Tag:
Arcalyst
Latest Headlines
Latest Headlines
FDA panel nixes Regeneron's Arcalyst for gout
Regeneron may not be able to aim Aracalyst at the lucrative gout market.
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.
How do the 12 priciest drugs in the U.S. stack up?
Last week, Vertex Pharmaceuticals ( $VRTX ) got FDA approval for Kalydeco, the first cystic fibrosis drug to address the disease's cause, rather than just its symptoms. The price tag: $294,000. But as
Slew of data backs Regeneron med for gout
Regeneron has unleashed a torrent of promising late-stage safety and efficacy data on Arcalyst, teeing up a strong new regulatory filing backing its quest to market the drug against gout. Report
Regeneron scores big success with Ph3 Arcalyst gout data
Regeneron has unleashed a torrent of promising late-stage safety and efficacy data on Arcalyst, teeing up a strong new regulatory filing backing its quest to market the drug against gout. In one of
Ambitious Regeneron unveils mixed PhIII results for gout drug
Inspired by a string of development failures, Tarrytown, NY-based Regeneron Pharmaceuticals is endeavoring to find out if it can duplicate the ambitious R&D strategy that made Genentech a star in
Regeneron's Arcalyst a success in Phase II
Regeneron Pharmaceuticals is reporting a success in the mid-stage trial of its gout drug Arcalyst. Researchers say the drug reduced gout flares by 81 percent in the 83-person study. And it hit its
