Blog
RSS FeedPosted by Michael Wonder on 09 Sep 2021
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 ...
Posted by Michael Wonder on 31 Aug 2021
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 ...
Posted by Michael Wonder on 17 Aug 2021
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 ...
Posted by Michael Wonder on 16 Aug 2021
PHARMAC must explain funding decisions
16 August 2021 - “A report this morning that all PHARMAC staff, rather than clinical experts or those with patient ...
Posted by Michael Wonder on 15 Aug 2021
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 ...
Posted by Michael Wonder on 05 Aug 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 28 Jul 2021
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 ...
Posted by Michael Wonder on 25 Jul 2021
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 ...
Posted by Michael Wonder on 19 Jul 2021
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 ...
Posted by Michael Wonder on 19 Jul 2021
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 ...
Posted by Michael Wonder on 19 Jul 2021
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 ...
Posted by Michael Wonder on 19 Jul 2021
Decision to fund rasagiline
16 July 2021 - PHARMAC is pleased to announce the decision to fund rasagiline (Azilect) a new treatment for people ...
Posted by Michael Wonder on 18 Jul 2021
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, ...
Posted by Michael Wonder on 10 Jul 2021
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 ...