News & Analysis on Clinical Trial Services & Contract Research And Development
Synexus' new trial site in Bulgaria, which is part of the firm’s clinical research centre strategy, will help sponsors cut development times and significantly reduce costs, according to CEO Michael Fort.
Novartis has recalled two batches of meningitis C vaccine from the UK after the solvent used in their preparation was discovered to be contaminated with Staphylococcus aureus.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
Kendle International posted a 22 per cent drop in net income to $5m, after a computer error led to problems with a clinical trial carried out for one of its customers.
Ranbaxy’s problems with the US FDA were ratcheted up a notch yesterday when the agency halted its review of products made at the firm’s plant in Paonta Sahib, India after uncovering “untrue statements” in ANDA’s and NDA filings.
Contract research firm Icon Clinical saw its revenues advance by nearly 22 per cent in the last quarter of 2008, but still saw its share price slide as investors got the jitters over the firm’s cautious predictions for 2009.