Out of the more than 40 approvals granted to new drugs in China in 2021, domestic companies bagged around half to catch up with their multinational peers in the annual innovation scorecard.

Ahead of the usual flurry of deal-making in January, Roche gets retinal cell therapy candidate from Lineage Cell Therapeutics, Pfizer subsidiary Amplyx licenses antiviral candidate to Vera, and GSK expands neurology tie-up with Ligand.

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.

US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.