The European Medicines Agency rejected Santhera’s Raxone as a treatment for Duchenne muscular dystrophy but the prospect of definitive data supporting the new indication means idebenone will still be available to patients in the UK under the early access scheme for promising new medicines.
The UK drug regulator has decided not to drop Santhera Pharmaceuticals’s drug Raxone (idebenone) from its early access to medicines scheme (EAMS) as a treatment for Duchenne muscular dystrophy, despite the European Medicines Agency saying the product should not be approved.
The EAMS designation for Raxone was granted last June and allows Santhera to make the drug available to patients in...
China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.
Insurance trade groups warned that the Big Beautiful Bill destabilize Medicaid and result in the largest ever roll-back in health care coverage in the US.
The creation of a single national formulary for medicines prescribing that could impact industry is among the action points in the UK government’s new 10-year health plan for the National Health Service in England.
Final guidelines explaining how staff at Canada’s Patented Medicine Prices Review Board should go about identifying drugs that could be considered for an excessive price hearing will come into force soon.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
