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Gilead's New Hep C Combination Backed by EMA
Harvoni, the sofosbuvir/ledipasvir combination, received accelerated assessment and will now be sent to the European Commission for EU-wide marketing authorization.
The European Medicines Agency has recommended the authorisation of Harvoni (ledipasvir / sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults.
HCV infection is a major European public-health challenge. It affects between 0.4% and 3.5% of the population in different European Union (EU) Member States and is the most common single cause of liver transplantation in the EU.
Harvoni belongs to a new generation of antiviral products for chronic HCV infection that have high cure rates and have recently reshaped the treatment landscape for this disease. It is a combination of the active substances sofosbuvir and ledipasvir, which block the action of proteins which are essential for HCV to replicate - the protein NS5B for sofosbuvir and NS5A for ledipasvir.
These new regimens allow cure of patients with chronic HCV infection without the need for treatments involving interferons, medicines which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of HCV patients.
Press release from the European Medicines Agency: http://bit.ly/1vajGRG
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
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Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
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Early Involvement Critical in Treating Immunotherapy-Induced Overlap Syndrome
April 19th 2024A series of case studies reveals the importance of early diagnosis and involvement of special teams of clinicians when dealing with potential cases of overlap syndrome, which encompasses myocarditis, myasthenia gravis, and immune checkpoint inhibitor–related myositis.
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Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
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