US FDA approves Genzyme's stem cell transplant primer Mozobil
This article was originally published in Scrip
Executive Summary
The US FDA has approved Genzyme's stem cell transplantation primer Mozobil (plerixafor injection), for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise haematopoietic stem cells from the bone marrow into the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma. The product was also granted orphan status.
You may also be interested in...
P&G to co-promote Somaxon's Silenor in the US
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US.
GSK's shingles vaccine begins Phase III studies
GlaxoSmithKline has begun the Phase III clinical trials programme for its adjuvanted vaccine candidate (GSK1437173A) against herpes zoster for the prevention of shingles.
Optimer's fidaxomicin filing accepted in EU
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.