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Latest From INC Research Holdings, Inc.
Biopharma Industry Sharply Divided Over Supreme Court Antibody Patent Brawl
Big biologic makers line up on opposite sides of dispute between Amgen and Sanofi over whether Amgen’s Repatha patents cover analogous antibodies with the same functional characteristics.
Biogen And Millennium May Be Ensnared In Tentacles Of Genentech’s Expired Cabilly Patent
Genentech claims Biogen and Millennium owe royalties on sales of Tysabri and Entyvio that were stockpiled when the Cabilly patent expired. Hospira faced similar litigation over its erythropoietin biosimilar and had to pay Amgen $70m in damages.
FDA Panel Agrees GSK’s RSV Vaccine Is Effective But Wants More Data Before Approval
Advisory committee votes 10-2 that data are adequate to support safety of the vaccine in adults 60 and older, voicing concern about small potential safety signals after co-administration with influenza shot. Several members question rush to market with just one season of data.
Sanofi/AstraZeneca’s Nirsevimab Is Set To Transform RSV Treatment In Infants
Sanofi executives discuss ongoing efforts to make the monoclonal antibody available for the next RSV season and the impact it will have as the first prophylactic treatment for all infants. An FDA advisory committee is expected to discuss the biologics license application at a yet-to-be announced meeting.
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