ZURICH (Reuters)—The U.S. Food and Drug Administration has granted breakthrough status to Roche’s rheumatoid arthritis medication Actemra (tocilizumab) for giant cell arteritis, the Swiss drugmaker said, a step which could help it broaden applications for the medicine. Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition caused by inflammation of large and medium-sized arteries,…
FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database
Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…
Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs
ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…
Anti-TNFs in Early Puberty May Improve Growth in Pediatric IBD
NEW YORK (Reuters Health)—Anti-TNF drugs are more likely to improve growth in children with inflammatory bowel disease (IBD) if they’re given in the earlier stages of puberty, new findings show.¹ Children who achieve remission are also more likely to have satisfactory growth, the research team reported online on Sept. 21 in the Journal of Pediatric…
Do RA Patients in Clinical Trials for Biologics Represent the Average?
It’s estimated that a majority of patients with rheumatoid arthritis (RA) have been exposed to biologic treatments. However, the randomized controlled trials demonstrating the safety and efficacy of these biologic agents have strict participant eligibility requirements. New research has examined the requirements of 30 trials for biologics and applied those standards to two large clinical cohorts. The result: A majority of these RA patients did not satisfy the criteria…
Adalimumab-atto, Biosimilar to Humira, Receives FDA Approval
Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…
FDA Approves Ustekinumab for Crohn’s Disease
(Reuters)—Johnson & Johnson says on Monday that the U.S. Food and Drug Administration approved the company’s psoriasis drug, ustekinumab (Stelara), for use in adults with Crohn’s disease. The drug is approved in the U.S. to treat plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s is a chronic inflammatory condition in the gastrointestinal…
FDA Approves Adalimumab-atto, a Biosimilar of Humira
WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira). The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved…
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
U.S. Justice Department to Push Prosecutors on Opioids
WASHINGTON (Reuters)—The U.S. Justice Department will enlist federal prosecutors to help fight the nation’s opioid crisis by sharing information on overprescribing doctors and coordinating with public health officials to address addiction, USA Today reported on Friday. “You can’t just have an enforcement strategy alone,” Attorney General Loretta Lynch told the newspaper in an interview. She…
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