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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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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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Gilead to launch generic hepatitis drugs

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.

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Walgreens to supply Kaleo’s allergy shots as EpiPen shortage drags

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.

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FDA extends EpiPen expiry date to combat shortage

The U.S. Food and Drug Administration extended the expiration date of specific lots of Mylan NV’s EpiPen allergy injectors by four months to mitigate the shortage of the life-saving treatment.

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FDA approves Teva’s generic of Mylan’s EpiPen

The U.S. Food and Drug Administration approved Teva Pharmaceutical Industries Ltd.’s generic version of Mylan NV’s life-saving allergy injection EpiPen.

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Adamis Pharma Sells Epinephrine Injector Rights to Novartis

Adamis Pharmaceuticals is selling U.S. commercial rights to Symjepi, a competitor to Mylan’s EpiPen, to Novartis.

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FDA says Mylan’s EpiPen is in shortage

U.S. regulators said Mylan NV’s EpiPen products are in shortage, due to manufacturing delays that are creating intermittent supply constraints of the emergency allergy treatment.

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