Monday, July 11, 2016
The Partnership for Research on Ebola Virus in Liberia (PREVAIL), a U.S.-Liberia joint Clinical Research Partnership, has announced the opening of PREVAIL IV, a treatment trial for men who have survived Ebola virus disease (EVD) but continue to have evidence of Ebola virus genetic material, RNA, in their semen.
GeoVax Labs, a biotechnology company developing human vaccines, announced today the filing of an Investigational New Drug (IND) application with the FDA for the conduct of the next human clinical trial of GeoVax’s preventive HIV vaccine. The IND was filed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The FDA has approved AbbVie’s Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with noninfectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for Humira in the U.S. for immune-mediated diseases.
Synexus acquired by Jaguar Holding Company
Shire has announced that its phase II study evaluating an investigational protein replacement, SHP607, did not meet its primary endpoint of reducing the severity of retinopathy of prematurity (ROP), a rare eye condition. The study, however, demonstrated clinically relevant effects in secondary endpoints related to the development of severe bronchopulmonary dysplasia (BPD), a chronic lung disease, and severe intraventricular hemorrhage (IVH), a type of brain injury, both of which have lifelong negative implications for normal development.
Three resonating patient-centric initiatives
Agilis Biotherapeutics, a biotechnology company advancing innovative DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS), has announced that the FDA has granted Orphan Drug Designation to Agilis’ gene therapy product candidate, AGIL-AADC, being developed for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency.
The National Institutes of Health and Fundacao Oswaldo Cruz-Fiocruz (Fiocruz), a national scientific research organization linked to the Brazilian Ministry of Health, have begun a multi-country study to evaluate the magnitude of health risks that Zika virus infection poses to pregnant women and their developing fetuses and infants. The study is opening in Puerto Rico and will expand to several locations in Brazil, Colombia and other areas that are experiencing active local transmission of the virus.
Researchers supported by the National Institutes of Health developed a clinical-grade stem cell line, which has the potential to accelerate the advance of new medical applications and cell-based therapies for millions of people suffering from such ailments as Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy.