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The Pulse of the Pharmaceutical Industry

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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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U.S. FDA Approves Kaléo’s AUVI-Q 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

Privately held pharmaceutical company kaléo announced that the U.S. Food and Drug Administration approved its supplemental New Drug Application for AUVI-Q (epinephrine injection, USP) 0.1 mg.

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Adamis wins U.S. approval to sell EpiPen rival

Adamis Pharmaceuticals Corp. received U.S. approval for its emergency epinephrine syringes to treat severe allergic reactions that the company intends to be a lower cost rival to Mylan NV’s widely used EpiPen, sending its shares up more than 50 percent.

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Mylan says being investigated over EpiPen practices

Mylan NV said U.S. antitrust authorities had launched an investigation into its EpiPen emergency allergy treatment.

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U.S. health agency tells Grassley there is no EpiPen deal yet

Mylan NV has yet to reach a settlement with the U.S. Department of Justice over the classification in the Medicaid program of its life-saving EpiPen allergy treatment, according to a regulatory agency.

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EpiPen rival plans on U.S. market return in 2017

Privately held drugmaker Kaleo Inc. announced plans for a U.S. relaunch of its Auvi-Q injector for life-threatening allergic reactions in the first half of 2017.

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Mylan to pay $465 million over EpiPen Medicaid rebate dispute

Mylan NV will pay $465 million to settle questions of whether it underpaid U.S. government healthcare programs by misclassifying its EpiPen emergency allergy treatment.

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Teva hoping for 2017 launch of EpiPen-like device

Teva Pharmaceutical Industries hopes to win U.S. approval by late 2017 or early 2018 for its version of Mylan’s EpiPen device to treat severe allergic reactions.

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Mylan offers discounts on EpiPen after criticism

Mylan NV said it would reduce the out-of-pocket cost of its severe allergy treatment EpiPen through a discount program after lawmakers criticized the drug’s high price.

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U.S. lawmakers press Mylan on EpiPen price hike

Two senior lawmakers on the U.S. Senate’s Judiciary Committee pushed for information regarding sharp price increases for EpiPens, drug-filled injectable devices.

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April 2019 Focus: Healthcare agency & network profiles, industry overview & awards, and more!


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