Clinical Intelligence

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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Teva receives FDA NDA acceptance for Huntington’s treatment SD-809

Thursday, August 13, 2015

Teva Pharmaceutical Industries has announced that its NDA for SD-809 (deutetrabenazine) has been accepted by the FDA for the treatment of chorea associated with Huntington’s disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in Western countries, according to the World Health Organization.

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Hybrigenics’ inecalcitol gets FDA Orphan designation for AML

Wednesday, August 12, 2015

Hybrigenics, a Paris-based biopharmaceutical company, has received Orphan Drug designation by the FDA for inecalcitol for the treatment of acute myeloid leukemia (AML) in the U.S. Orphan designation qualifies the sponsor of the drug for various development incentives of the Orphan Drug Act, including tax credits for qualified clinical testing.

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XBiotech expands global phase III Xilonix study

Monday, August 10, 2015

XBiotech, a developer of next-generation True Human therapeutic antibodies, has expanded its XCITE cancer study into Europe. XCITE is an FDA Fast-Tracked, pivotal phase III study of its cancer drug Xilonix for treatment of metastatic colorectal cancer. Screening now has begun at the Marii Sklodowskiej-Curie Oncology Center in Warsaw, Poland, marking the first patient recruitment site outside the U.S. and the commencement in earnest of the global phase of the FDA study.

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