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.
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.
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.
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.
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.
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.
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.
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.
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.
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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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!