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Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

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…

Sanofi to Invest Further in Biologics

Matthias Blamont  |  

PARIS (Reuters)—Sanofi announced plans to invest 600 million euros ($673 million) annually over the next two to three years in the field of biologics production, an area of strong growth potential. In contrast to most drugs that are chemically synthesized, many biologics are produced using living cells. They are seen as a promising answer in…

Centrexion’s Chili-Based Painkiller Offers Relief for 6 Months—Study

Natalie Grover  |  

(Reuters)—A synthetic version of a medicine traditionally extracted from chili plant relieved knee pain among osteoarthritis patients for up to six months, data showed, bringing Centrexion Therapeutics a step closer to developing a safe and effective analgesic. The drug, designed to be injected at the site of pain, is being developed by the privately-held company…

U.S. Supreme Court Speeds Copycat Biologic Drugs to Market

Andrew Chung  |  

WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…