Shire, which announced its deal for NPS Pharma on Sunday, is already readying itself to take on-market short bowel syndrome-fighter Gattex--launched in the U.S. in Q1 2013 and in Europe in Q3 2014--to the next level.
Our readers who regularly check our website know that we kept up with the news online. But for everyone else, here's a roundup of the regulatory actions you may have missed.
The FDA has stamped an approval on NPS Pharmaceuticals' Gattex for treating patients with short bowel syndrome. The approval sets the stage for the U.S. launch of the company's lead drug and adds to U.S. regulators' impressive tally of more than 30 new drug nods in 2012.
If all goes as planned for NPS, the FDA will heed the advice of its panel of non-agency experts and stamp an approval on the drug before the end of the year.
NPS Pharmaceuticals got a big boost this morning when the FDA issued an upbeat preview of its short bowel syndrome drug Gattex, endorsing the developer's efficacy claims and key aspects of the risk evaluation and mitigation strategy it proposed to manage a potential cancer risk, among other safety issues.
NPS Pharmaceuticals gave investors a reason to run yesterday, but at least one analyst says today that the reaction was too much. The Bedminster, NJ-based developer said that three patients at sites
NPS Pharmaceuticals ($NPSP) says that it's on track to file for regulatory approval of Gattex after a late-stage study involving 86 patients demonstrated promising results for reducing the need for