Several first-to-file ANDAs are on the line for Ranbaxy as it tries to resolve data integrity issues at its Paonta Sahib facility with U.S. FDA
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In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
Private Company Edition: Antares’ lead asset will enter the clinic in 2026 after Lilly committed up to $2.5bn for Scorpion’s Phase I/II PI3Kα inhibitor STX-478. Also, Amplify raised $200m for its first biotech VC fund and Mosanna raised an $80m series A round, among other financings.
