Clinical Intelligence

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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First patients enrolled in multicenter trial of Fractyl Revita DMR System

Friday, July 17, 2015

Fractyl Laboratories, a private company based in Waltham, Mass., has begun patient enrollment in a multicenter clinical trial (Revita-1) being conducted in Europe and South America to evaluate the safety and performance of the Revita Duodenal Mucosal Resurfacing (DMR) System. Revita is the first non-invasive, implant free duodenal resurfacing procedural therapy designed to directly treat the digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes.

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NIH-funded vaccine for West Nile virus enters human clinical trials

Wednesday, July 8, 2015

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The experimental vaccine was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. The scientists were funded with a $7.2 million grant from NIAID, awarded in 2009. The new vaccine is being tested in a phase I clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs).

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Catabasis Pharmaceuticals receives FDA Fast Track for CAT-1004

Wednesday, July 8, 2015

Catabasis Pharmaceuticals, a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that CAT-1004 has received Fast Track designation from the FDA for the treatment of Duchenne muscular dystrophy (DMD). CAT-1004 is designed to inhibit activated NF-kB, which has the potential to reduce muscle inflammation and degeneration, and promote muscle regeneration for patients with DMD regardless of the underlying mutation. DMD is a rare disease that involves progressive muscle degeneration that eventually leads to death and for which there are no approved therapies in the U.S.

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Evotec, Roche provide initial update from phase IIb trial in Alzheimer’s disease

Wednesday, July 8, 2015

Evotec was updated by its partner Roche on the initial results of the phase IIb trial with Sembragiline (RG1577, EVT302), a MAO-B inhibitor for the treatment of Alzheimer’s disease (AD). In this study, Sembragiline failed to demonstrate benefit on the primary endpoint (Alzheimer’s Disease Assessment Scale—Cognitive Behaviour Subscale, ADAS-cog-11) after 52 weeks of treatment.

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Biotronik initiates BIOWOMEN study

Wednesday, July 8, 2015

Biotronik, a manufacturer of cardio- and endovascular medical devices, has enrolled its frist patient in its BIOWOMEN clinical study. BIOWOMEN will investigate cardiac resynchronization therapy (CRT) response in women and men to evaluate if women respond better to treatment. It is the first study of its size to investigate the topic, addressing the urgent medical need for global, gender-specific clinical trials of heart failure (HF) patients.

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