Consumers to have more say on medicine access issues

7 September 2021 - Consumer involvement in Australia’s medicines choices has been further strengthened under a new strategic agreement Medicines ...

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Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study

August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...

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Information Act shows racism in PHARMAC’s decision-making

17 August 2021 - Paati Māori Co-leader, Debbie Ngarewa-Packer, has received information that blatantly outlines the inequity within PHARMAC and ...

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PHARMAC must explain funding decisions

16 August 2021 - “A report this morning that all PHARMAC staff, rather than clinical experts or those with patient ...

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PHARMAC invites entire staff to top secret drug ranking meetings

16 August 2021 - Highly confidential meetings where PHARMAC ranks the funding priority of potentially life-saving medicines are open to ...

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From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness

4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...

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Cancer patients, advocates 'gobsmacked' PHARMAC declining funding application for life-changing drug

29 July 2021 - Ovarian cancer patients and advocates are "utterly gobsmacked" Pharmac has proposed to decline a funding application ...

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PHARMAC commits to being more transparent

28 July 2021 - For the first time, PHARMAC is sharing its priority lists for all funding applications for medicines ...

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Patient advocacy organisations and FDA drug approval: lessons from Aduhelm

23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry ...

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Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm

19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...

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Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis

16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...

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AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.

16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...

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Decision to fund rasagiline

16 July 2021 - PHARMAC is pleased to announce the decision to fund rasagiline (Azilect) a new treatment for people ...

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Considering and communicating uncertainty in health technology assessment

15 July 2021 - As health technology assessment seeks to combine complex sets of evidence, values, and perspectives to support open, ...

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FDA seeks to probe talks between staff and Biogen on Alzheimer’s drug

9 July 2021 - The FDA’s chief is taking the highly unusual step of asking for a federal investigation of doctors ...

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