News & Analysis on Clinical Trial Services & Contract Research And Development
By early next year the US FDA is set to launch a new “super” office known as OPQ (Office of Pharmaceutical Quality), which will better align the review, inspection, and research of drugs.
Correction
Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.
Little more than a week after purchasing the UK RTSM provider ClinIntel, Parexel has secured new office space in Nottingham, UK and won grants totalling £1m ($1.6m).
NEWS FROM CPHI
Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.
Venom from a Brazilian Wandering Spider that ‘wandered’ into a UK household’s shopping basket could treat erectile dysfunction, according to scientists, in one example of drug ingredients being sourced from nature.
Squeezed by the pressure of shorter deadlines and higher quality expectations, as well as by competition from larger peers, mid-size CROs may need to think more about innovation to stay ahead, a CEO of a mid-size CRO told us.
Swiss-based Sellas Life Sciences Group has signed a definitive master service agreement with CRO Pharmaceutical Product Development (PPD) to advance and expand clinical and regulatory development.
News from CPHI Paris
Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.