Blog
RSS FeedPosted by Michael Wonder on 21 Sep 2021
Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown
22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...
Posted by Michael Wonder on 17 Sep 2021
ICER releases draft evidence report on therapies for severe asthma
16 September 2021 - Public comment period now open until 14 October 2021; requests to make oral comment during public ...
Posted by Michael Wonder on 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 16 Sep 2021
ATAGI update following weekly COVID-19 meeting – 15 September 2021
16 September 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 15 ...
Posted by Michael Wonder on 16 Sep 2021
Raising the bar for using surrogate outcomes in drug regulation and health technology assessment
16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...
Posted by Michael Wonder on 16 Sep 2021
Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19
16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...
Posted by Michael Wonder on 16 Sep 2021
Drug makers see disaster in Medicare negotiating prices. Don’t listen to them.
16 September 2021 - The pharmaceutical industry, bizarrely, told the American people this week that allowing Medicare to negotiate drug ...
Posted by Michael Wonder on 16 Sep 2021
With remdesivir, the Federal Joint Committee assesses the additional benefit of an anti-viral COVID-19 drug for the first time
16 September 2021 - Do patients with COVID-19 have a better chance of surviving and recovering faster if they are treated ...
Posted by Michael Wonder on 16 Sep 2021
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis
16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...
Posted by Michael Wonder on 16 Sep 2021
Nivolumab in skin cancer: additional benefit upgraded on the basis of an indirect comparison
16 September 2021 - For nivolumab (Opdivo), the pharmaceutical company was able to achieve a significantly better result in a second ...
Posted by Michael Wonder on 16 Sep 2021
BioCryst’s HAE med Orladeyo wins NICE nod
16 September 2021 - BioCryst’s Orladeyo (berotralstat) has received a positive recommendation from NICE for preventing recurrent attacks of hereditary ...
Posted by Michael Wonder on 16 Sep 2021
COVID-19 vaccine weekly safety report (16 September 2021)
16 September 2021 - To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million ...
Posted by Michael Wonder on 16 Sep 2021
Sage Therapeutics receives fast track designation for SAGE-718 for the treatment of Huntington’s disease
15 September 2021 - Sage Therapeutics today announced that the U.S. FDA has granted fast track designation to SAGE-718 for development ...
Posted by Michael Wonder on 16 Sep 2021
PHARMAC funds tocilizumab to treat cases of COVID-19
16 September 2021 - PHARMAC is widening funded access to tocilizumab, an immunosuppressive drug used mainly to treat arthritis, to treat ...
Posted by Michael Wonder on 16 Sep 2021
PHARMAC funds new treatment for rheumatoid arthritis to support people impacted by tocilizumab stock shortage
16 September 2021 - PHARMAC has funded upadacitinib tablets as an alternative treatment for New Zealanders with severe rheumatoid arthritis, ...
Posted by Michael Wonder on 16 Sep 2021
Takeda’s Exkivity (mobocertinib) approved by U.S. FDA as the first oral therapy specifically designed for patients with EGFR exon 20 insertion positive NSCLC
15 September 2021 - Next generation sequencing companion diagnostic test approved simultaneously to support identification of patients with EGFR exon 20 ...