(Reuters)—A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Privately owned, Connecticut-based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food…
U.S. Sen. Markey Places Hold on Obama’s Nominee to Lead FDA
(Reuters)—U.S. Sen. Edward Markey (D-Mass.) said on Monday he has placed a hold on President Barack Obama’s nominee to head the U.S. Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee…
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…
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…
Sarilumab Is Effective for RA, Pregabalin Fails to Meet Study Endpoint & Ibuprofen Can Be Administered with a Patch
Sarilumab is proving effective for treating RA. In a clinical trial, pregabalin did not meet its endpoint for treating post-traumatic peripheral neuropathic pain. And a 12-hour ibuprofen patch is in development…
Combo Drug for Arthritis & Hypertension Meets Goal in Phase 3 Study
(Reuters)—Kitov Pharmaceuticals Holdings Ltd. said on Tuesday its lead drug, KIT-302, met the main goal of a late-stage study, reducing pain without increasing the risk of heart diseases in patients with osteoarthritis. Israel-based Kitov says its drug does not need to be labeled with health warnings, but will instead say it reduces the risk of…
FDA Approves Drug to Counter Opioid ODs
The FDA recently approved a form of naloxone hydrochloride in a nasal spray that will help counter opioid overdoses. The FDA also approved an ibuprofen injection as an adjunct to opioids for use in children 6 months and older…
Oxycodone Capsules Put on Hold; Clinical Trials for Lupus Nephritis & SLE Therapies
Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval
The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…
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