Clinical Intelligence

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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St. Jude Medical receives FDA approval for spinal cord stimulation trial system

Thursday, July 23, 2015

St. Jude Medical, a global medical device company, has received FDA approval of the St. Jude Medical Invisible Trial System. The system, which received CE Mark in June 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers. The system is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.

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Novavax announces positive top-line data from phase I Ebola vaccine trial

Thursday, July 23, 2015

Novavax, a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, has announced positive top-line data from a phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M as part of the World Health Organization’s (WHO) Fifth Teleconference on Ebola Vaccine Clinical Trials. The trial demonstrated that the Ebola GP Vaccine was highly immunogenic, well-tolerated and, in conjunction with Novavax’ proprietary Matrix-M adjuvant, resulted in significant antigen dose-sparing. 

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First made-in-Singapore cancer drug enters clinical testing

Thursday, July 23, 2015

A made-in-Singapore cancer drug has advanced into clinical trials, charting a milestone in Singapore’s biomedical sciences initiative that will go towards improving the lives of cancer patients in Singapore, and worldwide. The Agency for Science, Technology and Research (A*STAR) and Duke-National University of Singapore Graduate Medical School (Duke-NUS) have announced the start of a phase I clinical trial of novel cancer drug candidate, ETC-159.

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Exco InTouch granted U.S. patent for mDNA technology

Thursday, July 23, 2015

Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has been granted a U.S. Patent corresponding to its mDNA technology. mDNA is an automated management tool that identifies, distributes and manages patients and their mobile device interactivity in clinical and healthcare programs.

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Baxalta’s shows positive data for BAX 855 in hemophilia A

Friday, July 17, 2015

Baxalta, a global biopharmaceutical provider dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has published complete data from the phase II/III pivotal study and phase I trial of BAX 855 in Blood, the journal of the American Society of Hematology. BAX 855 is Baxalta’s investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)], a treatment for hemophilia A with more than 11 years of real-world patient experience.

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