Archives: 2022-01-26

FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19

The U.S. Food and Drug Administration took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to

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Landing therapeutic genes safely in the human genome

Researchers at Harvard’s Wyss Institute, Harvard Medical School, and the ETH Zurich predict and validate genomic safe harbors for therapeutic genes, enabling safer, more efficient, and predictable gene and cell therapies. Many future gene and cell therapies to treat diseases like cancer, rare genetic and other conditions could be enhanced in their efficacy, persistence, and

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Current vaccines teach T and B cells to fight Omicron: results published in two new papers

Scientists at La Jolla Institute for Immunology (LJI) have found that four COVID-19 vaccines (Pfizer-BioNTech, Moderna, J&J/Janssen, and Novavax) prompt the body to make effective, long-lasting T cells against SARS-CoV-2. These T cells can recognize SARS-CoV-2 Variants of Concern, including Delta and Omicron.  “The vast majority of T cell responses are still effective against Omicron,”

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Two new papers reveal through cryo-EM analysis the structural basis of antibody evasion and enhanced transmission of the Omicron variant

In a study recently published on Cell, researchers used cryogenic electron microscopy (cryo-EM) analysis to capture the open and closed states of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant’s spike protein. The open and closed states of the Omicron spike appeared more compact compared to that of the SARS-CoV-2 G614 strain, which is likely due to

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Multiple Early Factors Anticipate Post-Acute COVID-19 Sequelae: a new paper published on Cell

A significant portion of people who contract the SARS-CoV-2 virus—some estimates suggest more than 40 percent—suffer chronic effects known as Post Acute Sequelae of COVID-19 (PASC), commonly referred to as long COVID. PASC symptoms include fatigue, brain fog, the loss of taste and smell, shortness of breath, and more. Now, researchers have identified several factors

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New gene therapy treatment resulted in sustained, clinically relevant benefits in children with Metachromatic Leucodystrophy: long term results published.

An investigational gene therapy showed benefit in pediatric patients with early-onset metachromatic leukodystrophy (MLD), a small study showed. Treatment with atidarsagene autotemcel (arsa-cel) preserved motor development and cognitive function in MLD patients enrolled in a prospective phase I/II trial or treated through expanded access programs, reported Alessandro Aiuti, MD, of the San Raffaele Telethon Institute for Gene

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50-64 age unvaccinated people were 44 more times to be hospitalized with COVID-19 than those who were fully vaccinated and had a booster shot, CDC shows

The risk of hospitalization for COVID-19 among older Americans is far higher for those who are unvaccinated than for those who are fully vaccinated and have had a booster shot, new government data shows. The differences were stark: In December, unvaccinated people 50 and older were 17 times more likely to be hospitalized with COVID-19 than those

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New EMA report on International regulators’ recommendations on COVID-19 vaccines and the Omicron variant

International regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against the COVID-19 Omicron variant, regulatory requirements for a variant vaccine and considerations on clinical study design. The workshop on the global response to the COVID-19 Omicron variant was organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and

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