EMA Reflects on Coated Nanomedicines
EMA publishes reflection paper on issues regarding the parenteral administration of coated nanomedicines.
The European Medicines Agency (EMA) has published a reflection paper on general issues regarding the development of coated nanomedicines. The paper addresses issues that may arise in the development of nanomedicines that have a coating, including the effect of the coating on stability and possible interactions with other molecules.
The reflection paper is one in a series of four guidance documents discussing nanomedicines. EMA’s Committee for Medicinal Products for Human Use began developing guidance on the development of new nanomedicines and nanosimilars in 2011.
Source: European Medicines Agency
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
