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Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study

Objectives To evaluate the added benefit and revenues of oncology drugs, explore their association, and investigate potential discrepancies between added benefit and revenues across different approval pathways of the European Medicines Agency (EMA).

Design Retrospective cohort study.

Setting Oncology drugs and their indications approved by the EMA between 1995 and 2020.

Main outcome measures Added benefit was evaluated using ratings published by seven organisations: health technology assessment agencies from the United States, France, Germany, and Italy, two medical oncology societies, and a drug bulletin. All retrieved ratings were recategorised using a four point ranking scale to indicate negative or non-quantifiable, minor, substantial, or major added benefit. Revenue data were extracted from publicly available financial reports and compared with published estimates of research and development (R&D) costs. Finally, the association between added benefit and r ....

United States , Rick Vreman , Lourenst Bloem , Daan Marselis , Jan Willem Versteeg , Wimg Goettsch , Francine Brinkhuis , Gemeinsamer Bundesausschuss , European Medicines Agency , European Commission Union Register , Jan Willem Versteeg Utrecht University , World Health Organization , Utrecht University , American Society Of Clinical Oncology , Oslo Medicines Initiative , European Union , Drug Administration , Institute For Clinical , European Society For Medical Oncology , Anatomical Therapeutical Chemical , Economic Review , Italiana Del Farmaco , Medical Oncology , Clinical Oncology , European Commission , Union Register ,

Transferable exclusivity voucher: a flawed incentive to stimulate antibiotic innovation

As antibiotic resistance increases globally, antibiotic innovation is struggling.
WHO states that the antibiotic clinical pipeline is “insufficient to tackle the challenge
of increasing emergence and spread of antimicrobial resistance”.1 To prevent the development
of resistance, new antibiotics are used as last resort treatments and, if properly
used, have small patient populations, resulting in fairly low sales revenues for industry. ....

France General , United Kingdom , Bruxelles Capitale , City Of , The Netherlands , Regional Office For Europe , Institute For Human Data Science , European Federation Of Pharmaceutical Industries , Public Health Agency Of Sweden , Japanese Pharmaceuticals , Organisation For Economic , Drug Administration , European Commission , World Health Organization , Digital Executive Agency Ha , European Health , Health Aff Millwood , European Medicines Agency , Devices Agency , Health Canada , Oslo Medicines Initiative , Health Organization , Pharmaceutical Industries , Exclusivity Extension , Medical Devices Agency , Infect Dis ,