Biologics with their brand name dropped from the label could become the alternative to an ‘authorized biosimilar,’ which is not allowed under the law.

Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.

Kodak, Fujifilm and startups Civica Rx and Phlow fight with grit, vision and government support to restore US pharmaceutical manufacturing.

Antitrust regulators in the US, Europe and elsewhere say they will now collaborate on how to best assess pharmaceutical mergers, in a move that could restrict deals on grounds they excessively raise prices paid by consumers or dampen medical innovation.