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Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval

This study aims to determine whether cancer drugs granted accelerated approval from the US Food and Drug Administration ultimately demonstrate clinical ....

Boston , Massachusetts , United-states , San-diego , California , American , Aarons-kesselheim , Commonwealth-fund , American-association-for-cancer-research-annual-meeting , Division-of-pharmacoepidemiology , National-clinical-trial

Clearer Definitions of Added Benefit, Unmet Needs Could Improve EU Oncologic Drug Approval Process

Investigators emphasize the importance of firming a widely understood definition of unmet needs in cancer care due to their impact on drug approvals. ....

Utrecht , Netherlands , United-states , Lourenst-bloem , Francine-brinkhuis , Division-of-pharmacoepidemiology , European-medicines-agency , European-union , Utrecht-institute-for-pharmaceutical-sciences , Clinical-pharmacology , Utrecht-institute , Pharmaceutical-sciences

Retrospective Study Suggests Large Proportion of EU-Approved Oncology Drugs Offer Minimal or No Added Benefit

Most oncology drugs approved by the EMA recover research and development costs within a few years, even if the drug is providing little added benefit. ....

Utrecht , Netherlands , United-states , Lourenst-bloem , Francine-brinkhuis , European-medicines-agency , Division-of-pharmacoepidemiology , Utrecht-university , European-union , Clinical-pharmacology , Utrecht-institute , Pharmaceutical-sciences

Direct-to-Consumer Drug Company Pharmacies

The recent launch of direct-to-consumer pharmacy LillyDirect prompts the author of this Viewpoint to consider why it was created and also to raise concerns abou ....

Rome , Lazio , Italy , Boston , Massachusetts , United-states , Mark-cuban , Eli-lilly , Department-of-medicine , Elevance-health-public-policy-institute , National-academy-for-state-health , Novo-nordisk

Study Finds Efficiency Frontier Approach Provides Solution to High Drug Prices for Psoriasis in the US

Researchers suggest an alternative method to align drug prices with clinical benefits for patients with psoriasis.
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Australia , France , Germany , Canada , Alexander-egilman , Institute-for-clinical , Harvard-medical-school-brigham-women-hospital , Program-on-regulation , Division-of-pharmacoepidemiology , Harvard-medical , Psoriasis-area , Severity-index