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Take a Bow, Pharma, for the Hepatitis C Drugs

It may be time to take a break, for just a moment, from criticizing drug manufacturers for their price gouging and other sins and allow them to take a victory lap for some good work they have done. In less than four years, the treatment of hepatitis C has gone from failure rates as high as 70% to success…
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#Metoo and American Health Care

As we went to press, the first of what may be up to 100 women were giving their victims statements against Larry Nassar, the former team doctor for the USA Gymnastics team. Nassar had already pleaded guilty to 10 counts of sexually assaulting young girls, and prosecutors had recommended a stiff sentence…
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Value-Based Health Care Offers Answers and Questions

The sitcom created by Chris Rock, Everybody Hates Chris, which ran from 2005 until 2009, conjured laughs out of the everyday. One bit I particularly relish is when the narrator (the persona of Rock as a teenager) says that his father was like Rain Man when it came to knowing what everything costs. “That’s…
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How RWE Is Becoming the Real Deal

The randomized controlled trial reigns supreme, but the FDA is working on ways to incorporate real-world evidence into its approval processes.

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FDA Approves Xgeva for Prevention of Skeletal Events In Multiple Myeloma

The FDA has expanded the approved indications for denosumab (Xgeva, Amgen) to include the prevention of skeletal-related events in patients with bone metastases with multiple myeloma. The medication was already approved to prevent skeletal events in patients with bone metastases from solid tumors. The…
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Ending Medicaid as We’ve Known It

The Trump administration and CMS Administrator Seema Verma are on their way to giving the 53-year-old Medicaid program a major makeover, changing it from being an entitlement program based on income to something that may more closely resemble a temporary assistance program with work, premiums, and other…
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FDA Clears the First Smart Watch for Use in Neurology

The FDA has cleared the Embrace smart watch (Empatica, Inc.) for use by patients with epilepsy. Embrace uses advanced machine learning to monitor for the most dangerous kinds of seizures, known as “grand mal” or “generalized tonic-clonic” seizures, and sends an alert to summon caregivers’…
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Zytiga Approved to Treat Earlier Form of Metastatic Prostate Cancer

Abiraterone acetate (Zytiga, Janssen Pharmaceutical) in combination with prednisone has received FDA approval for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). Approval of the new indication is based on phase 3 data from the pivotal LATITUDE clinical…
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ASHP Survey: IV Fluid Bag Shortage Affecting Patient Care

The shortage of small-volume parenteral solutions often supplied in intravenous fluid bags is affecting virtually all U.S. hospitals, according to results of a survey by the American Society of Health-System Pharmacists (ASHP). Nearly all of the respondents (99.1%) to the informal, nonscientific survey…
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Making Work a Must-Do for Medicaid

Kentucky was the first state to take advantage of the Trump administration’s invitation for states to set work requirements for Medicaid, but others are sure to follow.

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FDA Approves the First Oral Liquid for Valsartan in the U.S.

The FDA has approved valsartan oral solution (Prexxartan, Medicure), the first and only approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the United States. Previously, on October 31, 2017, Medicure announced that, through its subsidiary, Medicure International, Inc.,…
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Questions Health Plans Must Ask Before Considering a Laboratory Benefit Management or Prior Authorization Program

These eight questions show that the use of an LBM or a PAP should be just one of the potential results of your laboratory benefit management program, not the program itself. You shouldn’t have to pay for services you already provide yourselves or add a middleman that’s not necessary.

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FDA Approves Once-Daily Osmolex ER for Parkinson’s Disease Treatment

The FDA has approved an amantadine extended-release tablet (Osmolex ER, Osmotica Pharmaceutical) for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adults. Extrapyramidal symptoms are known side effects of many common medications. Osmolex ER…
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FDA OKs Single-Shot Dexycu to Replace Eye Drops After Cataract Surgery

The FDA has approved dexamethasone intraocular suspension (Dexycu, Icon Bioscience, Inc.), a long-acting treatment for inflammation associated with cataract surgery that allows patients to dispense with weeks of self-administered eye drops. Under the current standard of care for inflammation associated…
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What’s in That IV Bag? Don’t Use Saline, Studies Suggest

Two new studies suggest that patients do better when providers switch from using intravenous saline therapy to balanced fluids that closely resemble the liquid part of blood. Vanderbilt University Medical Center researchers believe the studies could improve survival and decrease kidney complications.…
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