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
By sonia ziouani ammor In Events Tagged Adaptive Pathways, Clinical Trials, Drug Development, Early Access, Early dialogue, EMA, Europe, MHRA, Patient Access, PIM, PRIME, regulatory affairs
With the increasing acknowledgement of the need to develop an overarching scheme to enhance support for sponsors developing medicines, tackling unmet medical needs to ensure timely access to beneficial therapies, the EMA launched the PRIME scheme in March 2016. This
