News & Analysis on Clinical Trial Services & Contract Research And Development
The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.
Axon has chosen Swiss CMO Bachem to manufacture the peptide API and finished form for its clinical trials.
Preclinical CRO Absorption Systems has partnered with Indian consulting firm Synerzys Lifecare to promote the benefits of BCS testing to the country's generic drugmakers.
High drug industry demand for safety monitoring expertise drove Telerx’s acquisition of Sentrx Safety Solutions says deal broker.
Crown Bioscience and Horizon Discovery have teamed up to develop more accurate preclinical models for the development of personalized medicines.
Early phase clinical trial provider CPR Pharma Services has expanded its bioanalytical offerings with a ligand-binding assay service for its clients developing large molecules such as biologics, monoclonal antibodies and biosimilars.
Pfizer’s recall of Levoxyl has created a stink among manufacturers of the oxygen-absorbing canisters designed to stop such drugs degrading.
An uptick in the outsourcing of preclinical trials is expected as pharmaceutical companies look to restructure and cut costs, but that increase won't necessarily begin in 2013, according to an analyst.
As it inks a major commercial supply agreement, Unilife says its EZMix dual-chamber syringe will significantly cut reconstitution steps in combination therapy delivery.
Alkermes says it intends to continue investing in its Irish facility although a restructuring plan will end some manufacturing operations and cost 130 jobs.