Our Associate Director, Dr Graeme Deuchar, will be presenting an “Overview and Real World Experience of MHRA’s PIM Designation / Early Access to Medicines Scheme” at the next TOPRA in Scotland meeting. The meeting will be held on 27 September

Kinesys Consulting Ltd is pleased to announce that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug designation to Soligenix’ recombinant modified ricin toxin A-chain

The European Medicines Agency (EMA) will now be publishing “orphan maintenance assessment report” for every orphan-designated medicine which has been recommended for marketing authorisation.To qualify for orphan designation, a medicine must target a disease that is life-threatening or chronically debilitating that affects

Since 2014, there has been a welcome recognition within Europe of the need for improved regulatory mechanisms whereby medicines being developed to target serious or life-threatening diseases that represent an unmet clinical need can be made available to patients at

Orphan Drugs Pricing and Sustainability At a workshop entitled “Sustainable Funding and Fair Pricing for Orphan Drugs: What Are the Solutions?”, the panellists discussed the options that exist to make funding of valuable orphan medicinal products (OMPs) sustainable for healthcare systems while also