Tag: European

European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab

TOKYO – WEBWIRE – Friday, July 14, 2023 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, Astellas) today announced the European Medicines Agency (EMA) has accepted for regulatory review the companys marketing authorization application (MAA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy available in Europe for these patients. Gastric cancer accounted for 3.1% of all new cancer cases in Europe in 2020, with around ... Read more

GSMA And European Space Agency Launch New Communications Innovation Partnership

New Collaboration Will Look to Accelerate Advancements in Satellite and Terrestrial Communications Network Integration OXFORDSHIRE – WEBWIRE – Thursday, July 13, 2023 The GSMA and European Space Agency (ESA) signed a Memorandum of Intent (MOI) to bring the mobile and satellite industries closer together to collaborate on developing new, innovative satellite and terrestrial networks technologies. The ambition of the partnership is to further strengthen the competitiveness of both mobile and satellite network industries, by creating an ecosystem which can fast-track the development of new complimentary technology solutions for businesses and consumers. The two organisations will join efforts to speed-up innovation ... Read more

Data Protection: European Commission adopts new adequacy decision for safe and trusted EU-US data flows

Brussels – WEBWIRE – Tuesday, July 11, 2023 An adequate protection of our personal data is a fundamental right, and one whose importance only continues to grow in our day-to-day lives. The European Commission adopted its adequacy decision for the EU-U.S. Data Privacy Framework. The decision concludes that the United States ensures an adequate level of protection comparable to that of the European Union for personal data transferred from the EU to US companies under the new framework. On the basis of the new adequacy decision, personal data can flow safely from the EU to US companies participating in the ... Read more

Canada – Minister Ng speaks with European Commission Executive Vice-President and European Union Commissioner for Trade 

Yesterday, the Honourable Mary Ng, Minister of International Trade, Export Promotion, Small Business and Economic Development, met virtually with Valdis Dombrovskis, European Commission Executive Vice-President and European Union Commissioner for Trade. January 19, 2022 – Ottawa, Canada – Global Affairs Canada Yesterday, the Honourable Mary Ng, Minister of International Trade, Export Promotion, Small Business and Economic Development, met virtually with Valdis Dombrovskis, European Commission Executive Vice-President and European Union Commissioner for Trade. Minister Ng extended her appreciation of the EU’s ongoing engagement in the Ottawa Group and support to advance work on WTO reform priorities. The ministers agreed to continue ... Read more

Japan – European Commission Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) for Patients With Certain Types of Endometrial Carcinoma

Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the European Commission has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. This marks the first combination of ... Read more