Santhera Pharmaceuticals AG
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74 articles with Santhera Pharmaceuticals AG
Three biopharma companies recently shuttered their clinical programs after either their compounds failed clinical trials or interim futility analysis suggested they were unlikely to meet their clinical endpoints. Here’s a look.
Santhera said the restructuring will allow the company to focus on the development of vamorolone, a first-in-class dissociative steroid with a novel mode of action that it gained the rights to from ReveraGen BioPharma.
This comes after data from an interim analysis suggested that the trial was unlikely to meet its primary endpoint.
Santhera Announces Publication of Long-term Idebenone Data from SYROS Study in Duchenne Muscular Dystrophy
The objective was to assess the respiratory function evolution during periods of treatment with idebenone
Santhera Pharmaceuticals announces a strategic change to its management team with the appointment of Dario Eklund as CEO, effective December 1, 2019.
Vamorolone Designated Promising Innovative Medicine (PIM) for Treatment of Duchenne Muscular Dystrophy by the UK MHRA
Santhera Pharmaceuticals announces that the UK’s Medicines and Healthcare Products Regulatory Agency has informed ReveraGen BioPharma about having designated vamorolone as Promising Innovative Medicine for the treatment of Duchenne muscular dystrophy
Santhera Announces Presentation by ReveraGen of Positive 18-Month Data with Vamorolone in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals announces presentation of data showing continued improvement of muscle function and improved tolerability compared with corticosteroids of 18-month vamorolone treatment in Duchenne muscular dystrophy.
Santhera to Present Long-Term Data with Puldysa® (Idebenone) in Duchenne Muscular Dystrophy at Upcoming Medical Congresses
Santhera Pharmaceuticals will present data on the therapeutic effects of long-term treatment with Puldysa® in Duchenne muscular dystrophy at the forthcoming medical conferences of the European Paediatric Neurology Society, European Respiratory Society and World Muscle Society.
Pratteln, Switzerland, September 10, 2019 – Santhera Pharmaceuticals announces the online publication of Phase I data with its human neutrophil elastase inhibitor POL6014 in the Journal of Cystic Fibrosis.
Santhera Pharmaceuticals reports first half-year results as of June 30, 2019, and provides an update on its pipeline and strategic focus.
Santhera Announces Publication by ReveraGen of Positive Phase IIa-Extension Study Results with Vamorolone in Patients with Duchenne Muscular Dystrophy
Santhera Pharmaceuticals announces publication by ReveraGen of positive study data with vamorolone in patients with Duchenne muscular dystrophy.
Santhera Pharmaceuticals announces that Christoph Rentsch has decided to step down as Chief Financial Officer of Santhera by end of this year, in order to pursue his career outside the Company.
Pratteln, Switzerland, August 2, 2019 – Santhera Pharmaceuticals announces the closing of the licensing transaction with Chiesi Farmaceutici, an international research-focused healthcare group.
MHRA again confirmed its positive scientific opinion for idebenone under the EAMS while a corresponding European marketing authorization application (MAA) has recently been submitted.
Participating shareholders represented a total of 4’109’097 shares or 36.8% of the share capital.
Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy
Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) for Puldysa® (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) to the European Medicines Agency (EMA).
Santhera Enters into License Agreement with Chiesi Group for Raxone® in LHON Valued at up to CHF 105 Million
Santhera Pharmaceuticals (SIX: SANN) announces that it has entered into an exclusive license agreement with Chiesi Farmaceutici, an international research-focused healthcare group (Chiesi Group), under which Chiesi Group will in-license Raxone® for the treatment of LHON for a total consideration of up to CHF 105 million
Santhera Starts Collaboration in Gene Therapy Research for Congenital Muscular Dystrophy with the Biozentrum, University of Basel, Co-Financed by Innosuisse
Santhera Pharmaceuticals (SIX: SANN) announces its collaboration with the Biozentrum of the University of Basel to advance gene therapy research for the treatment of LAMA2-deficient congenital muscular dystrophy (LAMA2 MD or MDC1A)
Santhera Reports Strong Top-line Growth for 2018 and the Successful Expansion of its Rare Disease Pipeline
Santhera Pharmaceuticals (SIX: SANN) announces the Group’s audited financial results for 2018.
Santhera to Present Long-term Efficacy Results with Idebenone in DMD at the 2019 MDA Clinical and Scientific Conference
Santhera Pharmaceuticals (SIX: SANN) and its collaborating clinical experts present results of long-term efficacy on respiratory function outcomes in idebenone-treated patients with Duchenne muscular dystrophy (DMD) at the 2019 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference held in Orlando, USA, April 13-17, 2019.