Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From Adolor Corporation
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.
Keeping Track: Longer US FDA Reviews For Tislelizumab, Toripalimab, Olipudase; Perrigo Wants OC To Go OTC
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker