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Keeping Track: Longer US FDA Reviews For Tislelizumab, Toripalimab, Olipudase; Perrigo Wants OC To Go OTC

Executive Summary

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

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BeiGene/Novartis's Tislelizumab Faces US Delay Over China Inspection Challenges

An inability to conduct manufacturing field inspections in China due to strict local COVID-19 policies is cited as the only reason for the delay for the anti-PD-1 drug, for which the timescale for resolution is currently unclear.

US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application

Perrigo's HRA Pharma submits to FDA on 11 July an NDA by for OTC 0.075-mg norgestrel, branded Opill, The same formulation previously was available Rx 30 years. 

Acer’s ‘Misunderstood Drugs’ Strategy Faces Regulatory Hurdles

Acer repurposes drugs with available data (like a 40-year-old European antihypertensive) into rare disease treatments (like Edsivo for vascular Ehlers-Danlos syndrome), but approval remains elusive, with a CRL for ACER-001 just as Edsivo is poised to enter a new clinical trial, armed with a new breakthrough designation. The Pink Sheet delves into regulatory history and strategy with CEO Chris Schelling.

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