LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
Do Bisphosphonates Increase Risk of Carpal Tunnel Syndrome?
In a large-scale study, researchers demonstrated that the use of bisphosphonates in postmenopausal women is associated with an increased risk of carpal tunnel syndrome, in addition to other known risks (e.g., incapacitating bone, joint and/or musculoskeletal pain, and osteonecrosis of the jaw)…
From the Expert: Insight into the Intersection of Cancer & Autoimmunity
Research by Dr. Anthony Rosen, MD, and colleagues found a link between cancer and scleroderma, suggesting the immune system may edit cancer cells. In an interview with The Rheumatologist, Dr. Rosen explores the meaning of this finding and its potential…
Patients Get Mixed Reactions from Docs over Mail-Ordered Genetic Tests
(Reuters Health)—Patients who order direct-to-consumer genetic tests report mixed experiences when they take the results to their doctors, a new study found. About a quarter of people who ordered direct-to-consumer genetic testing from such companies as 23andMe reported discussing the results with their primary care doctors. But nearly one in five were not at all…
Tofacitinib Shows Ongoing Action Against Plaque Psoriasis
NEW YORK (Reuters Health)—The oral Janus kinase inhibitor tofacitinib (Xeljanz, Pfizer) shows long-term efficacy against chronic plaque psoriasis, according to findings from two randomized studies and an extension trial. The outcome, Dr. Svitlana Tatulych told Reuters Health by email, “demonstrated that oral tofacitinib, at both the 10 mg and 5 mg twice-daily doses, provided sustained…
Titanium Dioxide Additives May Boost Intestinal Inflammation
NEW YORK (Reuters Health)—Murine and other studies suggest that titanium dioxide (TiO2) nanoparticles, widely used as food additives and in drug formulations, may be involved in intestinal inflammation, according to Swiss researchers. As Dr. Gerhard Rogler told Reuters Health by email, “It seems that titanium dioxide nanoparticles are not harmful for a healthy person with…
U.S. Hospital Group Warns of Blue Cross Dominance if Anthem Buys Cigna
(Reuters)—The American Hospital Association warned U.S. antitrust regulators that Anthem Inc.’s proposed acquisition of Cigna Corp. will hurt other health insurers’ ability to compete with Blue Cross Blue Shield plans, leading to higher premiums for consumers. Anthem, the country’s second-largest health insurer, runs Blue Cross Blue Shield plans in 14 states. The hospital group, in…
Tofacitinib Released from FDA REMS Requirement; Plus Biosimilars for Etanercept & Adalimumab Show Promise
Tofacitinib has been released from the FDA’s risk evaluation and mitigation strategy requirement. The FDA is also reviewing a biologics license application for ABP-501, an adalimumab biosimilar. And CHS-0214, a proposed etanercept biosimilar, has met its primary endpoint at Week 24 in an ongoing 52-week study…
The Biosimilars Debate Heats Up: Potential cost savings weighed against patient health & safety
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
Parents Often Catch Hospital Errors Doctors Missed
(Reuters Health)—Parents often catch medical errors that their child’s doctor missed, according to a U.S. study that suggests families may be an untapped resource for improving hospital safety and preventing mistakes. Roughly one in 10 parents spotted mistakes that physicians did not, according to the study of safety incidents observed on two pediatrics units at…
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