Despite a raft of measures to prevent substandard or falsified (SF) medicines from reaching individuals, these medicines proliferated with the growth of e-commerce during the COVID-19 pandemic. The problem requires multistakeholder counter efforts, and for providers and patients to change their behaviors.

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.

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.

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