(Reuters)—Recro Pharma’s IV meloxicam, a non-opioid injection, did not get approval from the U.S. Food and Drug Administration because the agency said the drug’s pain-relieving effect did not meet its expectations. The company said it plans to meet with the FDA to find solutions. Unlike the drug’s oral version, which has been on the market…
Articles by Cindy Devone-Pacheco
Novartis Receives EU Approval for Infliximab Biosimilar Zessly
ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,…
HCV-Associated Cryoglobulinemic Vasculitis Resolves after Virologic Cure
NEW YORK (Reuters Health)—Cryoglobulinemic vasculitis associated with hepatitis C virus (HCV) infection resolves after effective treatment with direct-acting antivirals (DAAs), with most patients remaining in remission for two or more years, researchers from Spain report. “Most clinical manifestations of the disease improve over time, but some patients may have a clinical recurrence of their disease…
FDA Names Drugmakers Potentially Acting to Delay Cheap Generics
(Reuters)—The U.S. Food and Drug Administration on Thursday listed drugmakers, including Celgene Corp, Johnson & Johnson, Gilead Sciences and Novartis AG, who the regulator says are potentially blocking access to samples of their drugs to delay generic competition. Generic drugmakers may not be able to develop alternatives without access to samples of branded products they…
Romosozumab Has Biggest BMD Benefit in First Year of Treatment
NEW YORK (Reuters Health)—Romosozumab shows smaller benefits for increasing bone mineral density (BMD) in the second year of treatment compared to the first, new research suggests. The extension of a phase 2 study in postmenopausal women with low bone mass also found BMD decreased sharply when patients on romosozumab were switched to placebo after two…
Cutaneous Lupus Tied to Risk for Coexisting Autoimmune Conditions
NEW YORK (Reuters Health)—Patients with cutaneous lupus erythematosus (CLE) should be monitored closely for other autoimmune conditions, researchers suggest. Dr. Benjamin Chong, Dr. Linda Hynan and Elaine Kunzler of the University of Texas Southwestern Medical Center in Dallas analyzed data from 129 adults in the UTSW Cutaneous Lupus Registry (mean age, 49; 79% women). Individuals…
Clinical Remission Should Be Target of JIA Treatment: Task Force
NEW YORK (Reuters Health)—An international task force says patients with juvenile idiopathic arthritis (JIA) should be treated to a target of clinical remission, among other new recommendations. “The Task Force is convinced that transferring (the recommendations) into clinical practice will significantly improve the outcomes in patients with JIA,” Dr. Angelo Ravelli of the Istituto G….
CVS Rolls Out New Tool to Combat Rising Drug Prices
(Reuters)—Drugstore chain CVS Health Corp on Wednesday launched a new tool that will allow pharmacies help customers tackle the soaring cost of drugs by comparing prices of medicines. U.S. healthcare companies, ranging from insurers to drug retailers, are stepping up efforts to combat rising drug prices that has been widely criticized by regulators and has…
Many in U.S. Take More Calcium Supplements than Necessary
(Reuters Health)—Some adults in the U.S. who use supplements to get their daily requirement of calcium are taking higher doses than necessary, a recent study suggests. Researchers examined nationally representative survey data on dietary habits and vitamin and supplement use collected between 1999 and 2014 from 42,038 adults. About one in 20 adults got a…
Abaloparatide Appears Safe, Effective for Boosting BMD in Women 80 & Up
NEW YORK (Reuters Health)—Abaloparatide appears to be a safe and effective drug for increasing bone mineral density (BMD) in women 80 and older, new research shows. The study is a post hoc analysis of the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial, which found patients who received abaloparatide subcutaneously for 18 months had increased…
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