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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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