The risks of major congenital malformations in children born of women who took the anti-epileptic valproate have been confirmed by a new French study, which has also detected new risks with both old and more recent drugs for epilepsy and bipolar disorder.
New results obtained by the French health authorities have further confirmed the “highly teratogenic nature” of valproate when used for the treatment of epilepsy and bipolar disorder in women during pregnancy, with as many as 4,100 French children potentially having suffered major birth defects since the drug’s launch in 1967.
The risk level varies depending on the disorder the drug is used for: the risk of major congenital malformations (MCMs)...
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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