18:44 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Ultragenx's Mepsevii gets European approval

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission approved an MAA for Mepsevii vestronidase alfa to treat mucopolysaccharidosis VII (MPS VII; Sly syndrome). The biotech said the drug is the first approved in Europe for...
20:05 , Aug 27, 2018 |  BC Extra  |  Company News

Ultragenyx's Mepsevii gets European approval

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission approved an MAA for Mepsevii vestronidase alfa to treat mucopolysaccharidosis VII (MPS VII; Sly syndrome). The biotech said the drug is the first approved in Europe for...
16:32 , Apr 20, 2018 |  BC Week In Review  |  Clinical News

Ultragenyx gains rare disease approval, voucher

FDA approved Crysvita burosumab-twza (KRN23, UX023) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia in patients aged one year and older. FDA said Crysvita is the...
19:57 , Apr 17, 2018 |  BC Extra  |  Company News

Ultragenyx gains rare disease approval, voucher

FDA approved Crysvita burosumab-twza (KRN23, UX023) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and partner Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) to treat X-linked hypophosphatemia in patients aged one year and older. FDA said Crysvita is the...
19:26 , Dec 22, 2017 |  BC Week In Review  |  Company News

Novartis buys Priority Review voucher from Ultragenyx

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said it will sell its rare pediatric disease Priority Review voucher to Novartis AG (NYSE:NVS; SIX:NOVN) for $130 million. Ultragenyx received the voucher in November, when FDA approved Mepsevii vestronidase alfa-vjbk...
19:52 , Dec 18, 2017 |  BC Extra  |  Company News

Novartis buying Ultragenyx’s Priority Review voucher

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said it will sell its rare pediatric disease Priority Review voucher to Novartis AG (NYSE:NVS; SIX:NOVN) for $130 million. Ultragenyx received the voucher in November, when FDA approved Mepsevii vestronidase alfa-vjbk...
18:13 , Dec 8, 2017 |  BioCentury  |  Product Development

Making of Mepsevii

It may take a few years for Ultragenyx Pharmaceutical Inc. to recoup its investment in Mepsevii vestronidase alfa-vjbk, but the company expects to continue to reliably churn out treatments for ultra-rare diseases alongside a portfolio...
03:49 , Nov 17, 2017 |  BC Week In Review  |  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 (MPS VII; Sly syndrome). Mepsevii is the first therapy approved for the indication. Ultragenyx said Mepsevii will be available...
21:12 , Nov 15, 2017 |  BC Extra  |  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 (MPS VII; Sly syndrome). Mepsevii is the first therapy approved for the indication. Ultragenyx said Mepsevii will be available...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...