Volunteer drug users: the highs and lows of addiction trials
CROs must design their abuse liability studies to cope with volunteers who arrive under the influence or give misleading patient histories, says a specialist consultancy.
Archives for August 25, 2014
Reinspection lands Alexion with 483 for Soliris plant
A US FDA reinspection of Alexion’s Rhode Island facility hit with a warning letter last year has resulted in a Form 483 with three observations.
EMD Millipore to supply Samsung's Yervoy plant in 10-year deal
EMD Millipore has been contracted to supply raw materials to the Samsung Biologics plant where ingredients for BM-S’ anticancer monoclonal antibody Yervoy (ipilimumab) are made.
Recipharm: 'Client investment gives us competitive edge in CDMO space'
Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.
DEA approves manufacture of GHB at Patheon Cincinnati plant
Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.
USP joins campaign against illegal online pharmacies
Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.