Day: December 18, 2023

Mithra Receives Positive DSMB Opinion on DONESTA® European Phase 3 TrialThe DSMB recommends continuing the phase 3 trial in Europe following regular safety assessment The menopause phase 3 program has previously reported positive top-line data; extension to Europe trial ongoing Additional endometrial data analyses ongoing for inclusion in regulatory submissions Mithra plans to submit DONESTA® for approval by U.S. and European regulators in Q4 2024Liege, Belgium, 18 December 2023 – 7:00 CET – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces it has received a positive review from the independent Data and Safety Monitoring Board (DSMB) on its phase 3 program for DONESTA®, its investigational, next generation hormone therapy medicine containing estetrol (E4) for the treatment of the symptoms of...

WISeKey’s Subsidiary, WISe.ART, in Collaboration with GMA, Unveils Innovative Digital Renaissance Initiative in RomeGENEVA/Madrid/Rome – December 18, 2023 – WISeKey International Holding Ltd. (“WISeKey”) (SIX: WIHN, NASDAQ: WKEY), a global leader in cybersecurity, digital identity, and Internet of Things (IoT) solutions operating as a holding company, through its subsidiary WISe.ART, a leader in the field of digital art and luxury collectibles, together with GMA, proudly announce the launch of the Digital Renaissance initiative in Rome. This cutting-edge project represents a transformative leap in the promotion, investment, and preservation of art. WISe.ART and GMA’s Digital Renaissance initiative kicks off with the celebrated work of Pedro Sandoval, an artist renowned for his unique blend of contemporary and classical...

European Commission (EC) grants marketing authorization for AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older AGAMREE® is the only approved medication in the European Union (EU) for treating DMD, and the first DMD treatment approved in both the U.S. and EU First commercial launch of AGAMREE®, in Germany, expected in Q1-2024 EMA acknowledges safety benefits of AGAMREE® with regards to preserving bone health and maintaining growth compared to standard of care corticosteroidsPratteln, Switzerland, December 18, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces that AGAMREE® (vamorolone) has been approved in the European Union (EU) for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older, independent of the underlying mutation and ambulatory status....