CBER director said unlicensed stem cell clinics often report adverse events not made public, which is a concern under Right To Try.
Asked about the US's Right to Try law, Center for Biologics Evaluation and Research Director Peter Marks said he needed to "carefully side-step" the issue, but he was willing to discuss what he called a surrogate marker for the new framework.
During the Nov. 14 Biopharma Congress IV, sponsored by Prevision Policy and the Friends of Cancer Research, he was queried...
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.
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.
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