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Vyjuvek Gets FDA Nod as First Topical Gene Therapy for Rare Skin Disease

XTalks

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB).

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Tarpeyo (Budesonide) Is Transforming IgA Nephropathy Care with FDA’s Full Approval

XTalks

Initially receiving accelerated approval in December 2021 based on proteinuria as a surrogate marker, Tarpeyo has now achieved the status of being the first treatment for IgAN to receive full FDA approval predicated on evaluations of kidney function.

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After Daybue’s Approval: Acadia Pharmaceuticals’ Next Steps for the Rett Syndrome Community

XTalks

The MeCP2 protein plays a crucial role in regulating the activity of genes involved in brain development. In March, the US Food and Drug Administration (FDA) approved Daybue (trofinetide) , the first and only treatment for Rett syndrome. Daybue (trofinetide) is the first and only FDA-approved drug for Rett syndrome.

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Pfizer Responds to Research Claims

Pfizer

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir.

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2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

Roche will present data on the increased use of home nursing capabilities in the Phase III GRADUATE studies of gantenerumab during the COVID-19 pandemic, which enabled home-bound trial participants to continue dosing to maintain medicine exposure. Alzheimer’s Disease (AD). P1: Aging and Dementia: Biomarkers.

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4 Life Science Trends To Pay Attention To in 2021

XTalks

The test identifies SARS-CoV-2 protein fragments from nasal swab samples. As a result, nurses were deployed more broadly and became more involved in supporting a study. “[It] Even more interestingly, now there are drugs that have FDA approval that were conducted by decentralized clinical trials.

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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.