The FDA revised its warning and labeling recommendations for antiinflammatory drugs because of a greater understanding of the increased risks they pose for stroke and myocardial infarction…
Some Placebos More Effective Than Others in Osteoarthritis
NEW YORK (Reuters Health)—Some placebos are more effective than others, and these differences can influence the apparent outcomes of clinical trials, according to a systematic review and meta-analysis of osteoarthritis trials. “More surprising than the fact that all placebos are not equal is the magnitude of that difference,” Dr. Raveendhara R. Bannuru, from Tufts Medical…
Some Serious Drug Side Effects Not Reported to FDA Within 15 days
(Reuters Health)—Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds. Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths…
Evidence Lacking for Tests for Psoriasis Patients Using Biologic Agents
NEW YORK (Reuters Health)—Various organizations recommend dozens of screening and monitoring tests for patients with psoriasis or psoriatic arthritis who are using systemic biologic agents, despite sparse evidence to support any of them. “At a population level, these medications have proven to be very safe and the evidence does not support such extensive and frequent…
Anthem to Buy Cigna to Create Biggest U.S. Health Insurer
(Reuters)—Anthem Inc. said on Friday it would buy Cigna Corp. in a deal valued at $54.2 billion, creating the largest U.S. health insurer by membership. The deal—the biggest ever in the health insurance industry—comes three weeks after Aetna Inc agreed to buy Humana Inc for $37 billion and is part of an industry-wide consolidation following…
Most Rheumatologists Want FDA to Better Regulate Biosimilars
In a survey, the Coalition of State Rheumatology Organizations found a consensus among rheumatologists that the FDA should increase safety for biosimilar therapies via naming and labeling regulations…
Abaloparatide-SC May Reduce Fractures for Osteoporosis & New FDA Safety Website
In a 25 month Phase 3 trial, abaloparatide-SC reduced the risk of new fractures in patients suffering from postmenopausal osteoporosis. Plus, the FDA launches a new drug safety website.
Americans Want Medicare to Help Negotiate Down Drug Prices
NEW YORK (Reuters)—A vast majority of Americans say the Medicare health program for the elderly should be able to negotiate with drug companies to set lower medication prices, a practice currently prohibited by law, according to a survey released on Friday. The poll conducted by the Kaiser Family Foundation found that 87% of people surveyed…
Did Reports of Side Effects Contribute to Drop in Bone Drug Use?
(Reuters Health)—Media reports raising safety concerns about osteoporosis drugs known as bisphosphonates may have contributed to a sharp drop in their use—even though U.S. doctors and drug regulators haven’t recommended against taking them, a study suggests. Fosamax (alendronate sodium) won U.S. marketing approval in 1995. Widespread use of the drug and others like it over…
Certolizumab Pegol Effective for Treating Rheumatoid Arthritis
NEW YORK (Reuters Health)—Certolizumab pegol, a humanized anti-TNF antibody fragment conjugated to polyethylene glycol, is effective for treating early rheumatoid arthritis (RA) with poor prognostic factors, according to results from the C-OPERA study. Certolizumab is approved in the U.S. and other countries for treating inflammatory diseases, including RA, but its effectiveness in methotrexate-naïve early RA…
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