(Reuters Health)—The safety and effectiveness of cancer immunotherapy is largely unknown in patients with autoimmune diseases, researchers say—and that might account for up to a quarter of individuals with lung cancer. Patients with autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis or psoriasis, have been mostly excluded from clinical trials testing immunotherapies over fears that…

Patients with RA Who Respond to Treatment Experience Increased Cholesterol
New research confirms that patients with rheumatoid arthritis who respond to treatment experience an increase in cholesterol levels, including total cholesterol, LDL-C and HDL-C levels. However, the use of triple therapy may be important for understanding this association and mitigating its risk…
Many Medical Devices Hit the Market before Safety Studies Are Published
(Reuters Health)—Medical devices approved by the U.S. Food and Drug Administration (FDA) are often cleared before studies on their safety or effectiveness have been released to the public, a report suggests. Without published data, doctors and patients may not be able to make informed decisions about whether to use the products, the authors warn. The…
Biomarkers Differentiate Crohn’s Disease from Ulcerative Colitis
NEW YORK (Reuters Health)—Newly identified biomarkers could aid in the diagnosis of inflammatory bowel disease (IBD) and help guide therapy, Canada-based researchers report. Accurately differentiating between Crohn’s disease (CD) and ulcerative colitis (UC) is important for ensuring early and appropriate treatment. However, the conditions can’t be reliably distinguished based on clinical symptoms, site of disease,…

Bacterial Curli Amyloid: Researchers Examine the Role of Bacterial Infection in Lupus Pathology
New research has found that the amyloid protein curli triggers immune activation and autoantibody production in lupus-prone and wild-type mice. Stefania Gallucci, MD, says these results provide insight into the mechanisms of bacterial infection that may result in lupus…
Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…
Diffuse Alveolar Hemorrhage Secondary to Antineutrophil Cytoplasmic Antibody–Associated Vasculitis: Predictors of Respiratory Failure and Clinical Outcomes
A variety of immune and nonimmune pathophysiologic mechanisms causing the disruption of alveolar capillaries with bleeding into the alveolar spaces can lead to diffuse alveolar hemorrhage (DAH). Immune-mediated mechanisms can cause DAH with or without the presence of capillaritis. The antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis (AAV) syndromes—granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)—are the…
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…

FDA Restricts Use of Systemic Fluoroquinolones Due to Side Effects & Will Review Application of Apadaz for Pain
The FDA has issued new safety guidelines for systemic fluoroquinolones, restricting their use to patients with no alternative treatment options…
Roche & Novartis Face Off in Biosimilar Drug Battle
ZURICH (Reuters)—Switzerland’s biggest drugmakers are clashing over cheaper copies of pricey biotech drugs—one reason why Novartis is considering selling its $14 billion stake in cross-town rival Roche. With a copycat of Roche’s blood cancer drug Rituxan (rituximab) pending European approval, Novartis aims to muscle in on a share of sales that last year hit 7…
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