HTA reform gets underway – terms of reference released today

22 March 2023 - Medicines Australia acknowledges the Health Technology Assessment Review Terms of Reference – released today – and ...

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Advancing regulatory science in the EU – mid-point report published

22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...

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Nivolumab in combination with chemotherapy for the neo-adjuvant treatment of patients with resectable non-small-cell lung cancer

22 March 2023 - NICE has published evidence based recommendations on the use of nivolumab (Opdivo) in combination with chemotherapy ...

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FDA approves first in class Evkeeza (evinacumab-dgnb) for young children with ultra rare form of high cholesterol

22 March 2023 - Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolaemia, an inherited condition characterised ...

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Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access

20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...

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Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis

21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...

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Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation

21 March 2023 - Biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation approved for seven indications of reference medicine Humira. ...

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Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes

20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...

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Moderna expects to price its COVID vaccine at about $130 in the US

20 March 2023 - Moderna expects to price its COVID-19 vaccine at around $130 per dose in the US going ...

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Terms of reference for the Health Technology Assessment Policy and Methods Review

22 March 2023 - The terms of reference for the Health Technology Assessment Policy and Methods Review is now available. ...

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Top FDA official: agency needs to start using accelerated approval for gene therapies

20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...

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Prestige Biopharma receives FDA fast track designation for PBP1510 in the treatment of pancreatic cancer

21 March 2023 - Prestige Biopharma has received fast track designation from the US FDA for PBP1510 (ulenistamab), in the ...

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Lobbying firms earning hundreds of thousands from contracts with Government agencies

20 March 2023 - The government drug buying agency PHARMAC made extensive use of Wellington firm Draper Cormack Group. ...

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Diabetes treatment can be incredibly costly. But the biggest cost is (surprisingly) not insulin.

19 March 2023 - Millions of Americans with diabetes have cheered as drug makers slashed the price of insulin, the ...

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Opioid settlement hinders patients’ access to a wide array of drugs

13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...

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