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HeartBeam Announces Acquisition of LIVMOR Assets

Legacy MEDSearch

Founded in 2016, LIVMOR developed the Halo+ Atrial Fibrillation (AF) Detection System, the world’s first FDA-cleared prescription wearable for continuous cardiac rhythm monitoring. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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US FDA grants approval for Gilead’s Vemlidy to treat HBV infection

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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Gene therapies transform rare disease treatment: hope for patients amidst regulatory, payer and developer challenges

Clarivate

Food and Drug Administration advisory committee’s narrow 8-6 vote in favor of recommending accelerated approval for a first-in-class gene transfer therapy was welcomed by Duchenne muscular dystrophy (DMD) patients and caregivers.

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Leading in Pharma: a woman’s pathway

European Pharmaceutical Review

She founded COMPASS Pathways with her husband George Goldsmith in 2016, having experienced at first hand the challenges in accessing evidence-based and effective mental health care for a family member. I am a physician by training, and I worked in New York hospital emergency rooms for many years. I believe we can and must do better.

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Precision Medicine Needs an Overhaul

PM360

Between 2015 and 2021, over a quarter of the drugs approved by the US Food and Drug Administration (FDA) were associated with specific biomarkers. Over a decade ago, AstraZeneca identified and tested specific biomarkers to develop drug molecules. Bright Spots.

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For rare disease patients in Mainland China, hope of greater access to treatment

Clarivate

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8]. 10] [11] [12].

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FDA Issues Final Guidance on Clinical Decision Support Software and Software as a Medical Device: Key Takeaways and What it Means for Digital Health Companies

Nixon Gwilt Law

Food and Drug Administration (“FDA”) released the final version of its guidance to industry stakeholders for Clinical Decision Support software (“CDS Guidance”). On September 27, 2022, the U.S. These RTM codes require use of a device, which of course includes SaMD, but does NOT include Non-Device CDS software.

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