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
By sonia ziouani ammor In Kinesys News Tagged CTCL, Drug Development, Early Access, Early dialogue, MHRA, Oncology, Orphan Drug, Patient Access, PIM, Real-World Evidence, regulatory affairs
Kinesys Consulting last month secured another PIM designation, this time for a new oncology product, on behalf of a US partner. The product, successfully designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for the treatment of
Kinesys Consulting has secured its first PIM designation, for a novel oncology supportive care product, on behalf of a US partner. The product, designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for
Why is the World of Orphan Haemato-Oncology Agents Changing?As an increasing number of targeted oncology and haematology products are getting approved by EMA and FDA, the orphan space is becoming more and more crowded in these therapeutic areas.Patients with a
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 SGX301(synthetic hypericin) for the treatment of
