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…
Obama Nominee to Lead FDA Defends Drug Industry Ties
(Reuters)—President Barack Obama’s nominee to head the U.S. Food and Drug Administration defended his ties to the pharmaceutical industry on Tuesday during a Senate committee hearing that included questions on soaring drug prices. Presidential candidate Bernie Sanders was among the Democrats who grilled Dr. Robert Califf (64), who joined the FDA in January as a…
WHO Warns of Widespread Misunderstanding of Superbug Threat
LONDON (Reuters)—People across the world are confused about the major threat to public health posed by drug-resistant superbugs and do not know how to stop that risk growing, the World Health Organization (WHO) said on Monday. Ramping up its fight against antibiotic resistance with a survey of public awareness, the United Nations health agency said…
Rheumatology Drug Updates on Brentuximab Vedotin, Tofacitinib Citrate
Brentuximab Vedotin Enters Phase 2 Trials Brentuximab vedotin (Adcetris), an antibody-drug conjugate (ADC) directed at CD30, is currently entering Phase 2 clinical trials for treating systemic lupus erythematosus (SLE).1 The ADC encompasses an anti-CD30 monoclonal antibody, which is attached by a protease-cleavable linker to a microtubule-disrupting agent, known as monomethyl auristatin E (MMAE). The ADC…
U.S. Drug Benefit Managers Clamp Down on Specialty Pharmacies
NEW YORK/LOS ANGELES (Reuters)—In recent days, the largest U.S. managers of private prescription drug benefits have cut off at least eight pharmacies that work closely with drugmakers, intensifying scrutiny of a system that helps inflate drug prices, officials at the benefit managers told Reuters. The terminations come from payers who together manage drug benefits for…
Does Methotrexate Increase Skin Cancer Risk?
A recent study connects the use of immunosuppressant and biologic agents to an increased risk of nonmelanoma skin cancer in patients being treated for RA and IBD…
Higher Tocilizumab Dose Plus Methotrexate Best for Early RA
NEW YORK (Reuters Health)—Tocilizumab improves remission rates and slows disease progression in patients with early rheumatoid arthritis (RA), a new randomized controlled trial demonstrates. Tocilizumab was effective both on its own and when combined with methotrexate, Dr. Gerd R. Burmester of Charite Medical University of Berlin and his colleagues found. Tocilizumab, an interleukin-6 (IL-6) blocker,…
RA Drug Tested & FDA Orders Drug-Interaction Studies for Kayexalate
In multiple trials, baricitinib has proved promising for treating RA. Also, the FDA is requiring drug-interaction studies for sodium polystyrene sulfonate…
Zimmer Wins First U.S. Trial over NexGen Flex Knee Devices
(Reuters)—Indiana-based medical device manufacturer Zimmer Biomet Holdings Inc. on Friday was cleared of liability in the first of more than 900 U.S. lawsuits to go to trial over claims that its NexGen Flex knee replacements were prone to painful, motion-impairing loosening. Following a three-week trial in the U.S. District Court for the Northern District of…
Methotrexate Increases Risk of Recurrent Nonmelanoma Skin Cancer
NEW YORK (Reuters Health)—Methotrexate appears to increase the risk of recurrent nonmelanoma skin cancer (NMSC) in patients with rheumatoid arthritis (RA), according to a retrospective study. “We have known for some time that several of the immunosuppressive agents used to treat RA and inflammatory bowel disease (IBD) are also associated with an increased risk of…
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