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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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FDA approves expanded label for Regeneron/Sanofi’s Dupixent

The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.

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Many epinephrine self-injectors still potent long after expiration date

EpiPens and other autoinjectors filled with epinephrine to treat severe allergic reactions may still be potent enough to work many months past their labeled expiration date, according to a study that concludes patients might need expensive refills less often.

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Many U.S. allergists now prescribe tablets instead of shots

Almost three in four U.S. allergy specialists are prescribing tablets to ease symptoms caused by pollen, ragweed and dust at least some of the time, though they have not completely shifted away from allergy shots, a survey suggests.

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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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IQVIA’s FluSTAR Online Dynamic Platform Helps Consumers Track Local Rates of Flu, Allergy and Asthma

IQVIA – a leader in human data science – provides consumers with quick and easy access to seasonal suffering data, giving them unique insights into important health related information. Recent data show that flu season is hitting hard in several key markets.

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Pfizer unit Meridian under civil investigation by U.S. Attorney

Pfizer Inc. received a request for documents as part of a U.S. investigation related to quality issues involving the manufacture of auto-injectors at the company’s Meridian Medical Technologies site.

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Exclusive: Teva’s generic EpiPen launch stalls months after approval

Many of the largest U.S. pharmacies and drug distributors do not have Teva Pharmaceutical Industries Ltd.’s generic version of EpiPen five months after the life-saving allergy treatment was approved for sale in the United States, pharmacy chains and a group that tracks drug shortages told Reuters.

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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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