FDA approves Blincyto (blinatumomab) for use In paediatric patients with Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia

1 September 2016 - Amgen today announced that the U.S. FDA has approved the supplemental biologics license application for Blincyto (blinatumomab) ...

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Elotuzumab in multiple myeloma: additional clinical benefit is not proven

1 September 2016 - The only study available was unsuitable for the benefit assessment. ...

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Genmab announces U.S. FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed CLL

31 August 2016 - Arzerra now approved by U.S. FDA for use in combination with fludarabine and cyclophosphamide in relapsed CLL ...

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TGA approves new diagnostic agent

31 August 2016 - The TGA has approved Juno Pharmaceuticals' Hexvix. ...

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Xalkori (crizotinib) receives approval in European Union for the treatment of patients with ROS1-positive advanced non-small cell lung cancer

31 August 2016 - Xalkori is the first and only approved biomarker-driven therapy for ROS1-positive advanced non-small-cell lung cancer in the ...

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TGA approves Zepatier

31 August 2016 - The TGA has approved MSD's Zepatier (grazoprevir with elbasvir). ...

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FDA approves Sandoz Erelzi to treat multiple inflammatory diseases

30 August 2016 - Erelzi is the first biosimilar etanercept approved by the FDA, offering expanded access to this important medicine. ...

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Decision to award sole supply to Zoladex and reference price Eligard and Lucrin

30 August 2016 - PHARMAC has made decisions to award the Zoladex brand of goserelin acetate sole subsidised supply in the ...

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CADTH recommends Brilinta (ticagrelor)

25 August 2016 - CADTH has recommended the reimbursement of AstraZeneca's Brilinta (ticagrelor) for the secondary prevention of atherothrombotic events. ...

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CADTH recommends the reimbursement of Invokamet (canagliflozin hemihydrate with metformin hydrochloride)

25 August 2016 - CADTH has published its final recommendation on the reimbursement of Invokamet in Canada. ...

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Seqirus receives FDA approval for Afluria Quadrivalent (influenza vaccine) for people 18 years of age and older

29 August 2016 - Seqirus is shipping trivalent and quadrivalent formulations of Afluria in the 2016-2017 influenza season. ...

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CADTH recommends against the reimbursement of Egrifta (tesamorelin acetate)

24 August 2016 - CADTH is not convinced that Egrifta should be reimbursed in Canada. ...

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CADTH recommends the reimbursement of Descovy (emtricitabine with tenofovir alafenamide fumarate)

24 August 2016 - CADTH is in favour of the reimbursement of Gilead's new dual combination product for HIV-1 infection. ...

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Amgen's shameful silence covers up reasons for FDA drug rejection

25 August 2016 - An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. FDA  but the company has offered ...

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CADTH recommends reimbursement of secukinumab (Cosentyx) for ankylosing spondylitis

23 August 2016 - CADTH publishes second outcome for Cosentyx this month.  ...

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