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FDA Advisory Committee Votes in Favor of Romosozumab Approval

Michele B. Kaufman, PharmD, BCGP  |  January 30, 2019

An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.

New EPA Rule May Hinder Health Research

Linda Carroll  |  January 29, 2019

(Reuters Health)—A new rule proposed by the U.S. Environmental Protection Agency (EPA) may make it almost impossible to uncover hazards such as dirty air, polluted water and environmental toxins, researchers say. The rule mandates that all underlying data from studies be made available to any and all researchers in the interests of transparency. But while…

PAD2 & PAD4 Modulate Immune Response in TLR-7-Dependent Lupus

Lara C. Pullen, PhD  |  January 28, 2019

A study in mice suggests that targeting peptidyl arginine deiminases in lupus patients may have a therapeutic role in T cell-mediated diseases, affecting innate and adaptive immunity, as well as modulating dysregulated toll-like receptor 7-dependent immune responses…

Not-for-Profit to Offer 20 Generic Drugs in 2019 to Alleviate Shortages

Jilian Mincer  |  January 25, 2019

(Reuters)—A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Since the start-up of Civica Rx spearheaded by Intermountain Healthcare was…

Rheumatology Board Certification: Exploring Change

From the College  |  January 24, 2019

The ACR has been engaged in a measured, inclusive process with rheumatologists to determine if rheumatology board certification should move from the American Board of Internal Medicine (ABIM) to the American Board of Allergy and Immunology (ABAI), which would become a new, combined board of Allergy, Immunology and Rheumatology. “As ACR leaders have traveled around…

FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones

Michele B. Kaufman, PharmD, BCGP  |  January 23, 2019

The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…

OA Patient-Reported Outcomes Positive for Intra-Articular Injection

Carina Stanton  |  January 21, 2019

In a recent Phase 2 clinical trial, patient-perceived pain and function measures improved with SM04690, an injectable, disease-modifying osteoarthritis treatment currently in development…

Do Osteoporosis Screening Guidelines Meet Patient Needs?

Lara C. Pullen, PhD  |  January 21, 2019

A recent study found that clinical practice guidelines for osteoporosis screening vary in quality and recommendations—even within the same country. Assessing guidelines from 13 countries, researchers found osteoporosis screening standards have not improved over time and many fail to include patients in guideline development…

Med Student Documentation Guidelines Need Careful Implementation

Will Boggs, MD  |  January 18, 2019

NEW YORK (Reuters Health)—New student-documentation guidelines from the Centers for Medicare and Medicaid Services (CMS) require careful implementation to avoid reductions in meaningful teaching physician involvement, according to a new report. The revised Medicare Claims Processing Manual allows the teaching physician to verify in the medical record any student documentation of services, rather than re-documenting…

Walgreens & Microsoft Partner to Develop Digital Healthcare Services

Reuters Staff  |  January 18, 2019

(Reuters)—Drugstore chain Walgreens Boots Alliance Inc and Microsoft Corp said on Tuesday they have entered a seven-year agreement to research and develop new methods of delivering healthcare services through digital devices. As a part of the deal, the companies will focus on virtually connecting people with Walgreens stores and provide services on therapeutic areas ranging…

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