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Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

RA Treatments Show Mixed Results

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Highlights from the 2017 EULAR Congress MADRID—The anti-IL6 “nanobody,” vobarilizumab, produced mixed results when used with methotrexate (MTX), 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…

Tofacitinib with Methotrexate Not Inferior to Adalimumab with Methotrexate

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Highlights from the 2017 EULAR Congress MADRID—Tofacitinib (a JAK inhibitor) used with methotrexate (MTX) is not inferior to adalimumab (a TNF inhibitor) plus MTX 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…

Rituximab for Fatigue & Oral Dryness in Primary Sjögren’s Syndrome

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These researchers investigated whether rituximab, an anti-B cell therapy, improves symptoms of fatigue and oral dryness in patients with primary Sjögren’s syndrome (SS). The multicenter, randomized, double-blind, placebo-controlled, parallel-group trial included a health economic analysis. There were no significant improvements in any outcome measure with rituximab except for unstimulated salivary flow. The study concludes that rituximab is neither clinically effective nor cost effective in this patient population…

U.S. FDA Moves to Prevent Pharma from “Gaming” Generic Drug System

Toni Clarke  |  

WASHINGTON (Reuters)—The U.S. Food and Drug Administration moved on Wednesday to prevent pharmaceutical companies from “gaming” the system to block or delay entry of generic rivals. FDA Commissioner Scott Gottlieb said in a blog post that the agency plans to hold a public meeting on July 18 to identify ways pharmaceutical companies are using FDA…

Missouri Sues Opioid Manufacturers, Joining Two other U.S. States

Nate Raymond  |  

(Reuters)—Missouri on Wednesday became the third U.S. state to accuse major drug manufacturers of fraudulently misrepresenting the risks of opioid painkillers now at the center of a national addiction epidemic. Missouri Attorney General Josh Hawley said his office filed a lawsuit in a state court in St. Louis against Purdue Pharma LP, Johnson and Johnson…

FDA Responds to New Drug Application for Baricitinib

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Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…