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February 19, 2014
08:17 EDTRGLS, SNYRegulus Therapeutics nominates RG-102 as Orphan Drug candidate
Regulus Therapeutics (RGLS) nominated its second microRNA candidate for clinical development, RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport Syndrome, a life-threatening, genetic kidney disease with no approved therapy. Regulus is responsible for advancing RG-012 to proof-of-concept. At that stage of development, Regulus' strategic alliance partner, Sanofi (SNY), has an exclusive option exercisable after proof-of-concept to assume all costs, responsibilities and obligations for further development and commercialization of RG-012. If Sanofi chooses to exercise its option on RG-012, Sanofi will reimburse Regulus for a significant portion of its preclinical and clinical development costs and will pay Regulus an option exercise fee. Regulus is eligible to receive development and commercialization milestone payments and will have an option to co-promote in the United States or receive royalty payments in the mid 10% to 20% range.
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September 18, 2014
08:07 EDTRGLSRegulus Therapeutics initiates ATHENA study in Alport syndrome patients
Regulus Therapeutics has initiated its ATHENA natural history of disease study in patients with Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. The ATHENA study is designed to characterize the natural decline of renal function markers such as Glomerular Filtration Rate, creatinine, proteinuria and beta-2 microglobulin, in Alport syndrome patients over time. The data collected from the ATHENA study will provide information about the changes in renal function over time in Alport syndrome patients, which will inform future clinical development plans of Regulus' RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, currently in development to treat renal dysfunction in Alport syndrome patients.
September 17, 2014
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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