Tag:
gout
Latest Headlines
Latest Headlines
FDA advisers snub Regeneron drug for gout
An FDA advisory committee rejected Arcalyst in an 11-0 vote against approval as experts harbored concerns about the lack of safety data and the limited time period of 16 weeks patients took the drug in studies.
FDA notes cancer cases linked to Regeneron gout drug
The FDA staff review questioned whether the risks of the treatment overwhelm the benefits of the drug in combating gout flare-ups.
AstraZeneca reels in promising PhIII gout drug in $1.26B Ardea buyout
Hounded by a group of critics demanding a better pipeline strategy, AstraZeneca this morning wrapped a deal to buy Ardea Biosciences.
BioCryst shares surge on positive IIb study for gout drug
Shares of BioCryst Pharmaceuticals ( $BCRX ) bumped up 12% this morning after the biotech unveiled a set of positive top-line data for its mid-stage gout drug. In a 12-week Phase IIb study of BCX4208,
FDA experts reject Novartis gout drug
A solid majority of the experts sitting on an FDA advisory committee has turned thumbs down on Novartis's application for the gout therapy Ilaris, citing safety concerns. But the 11-1 rejection
Novartis gins promising data for late-stage gout drug
One of Novartis's top blockbuster hopefuls registered promising data in two pivotal trials for gout, offering supportive data for a string of regulatory filings in Europe and the U.S. ACZ885--an
Ardea's Phase II gout drug shows promise
San Diego-based Ardea Biosciences has unveiled promising Phase II results from a trial of its oral gout drug RDEA594. When combined with the standard treatment allopurinol, 89 percent of patients
BioCryst shares surge on positive PhIIa gout data
Shares of Birmingham, AL-based BioCryst Pharmaceuticals ( NASDAQ: BCRX ) surged 15 percent this morning after the developer announced positive data from the interim analysis of a Phase IIa study of its
Ardea shares spike on promising PhIIb gout drug data
Shares of Ardea Biosciences ( RDEA ) surged 23 percent in after-market trading yesterday evening after the developer posted positive data for its dose-ranging, mid-stage trial of its experimental gout
Savient says gout drug on track, no trial needed
Savient Pharmaceuticals says it's on track to resubmit its closely-watched gout drug for FDA marketing approval by the early part of 2010 after the FDA made it clear in a recent meeting that the
