After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

BioMed X teams with J&J on inflammation, drug delivery research. Stem cell firm Calidi inks licensing deals with U. of Chicago, City of Hope and Northwestern. MD Anderson teams with Blueprint and Hummingbird.

China's top regulator grants approvals to a record number of novel drugs, including multiple oncology products from domestic companies, which are increasingly shifting to innovation, supported by positive regulatory changes over the past few years.