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Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase

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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Finance Watch: Venture Capital, Debt Financings Led Fundraising Surge In Q2

New VC deals include a $60m series C-1 round for DiCE Molecules a day before it filed paperwork to support a $100m IPO and a $100m financing for China’s IONOVA Life Science. Also, RenovoRx was the 84th company to go public in the US this year and ADC Therapeutics executed a $325m royalty deal. 

FDA Thwarts Leo Pharma's US Launch Plans For Tralokinumab

A week after getting the thumbs-up from the CHMP for tralokinumab, the Denmark-based dermatology specialist has been hit by a complete response letter from US regulators requesting more data about a device component of the IL-13 inhibitor.

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