Keyword: Kyowa Hakko Kirin
Kyowa Kirin won FDA approval for istradefylline as an add-on treatment for Parkinson’s disease in August, more than 10 years after it was handed a thumbs-down in 2008 and six years after it got its Japanese go-ahead.
In nine years, Ultragenyx grew from two employees to 700, striking partnerships, jumping into gene therapy through its acquisition of Dimension Therapeutics and getting two rare disease drugs to market.
The filing follows data from Japanese phase 3 trials that assessed the oral HIF-PHI in chronic kidney disease patients.
Kyowa Hakko Kirin has posted a look at proof-of-concept data on adenosine A2A receptor antagonist KW-6356 in early Parkinson’s disease patients.
Ultragenyx needed a win for its lead drug burosumab after a midstage pipeline failure and delivered with a good set of phase 3 results.
ArQule's lead drug has failed yet another late-stage trial, drawing a line under the program as the biotech tries to move beyond what CEO Paolo Pucci has called the company's "tivantinib cycle."