Menopause Drug A Priority For Astellas
Fast Track For Fezolinetant
The Japanese group has used a priority review voucher for fezolinetant to move further ahead of Bayer’s elinzanetant as it seeks regulatory approval to bring a non-hormonal therapy for menopausal symptoms such as hot flashes and night sweats to market.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The main Japanese pharma players report a generally strong fiscal Q1, helped by mainstays including Daiichi Sankyo's Enhertu, Astellas's Xtandi and Padcev and Chugai's Actemra, and in some cases by the weaker yen.
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.