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Aimmune Presents New Peanut Allergy Data and Presses for Real-World Data Approaches

Aimmune Therapeutics presented new data on the company’s AR101 peanut allergy therapy as well as a real-world data study at the American College of Asthma, Allergy and Immunology (ACAAI) Annual Scientific Meeting in Houston.

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DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut for the Treatment of Peanut Allergy

The U.S. Food and Drug Administration accepted for review the Biologics License Application (BLA) for DBV Technologies’ investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.

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First peanut allergy therapy gets backing from U.S. regulators’ expert advisers

A U.S. Food and Drug Administration advisory panel recommended approving the first therapy for peanut allergies, which affect over 1.6 million children in the United States, despite raising concerns about the risk of severe allergic reactions Palforzia poses to young patients.

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DBV Technologies Resubmits BLA for Viaskin Peanut

After an eight month delay, France-based DBV Technologies announced the resubmission of a Biologics License Application to the U.S. FDA for the non-invasive allergy patch Viaskin Peanut.

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Aimmune’s Peanut Allergy Product Hits Primary Endpoint in European Phase III Trial

Aimmune Therapeutics announced that the Brisbane, Calif.-based company’s Phase III European clinical trial of AR101 for the treatment of peanut allergy met the primary efficacy endpoint.

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Hundreds of FDA staff return to work amid shutdown: Commissioner

About 400 U.S. Food and Drug Administration staffers returned to their posts from furlough, including some food inspectors and support professionals, Commissioner Scott Gottlieb said in a tweet.

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Aimmune Therapeutics’ Peanut Allergy Immunotherapy Looks Promising in Phase III Trial

Aimmune Therapeutics announced the publication of the company’s successful Phase III PALISADE clinical trial of AR101 to desensitize patients with peanut allergies. The research was published in the New England Journal of Medicine.

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Nestle raises stake in food allergy drug developer

Nestle’s health science arm will pay $98 million to raise its stake in Aimmune Therapeutics in preparation of submitting a marketing application for the peanut allergy drug AR101 by year-end 2018.

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Aimmune’s peanut allergy drug meets main goal

U.S. drug developer Aimmune Therapeutics Inc.’s peanut allergy drug met the main goal of an eagerly awaited late-stage study.

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DBV Allergy Drug Flunked Phase III Test

DBV Technologies’ Phase III peanut allergy trial failed to show a statistically significant response against placebo.

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