NEW YORK (Reuters Health)—Patients with early rheumatoid arthritis (RA) treated with IV tocilizumab alone or with methotrexate maintained clinical benefits during their second year of treatment, researchers say. Sophie Dimonaco of Roche Products Ltd. in Welwyn Garden City, UK and colleagues sought to determine whether the efficacy and safety of IV tocilizumab, as demonstrated in…
Brodalumab Approved for Plaque Psoriasis, Plus Baricitinib Effiicacy Studied for RA
Brodalumab Approved for Plaque Psoriasis The U.S. Food and Drug Administration has approved brodalumab, a monoclonal antibody that targets interleukin 17 (IL‑17).1,2 Brodalumab (Siliq) was approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond to, or have lost response to, other…
Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety
WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…
Nevada Rheumatologists Take on Biologic and Biosimilar Substitution
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…
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