Schedule of Pharmaceutical Benefits - 1 August 2024

1 August 2024 - The August 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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Fosdenopterin hydrobromide for the treatment of patients molybdenum cofactor deficiency type A

19 September 2024 - The Department of Health and Social Care has NICE to produce guidance on the use of ...

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BioCryst and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Orladeyo (berotralstat), an oral, once daily therapy for the prevention of hereditary angioedema attacks

17 September 2024 -  BioCryst Pharmaceuticals today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for oral, ...

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Bavarian Nordic receives EMA approval of mpox vaccine for adolescents

19 September 2024 - MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review ...

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Abrysvo: Pfizer Canada's newly publicly funded vaccine a step towards national RSV prevention in older adults

19 September 2024 -  Today, Pfizer Canada announced that Abrysvo has been selected as the publicly funded vaccine for the ...

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FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations

19 September 2024 - Today, the FDA approved amivantamab-vmjw (Rybrevant, Janssen) with carboplatin and pemetrexed for adult patients with locally ...

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Daiichi Sankyo’s Vanflyta recommended by NICE for acute myeloid leukaemia

19 September 2024 - Daiichi Sankyo’s Vanflyta (quizartinib) has been recommended by NICE for certain cases of acute myeloid leukaemia. ...

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FDA declines to approve Vanda's marketing application for tradipitant in gastroparesis

19 September 2024 - - Vanda Pharmaceuticals today provided an update on its tradipitant development program. ...

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Program to protect SA newborns from RSV

17 September 2024 - South Australia will protect newborn babies from the impacts of respiratory syncytial virus for the winter ...

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Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada

18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...

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Azitra receives fast track designation for ATR-04 for skin rash from EGFR inhibitors

18 September 2024 - Azitra today announced the US FDA has granted fast track designation for topically applied ATR-04 to treat ...

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Glycomine receives FDA fast track designation for GLM101 for the treatment of PMM2-CDG

18 September 2024 - Glycomine announced today that the US FDA has granted fast track designation for GLM101, a mannose-1-phosphate ...

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ImCheck receives FDA fast track designation for ICT01 in combination with azacitidine and venetoclax in first-line acute myeloid leukaemia for patients unfit for induction chemotherapy treatment

18 September 2024 - ICT01, a humanised anti-butyrophilin 3A monoclonal antibody designed to selectively activate Vγ9Vδ2 T cells, has shown ...

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The ICER developing special report for submission to CMS as part of public comment process on Medicare drug price negotiations

18 September 2024 - Report to reflect legislative specifications in the Inflation Reduction Act and subsequent CMS guidance regarding price ...

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EMA publishes agenda for 16-19 September 2024 CHMP meeting

16 September 2024 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Biogen's new drug submission for omaveloxolone accepted for priority review by Health Canada for the treatment of Friedreich's ataxia

17 September 2024 - If approved, omaveloxolone would be the only disease specific treatment option for patients living with this progressive ...

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