On March 22, 2017, Ewa Olech, MD, testified at a hearing before the Nevada State Assembly to voice support for A.B. 245, a bill governing biologic medications and biosimilar substitution in that state. She spoke on behalf of the Rheumatology Association of Nevada (RAN), as its president and founder. The bill establishes guidelines regarding biosimilars and requires…
Opioid Use Common Even After Minor Surgery
(Reuters Health)—The risk that surgery patients will become chronic opioid users may be similar after minor procedures or major operations, a U.S. study suggests. Three to six months after surgery, new chronic opioid use was about 5.9% with minor operations and 6.5% with major surgery, the study found. The rate was just 0.4% in people…
FDA Drug Labeling, Approval Process Help Minimize Lawsuits Against Pharmaceutical Companies
Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the early morning talk shows. In contrast to the television series I binge on later in…
U.S. FDA Declines to Approve Eli Lilly & Incyte Arthritis Drug
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
The Risks of Opana Extended Release
In March, an FDA advisory committee voted that the risks of Opana ER to public health outweigh its benefits as a chronic pain treatment…
Insufficient Evidence Regarding Osteoporosis Medications in Kidney Patients
NEW YORK (Reuters Health)—There are insufficient data to make evidence-based decisions regarding the benefits and harms of osteoporosis medications in patients with chronic kidney disease (CKD), according to a systematic review and meta-analysis. “We found low to moderate evidence for the effects of some but not all of the medications, and the evidence was limited…
FDA Warns Mylan Over Quality Concerns at India Facility
(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of…
U.S. & Europe Evaluate Abaloparatide Injection & Europe Approves Marketing Baricitinib for RA
Injectable abaloparatide is being evaluated in the U.S. and Europe to treat postmenopausal women with osteoporosis…
Corbus Pharma Outlines U.S. Approval Path for Scleroderma Drug
(Reuters)—The U.S. Food and Drug Administration needs Corbus Pharmaceuticals to show positive data from only one late-stage study on its experimental treatment for scleroderma to support a marketing application, the company said. Corbus said on Wednesday it expects to start the study on 270 patients in the fourth quarter and that it was in talks…
Sirukumab Promising for RA
In a clinical trial, RA patients on sirukumab experienced decreased disease activity and improved physical function…
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