Lowering The Bar

Sometimes data supporting drug's initial approval can serve as confirmatory evidence for full approval of a subsequent indication based on an intermediate endpoint, US FDA Oncology Center of Excellence Director Pazdur says; proposed framework discussed at Friends of Cancer Research meeting would establish more systematic approach to streamlining supplemental approvals.

Drug Approval Standards Review Pathway
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