A recent clinical trial found that upadacitinib may effectively reduce disease activity at Week 12 for patients with moderate to severe rheumatoid arthritis…
Rituximab for Fatigue & Oral Dryness in Primary Sjögren’s Syndrome
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
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
(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 Requests Removal of Opana ER; Plus Abatacept’s New Dosing Option
The FDA has asked the manufactures of Opana ER to remove the opioid from the U.S. market due to the public health risk of abuse…
News Updates for Diclofenac Sodium, Denosumab & Sarilumab
In drug news, a generic 2% diclofenac sodium solution is now available, denosumab is promising to treat osteoporosis, and the FDA has approved sarilumab to treat adults with RA…
FDA Responds to New Drug Application for Baricitinib
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…
The Birth and Growth of Biotechnology, and the Impact of Biologic Drugs on Rheumatology
Here’s a trivia question: Where were the big ideas for the field of biotechnology first discussed? Answer: At a since-demolished delicatessen in Waikiki Beach, Hawaii. Go figure. The year was 1972, and Stanley Cohen, MD, professor of medicine at Stanford University in Palo Alto, Calif., and Herbert Boyer, PhD, a former professor and biochemist at the…
Sanofi to Invest Further in Biologics
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
(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…
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