EMA Starts Evaluation of Moderna’s COVID-19 Vaccine for Children
The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.
Then European Medicines Agency (EMA) announced on Nov. 10, 2021 that it has begun evaluating Moderna’s application to extend the use of its COVID-19 vaccine, Spikevax, to children ages 6–11. The agency’s Committee for Medicinal Products for Human Use (CHMP) will review vaccine data and results from an ongoing clinical study that includes children aged 6–11. EMA anticipates the evaluation to take two months, approximately. Once the CHMP reaches an outcome from the review, its opinion will be forwarded to the European Commission for a final decision.
Spikevax is currently authorized in the European Union for use in people 12 years and older.
Source: EMA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
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.
