BioCentury | Feb 28, 2020
Product Development

Feb. 27 Quick Takes: FDA approves Biohaven’s migraine therapy, plus Acacia, Zogenix, Ultragenyx-Kyowa, GSK, Illumina-BGI

Migraine drug marks Biohaven’s first FDA approval Biohaven Pharmaceutical Holding Co. Ltd. (NYSE:BHVN) announced after market close that FDA approved NURTEC ODT rimegepant as an acute treatment for migraine, marking the company’s first U.S. approval....
BC Innovations | Oct 3, 2019
Product Development

Kidney is the new liver: why kidney indications are coming into sharp focus

Interest in kidney diseases is mounting among investors, biotechs and pharmas at a rate reminiscent of the liver disease explosion almost a decade ago. The momentum is driven by improvements at both ends of the...
BC Extra | Sep 3, 2019
Clinical News

Ardelyx gains on Phase III hyperphosphatemia combination data

Ardelyx's tenapanor combination met all endpoints in the Phase III AMPLIFY trial for hyperphosphatemia, setting the stage for a planned 2020 NDA submission once it has long-term monotherapy safety data in hand. Ardelyx Inc. (NASDAQ:ARDX)...
BioCentury | Oct 6, 2018
Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
BC Week In Review | Aug 3, 2018
Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare pediatric disease Priority Review voucher during 2Q18 to an undisclosed company for $80.6 million. Ultragenyx spokesperson Danielle...
BC Extra | Jul 31, 2018
Company News

Kyowa, Ultragenyx sell Priority Review voucher for $80.6M

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) revealed that it and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) sold a rare pediatric disease Priority Review voucher during 2Q18 to an undisclosed company for $80.6 million. Ultragenyx spokesperson Danielle...
BC Week In Review | Jun 29, 2018
Clinical News

Ultragenyx's Crysvita meets in Phase III for pediatric XLH

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) and Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) said Crysvita burosumab-twza (KRN23, UX023) met the primary endpoint of improving rickets compared with conventional therapy in the Phase III PIXLES trial to treat...
Regulatory | Apr 20, 2018
Regulatory

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...
BC Extra | Apr 17, 2018
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...
BC Week In Review | Mar 2, 2018
Clinical News

Kyowa XLH therapy approved in EU

Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and partner Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) said the European Commission granted conditional approval to an MAA for Crysvita burosumab (KRN23, UX023) to treat X-linked hypophosphatemia with radiographic evidence of...
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