Monday, August 31, 2015
Symbiomix has completed patient enrollment in a phase III clinical study, the second pivotal trial of SYM-1219, a single-dose, oral product candidate for the treatment of bacterial vaginosis (BV). Earlier this year Symbiomix announced positive results from the first pivotal trial for SYM-1219. Symbiomix expects to finish the second pivotal trial by the end of 2015, which would enable an NDA filing with the FDA in mid-2016.
Repatha, the second drug approved in a new class of drugs known as PCSK9 inhibitors, has been approved by the FDA for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol.
A new study will expose healthy adult volunteers to respiratory syncytial virus (RSV), a virus that causes cold-like symptoms in adults. Better understanding of how adults develop RSV infection and immune system responses to infection will assist researchers in developing and testing future antivirals and vaccines to combat the virus. The research is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Genentech has initiated a phase III clinical trial investigating the use of Rituxan (rituximab) in patients with pemphigus vulgaris (PV), a rare, chronic and potentially fatal, blistering skin disease. The aim of the study, called PEMPHIX, is to determine the efficacy and safety of Rituxan for the treatment of PV. The current standard-of-care includes high doses of corticosteroids taken for several weeks and corticosteroids in combination with the off-label use of corticosteroid-sparing immunosuppressive drugs for many months, which can cause significant, long-term side effects.
The FDA has approved an expanded use for Novartis’ Promacta (eltrombopag) to include children age 1 and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 and older and in 2008 for use in adult patients with the same condition.
With interest in personalized medicines growing, drug and diagnostics companies are investing in the development of companion diagnostics that can show that their use in conjunction with personalized therapeutics will lead to positive health outcomes, according to R&D leaders participating in a roundtable recently hosted by the Tufts Center for the Study of Drug Development (CSDD).
Valeant Pharmaceuticals International has entered into a definitive agreement under which a wholly owned subsidiary of Valeant will acquire Sprout Pharmaceuticals on a debt-free basis for about $1 billion in cash, plus a share of future profits based upon the achievement of certain milestones.