MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…
Search results for: biosimilars
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…
Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
Apremilast Effective for Psoriatic Arthritis
NEW YORK (Reuters Health)—Apremilast improves clinical outcomes in patients with psoriatic arthritis and active psoriasis, according to results from the PALACE 3 randomized controlled trial. Apremilast, a phosphodiesterase 4 (PDE4) inhibitor, showed efficacy against psoriatic arthritis in the PALACE 1 trial. Dr. Christopher J. Edwards from University Hospital Southampton in the U.K. and colleagues evaluated…
FDA Approves New Drugs for Pain
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths…
The ACR/ARHP Award Winners Discuss Their Contributions to Rheumatology
At the 2015 ACR/ARHP Annual Meeting in San Francisco in November, the ACR and the ARHP honored a group of distinguished individuals who have made significant contributions to rheumatology research, education and patient care. In the December 2015 issue, The Rheumatologist reported on the ACR’s awards. This month, we speak with the ARHP winners about…
Pharmaceutical Care Models, Tools for Treating Patients with Rheumatoid Arthritis
Rheumatoid arthritis (RA) can be defined as a chronic autoimmune systemic inflammatory condition characterized by symmetrical polyarthritis. Typically, patients present with pain, stiffness and warmth of the affected joints. The condition can result in extra-articular features, adding to disability, and may eventually lead to premature death, especially if not treated early and appropriately.1,2 Over the…
How to Choose the Best Course of Treatment to Manage Rheumatoid Arthritis
Diagnosing rheumatoid arthritis (RA) early in the disease process is ideal, because treatments are more likely to be effective and less damage will occur. Guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) state that using newer biologic medications, in addition to more aggressive dosing of traditional medications, is…
U.S. Patent Office Rules Against Amgen Humira Challenge
(Reuters)—U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira (adalimumab), a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine. In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that…
Dr. Michael Weinblatt Discusses Current & Future RA Therapies
According to former ACR President Michael Weinblatt, MD, the future of drug therapies for patients with RA rests in the careful and intelligent prescription of current medications and treatment combinations, as well as better patient access through lower costs…
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