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
Executive Summary
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.