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Shire PLC

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

Latest From Shire PLC

Protalix and Chiesi Plan Q1 2020 Filing For Accelerated FDA Approval

The companies plan to use surrogate endpoint data to win approval to challenge Sanofi and Shire for the Fabry disease market.

Approvals Rare Diseases

BIO 2019 Notebook: Sharpless On Pricing, Marks On Gene Therapy, Takeda On M&A

News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates; and Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout.

Pricing Debate Drug Review

BIO 2019 Notebook: Sharpless On Pricing, Takeda M&A Strategy, FDA Cell And Gene Therapy Staffing

News and views from day two of the BIO International Convention: US FDA's Sharpless decries the focus on the price of "medical miracle" Zolgensma; Takeda explains why its business development philosophy leads to the valuation seen in the Ariad buyout; and CBER Director Marks talks about how his division will staff up to review cell and gene therapy candidates.

Pricing Debate M & A

US FDA Approval Actions To Watch Out For In June

User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.

Drug Review Drug Approval Standards
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