WASHINGTON (Reuters)—Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration (FDA), said on Thursday the agency would reform its process for approving opioid painkillers. Last month, Sen. Edward Markey (D-Ma.) placed a hold on Califf’s nomination, preventing it from being voted on by the…
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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…
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…
Best Practices for Treating Non-Specific Low Back Pain
Low back pain (LBP) is one of the most common reasons for physician appointments. However, treatment results remain suboptimal, resulting in high rates of chronic pain, narcotic usage, surgery, depression and disability—all at great cost to individuals and the nation. One reason for this is the current practice of grouping all low back pain patients…
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…
Rheumatologist Steven S. Overman Reflects on His Last Day of Practice, Future of Specialty
I am a few weeks post-retirement. Having written thank you notes and completed urgent home projects, I swing in a hammock at our currently fire-threatened cabin north of Winthrop, Wash., and reflect. I feel like a young boy while freely flipping pages of a hand-scribed picture book, The Principles of Uncertainty, by Maira Kalman. She…
FDA Warns ‘Don’t Use Tramadol in Children’ & More
New studies show ABT-494 is an effective alternative to anti-TNF alpha agents, as well as methotrexate, for RA. Also, the FDA issued a warning against using tramadol for young patients due to their increased risk of respiratory side effects…
Ustekinumab Can Be Used to Safely Treat Teens & More
A recent study showed ustekinumab can be used to treat teens with moderate to severe psoriasis. Also, Phase 2 trials for an analgesic combination drug show it holds promise for reducing post-operative pain…
Rituximab for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
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