European Pharmacopoeia Commission Updates Ph.Eur.
The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
The European Directorate for the Quality of Medicines & HeathCare (EDQM) announced that the European Pharmacopoeia Commission (Ph.Eur.) announced that the commission held its 152nd session in Strasbourg on June 16–17, 2015. The session resulted in six new texts, 31 revised monographs, and six revised general chapters.
The following were included in the updates:
- A new general monograph on chemical precursors for radiopharmaceutical preparations.
- A revised chapter on the use of the test for bacterial endotoxins, which includes new recommendations on the need to perform risk assessment when using the bacterial endotoxin test as a pyrogenicity test, due to the potential contamination by nonendotoxin pyrogens; and a section on how to set limits for bacterial endotoxins.
- A revision to the general chapter on potentiometric determination of pH.
- A revision to the general chapter on residual solvents to align the latter to the latest version of the ICH Q3C (R5).
- A revised version of the chapter on pyrogens, which recommends replacing this test by the Monocyte-activation test wherever possible and after product-specific validation to avoid the use of live animals.
The new texts become affective July 1, 2016 and will be published in Supplement 8.8 of the Ph.Eur.
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.
