Clinical Intelligence

Helius, USAMRMC enroll last subject enrolled in TBI trial

Monday, July 17, 2017

Helius Medical Technologies, a medical technology company focused on the treatment of neurological symptoms caused by disease or trauma, and the United States Army Medical Research and Materiel Command (USAMRMC) announce that the last subject has been enrolled in the registrational clinical trial to investigate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) device for the rehabilitation of chronic balance deficits caused by mild-to-moderate Traumatic Brain Injury (mTBI). The trial is intended to serve as the basis for Helius to submit applications for marketing clearance in the U.S., Canada and Europe for the PoNS device.

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Vertex gains reimbursement agreement in Italy for cystic fibrosis drug Orkambi

Friday, July 14, 2017

Vertex Pharmaceuticals announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA) has agreed to reimburse Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The agreement is published online in the Italian Official Gazette.

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Boehringer Ingelheim releases phase III praxbind study results

Wednesday, July 12, 2017

Boehringer Ingelheim announced final results from RE-VERSE AD. The study shows that idarucizumab, marketed in the U.S. as Praxbind, was able to immediately reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients in emergency situations. The effects were consistent both in patients requiring an urgent surgery or intervention, and in patients presenting with uncontrollable or life-threatening bleeding. The reversal of the anticoagulant effect of Pradaxa allowed physicians to quickly initiate necessary emergency interventions. The findings were presented at the International Society on Thrombosis and Haemostasis (ISTH) 26th Biennial Congress in Berlin, Germany and simultaneously published in the New England Journal of Medicine.

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FDA approves Endari, first treatment for pediatric sickle cell disease

Wednesday, July 12, 2017

Emmaus Life Sciences announced that the FDA approved Endari (L-glutamine oral powder) to reduce the severe complications of sickle cell disease (SCD) in adult and pediatric patients age 5 and older. Endari reduces oxidant damage to red blood cells by improving the redox potential of nicotinamide adenine dinucleotide (NAD), a coenzyme that has been identified as the primary regulator of oxidation.

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InVivo Therapeutics opens first U.K. INSPIRE Study site

Tuesday, July 11, 2017

InVivo Therapeutics announced that James Cook University Hospital in Middlesbrough, United Kingdom, has been added as the U.K.’s first clinical site for The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury. The Golden Jubilee Regional Spinal Cord Injuries Centre located at the James Cook University Hospital, a major trauma center, focuses exclusively on patients with spinal cord injuries and is one of eight specialist centers within England.

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ALK’s five-year GRAZAX asthma prevention trial reveals benefits

Friday, July 7, 2017

ALK has released further analysis of data from its landmark five-year GRAZAX® Asthma Prevention (GAP) clinical trial in children. The analysis, which appears online in press in The Journal of Allergy and Clinical Immunology, shows that the benefits of GRAZAX® in prevention of asthma symptoms were even more pronounced when treatment was initiated at an earlier age.

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