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 Extra | Dec 18, 2019
Company News

Dec. 18 Company Quick Takes: FDA approves enfortumab vedotin; plus ODAC roundup, Illumina-PacBio, Benlysta, Ultragenyx, Syros-GBT, Xtandi

Enfortumab vedotin approved for urothelial cancer FDA granted accelerated approval to Padcev enfortumab vedotin-ejfv from Seattle Genetics Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (Tokyo:4503) to treat locally advanced or metastatic urothelial cancer in adults who...
BC Extra | Aug 2, 2019
Company News

Crysvita sales push Ultragenyx ahead for the quarter

Sales of Ultragenyx's Crysvita hint at the XLH therapy's launch trajectory as it drove the biotech's revenues for the quarter. Ultragenyx and partner Kyowa Hakko Kirin Co. Ltd. received FDA approval on April 17, 2018...
BC Extra | Mar 28, 2019
Politics & Policy

China lists 30 more overseas drugs eligible for Priority Review

China’s Drug Evaluation Center posted a second batch of drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China. Fourteen of the 30 drugs on the list...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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...
BioCentury | Jun 30, 2018
Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
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