TOKYO (Reuters)—Prime Minister Shinzo Abe’s economic advisers, hoping to curb Japan’s ballooning healthcare costs, proposed on Wednesday reforms to the way drug prices are set, a step opposed by foreign and domestic drug makers who say the changes will stifle investment. The proposals follow a decision to halve the price of Bristol Myers Squibb Co’s…
Rheumatologists Should Discuss with Patients Use of Immunomodulatory Agents During Pregnancy
The decision to continue or discontinue immunomodulatory medications during pregnancy is a difficult one for both patients and physicians. On the one hand, when left untreated, rheumatic conditions can cause harm to an unborn child, as well as to the pregnant mother. On the other hand, medications can be harmful to a developing fetus. In…
2015 Treatment Recommendation Updates for Psoriatic Arthritis Address Comorbidities, New Medications
In May, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) published its recommendations for the treatment of psoriatic arthritis (PsA).1 The updated recommendations represent advances in drug development and availability since previous recommendations published in 2009, as well changes in treatment paradigms and the importance of associated aspects of the disease.2…
Update on Legislation, Notification Rules Concerning the Substitution of Interchangeable Biologic Drugs
Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics. As many as 15 states will have biosimilar-related legislation introduced by coalitions in…
Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis
Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…
Rheumatology Drug Updates: Infliximab Biosimilar Cross Reacts to Infliximab Antibodies
Cross Reactions A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to…
The ACR’s Advocacy at State Legislature Level in 2016 Focuses on Biosimilars, Step Therapy
A majority of state legislatures have concluded their work for 2016. The ACR’s state advocacy efforts continued to focus on policy benefiting rheumatologists and patients alike. The two dominant issues this year were biosimilar substitution and step therapy. Biosimilar Substitution Biosimilar substitution remains the most prevalent issue throughout the states. The ACR continues to monitor…
Rheumatology Drug Updates: Labeling for Fluoroquinolones; FDA to Review Benzhydrocodone/Acetaminophen Combination
FDA Restricts Fluoroquinolone Use The U.S. Food and Drug Administration (FDA) has twice previously communicated safety information about systemic fluoroquinolones—in August 2013 and July 2008. The safety issues of this medication class described in its latest Drug Safety Communication were also discussed at a November 2015 FDA Advisory Committee meeting.1 The FDA is now advising…
Rheumatology Drug Updates: Etanercept for Pediatric Plaque Psoriasis
Etanercept Submitted for Chronic, Severe Plaque Psoriasis in Children The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for etanercept (Enbrel) for treating pediatric patients with chronic, severe plaque psoriasis.1 The application was submitted in early January 2016 and is based on results of a one-year Phase 3 study with…
Rheumatology Drug Updates: Infliximab Biosimilar Gets FDA Approval & More
April 5, 2016, marks a revolutionary day in the treatment of autoimmune diseases: The U.S. Food and Drug Administration (FDA) approved an infliximab (Remicade) biosimilar, known as Inflectra (infliximab-dyyb). Infliximab-dyyb, which is administered by intravenous infusion, is the first biosimilar drug approved to treat rheumatic disease in the U.S.1 Infliximab-dyyb has received approval for almost…
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