Shingles, also known as herpes zoster (HZ), is a common and sometimes debilitating disease that disproportionately affects elderly individuals and those who are immunocompromised. Patients with rheumatoid arthritis (RA) have a 1.5–2-fold higher risk of developing HZ compared with healthy adults. Treatment with some disease-modifying anti-rheumatic drugs (DMARDs) has been shown to increase this risk….
Efficacy Studied Following Accelerated Drug Approvals
In recent years, the number of drugs to receive accelerated FDA approval has increased. A new study examined whether these drugs have demonstrated efficacy in post-approval trials…
Washington State Sues OxyContin Maker Purdue Pharma
(Reuters)—Washington state on Thursday sued OxyContin maker Purdue Pharma LP, becoming the latest state or local government to file a lawsuit seeking to hold pharmaceutical companies accountable for a national opioid addiction epidemic. The city of Seattle also filed a separate lawsuit against Purdue as well as units of Teva Pharmaceutical Industries Ltd, Johnson and…
Makers of Fast-Acting Opioids Will Have to Pay for Training—FDA
NEW YORK (Reuters)—Makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives, the course said on Thursday. The FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses…
Sequential Therapy May Reduce Hip Fracture Risk; Plus New Biosimilar Available in Canada
Patients who receive abaloparatide and switch to alendronate have a statistically significant reduction in fracture risk through 3.5 years, according to a new study…
Many Drug Companies Fail to Conduct Timely Safety Checks on Medicines after FDA Approval
(Reuters Health)—In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. A September 20 online analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done….
Reassuring Data on Cancer Risk with Contemporary RA Drugs
NEW YORK (Reuters Health)—A large Swedish study1 provides reassuring data on the risk of cancer in patients with rheumatoid arthritis (RA) treated with tumor necrosis factor (TNF) inhibitors or with tocilizumab, abatacept or rituximab. Overall, the risk of malignant neoplasms did not differ between patients treated with a first anti-TNF drug; a second anti-TNF drug; tocilizumab,…
Unbudgeted: How the Opioid Crisis Is Blowing a Hole in Small-Town America’s Finances
INDIANA, Pa./CHILLICOTHE, Ohio (Reuters)—As deaths mount in America’s opioid crisis, communities on the front lines face a hidden toll: the financial cost. Ross County, a largely rural region of 77,000 people an hour south of Columbus, Ohio, is wrestling with an explosion in opioid-related deaths—44 last year compared with 19 in 2009. The drug addiction…
CMS Implements Part B Modifiers for Biosimilars
With the advent of biosimilars to the marketplace, the Centers for Medicare and Medicaid Services (CMS) now requires modifiers to identify the manufacturer of a biosimilar/biological product on Part B claims. Modifiers were put in place to provide the CMS with the necessary data needed to track claims payments, as well as the ability to…
Rheumatoid Arthritis Treatments Show Mixed Results
MADRID—The anti-IL6 “nanobody,” vobarilizumab, produced mixed results when used with methotrexate (MTX) and compared with MTX and placebo, according to results of a 24-week, double-blind Phase 2b study of patients with rheumatoid arthritis (RA), which were presented in an abstract session at the Annual European Congress of Rheumatology (EULAR). The drug missed its primary endpoint…
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