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Santhera's AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy - Vimarsana News

Santhera's AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy

European Commission (EC) grants marketing authorization for AGAMREE® for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and olderAGAMREE® 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 EUFirst 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

Source: yahoo.com
Santhera Appoints Executive Committee Members as it Transitions into Commercial Stage - Vimarsana News

Santhera Appoints Executive Committee Members as it Transitions into Commercial Stage

Pratteln, Switzerland, December 7, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the promotion of Geert Jan van Daal, MD, PhD, to Chief Commercial Officer (CCO) and of Marc Schrader to Chief Technology Officer (CTO). Both will join the six-member Executive Committee effective January 1, 2024. “Santhera is transitioning to the commercial phase and will make AGAMREE® (vamorolone) available to patients in Europe starting in Germany in early 2024, subject to approval by the European Commissi

Source: yahoo.com
Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy - Vimarsana News

Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Ad hoc announcement pursuant to Art. 53 LR Food and Drug Administration (FDA) approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in children and adults aged 2 years and olderU.S. license holder Catalyst Pharmaceuticals plans for commercial launch in Q1-2024FDA approval triggers USD 36 million payment obligation from Catalyst to Santhera, of which USD 26 million will be used to cover Santhera’s third-party milestone obligationsFollowing the recent positive CHMP

Source: yahoo.com
Santhera Announces Closing of Exclusive North America - Vimarsana News

Santhera Announces Closing of Exclusive North America

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, July 19, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the closing of the...

Santhera Announces Closing of Exclusive North America License Agreement with Catalyst Pharmaceuticals for Vamorolone - Catalyst Pharmaceuticals (NASDAQ:CPRX) - Vimarsana News

Santhera Announces Closing of Exclusive North America License Agreement with Catalyst Pharmaceuticals for Vamorolone - Catalyst Pharmaceuticals (NASDAQ:CPRX)

Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, July 19, 2023 – Santhera Pharmaceuticals (SIX: SANN) announces the closing of the exclusive license agreement for vamorolone in North America (NA) with