Lung cancer and leukaemia treatments to be added to PBS

19 November 2019 - “Game changing” drugs for types of lung cancer and leukaemia will be added to the Pharmaceutical Benefits ...

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FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions

18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...

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Improving transparency in decision models: current issues and potential solutions

23 October 2019 - Decision-analytic models have become an essential tool used to inform health technology assessments. ...

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NICE, in confidence: an assessment of redaction to obscure confidential information in single technology appraisals by the National Institute for Health and Care Excellence

17 November 2019 - Health technology assessment aims to provide a transparent framework within which normative judgements can be applied for ...

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Statement from Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

15 November 2019 - Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses.  ...

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Biostatistics: a fundamental discipline at the core of modern health data science

28 October 2019 - The value of our health and medical research investment is at risk unless we foster the discipline ...

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Picturing ELSI+: a visual representation of ethical, legal, and social issues, and patient experiences in health technology assessment in Canada

15 November 2019 - Consideration of ethical, legal, and social issues plus patient values (ELSI+) in health technology assessment is challenging ...

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'This drug saved my life;' cystic fibrosis patient accuses drug company, Canada of stalling on approval

17 November 2019 - A West Island woman living with cystic fibrosis says the prohibitive price of a drug is ...

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Tricida announces FDA acceptance of new drug application for veverimer

14 November 2019 - Tricida announced today that the U.S. FDA has accepted for review its new drug application for ...

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CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment

15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...

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CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma

15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...

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Labour will exclude the NHS and medicines from trade deals with the US

17 November 2019 - Donald Trump wants the big US pharmaceutical companies to get its hands on our public services – ...

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Booker and Sanders propose a new federal agency to set drug prices

15 November 2019 - Senators Cory Booker and Bernie Sanders are pushing for the creation of a new federal agency ...

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PBAC Public Summary Documents - July 2019 meeting

15 November 2019 - The Public Summary Documents (first time rejections and deferrals) from the July 2019 PBAC meeting are now ...

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Novartis receives positive CHMP opinion for Mayzent (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis

15 November 2019 - If approved, Mayzent (siponimod) will be the first and only oral treatment specifically indicated for patients ...

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Highlights from the CHMP 11-14 November 2019 meeting

15 November 2019 - Seven new medicines recommended for approval. ...

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