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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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.
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.
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 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’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.
Gilead Sciences Inc. plans to launch generic versions of the company’s hepatitis C drugs in the United States, at a time when regulators are looking to lower healthcare costs.
Walgreens Boots Alliance Inc. said emergency allergy shots from Kaleo will be available in the U.S. drugstore chain’s stores, the latest effort to address shortages of the lifesaving treatment during the back-to-school season.