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Latest From AbbVie Inc.

Japan Nod For Quizartinib In First-Line AML

Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.

Japan Approvals

Eisai/Biogen’s Leqembi Gets Some Medicare Coverage Certainty In CMS Update

CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry. 

Government Payers Market Access

MDSAP Audit Allows Emerging Firm To Expand Internationally

Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight

Regulation Strategy

AstraZeneca’s Lynparza Adds Narrow Prostate Cancer Indication

AstraZeneca had hoped data from Phase III PROpel would lead to an all-comers indication in first-line, metastatic castration-resistant prostate cancer, but new indication is limited to BRCA mutations.

Approvals Business Strategies
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    • Luminera
    • Mavupharma
    • Pharmacyclics, Inc.
    • Stemcentrx, Inc.
    • Syndesi Therapeutics SA
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