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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1 October 2021 price disclosure confirmed prices

13 September 2021 - Confirmed 1 October 2021 prices resulting from the 2021 October cycle of price disclosure have now been ...

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Biden Administration’s prescription drug pricing plan promotes incremental change, not overhaul of system

12 September 2021 - On Thursday, September 9th, the White House released a long awaited plan to reduce prescription drug ...

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NHS lung cancer patients in England get early access to ‘breakthrough’ cancer drug

10 September 2021 - The MHRA has approved a first-of-its-kind cancer drug – capable of targeting a gene mutation that ...

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MHRA statement on booster doses of Pfizer and AstraZeneca COVID-19 vaccines

9 September 2021 - The regulatory changes made by the MHRA today give further options for the deployment programme. ...

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Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment

9 September 2021 - In June 2021, the US FDA granted accelerated approval for aducanumab to treat patients with mild cognitive ...

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Estimated savings from international reference pricing for prescription drugs

10 September 2021 - High prescription drug prices have important implications for health care spending, patient financial burden, and adherence. ...

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MHRA approves Amgen’s Lumykras under Project Orbis

10 September 2021 - Amgen has announced that is first-in-class KRAS G12C inhibitor Lumykras (sotorasib) has been received a conditional ...

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ICER publishes evidence report on treatments for myasthenia gravis

10 September 2021 - While eculizumab and efgartigimod each provide important health benefits, both would need to be priced more than ...

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UK approval for Pfizer’s JAK inhibitor Cibinqo

10 September 2021 - The UK MHRA has approved a marketing authorisation for Pfizer’s oral Janus kinase 1 inhibitor Cibinqo ...

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PBAC Public Summary Documents (first time decisions not to recommend, deferrals and other matters) – May 2021 meeting

10 September 2021 - The Public Summary Documents (first time decisions not to recommend, deferrals and other matters) from the May ...

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Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study

9 September 2021 - The researchers set out to investigate the regulatory handling of cancer drugs that were granted accelerated approval ...

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Decibel Therapeutics receives orphan drug and rare paediatric disease designations for DB-OTO for the treatment of otoferlin related congenital hearing loss

9 September 2021 - Decibel Therapeutics today announced that the U.S. FDA has granted both orphan drug designation and rare paediatric ...

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FDA grants breakthrough device designation to the NovoTTF-200T system for advanced liver cancer

9 September 2021 - Novocure today announced the United States FDA has granted breakthrough designation to the NovoTTF-200T System, a Tumour ...

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VOR33 granted U.S. FDA fast track designation for AML

9 September 2021 - Vor Biopharma today announced that the U.S. FDA has granted fast track designation to VOR33, the ...

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Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates

9 September 2021 - Senate lawmakers are actively considering pegging the prices Medicare pays for drugs to those drug makers ...

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