Portola Pharmaceuticals receives complete response letter from FDA for biologics license application for AndexXa (andexanet alfa)

17 August 2016 - Portola Pharmaceuticals today announced that it has received a complete response letter from the U.S. FDA regarding ...

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NICE recommends crizotinib, first pill for lung cancer

18 August 2016 - New draft guidance from NICE means hundreds of people will now have access to crizotinib, a twice-a-day ...

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Emtricitabine with tenofovir alafenamide fumarate in HIV infection: additional benefits not covered

15 August 2016 - Deviation from the appropriate comparator therapy/higher loss for certain patients. ...

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TGA approves Briviact (brivaracetam)

12 August 2016 - The TGA has approved UCB's Briviact (brivaracetam). ...

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TGA approves Tagrisso (osimertinib mesylate)

12 August 2016 - The TGA has approved AstraZeneca's Tagrisso (osimertinib mesylate). ...

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CADTH issues initial pERC outcome for Lynparza (olaparib)

5 August 2016 - CADTH has published pERC's initial recommendation on the use of olaparib for use as monotherapy maintenance treatment ...

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Health Canada approves new indication for Jardiance (empagliflozin) tablets for adults with type 2 diabetes and established cardiovascular disease

11 August 2016 - Approval based on cardiovascular outcome clinical trial EMPA-REG OUTCOME, which demonstrated empagliflozin significantly reduced the incidence of ...

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Thousands to benefit as NICE set to recommend drug to prevent heart attacks and strokes

12 August 2016 - NICE has published draft guidance recommending anti-clotting drug ticagrelor 60 mg with aspirin for people who have ...

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Heron Therapeutics announces U.S. FDA approval of Sustol (granisetron) extended-release injection for the prevention of chemotherapy-induced nausea and vomiting

10 August 2016 - Sustol is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea ...

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PBAC Drug Utilisation Sub Committee outcome statement

10 August 2016 - The outcome statement from the PBAC Drug Utilisation Sub Committee June 2016 meeting is now available. ...

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Cardiome announces Xydalba single dose infusion approval by European Medicines Agency

9 August 2016 - Cardiome Pharma Corporation has announced that Xydalba (dalbavancin hydrochloride) has been approved by the EMA for administration ...

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NICE issues draft guidance on the use of talimogene laherparepvec

9 August 2016 - Talimogene laherparepvec (Imlygic) is the first cellular therapy to be appraised by NICE. ...

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Proposal to award sole supply of leflunomide

9 August 2016 - PHARMAC is seeking feedback on a proposal to award Sole Supply Status in the community for leflunomide to ...

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New treatment option for Canadians living with multiple myeloma

8 August 2016 - Takeda Canada receives approval for Ninlaro (ixazomib) - the first and only oral proteasome inhibitor providing a ...

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CADTH issues final pERC outcome for Yondelis (trabectedin)

5 August 2016 - CADTH has published pERC's final recommendation on the use of trabectedin for patients with metastatic liposarcoma ...

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