News & Analysis on Clinical Trial Services & Contract Research And Development
German-based contract manufacturer apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies.
BIO 2015
Eli Lilly’s President of Biomedicines says the transatlantic trade agreement TTIP will “force” the FDA and EMA to standardise regulations on manufacturing and trials.
Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.
Recipharm has completed the acquisition of Uppsala, Sweden-based CRO OnTarget Chemistry for about $1.8m (SEK 15.1m).
BIO 2015
China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015.
Health Action International (HAI) has set up an office in Brussels, Belgium in a bid to further influence European pharmaceutical policy and improve access to medicines and public health.
Industry efforts set up a drug database to help Europeans identify fake pharmaceuticals progressed this week after thee software firms signed development deals with project leader, EMVO.