Clinical Intelligence

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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FDA approves first 3D printed drug product

Wednesday, August 5, 2015

The FDA has approved Aprecia Pharmaceuticals’ SPRITAM levetiracetam for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy. SPRITAM utilizes Aprecia’s proprietary ZipDose Technology platform, which uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. While 3DP has been used previously to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.

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Merck’s investigational Ebola vaccine shows 100% efficacy rate

Monday, August 3, 2015

Merck, (known as MSD outside the U.S. and Canada), has announced its investigational Ebola vaccine candidate, rVSV-ZEBOV, was found to have 100% efficacy in an analysis of interim data from a phase III ring vaccination trial in Guinea. Preliminary conclusions from this study, which is continuing, were published online in The Lancet. The authors report that vaccine efficacy was 100% (95% confidence interval: 74.7 – 100%; p=0.0036) following vaccination with a single dose of the rVSV-ZEBOV vaccine. It appeared that all vaccinated individuals were protected against Ebola virus infection within six to 10 days of vaccination.

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