FDA updates Repros on Proellex clinical hold
This article was originally published in Scrip
The US FDA has provided Repros Therapeutics with further clarification over the full clinical hold status of its lead drug, the orally selective progesterone antagonist Proellex, and guidance for the company to get the hold lifted. The drug was being looked at for the treatment of chronic symptomatic uterine fibroids and associated anaemia, as well as endometriosis.
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.