ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
Drug Industry Must Address Image Problem over Prices
NEW YORK (Reuters)—Teva Pharmaceutical Industries Ltd’s research chief said on Tuesday the drug industry must act responsibly when it comes to pricing medications, given the mounting anger over the high cost of therapies in the U.S. Democratic presidential candidate Hillary Clinton brought new attention to the issue last week, proposing to cap patients’ treatment costs,…
Rituximab for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
FDA Issues Warning for Joint Pain from Diabetes Drugs
Severe and disabling joint pain has been connected to the use of dipeptidyl peptidase-4 inhibitors and combination therapies for diabetes, prompting a new FDA warning…
FDA’s ‘Breakthrough Drug’ Terminology Confuses the Public
NEW YORK (Reuters Health)—What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence…
Methotrexate Halt Feasible in Some Etanercept RA Responders
NEW YORK (Reuters Health)—Certain rheumatoid arthritis (RA) patients doing well on etanercept and methotrexate may be able to quit the latter agent if they have tolerability problems, according to an open-label Canadian study. In a Sept. 11 online paper in Rheumatology, Dr. Boulos Haraoui, of the University of Montreal, and colleagues noted that although combination…
New Labeling for Infused Golimumab; Phase 3 Trial for Romosozumab Promising
The FDA has approved new labeling for infused golimumab to include measures of mental and physical health. Plus romosozumab meets primary endpoints in postmenopausal women with osteoporosis during a Phase 3 trial…
Guselkumab Studied to Treat RA, Plaque Psoriasis
Guselkumab Studied to Treat RA & Plaque Psoriasis Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets interleukin (IL) 23.1 It is being investigated in a Phase 2 study to treat rheumatoid arthritis (RA) and moderate to severe plaque psoriasis (PsA). On June 11, 2015, at the 2015 meeting of the European League Against…
XenoPort’s Psoriasis Drug Found Effective in Phase 2 Trial
(Reuters)—Drug developer XenoPort Inc. said on Tuesday its experimental drug was effective in treating psoriasis, sending its shares up 19% in premarket trading. The oral drug met the main goal in a phase 2 trial of patients with moderate-to-severe chronic plaque-type psoriasis, the company said. XenoPort said it expected to start late-stage trials next year…
EULAR 2015: Problems with Biomarkers
ROME, Italy—The traditional approach to trials to assess new biomarkers and related treatments has largely been inefficient, and a better strategy is needed to make stratified treatment available for patients more quickly, an expert said at EULAR 2015, the annual congress of the European League Against Rheumatism (EULAR). Mahesh Parmar, PhD, director of the Medical…
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