Clinical News

Cheaper hep C drug enters competitive market
Cheaper hep C drug enters competitive marketA new drug approved by FDA to treat chronic hepatitis C virus (HCV) infection this week enters a competitive, lucrative market headed up by Gilead Science’s Sovaldi and Harvoni, as well as AbbVie’s Viekira Pak. FDA granted priority review and breakthrough therapy designation to Gilead’s combination product, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg).
Patient navigators can benefit diabetes outcomesStudy seeks to determine whether significant improvement in glycemic control can be achieved when regular coaching is part of the process.
Empowered patients more likely to stick to diabetes treatmentsEmpowerment is an important factor to address everyday aspects of dealing with a chronic disease, including diabetes, according to a study that evaluated the effect of diabetes empowerment on medication adherence and self-care behaviors in adults with type 2 diabetes.
Zika vaccine on the horizonThe U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.
FDA approves rare liver disease drugFDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA approves first treatment for acute GVHDFDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).
FDA approves novel kidney disease drugAfter initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline. Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
New kidney warning on popular diabetes drugsSoon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).
First US cholera vaccine availableFDA approved the first US vaccine for cholera, Vaxchora, made by PaxVax Bermuda Ltd. in Hamilton, Bermuda. Vaxchora is the only single-dose vaccine for cholera currently licensed anywhere in the world.
Teva halts migraine patch sales over burnsTeva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.