News & Analysis on Clinical Trial Services & Contract Research And Development
Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems.
The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations.
European CRO KCR has acquired a portfolio of clinical projects from the Ukrainian CRO Axis Group thereby making the country the most important location for KCR in the region of the Commonwealth of Independent States (CIS).
For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.
Cromos Pharma has launched a free or reduced cost trial model to help small and mid-sized drugmakers overcome the funding Catch-22 that can derail development efforts.
Festive Film
The holidays are fast upon us, so let’s put ‘business’ to one side and get into the festive mood. To keep in the spirit of things, we’ve got a ‘gift’ for you – enjoy. Happy Holidays!
An AstraZeneca API plant in Bristol, UK will close its doors within two years due to patent expirations of its cholesterol-lowering blockbuster Crestor.