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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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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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FDA approval for Janssen’s prostate cancer treatment

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). ” In April 2016, Janssen Biotech, Inc. ” In April 2016, Janssen Biotech, Inc.

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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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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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Healthcare Watch July/August 2022

PM360

Sermo , a physician-first online community, found the tracks at ASCO that oncologists felt were the most transformative to be breast cancer (58%), lung cancer (34%), and developmental therapeutics—molecularly targeted agents and tumor biology (32%). EPA Administrator Michael Regan said the agency will take more aggressive action against PFAS.