Savient faces US delay for gout candidate
This article was originally published in Scrip
The US FDA has extended the user fee date of the BLA for Savient Pharmaceuticals' lead gout candidate, pegloticase (newly branded Krystexxa), by three months to July 30th, after requesting extra information and data analysis. It also said that an advisory panel meeting that was previously scheduled for March 5th will now be rescheduled. The announcement sent the company's share price down by 19% to close at $5.94 on Nasdaq on February 13th.
You may also be interested in...
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US.
GlaxoSmithKline has begun the Phase III clinical trials programme for its adjuvanted vaccine candidate (GSK1437173A) against herpes zoster for the prevention of shingles.
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI.