FDA Confirms Paragraph IV Patent Litigation for Galafold (Migalastat Hydrochloride)
PHILADELPHIA, April 19, 2022 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for...
The pact sees Amicus’ gene therapy business bought out by ARYA Sciences Acquisition Corp IV, a SPAC sponsored by Perceptive Advisors. Caritas gets around $400 million in funding to start with, while Amicus adds about $200 million in private funding from “leading biotechnology investors.”
The FDA has started its review of Israeli biotech Protalix BioTherapeutics and partner Chiesi’s Fabry disease therapy pegunigalsidase alfa, setting up a possible approval by 27 January.
Apart from get­ting the FDA to have a change of heart on its Fabry dis­ease ther­apy, Galafold, last year, Am­i­cus Ther­a­peu­tics joined forces with the Uni­ver­sity of Penn­syl­va­nia to work on gene ther­a­pies for four dif­fer­ent dis­or­ders — Pompe dis­ease, Fabry dis­ease, CDKL5 de­fi­ciency and an undis­closed rare meta­bolic dis­or­der. On Wednes­day, the two ex­panded their col­lab­o­ra­tion — to in­clude ad­di­tional lyso­so­mal dis­or­ders and rare dis­eases.
Let’s have a look at the recent new drug approvals. 2018 was quite a year, by the numbers. C&E News has a comprehensive roundup: 59 approvals (versus 46 in 2017, which was already a record by itself), and about two-thirds of those small molecules. There are some very interesting molecules in the list, and I always recommend that medicinal chemists sit down every so often and look over the structures of approved drugs as if you’re seeing them for the first time (say, as screening hits). You might be surprised at how many of them you find chemically somewhat unappealing – would you aim for an n-hexyl ether in your final structure (Mulpleta/lusutrombopag), the heterocyclic ring in the lower section of Xofluza (baloxivir marboxil), or think that 3,4-diaminopyridine (Firdapse) or Diacomet (stiripentol) could be drugs at all?
Amicus’ Galafold and Biogen’s Spinraza have won the two top prizes at the UK Prix Galien, the biennial awards which recognise the most innovative and high impact new treatments for patients.
The U.S. Food and Drug Administration (FDA) has had a busy August. In addition to the number of draft guidances the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.
CRANBURY, N.J., Aug. 10, 2018 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Galafold™ (migalastat) 123 mg capsules. Galafold is an oral, precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease
It turns out the FDA wasn’t done Friday with the historic approval for Alnylam’s world’s-first RNAi drug. After the market close, Amicus Therapeutics $FOLD revealed that the agency had also come through with an OK for Galafold (migalastat), a controversial new med that had initially been firmly rejected by the agency.