(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…
Effectiveness of Tofacitinib with Methotrexate, Adalimumab Therapy Evaluated in Patients with RA
MADRID—Tofacitinib (a JAK inhibitor) used with methotrexate (MTX) is not inferior to adalimumab (a TNF inhibitor) in rheumatoid arthritis (RA) patients who’ve had an inadequate response to MTX alone, according to results of a Phase 3B/4 trial presented in a session at the Annual European Congress of Rheumatology (EULAR). The findings came in a one-year…
FDA Approves Lesinurad + Allopurinol
Duzallo, a combination of lesinurad and allopurinol, was approved by the FDA in August to treat hyperuricemia associated with gout…
Costly Drugs to Weigh on U.S. Employers’ Expenses in 2018
(Reuters)—U.S. employers are bracing for higher health care expenses in 2018 as spending on new drugs to treat diseases, such as cancer, multiple sclerosis and hepatitis C, is expected to rise more than 7%, according to consultancy firm Mercer.1 Between 40 and 50 new specialty drugs are set to hit the market each year in…
Abatacept Approved for Psoriatic Arthritis in Adults; Sirukumab Approval Stalls
Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…
Drug Industry on Tenterhooks as Maryland Price-Gouging Law Nears
(Reuters)—As U.S. consumer outrage grows over prescription drug prices, state authorities and patient advocates in Maryland are preparing to enforce the nation’s first law designed to punish drugmaker price-gouging. The Maryland Attorney General’s office said it will field complaints and investigate “unconscionable increases” in essential generic medicines when the closely watched law takes effect Oct….
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