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FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database

Michele B. Kaufman, PharmD, BCGP  |  October 5, 2016

Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…

Tenet Healthcare to Pay More Than $513 Million in Fraud Scheme

Reuters Staff  |  October 4, 2016

WASHINGTON (Reuters)—U.S. hospital chain Tenet Healthcare Corp. and two of its Atlanta-area units will pay more than $513 million to resolve criminal charges and civil claims relating to a scheme to defraud the U.S. and pay kickbacks in exchange for patient referrals, the U.S. Department of Justice said on Monday.1 Tenet had disclosed in August…

Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs

John Miller  |  October 4, 2016

ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…

Anti-TNFs in Early Puberty May Improve Growth in Pediatric IBD

Reuters Staff  |  October 4, 2016

NEW YORK (Reuters Health)—Anti-TNF drugs are more likely to improve growth in children with inflammatory bowel disease (IBD) if they’re given in the earlier stages of puberty, new findings show.¹ Children who achieve remission are also more likely to have satisfactory growth, the research team reported online on Sept. 21 in the Journal of Pediatric…

Do RA Patients in Clinical Trials for Biologics Represent the Average?

Arthritis Care & Research  |  October 4, 2016

It’s estimated that a majority of patients with rheumatoid arthritis (RA) have been exposed to biologic treatments. However, the randomized controlled trials demonstrating the safety and efficacy of these biologic agents have strict participant eligibility requirements. New research has examined the requirements of 30 trials for biologics and applied those standards to two large clinical cohorts. The result: A majority of these RA patients did not satisfy the criteria…

The Role of Benign Joint Hypermobility in Functional Pain Disorders

Lara C. Pullen, PhD  |  October 3, 2016

Physicians have been puzzled by the role of benign joint hypermobility syndrome in the development of gastrointestinal disorders and other autonomic symptoms and co-morbidities. However, new research found that benign joint hypermobility syndrome only minimally affects autonomic abnormalities…

How to Thrive—Not Just Survive—as a New Manager, Part 2

Karen Appold  |  September 30, 2016

In Part 2 of how to thrive as a new manager, our experts expand on how age can affect the transition to management, what it’s like to join a new practice as a manager and how to take charge with grace…

Pregnancy Outcome in Early Rheumatic Disease

Arthritis & Rheumatology  |  September 28, 2016

Systemic autoimmune rheumatic diseases are associated with increased rates of adverse pregnancy outcomes, including spontaneous abortion, preeclampsia, fetal growth restriction (FGR) and prematurity. In this study population, preclinical rheumatic disorders were associated with an increased risk of FGR, preeclampsia and small-for-gestational-age infants. The impact of these findings and their utility in screening for fetal growth restriction/preeclampsia need to be confirmed in population studies…

Adalimumab-atto, Biosimilar to Humira, Receives FDA Approval

Michele B. Kaufman, PharmD, BCGP  |  September 27, 2016

Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…

FDA Approves Ustekinumab for Crohn’s Disease

Reuters Staff  |  September 26, 2016

(Reuters)—Johnson & Johnson says on Monday that the U.S. Food and Drug Administration approved the company’s psoriasis drug, ustekinumab (Stelara), for use in adults with Crohn’s disease. The drug is approved in the U.S. to treat plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s is a chronic inflammatory condition in the gastrointestinal…

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