EMA Creates Taskforce on Big Data
The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.
The European Medicines Agency (EMA) announced on March 23, 2017 that, along with heads of medicines agencies in the European Economic Area (EEA), it was establishing a taskforce to evaluate the use of big data to support pharmaceutical research, innovation, and development. The taskforce will be evaluating data from electronic health records, genomics, social media, clinical trials, and adverse reaction reports to assess the potential for these data to help in the determination of the risk and benefits of medicines over their lifecycle.
The taskforce will be chaired by the Danish Medicines Agency and EMA and include staff from regulatory agencies in the EEA. The group will be mapping sources and characteristics of data, explore applicability and impact of data on regulation, and develop recommendations for changes to legislation or guidelines. They will also collaborate with regulatory authorities outside the EEA to gain further insight.
Source: EMA
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.
