The FDA approved secukinumab (Cosentyx) this past week for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis. These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA…
Opioid Investigated to Treat Acute & Chronic OA Pain; Plus New RA Treatment & More
In Phase 2 trials, the oral opioid, CR845, has proved promising in treating pain in patients with hip and knee osteoarthritis. Olokizumab is being investigated to treat RA, and in Canada, adalimumab has been approved to treat polyarticular JIA in 2–4 year-olds…
French ‘Cannabis’ Drug Trial Volunteer Dies
RENNES, France (Reuters)—A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week. In total, 90 people took part in the trial of the drug made…
FDA Approves New Drugs for Pain
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths…
French ‘Cannabis’ Drug Trial Leaves 1 Brain Dead, 5 Injured
PARIS (Reuters)—One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug company, the French health ministry said on Friday, Jan. 15. The ministry did not say what the medicine was intended to be used…
Drug Shortages in U.S. Emergency Departments on the Rise
(Reuters Health)—U.S. emergency rooms are increasingly running short on medications, including many that are needed for life-threatening conditions, a recent study documents. Since 2008, the number of shortages has risen by more than 400%, researchers found. Half of all emergency room shortages were for life-saving drugs, and for one in 10 there were no available…
U.S. Patent Office Rules Against Amgen Humira Challenge
(Reuters)—U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira (adalimumab), a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine. In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that…
Disease Duration, Corticosteroid Use Predict Etanercept Response in JIA
NEW YORK (Reuters Health)—Almost half of juvenile idiopathic arthritis (JIA) patients treated with etanercept achieve minimal disease activity after one year of treatment, according to new findings. Younger patients and those who did not require corticosteroid treatment were more likely to have an excellent response, Dr. Kimme Hyrich of the University of Manchester in the…
Major Drugmakers Push Back in U.S. Price Debate
SAN FRANCISCO (Reuters)—With a backlash brewing over the price of medicines in the U.S., drugmakers are pushing back with a new message: Most people don’t pay retail. Top executives from Eli Lilly and Co, Merck & Co and Biogen Inc. said in interviews with Reuters this week that the media focus on retail, or “list…
Anthem Targets $3 Billion in Drug Cost Cavings with Express Scripts
(Reuters)—Anthem Inc. could save $3 billion annually on drug costs from a re-pricing provision in its current contract with pharmacy benefits manager Express Scripts Holding Co, the health insurer’s chief executive officer said Tuesday. Anthem said it is working to renegotiate the contract this year to avoid overpaying for pharmaceuticals based on current market conditions….
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