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 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.
A late-stage study showed that at 48 weeks of treatment, ViiV Healthcare and Janssen's monthly, injectable two-drug regimen had similar efficacy to a once-daily, oral three-drug regimen in patients with HIV. The regimen's overall safety, virologic response and drug resistance results were consistent with earlier trial results.
Cellect Biotherapeutics and South Korean biotech Cell2in will collaborate on improving stem cell quality used for stem cell therapies. Cell2in's technologies will be tested by Cellect to provide more efficient quantification of mesenchymal stem cells and hematopoietic stem cells using ApoGraft technology versus current industry standards.
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