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Barriers to orphan drug development

This is the second in a series of articles aiming to highlight the vital role that drug development consultants play in helping small pharma companies to bring new medicines to the market. To put this properly into context, it is essential to understand the barriers currently restricting the development of new medicines for very rare […]

EMA issues guidance document in preparation for Brexit

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharma companies prepare for the UK’s withdrawal from the European Union. The first in a series of guides contains information around company location in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons […]

New route to treating Alzheimer’s Dementia

Boyds has been working with Australian-based biotech company, Actinogen Medical, to develop a novel approach to the treatment of Alzheimer’s disease. Rather than following the traditional treatment paths, it is taking a new route. This month the first of 174 patients on an international trial will begin taking a drug to lessen the level of […]

Falsified medicines – Anything but “fake news”

Dr Julie Warner, Director of Regulatory Affairs at Boyds, is also the Associate Editor of TOPRA’s Regulatory Rapporteur journal. In April, Dr Warner gave an overview of the current state of play relating to the Falsified Medicines Directive in Europe. Not a day goes by now without something “fake” in the news (and it’s often […]

Xanamem™ identified as a good candidate to investigate for the treatment of Alzheimer’s disease – Phase I data published in the British Journal of Pharmacology

The research paper, Selection and early clinical evaluation of the brain-penetrant 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitor UE2343 (Xanamem™) has been published in the British Journal of Pharmacology (BJP). Highlights The research paper, which was co-authored by Alan Boyd, reports that Phase I results show Xanamem™ is safe and well tolerated with no major safety issues. The […]