Bill Ferris defends R&D reform proposals

5 October 2016 - Fewer than 1% of the 10,000 companies receiving cash refunds as part of the research and development ...

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Obama extends controversial program for rare pediatric drugs

30 September 2016 - Despite objections from his own regulators, President Barack Obama signed into law a bill on Friday ...

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FDA eyes new diabetes outcome measures

29 September 2016 - A recent FDA workshop brought new diabetes outcome measures to the table, focusing on patient-oriented outcome measures. ...

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Innovation in medicine and device development, regulatory review, and use of clinical advances

26 September 2016 - Breakthrough advances in the understanding of fundamental biology and the dawn of an era of precision medicine ...

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EU-US collaboration to boost medicine development for rare diseases

26 September 2016 - The EMA and the U.S. FDA have set up a new ‘cluster’ on rare diseases to share ...

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Evaluating the FDA’s approach to cancer clinical trials

16 September 2016 - Since the announcement of the FDA Oncology Center of Excellence in June 2016 as part of the ...

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The boys who beat the FDA

19 September 2016 - The agency approves a new medicine after an ugly bureaucratic brawl. ...

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FDA launches competition to spur innovative technologies to help reduce opioid overdose deaths

19 September 2016 - Contest seeks to stimulate development of a mobile app to connect those experiencing an overdose with the ...

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SMC introductory industry engagement event - September 2016

13 September 2016 - This event is designed to help pharmaceutical industry members who require an understanding of the processes for ...

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Access to Medicines Working Group communiques

8 September 2016 - The communiques from the February 2015, September 2015 and April 2016 meetings of the Access to Medicines ...

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The impact of innovative pharmaceuticals on New Zealand cancer patients

22 August 2016 - Medicines New Zealand is hosting an educational seminar in Wellington on Wednesday 24 August with University of ...

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“Adaptive pathways” to drug authorisation: adapting to industry?

16 August 2016 - The evidence for benefits of adaptive pathways to patients and public health is lacking or contradictory, ...

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Cancer drug appraisal needs to be reviewed

18 August 2016 - ABPI Executive pens letter to The Guardian. ...

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Proposed new drug guidelines for the PBS put cost-cutting before patients

17 August 2016 - The sustained accessibility of Australians to world-class medicines will be in question if proposed drug review guidelines ...

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German body calls for pause in European plan for fast track drug approval

16 August 2016 - Plans by the European Medicines Agency to expand its fast track approach to approving new drugs have ...

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