(Reuters Health)—When patients have drug benefits that encourage them to save money by using certain pharmacies, they may end up filling more prescriptions, a company-funded study suggests. Narrow pharmacy networks that cover prescriptions only at certain retailers and drug benefits that offer consumers lower out-of-pocket fees at a subset of preferred pharmacies have become more…
Regulatory Backlog in Emerging Nations Adding Years to Drug Approvals
BASEL (Reuters)—A regulatory backlog in developing countries including China has created wait times for drugs awaiting approval of up to seven years, Roche Holding AG Chief Executive Severin Schwan said on Tuesday. “Unfortunately, time lines are getting longer and longer in countries like China,” Schwan said at an oncology event at the Swiss company’s headquarters…
Lupus Nephritis Therapies Compared, Plus Naming Guidance for Biosimilars
Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
Novartis Launches First U.S. Biosimilar Drug at 15% Discount
LONDON/ZURICH (Reuters)—Novartis kicked off a new era in U.S. medicine on Thursday with the launch of the first biosimilar copy of a biotechnology drug approved in the U.S., at a discount of 15% to the original. The Swiss drugmaker’s generics unit Sandoz said Zarxio, its form of Amgen’s white blood cell-boosting product Neupogen (filgrastim), would…
Resunab Fast Tracked to Treat Scleroderma, Plus, Infliximab Biosimilars in Europe
The FDA has fast-tracked the development of a drug to treat systemic sclerosis, or scleroderma; initial clinical trials started in June. Also, a major hospital group in France has selected the biosimilar infliximab to treat its patients with RA, Crohn’s disease and psoriasis…
FDA Warns of Severe Joint Pain Risk with DPP-4 Diabetes Drugs
(Reuters)—A class of diabetes drugs that include Merck & Co Inc.’s Januvia has been linked with severe joint pain, the U.S. Food and Drug Administration said on Friday. The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006,…
FDA Proposes Adding Suffixes to Distinguish Biosimilar Drug Names
WASHINGTON (Reuters)—The U.S. Food and Drug Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts. The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once…
Ustekinumab Found to Be Effective in Adolescents with Psoriasis
NEW YORK (Reuters Health)—Adolescents with moderate to severe psoriasis may respond to the human monoclonal antibody ustekinumab as well as adults, with no unexpected side effects, a new study found. The findings are exciting in part because patients in this age group have limited treatment options, the study’s lead author Dr. Ian Landells, of Memorial…
FDA Issues Boxed Warning for Hydroxyurea & Neutropenia May Occur after Rituximab Treatments
The FDA has issued a new boxed warning for Droxia (hydroxyurea). Also, according to a new study, RA patients receiving rituximab should be monitored for late-onset neutropenia…
Epratuzumab Results Disappointing, but Adalimumab Promising
Two Phase 3 trials have shown that epratuzumab did not meet its primary endpoints for treating SLE. Meanwhile, a Phase 3 study has shown adalimumab is effective for treating enthesitis-related arthritis in juveniles…
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