Clinical Intelligence

Symbiomix completes SYM-1219 enrollment

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.

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FDA approves Repatha injection

Monday, August 31, 2015

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.

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NIH launches human RSV study

Monday, August 31, 2015

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.

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Genentech initiates phase III trial of Rituxan

Thursday, August 27, 2015

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.

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FDA expands use of Promacta

Wednesday, August 26, 2015

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.

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Sprout receives FDA approval of Addyi for women’s sexual dysfunction

Thursday, August 20, 2015

The FDA has granted approval of Sprout Pharmaceuticals’ Addyi (flibanserin 100mg), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to one in 10 women in the U.S.

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Remedy initiates phase IIa study of CIRARA

Wednesday, August 19, 2015

Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA, a breakthrough drug for treating acute central nervous system conditions, has initiated a prospective, multicenter, open-label pilot study of CIRARA in patients with acute traumatic cervical spinal cord injuries.

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Aslan Pharmaceuticals’ ASLAN001 receives FDA Orphan designation

Monday, August 17, 2015

Aslan Pharmaceuticals, a biotech company focused on the development of immunotherapies and targeted agents for Asia prevalent tumor types, has received Orphan Drug designation for its pan-HER inhibitor ASLAN001 (varlitinib) from the FDA Office of Orphan Products Development (OOPD). The indication for the Orphan Drug designation is cholangiocarcinoma, a rare and very aggressive form of bile duct cancer that has no cure.

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