News & Analysis on Clinical Trial Services & Contract Research And Development
Pharma employees who report manufacturing misconduct to stop adulterated drugs getting to market put their careers at risk and face being blackballed by industry says an American advocacy group.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
Lonza has launched a service to help biopharmas decide if promising protein drug candidates are worth developing, from an immunogenicity and manufacturing standpoint.
The US Supreme Court has ruled unanimously that naturally occurring DNA is not patentable “merely because it has been isolated,” but synthetic DNA can be patented.
Catalent says customers are applying controlled release technology to transform drugs into better treatments across all stages of development as it expands its Kentucky manufacturing site.
The European Commission has welcomed the publication of the list of Indian API makers issued with “written confirmations” of quality by the CDSCO.
Canadian CMO Patheon’s second quarter revenues increased almost 40 percent as the company’s commercial manufacturing services revenues saw a similarly high rise over the same period from last year.