Stability of changes in health status: next step in comprehensively assessing patient reported outcomes

18 August 2022 - Chronic diseases can impair patients’ health status due to symptoms, functional limitations, and impaired quality of life. ...

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AARP Pennsylvania convenes discussion on lower prescription drug costs after Inflation Reduction Act signed into law

18 August 2022 - Senator Bob Casey joins AARP Discussion. ...

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Caps on prescription drug price hikes most popular aspect of Inflation Reduction Act: poll

18 August 2022 - A cap on prescription drug price increases is the most popular part of the Inflation Reduction ...

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Valneva initiates rolling submission of FDA biologics license application for its single shot Chikungunya vaccine candidate

18 August 2022 - Valneva today announces that it has initiated rolling submission of the biologics license application to the ...

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FDA label update reflects Bayer’s commitment to providing options for long-acting contraception

18 August 2022 - FDA approves extension of Mirena (levonorgestrel-releasing intrauterine system) 52 mg intrauterine device for up to eight years ...

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U.S. FDA accepts Astellas' new drug application for fezolinetant

18 August 2022 - If approved by the FDA, fezolinetant would be a non-hormonal treatment for moderate to severe vasomotor ...

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Early phase oncology trials: why so many designs?

12 August 2022 - The past 30 years have seen a considerable effort on the part of statisticians to improve the ...

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bluebird bio announces U.S. commercial infrastructure to enable patient access to Zynteglo, the first and only FDA approved gene therapy for people with beta thalassaemia who require regular red blood cell transfusions

17 August 2022 - Innovative outcomes-based contract offering includes single upfront payment and up to 80% risk-sharing. ...

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Accelerated approval of cancer drugs: no economic reward for drug makers that conduct confirmatory trials

17 August 2022 - The FDA uses expedited approval of drugs to speed the development and assessment of drugs that address ...

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FDA approves first cell based gene therapy to treat adult and paediatric patients with beta thalassaemia who require regular blood transfusions

17 August 2022 - Today, the US FDA approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of ...

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Samsung Bioepis and Organon announce FDA approval of citrate free high concentration Humira biosimilar Hadlima (adalimumab-bwwd)

17 August 2022 - Samsung Bioepis and Organon today announced the U.S. FDA has approved the citrate free, high concentration (100 ...

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Akorn announces FDA has approved generic cetrorelix acetate

16 August 2022 - Akorn announces that it received FDA approval for a generic version of cetrorelix acetate 250 mcg ...

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US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis

17 February 2022 - Regulatory submission included data from the pivotal MOMENTUM Phase 3 clinical trial that met all primary ...

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Sales from controversial drug discount program rose to $44 billion last year

15 August 2022 - Prescription medicines purchased in the US under a controversial government discount program amounted to $44 billion ...

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Cancer patient who devoted six years to drug pricing reform isn’t done yet

14 August 2022 - After six years of relentless advocacy work, David Mitchell was finally on the cusp of defeating ...

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