Early Access To Santheras Dmd Therapy Raxone Extended In The Uk - Latest News

UK patients gain early access to Duchenne drug

UK patients can gain access to Santhera’s as-yet unapproved Duchenne muscular dystrophy drug via an early access scheme. The Medicines and Healthcare products Regulatory Agency granted Raxone (idebeno... read more

Santhera facing long delay for muscular dystrophy drug in US

Santhera is facing a considerable delay in the US before it can get approval for Duchenne muscular dystrophy (DMD) candidate Raxone ... access to new therapies for the disease. In recent months the FD... read more

DMD patients in the UK win early access to Santhera’s Raxone

Santhera Pharmaceuticals’ Raxone has become the first drug for Duchenne Muscular Dystrophy (DMD) to join the UK’s Early Access to Medicines Scheme (EAMS). The UK’s Medicines and Healthcare products Re... read more

UK's MHRA renews Early Access to Medicines Scheme Scientific Opinion for Santhera's Raxone® (idebenone) in Duchenne Muscular Dystrophy

Pratteln, Switzerland, June 22, 2018 - Santhera ... UK`s Medicines and Healthcare products Regulatory Agency (MHRA) has renewed the Early Access to Medicines Scheme (EAMS) scientific opinion for Raxon... read more

Santhera Reports Preliminary Key Financial Figures for 2016 and Provides Corporate Update

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) designated Raxone as Promising Innovative Medicine (PIM) and as suitable candidate for entry into Step II of the Early Access to Med... read more

GTx, Inc. (GTXI)

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provi... read more

Santhera's Raxone® Receives First Positive EAMS Scientific Opinion from UK's MHRA in Duchenne Muscular Dystrophy

Liestal, Switzerland, June 22, 2017 - Santhera Pharmaceuticals (SIX: SANN) announces that the UK`s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Raxone (idebenone ... opinion ... read more

EU advisors reject Santhera’s Raxone for muscular dystrophy

Santhera's attempt to win approval for Raxone as a treatment for Duchenne Muscular Dystrophy ... via the Early Access to Medicines Scheme. We are in close contact with Santhera about what happens next ... read more

Santhera Reports Preliminary Key Financial Figures for 2017 and Provides Corporate Update

Santhera is currently conducting the Phase III SIDEROS trial with Raxone® in patients with Duchenne muscular dystrophy (DMD) in respiratory function decline. In collaboration with the U.S. National In... read more

Pharma collaborates to improve chances of NICE backing Duchenne drugs

A group of pharma companies and Duchenne UK are collaborating to improve the chances of new treatments for Duchenne muscular dystrophy ... rejected Santhera’s Raxone in September, although the drug is ... read more

Santhera enters into agreement to acquire option from Idorsia for exclusive sub-license of first-in-class dissociative steroid vamorolone

Eric Hoffman, PhD, Chief Executive Officer of ReveraGen, commented: "Our hope for vamorolone is that it can replace existing glucocorticoids in DMD therapy. Early clinical development ... and pulmonar... read more

BioMarin files muscular dystrophy drug in EU

BioMarin has filed its Duchenne muscular dystrophy (DMD) drug drisapersen in Europe, raising expectations of a second approved therapy for the disorder ... therapies through the pipeline include Santh... read more