Tag Archive for: regulatory

This week’s hot topic: Why Pharma will have to play the long game on Alzheimer’s drugs

By Stephen Adams, Optimum Strategic Communications Few people expected England and Wales’s drugs spending watchdog, the National Institute for Health and Care Excellence (“NICE”), to approve Eli Lilly’s new dementia drug donanemab for use on the NHS last week.  At a reputed annual cost of at least £60,000 a year, including the care bill, it […]

Update on Regulatory Review of leriglitazone in the EU

A re-examination for cerebral adrenoleukodystrophy (cALD) will be requested following a negative CHMP opinion Barcelona, Spain and Düsseldorf, Germany – 26 January, 2024 – Minoryx Therapeutics, a late stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused […]