Santhera is set to address questions that EU regulators have regarding its application to market Raxone for Duchenne muscular dystrophy.
Santhera Pharmaceuticals is hoping this week to provide EU regulators with the information they need to recommend that the company’s drug, Raxone (idebenone), be approved in the EU for the additional indication of Duchenne muscular dystrophy (DMD).
Santhera will address the European Medicines Agency’s key scientific committee, the CHMP, on Sept. 13, just two days after the...
With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
