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Xeris Pharmaceuticals Receives European Commission Approval of Ogluo (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus

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Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. The marketing authorisation is valid in all 27 countries of the European Union, plus Iceland, Norway, and Liechtenstein. As the EC decision was received after the end of the Brexit transition period, Xeris will complete a further administrative step in order to obtain a license in Great Britain. No re-examination of clinical data by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is expected. ....

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Xeris Pharmaceuticals Receives European Commission Approval of Ogluo™ (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus

Xeris Pharmaceuticals Receives European Commission Approval of Ogluo™ (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus
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Xeris Pharmaceuticals Granted Fast Track Designation by the FDA for Its Novel Concentrated Diazepam Formulation (XP-0863) For Injection

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Xeris Pharmaceuticals Granted Fast Track Designation by the FDA for Its Novel Concentrated Diazepam Formulation (XP-0863) For Injection
Xeris Pharmaceuticals Granted Fast Track Designation by the FDA for Its Novel Concentrated Diazepam Formulation (XP-0863) For Injection
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced it was granted Fast Track designation by the Food and Drug Administration (FDA) for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures. Xeris XP-0863 was previously granted orphan designations both for the treatment of acute repetitive seizures and for the treatment of Dravet Syndrome. ....

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Xeris Pharmaceuticals Announces Distribution Agreement With Megapharm Ltd. to Commercialize Gvoke® in Israel and the Palestinian Authority

Published: Dec 22, 2020
CHICAGO (BUSINESS WIRE) Xeris Pharmaceuticals, Inc.,(Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that it has entered into an exclusive distribution agreement with Megapharm Ltd. (“Megapharm”), a leading Israel-based pharmaceutical company, for the commercialization in Israel and the Palestinian Authority of Xeris’ Gvoke® (glucagon injection) for the treatment of severe hypoglycemia in adults and children with diabetes ages 2 years and above. Gvoke® is the world’s first and only ready-to-use liquid glucagon.
Under the terms of the agreement, Megapharm will be responsible for registration and marketing of Gvoke® in Israel and the Palestinian Authority, as well as named patient services supply, and Xeris will be responsible for manufacturing, product supply, quality assurance ....

United States , Miron Drucker , Paulr Edick , Exchange Commission , Xeris Pharmaceuticals Inc , Health Funds , Megapharm Ltd , Palestinian Authority , American Diabetes Association , Chief Executive Officer , Safety Information , About Severe , Xeris Pharmaceuticals , Private Securities Litigation Reform Act , Quarterly Report , ஒன்றுபட்டது மாநிலங்களில் , மைரான் டிரக்கர் , பரிமாற்றம் தரகு , ஆரோக்கியம் நிதி , ப்யாலெஸ்டிநியந் அதிகாரம் , அமெரிக்கன் நீரிழிவு நோய் சங்கம் , தலைமை நிர்வாகி அதிகாரி , பாதுகாப்பு தகவல் , ப்ரைவேட் பத்திரங்கள் வழக்கு சீர்திருத்தம் நாடகம் , காலாண்டு அறிக்கை ,