News of Novo Holdings acquiring Catalent, and Novo Nordisk taking in 3 Catalent fill-finish facilities, shakes up the outsourcing industry at a time when so many biopharma sponsors for already starved for capacity. Here's breaking analysis from chief editor Louis Garguilo.
The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
“Having been outsourcing to CDMOs for 20 years in the small-molecule space, I see a distinct difference in technical performance compared to my mid-2000s CDMOs," says an executive. What's going on here?
Learn how to navigate the wide range of "quality claims" and find a CDMO partner that is committed to a culture of quality, placing safety and product excellence at the core of their operations.
To improve the quality of abbreviated new drug applications (ANDAs) and to ensure improved consistency, the FDA has developed a new guidance to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval.
This website uses cookies to ensure you get the best experience on our website. Learn more
