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© 2021
Positief advies EMA voor anticonceptiepil met E4
/in News /by Astrid van den HeuvelPositief advies EMA voor anticonceptiepil met E4
In navolging van eerdere goedkeuring door gezondheidsinstantie van Canada
Zeist, 31 maart 2021 – Pantarhei Bioscience maakt bekend dat het Comité voor Geneesmiddelen voor Menselijk Gebruik (CHMP) van het Europees Geneesmiddelenagentschap (EMA) een positieve opinie heeft afgegeven voor de nieuwe anticonceptiepil Estelle® van Mithra Pharmaceuticals met het door Pantarhei Bioscience ontwikkelde oestrogeen Estetrol (E4). Goedkeuring voor de Europese markt door de Europese Commissie wordt tegen het einde van het tweede kwartaal van 2021 verwacht.
Voor meer informatie lees hier het Nederlandstalig Persbericht.
Positive advice of the EMA for contraceptive pill with Estetrol after earlier approval by Health Canada
Zeist, 31 March 2021 – Pantarhei Bioscience announces that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has published a positive opinion for a novel combined oral contraceptive (OC) containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP), developed by Pantarhei Bioscience and Mithra Pharmaceuticals. Subject to approval by the European Commission, the marketing authorization valid for all European Union Member States is expected to be granted by the end of the second quarter 2021. The product will be marketed in Europe by the Hungarian company Gedeon Richter under the brand name Drovelis®.
For more information please read the Press Release.
Dutch BioTech Pantarhei Bioscience’s success with new drug in Canada.
/in News /by Astrid van den HeuvelApproval by Health Canada of a new oral contraceptive with the “forgotten” estrogen Estetrol
Zeist, 22 March 2021 – Pantarhei Bioscience announces that Canada is the first country in the world to have approved the natural pregnancy estrogen Estetrol (E4) for use in the oral contraceptive Estelle®. The development of this new pill represents a joint effort between Pantarhei Bioscience and Mithra Pharmaceuticals in Belgium.
For more information please read the Press Release.
Het Nederlandse Pantarhei Bioscience behaalt succes met geneesmiddel in Canada
Canadese goedkeuring primeur voor anticonceptiepil met ‘vergeten’ hormoon E4
Zeist, 16 maart 2021 – Pantarhei Bioscience maakt bekend dat Canada als eerste land ter wereld goedkeuring heeft gegeven voor het gebruik van het natuurlijke zwangerschapsoestrogeen estetrol (E4) in de anticonceptiepil Estelle®, onder het handelsmerk Nextstellis®. Het is het eerste en enige orale anticonceptiemiddel op basis van het unieke oestrogeen Estetrol (E4), ontwikkeld door Pantarhei Bioscience en Mithra Pharmaceuticals.
Voor meer informatie lees hier het Nederlandstalig Persbericht.
Research paper on positive results treatment for advanced breast cancer with the fetal estrogen estetrol (E4) has been accepted for publication in the Journal of Cancer Research and Clinical Oncology
/in News, Publications /by Astrid van den HeuvelPantarhei Oncology proudly announces that its paper ‘Tumor Suppression, Dose Limiting Toxicity and Wellbeing with the Fetal Estrogen Estetrol (E4) in patients with advanced breast cancer’ has been accepted for publication in the Journal of Cancer Research and Clinical Oncology after comprehensive review. The Journal of Cancer Research and Clinical Oncology is an international peer-reviewed scientific journal in the field of oncology.
The research paper states that treating postmenopausal women diagnosed with advanced breast cancer can be treated safely with high doses of E4. All 12 patients enrolled had progressive, heavily pre-treated advanced breast cancer. No treatment-related serious adverse events or doses of limiting toxicity (DLTs) occurred during the first 4 weeks of E4 treatment allowing further investigation of all three doses. Five of nine patients completing 12 weeks of E4 treatment showed objective anti-tumor effects and six of nine patients reported improved wellbeing.
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