FDA's NDA And BLA Approvals: Xhance, Trelegy Ellipta, Clorotekal, Verzenio
Original new drugs and biologics approved by US FDA.
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GlaxoSmithKline is poised for a challenging 2018, with an interchangeable Advair generic expected to launch, but GSK believes growth from new products will make up some of the loss. US Advair sales could be slashed to £750m from £1.6bn in 2017.
Public Company Edition: Outside the US, Zai Lab raised more in its recent Hong Kong initial public offering – $766.4m – than PMV, Prelude, Taysha, Graybug and Greenwich combined. Also, Gilead priced debt to fund its $21bn Immunomedics buy and ADC Therapeutics raised $204m.
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.