EMA Publishes Annual Report
The European Medicines Agency's Annual Report highlights the agency's drug approvals, projects, and initiatives for 2013.
The European Medicines Agency (EMA) released its annual report detailing drug approvals and agency projects completed in 2013, as well as initiatives started in the past year. According to the report, EMA recommended 81 drugs for marketing authorization in 2013, up from 57 in 2012. There was also an increase in the number of drugs containing new active substance; however, the number of generic drugs remained stable. EMA also recommended two new advance-therapy drugs in 2013 and approved 11 orphan drugs.
The report also highlights projects, initiatives, and achievements made by the agency in 2013 including access to clinical trial data as part of a marketing authorization application, advancement in patient access to medicine, reorganization of the agency, and implementation of new legislation. The report also details the agency’s pharmacovigilance activities as part of implementation of the European Union’s pharmacovigilance legislation.
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.
