Expanding access to buprenorphine, a medication to treat opioid use disorder, is one of several new actions announced by Health and Human Services (HHS) to combat the opioid epidemic. Here are the top 4 new provisions from HHS.
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For the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").
A 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).
Study seeks to determine whether significant improvement in glycemic control can be achieved when regular coaching is part of the process.
Empowerment 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.
The 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 recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).
After 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.
Soon 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).
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Teva 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.
FDA 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.
FDA is warning consumers about the risk of serious bleeding when using over-the-counter aspirin-containing antacid products to treat heartburn. The agency also issued a separate warning about loperamide (Imodium, Johnson & Johnson), saying that abuse or misuse of the product can cause serious heart problems that can lead to death.
The first and only fixed-dose combination of a beta blocker beta blocker (BB) and angiotensin II receptor blocker (ARB) for hypertension will be available in the US in the second half of the year. FDA approved nebivolol and valsartan (Byvalson, Allergan) 5 mg/80 mg tablets in early June.
FDA recently approved daclizumab (Zinbryta, Biogen and AbbVie), a once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (RMS).
The global oncology market was worth $107 billion in 2015, and global annual cancer drug costs surged by 11.5% from 2011 to 2015, according to a new report.
FDA recently approved the first 4-strain, cell culture-derived, inactivated seasonal flu vaccine available in the United States. Flucelvax Quadrivalent influenza vaccine (Seqirus) helps protect against the 2 influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.
In a major new entry in the diabetes market, FDA just approved linagliptin and metformin hydrochloride extended-release tablets (Jentadueto XR, Boehringer Ingelheim and Eli Lilly and Company) to treat type 2 diabetes.
Novo Nordisk’s new diabetes drug production facility in Clayton, N.C., will ensure production capacity for these drugs in the United States for the decade ahead.
A systemic review highlights studies that improved medication adherence and patient outcomes using strategies that could be effective if employed in real-world healthcare settings.
FDA recently granted accelerated approval for atezolizumab (Tecentriq, Genentech), the first drug for bladder cancer that utilizes the body’s immune system. The drug will be available by early June.
FDA has approved lenvatinib (Lenvima, Eisai Inc.) in combination with everolimus for the treatment of advanced renal cell carcinoma.
In alarming news for diabetic patients taking canagliflozin (Invokana, Invokamet) medications, FDA is warning that interim safety results from an ongoing clinical trial found an increase in foot and leg amputations with the drugs.
Nivolumab (Opdivo, Bristol-Myers Squibb) received two new approvals from FDA to treat two different cancers.
After heavy criticism by Congress, presidential candidates and others, Valeant Pharmaceuticals is offering a discount program on its heart drugs Nitropress and Isuprel.
There's a growing need for improved access to medication-assisted treatment among patients with opioid use disorder, according to a new study presented at the American Society of Addiction Medicine 47th Annual Conference.
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