Clinical Intelligence

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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EMA approves GSK’s Malaria vaccine

Wednesday, July 29, 2015

GlaxoSmithKline (GSK) has received a positive opinion for its malaria vaccine candidate from the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The vaccine candidate Mosquirix (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision.

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Progenics receives FDA Breakthrough Therapy for Azedra

Wednesday, July 29, 2015

The FDA has designated Progenics Pharmaceuticals’ Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma. Azedra currently is being evaluated in a pivotal phase IIb trial, which is being conducted under a Special Protocol Assessment Agreement (SPA), and has received Orphan Drug and Fast Track designations from the FDA.

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FDA approves Sanofi, Regeneron’s Praluent (alirocumab) Injection

Monday, July 27, 2015

The FDA has approved Sanofi and Regeneron Pharmaceuticals’ Praluent (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

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