US FDA has received a total of 19 reports of T-cell malignancy involving BCMA- or CD19-directed autologous CAR-T cell immunotherapies and is evaluating the need for regulatory action. Focus on lentiviral and retroviral vectors could extend to safety of other types of gene therapies.
A US Food and Drug Administration alert about reports of T-cell malignancies with CAR-T therapies could heighten safety scrutiny of lentiviral and retroviral-based gene therapies in general and temper enthusiasm for use of CAR-T products outside of oncology/hematology indications.
On 28 November, the agency announced it has received clinical trial and postmarketing reports of T-cell malignancies, including chimeric antigen...
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The European Medicines Agency’s safety committee has concluded that the benefits of medicines containing metamizole continue to outweigh the risks but that new measures are needed to minimize the serious outcomes of agranulocytosis.
Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
