The European Medicines Agency and publication of clinical study reports: a challenge for the US FDA

20 February 2017 - The US FDA has been the standard of drug regulation worldwide for decades.  ...

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Registration of new chemical entities in Australia (2016)

31 January 2017 - The TGA has published its annual summary for 2016. ...

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Post-market review of ezetimibe – draft report

27 January 2017 - Public consultation on the draft Report to the PBAC of the post-market review of ezetimibe is ...

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Institute for Clinical and Economic Review releases evidence report on disease-modifying therapies for multiple sclerosis, including daclizumab and ocrelizumab

26 January 2017 - Report finds alemtuzumab represents best long-term cost-effectiveness; prices for most drugs not well-aligned with added value ...

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Call for feedback on a therapeutic review update of new second-line therapies for type 2 diabetes mellitus

20 January 2017 - Two draft science reports on new drugs for type 2 diabetes: second-line therapy : a therapeutic review ...

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ICER releases draft evidence report on treatments for rheumatoid arthritis

20 January 2017 - Public comment period now open - comments accepted until 17 February. ...

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Human medicines: highlights of 2016

17 January 2017 - 81 medicines recommended for approval, including 27 new active substances. ...

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U.S. spending more on specialty drugs via Medicare

5 January 2017 - Federal spending on a Medicare program for people with high drug costs has ballooned over the ...

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2016 financial year report from the Director

5 January 2017 - This letter is the Director's first annual report to various stakeholders. It summarises what Center have ...

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EMA publishes EPAR for Venclyxto

22 December 2016 - The EMA has published an EPAR for AbbVie's new BCL inhibitor. ...

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PBS expenditure and prescriptions for 2015-16

16 December 2016 - The PBS Expenditure and Prescriptions Report 2015-16 is now available. ...

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NICE publishes second appraisal consultation document for brentuximab vedotin

15 December 2016 - The appraisal consultation relates to the use of brentuximab vedotin to treat patients with CD30 positive, ...

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Prescription drugs: innovation, spending and patient access

14 December 2016 - The U.S. Department of Health and Human Services has released a new report to the U.S. congress ...

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EMA publishes EPAR for Ninlaro

7 December 2016 - The EMA has published a EPAR for Takeda's proteasome inhibitor. ...

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TGA business plan 2016-17

29 November 2016 - The TGA Business Plan 2016-17 provides an overview of our strategic considerations including: ...

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