Tag:

Gattex

Latest Headlines

Latest Headlines

NPS begins to rack up sales of pricey SBS drug

NPS Pharmaceuticals ($NPSP) racked up the first quarterly score on its $295,000-a-year treatment for short bowel syndrome, claiming early traction for Gattex. To be sure, the numbers are small: 42 patients and 160 prescriptions in Q1.

NPS nabs global Gattex rights in $80M buyback from Takeda

The company struck an $80 million deal to buy back ex-U.S. rights to the short-bowel syndrome drug from Takeda.

Last-minute drive at FDA added 6 new drug approvals

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.

NPS Pharma bags FDA approval for bowel drug

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.

FDA advisers back NPS Pharma's orphan bowel drug

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 Pharma shares jump on upbeat FDA review of Gattex

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 Pharma shares sink after cancers reported in patients on bowel drug

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 soars on positive Ph3 data for orphan SBS drug

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