In a second response letter, the FDA has cited the onset and duration of intravenous meloxicam, a non-opioid pain treatment, as concerns that it fails to meet prescriber expectations…
Trump Slams Drugmakers, Vows to Let U.S. States Buy Cheaper Medicines Abroad
WASHINGTON (Reuters)—U.S. President Donald Trump slammed the pharmaceutical industry for high prices of prescription drugs on Thursday and vowed to allow U.S. states to buy medicines from other countries if they cost less. Trump, who campaigned on a platform to reduce drug prices for U.S. consumers, has taken few concrete steps to lower medication costs…
U.S. to Require Drugmakers to Show Prices in TV Ads
(Reuters)—U.S. Centers for Medicare & Medicaid Services on Wednesday said it will require drugmakers to disclose the list price for their prescription drugs in direct-to-consumer television advertisements, part of the Trump administration’s efforts to lower costs for U.S. consumers. The list price should be included if it is equal to or greater than $35 for…
FDA Approves Drug for Lambert-Eaton Myasthenic Syndrome
(Reuters)—Jacobus Pharmaceutical Co Inc on Monday won U.S. approval for the first drug to treat children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder. The drug, Ruzurgi (amifampridine), was approved for use in patients ages 6–17, the according to the U.S. Food and Drug Administration (FDA). Lambert-Eaton myasthenic syndrome (LEMS), which affects about three people…
Health Canada Approves Certolizumab Pegol & NICE Issues Guidance for Certolizumab Pegol
Certolizumab pegol has been approved in Canada for treating adults with plaque psoriasis. The U.K. has also issued its final guidance for the treatment’s use…
Chronic Opioid Use in Rheumatoid Arthritis: Prevalence & Predictors
Over the past decade, physicians, patients and policy makers have expressed increasing concern about the high frequency of opioids being prescribed and the association between opioid use and poor outcomes. Rates of opioid prescriptions in the general population rose considerably from the 1990s through 2010, with a plateau in the early 2010s. In 2015, 38%…
FDA Approves Certolizumab Pegol for Treating Non-Radiographic Axial SpA
Certolizumab pegol is now FDA approved to treat adults with active non-radiographic axial spondyloarthritis…
Osteoporotic Fracture Rates Similar with Denosumab, Alendronate in Real World
NEW YORK (Reuters Health)—Rates of osteoporotic fracture were similar three years after starting either denosumab or alendronate in a real-world Danish population-based cohort study. “Previous studies have shown that denosumab is more efficacious than alendronate in increasing bone mineral density (BMD), possibly the best proxy outcome for subsequent fracture risk. However, previous studies were underpowered…
FDA Approves New Osteoporosis Medication
Romosozumab-aqqg has been approved in the U.S. for treating postmenopausal women with osteoporosis at high risk of fracture…
IBD Patients Who Switch from Infliximab to Biosimilar See Mixed Results
NEW YORK (Reuters Health)—Patients with inflammatory bowel disease (IBD) can safely switch from infliximab to the biosimilar CT-P13, though they may face a higher risk of clinical relapse, researchers from Spain report. Recent studies have demonstrated the effectiveness and safety of infliximab biosimilars in patients with IBD, but there are limited data about the effectiveness…
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