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Opinion: U.S. taxpayers should stop funding clinical trials of industry-owned drugs

STAT

The National Cancer Institute (NCI) has had a taxpayer-funded drug development program for nearly 70 years, initiated at a time when there was no private investment in oncology drugs.  taxpayers should stop funding clinical trials of industry-owned drugs. At this stage, U.S. Keytruda).

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The future of medical cannabis development in Europe

European Pharmaceutical Review

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 2,10 This data can help to inform the optimal drug candidates to take forward into clinical trials and inform pre-clinical research to iteratively develop medications for different clinical indications.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. 2005 [cited 2024May]. 2012/1916). BMB Reports. 2017;50(3):111–6.

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Cytisinicline – the solution to stop smoking?

pharmaphorum

She is an experienced executive in drug development and has over 30 years’ experience in the biotechnology and pharmaceutical industry. from September 2005 to August 2008. from September 2005 to August 2008. About the author. Dr Cindy Jacobs is president and chief medical officer of Achieve Life Sciences.

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Sleep tracking and the potential for digital endpoints

pharmaphorum

Since 2005, the number of peer-reviewed sleep journals has more than tripled , reflecting both the increased importance placed on a sufficient level of sleep and an ability to test patients in a more convenient manner. Why is sleep being discussed more? Novel digital endpoints.

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PREA is All You Need? FDA’s Recent Draft Guidance States an Intention to Limit Pediatric Exclusivity By Issuing Fewer Written Requests Under the BPCA

FDA Law Blog: Biosimilars

Clissold — In May 2023, CDER and CBER published a draft guidance titled “Pediatric Drug Development: Regulatory Considerations – Complying with the Pediatric Research Equity Act [“PREA”] and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act [“BPCA”]” (the “Draft Guidance”).

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STAT+: Report: Tuberculosis R&D funding is up, but still short of goals and dominated by a few players

STAT

Although research and development funding for tuberculosis reached new heights last year, the total fell substantially short of goals set by the United Nations and most of the increase came from just two organizations, according to a new report.