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FDA green lights AstraZeneca’s asthma drug Fasenra for self-administration

The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.

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Mylan to pay $30 million U.S. SEC fine related to EpiPen overcharge probe

Mylan NV agreed to settle U.S. SEC charges that the company hid from investors the impact of a federal probe into the drugmaker’s overbilling the government for the EpiPen allergy treatment.

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FDA approves drug for loss of sexual desire in women

The U.S. drug regulator approved Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women.

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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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Zealand Pharma’s Severe Hypoglycemia Treatment Hits the Mark in Another Phase III Trial

Shares of Zealand Pharma A/S were up more than 2 percent after the company announced that dasiglucagon, a potential treatment for severe hypoglycemia, hit the mark in a Phase III study.

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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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Impatient patients turn to online ‘buyers club’ for new drugs

Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club.

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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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AMAG Pharmaceuticals Divests Cord Blood Registry for $530 Million

Waltham, Mass.-based AMAG Pharmaceuticals will secure $530 million in cash as the company divests Cord Blood Registry to GI Partners, a private equity investment firm.

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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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