Compounding this issue has been the company’s consistent struggles with manufacturing, as Novartis received a Form 483 from the FDA over issues with the production process of Kymriah.

During fiscal year 2015, the FDA issued 678 Form 483s to pharma companies, as detailed in the report FY 2015 Inspectional Observation Summaries. This is up from 645 Form 483s in fiscal year 2014.

Get the latest news on government and institutions, including policies, regulations, and updates. Stay informed about government actions, institutional changes, and their impacts on the economy ...

Glycosylation plays a critical role in the biosynthetic-secretory pathway in the endoplasmic reticulum (ER) and Golgi apparatus. Over 50% of mammalian cellular proteins are typically glycosylated; ...