News & Analysis on Clinical Trial Services & Contract Research And Development
Janssen-Cilag’s quality control unit has found a defect in certain batches of its Ionsys (fentanyl hydrochloride) management system that could lead to a potentially life-threatening overdose.
Metrics’ new potent and cytotoxic drug development facility was the subject of a press conference at this year’s AAPS, where the company explained how the plant “raised the industry bar”.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
The US CRO market is predicted to have a healthy future, with the greatest potential for growth in the preclinical sector, according to a report by Frost & Sullivan.
European facilities owned by Israel’s Teva Pharmaceuticals and French drugmaker Servier are among the firms raided by the EC’s competition unit earlier this week, according to media reports.
The possible sell-off of Enzon Pharmaceuticals’ biotechnology drugs business has come under fire by one of the firm’s shareholders, DellaCamera Capital Management, which says it is opposed to the move.
Troubled contract research organisation Encorium Group finally published its delayed financial results yesterday, posting a net loss of $3.9m, three times the year-earlier loss.
An open-source software suit for electronic data capture (EDC) in clinical trials – OpenClinica - is starting to see a dramatic rise in usage, according to its developer Akaza Research.
Questions about the safety in children of a number of azo dye food colourings which are routinely found in pharmaceutical products could be answered within the next 18 months, according to the European Food Safety Agency (EFSA).