Testing Methods for Microbiological Control Addressed at Europe Symposium
EDQM held a symposium on microbiology to gather industry feedback on alternative testing methods for microbiological control and sterilization processes.
On October 10–11, 2017, the European Directorate for the Quality of Medicines & Healthcare (EDQM) held a symposium to discuss trends and innovation in microbiology. Pharmacopeial approaches and regulatory requirements were addressed. Participants of the symposium agreed that current pharmacopeial standards worldwide sufficiently covered alternative methods to detect, enumerate, and identify microorganisms.
Topics discussed at the symposium included modern methods for microbiological control, sterilization, biological indicators, rapid microbiological methods, and control methods for cell therapy products and pharmaceutical water. Acceptance of new technologies was also discussed.
Source:
EDQM
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.
