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Moderna COVID vaccine gets full approval for children

BioPharma Drive: Drug Pricing

Outside of the FDA, Kennedy last month abruptly fired all 17 members of an advisory panel to the CDC, replacing them with his own hand-selected advisers, who don’t all have the typical background and experience in epidemiology and vaccine science. This panel, known as ACIP for short, recommends who should receive FDA-approved vaccines.

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Topical Gene Therapy FDA-Approved for Severe Skin Disease, Dystrophic Epidermolysis Bullosa

PLOS: DNA Science

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). The gene treatment has been a long time coming, but it differs from the handful of other approved gene therapies: it isn’t a one-and-done. This DNA Science post from 2018 traces the history of the efforts.

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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?

FDA Law Blog: Drug Discovery

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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FDA OKs First Over-the-Counter Home Test for COVID-19

The Pharma Data

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA.

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Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir comp

The Pharma Data

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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Researchers uncover genetic factors for severe Lassa fever

Broad Institute

By Allessandra DiCorato February 8, 2024 Credit: NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland Scanning electron image of the Lassa virus budding off a cell. Other scientists had discovered that this gene was critical for the Lassa virus to enter cells. Finding participants for the study would be challenging too.

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FDA Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

“More than 100,000 in long-term care have died from this virus in the U.S. and our nursing homes are now experiencing the worst outbreak of new cases since last spring, with more than 2,000 residents succumbing to this virus each week.” When you don’t have that capacity, that means people will die.”

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