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FDA grants approval for Amylyx’s Relyvrio to treat ALS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). An oral, fixed-dose medicine, Relyvrio is also approved with conditions in Canada such as Albrioza to treat ALS.

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Pharma Injecting Life into Digital Health Amidst Funding Downturn

MedCity News

Investors in 2022 appeared confident that the continued transformation of drug research and development protocols and the overall life sciences industry will not only include digital health solutions, but will even depend on them for data collection, analysis, patient engagement, and even their therapeutic properties.

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Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

In both clinical research and clinical medicine, “we had a very limited view of social determinants.”. It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Switzerland Platform’ .

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”

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Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

In both clinical research and clinical medicine, “we had a very limited view of social determinants.” It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin.

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Uri Goren

Cadensee

11:50 Uri discusses the role of the Society of Participatory Medicine and the E-Patient Movement. 17:02 What is the best way to keep that balance of - the empowered patient, who is the most important person in the room, with the knowledge and judgment of the medical professional whose recommendations should be trusted.