The FDA received additional reports of canine heart disease cases linked to pet diets that contain legumes, legume seeds or potatoes as main ingredients. Prior to its public notice on July 12, there were 30 dogs and seven cats involved in reports to the agency over a three-year period.
The study of a retrovirus that infects koalas revealed that the replicated viral DNA adopted new functions or became noncoding DNA, and the finding, published in Proceedings of the National Academy of Sciences, may help scientists understand the function of noncoding DNA in humans. "This means that the koala, a species not usually associated with biomedical breakthroughs, is providing key insights into a process that has shaped 8% of the human genome, and will likely show us what happened millions of years ago when retroviruses first invaded the human genome," said study co-author Alex Greenwood.
Immune system T-cells triggered by bacteria caused retinal damage associated with glaucoma in mice, and blocking autoimmune activity might be a way to treat the eye disease, according to a study published in Nature Communications. "What we learn from the eye can be applied to the brain diseases, and may eventually help develop new methods of treatment and diagnosis," senior co-author Dong Feng Chen said.
The FDA approved inclusion of new drug-drug interaction data on the label of Gilead's HIV therapies Genvoya, or elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide; Stribild, or elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate; and Tybost, or cobicistat. Genvoya and Stribild are complete HIV-1 treatment regimens for certain patients, while Tybost is used to boost atazanavir or darunavir exposure in combination with other antiretroviral drugs.
A new drug application for midazolam nasal spray, indicated for the acute treatment of seizures in patients who require control of acute repetitive seizures or seizure clusters, was accepted by the FDA for review. Results from a late-stage study showed midazolam was safe and effective in patients with seizure clusters.
The FDA granted approval for Medicure's abbreviated new drug application for sodium nitroprusside injection 50 mg/2 mL single-dose vial, which is indicated to immediately reduce the blood pressure of pediatric and adult patients in hypertensive crisis. The drug, which is therapeutically equivalent to Nitropress, is also indicated to produce controlled hypotension to lessen bleeding during surgery and to treat acute congestive heart failure.
Dosing has been initiated in the first patients for Allena Pharmaceuticals' multicenter midstage trial to assess the efficacy and safety of its drug candidate ALLN-177 to treat adults and adolescents with primary hyperoxaluria or enteric hyperoxaluria with advanced chronic kidney disease and elevated plasma oxalate. ALLN-177 degrades oxalate within the gastrointestinal tract and could help chronically affected patients avoid decreased kidney function or the need to undergo dialysis or kidney transplantation.
Conavi Medical has recorded the first procedure that used its Novasight Hybrid System at Hamilton General Hospital under a Health Canada Investigational Testing Authorization. The system is a catheter intended for imaging coronary arteries via optical coherence tomography and intravascular ultrasound.
The FDA has granted BioSig Technologies clearance to market its Pure EP System, a signal processing platform designed to assist cardiologists in performing catheter ablation to reduce arrhythmias.
The Scottish Medicines Consortium approved for National Health Service use Tesaro UK's Zeluja, or niraparib, for patients with advanced ovarian cancer who do not have the BRCA mutation; Roche Holding's Alecensa, or alectinib, for the treatment of ALK-positive non-small cell lung cancer; Swedish Orphan Biovitrum's Ravicti, or glycerol phenylbutyrate, for patients age 2 months and older who require long-term treatment of urea cycle disorders; and Pharming's Ruconest, or conestat alfa, to treat acute hereditary angioedema.
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