News & Analysis on Clinical Trial Services & Contract Research And Development
The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database (IID) is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years.
ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.
One-third of clinical-trials results in the US go unreported, according to new figures published in the British Medical Journal underlining how far the drugs industry remains from full transparency.
Enabled-FIH programs integrate GMP manufacturing with clinical testing, which enables drug product manufacturing to occur in real-time prior to clinical dosing.
EFPIA welcomes EMA guidelines
Drugmakers seeking to stop “commercially confidential information” being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause says the EMA.
Synexus has bought trial site network Research Across America (RAA) in a deal it claims will give its customers access to the US market and additional study participants.
Selling most of its API business had only a limited impact on revenues in 2015 according to BASF, which has reiterated its plan to retain its ibuprofen, PEG and omega-3 operations.