News & Analysis on Clinical Trial Services & Contract Research And Development
Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.
A US FDA review panel has recommended that Afrezza be approved and concluded that the technology used to deliver MannKind's inhalable insulin does not damage airways or lung cells.
Argenta and BioFocus will add approximately $70m (€51m) to Charles River Laboratories’ 2014 revenues, the firm and an analyst say.
CRO BioClinica has signed two multi-year contract extensions worth $30m for cloud-based technologies and professional services and training across its e-clinical product suite.
Hikma has received a close-out letter for its oral manufacturing facility in New Jersey, two years after the US FDA issued a warning.
With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or...
Baxter has announced plans to buy gene therapy developer Chatham Therapeutics for $70m in a deal focused on the latter’s pipeline of haemophilia candidates and gene therapy delivery platform.