Whether the TGA should publish that a prescription medicine is under evaluation

15 February 2019 - The TGA is seeking comments from interested parties on whether or not the TGA should in future ...

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Bausch Health provides update for Duobrii filing

15 February 2019 - Bausch Health announced that the U.S. FDA will be unable to meet today's Prescription Drug User Fee ...

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Medicines for rare disorders

13 February 2019 - PHARMAC is working on policy and funding for medicines for rare disorders. ...

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How much will Americans sacrifice for good health care?

16 February 2019 - A battle is looming over universal health care. Politicians and voters will have to decide whether the ...

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High stakes as Trump, Democrats open drug price talks

16 February 2019 - Democrats and the Trump administration are beginning to hold talks on lowering drug prices as they ...

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Hospital drug prices are up to 7 times greater than Medicare pricing

15 February 2019 - A new study shows something many healthcare patients know all too well: hospitals are charging significant ...

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Decision on spinal muscular atrophy treatment Spinraza deferred

18 February 2019 - PHARMAC's decision to defer a decision on funding the only treatment for spinal muscular atrophy (SMA) ...

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OncoGenex announces fast track designation granted for custirsen in combination with cabazitaxel/prednisone as second-line chemotherapy in Phase 3 AFFINITY trial of men with metastatic castrate-resistant prostate cancer

 23 April 2014 - Third Phase 3 trial of custirsen to receive FDA fast track designation. ...

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Tokai Pharmaceuticals’ galeterone receives fast track designation from the FDA for the treatment of advanced prostate cancer

12 June 2012 - Tokai Pharmaceuticals today announced that its lead candidate, galeterone (TOK-001), has received fast track designation from ...

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Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint

24 October 2018 - Bayer has been granted fast track designation by the U.S. FDA for darolutamide in men with nmCRPC. ...

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Innocrin Pharmaceuticals granted fast track designation by FDA for VT-464 treatment of patients with metastatic castrate-resistant prostate cancer

6 January 2016 - Seviteronel to be presented in three sessions at the ASCO Genitourinary Cancer Symposium to be held in ...

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Alunbrig recommended by NICE for non-small-cell lung cancer

15 February 2019 - NICE has recommended the use of Alunbrig (brigatinib) for treating ALK-positive advanced non-small-cell lung cancer after ...

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FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for advanced renal cell carcinoma

15 February 2019 - Application based on overall survival and progression-free survival data from Phase 3 KEYNOTE-426 trial. ...

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CymaBay Therapeutics announces seladelpar granted breakthrough therapy designation by the FDA for the treatment of primary biliary cholangitis

15 February 2019 - CymaBay Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation for seladelpar for ...

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ICER publishes final new evidence update for alirocumab, a PCSK9 inhibitor for treating high cholesterol

15 February 2019 - Based on new analyses of published results of the ODYSSEY Outcomes trial, alirocumab would meet cost-effectiveness thresholds ...

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Italy proposes the WHO set international standards for drug pricing transparency

14 February 2019 - As more countries seek to control their health care spending, the Italian government is asking the ...

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