BioCentury | Aug 31, 2018
Clinical News

Ultragenx's Mepsevii gets European approval

...NASDAQ:RARE), Novato, Calif. Product: Mepsevii vestronidase alfa (rhGUS, UX003) Business: Endocrine/Metabolic Sandi Wong Mepsevii, vestronidase alfa-vjbk (UX003, rhgus) Ultragenyx...
BioCentury | Aug 27, 2018
Company News

Ultragenyx's Mepsevii gets European approval

...stream” of drugs for ultra-rare diseases (see "Making of Mepsevii" ). Sandi Wong Mepsevii, vestronidase alfa-vjbk (UX003, rhgus) Ultragenyx...
BioCentury | Jul 13, 2018
Clinical News

EMA's CHMP recommends CAR Ts, rare disease therapies

...Nanobody, caplacizumab (ALX-0081/ALX-0681) Duzallo (Brand), lesinurad/allopurinol (Generic), Duzallo (Other) Kymriah, tisagenlecleucel (CTL019, cart-19, tisagenlecleucel-t) Mepsevii, vestronidase alfa-vjbk (UX003, rhgus) Nerlynx...
BioCentury | Jun 29, 2018
Company News

CHMP backs CAR Ts, Orphan candidates

...Nanobody, caplacizumab (ALX-0081/ALX-0681) Duzallo (Brand), lesinurad/allopurinol (Generic), Duzallo (Other) Kymriah, tisagenlecleucel (CTL019, cart-19, tisagenlecleucel-t) Mepsevii, vestronidase alfa-vjbk (UX003, rhgus) Nerlynx...
BioCentury | Dec 8, 2017
Product Development

Making of Mepsevii

...and enzyme replacement followed by bone marrow transplantation.” Journal of Clinical Investigation (1997) Virginia Li, Staff Writer Mepsevii rhGUS Ultragenyx...
BioCentury | Nov 17, 2017
Clinical News

FDA approves Ultragenyx's Mepsevii for MPS VII

...FDA approved Mepsevii vestronidase alfa-vjbk (rhGUS, UX003) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat mucopolysaccharidosis VII...
...Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), Novato, Calif. Product: Mepsevii vestronidase alfa (rhGUS, UX003) Business: Endocrine/Metabolic Chris Lieu Mepsevii rhGUS UX003 vestronidase alpha Ultragenyx...
BioCentury | Nov 15, 2017
Company News

FDA approves Ultragenyx's Mepsevii for MPS VII

...FDA approved Mepsevii vestronidase alfa-vjbk (rhGUS, UX003) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat mucopolysaccharidosis VII...
...the EU (see BioCentury Extra, May 30) . Ultragenyx gained $1.77 to $47.32 on Wednesday. Chris Lieu rhGUS UX003 vestronidase alpha Ultragenyx...
BioCentury | Oct 6, 2017
Finance

Coasting on catalysts

...oliceridine Moderate to severe acute pain Submit NDA October Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) Vestronidase alpha (rhGUS; UX003...
...Ultragenyx Pharmaceutical Inc. Its vestronidase alpha ( rhGUS ; UX003), a recombinant human glucuronidase beta (GUSB) (rhGUS...
BioCentury | Sep 29, 2017
Regulation

Beyond compassion

...to generate safety data to support the approval of recombinant human beta-glucuronidase ( rhGUS ; UX003...
...UX003) to treat mucopolysaccharidosis VII (MPS VII; Sly syndrome). The first patient to receive rhGUS...
...helped persuade FDA to approve a Phase III trial with 12 patients, according to Mansbach. RhGUS...
BioCentury | Sep 22, 2017
Company News

Ultragenyx counters RegenxBio with bid for Dimension

...using RegenxBio's NAV technology, to which Dimension has a license. Ultragenyx's recombinant human glucuronidase beta (rhGUS...
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