The FDA has expanded the indications for golimumab, an anti-TNF-alpha monoclonal antibody, to include the treatment of active psoriatic arthritis and ankylosing spondylitis…
U.S. Approves Digital Pill that Tracks When Patients Take It
(Reuters)—U.S. regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.1 The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking…
Psoriasis Tied to Higher Risk of Serious Liver Disease
(Reuters Health)—People with chronic inflammatory disorders, such as psoriasis and rheumatoid arthritis (RA), may have an increased risk of developing serious liver damage, a recent study suggests. These inflammatory disorders are often treated with methotrexate, a medication linked to an increased risk of liver disease. For the current study, researchers followed more than 1 million…
Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
Bisphosphonates May Limit Fracture Risk in Users of Oral Glucocorticoids
NEW YORK (Reuters Health)—Early oral bisphosphonate use is associated with a lower risk of fractures among oral-glucocorticoid users, researchers from Canada report. Bisphosphonates are commonly used for glucocorticoid-induced osteoporosis, but their efficacy has been established only in primary osteoporosis, where the mechanism of action of bone loss differs from that seen with glucocorticoid use. Dr….
Kentucky Accuses Endo of Contributing to Opioid Epidemic
(Reuters)—Kentucky accused units of Endo International Plc. on Monday of contributing to drug overdoses by deceptively marketing its painkiller Opana ER, in the latest lawsuit by state or local governments against the drugmaker amid an opioid epidemic. Kentucky Attorney General Steve Beshear said the lawsuit would seek to hold Endo responsible for illegally building a…
J&J’s Stelara Shows Promise Against Lupus in Study
(Reuters)—Johnson & Johnson’s blockbuster psoriasis drug ustekinumab (Stelara) led to a significant reduction in disease activity in patients with systemic lupus compared with a placebo in a midstage clinical trial, according to data released on Nov. 4. Ustekinumab is already approved for psoriasis, psoriatic arthritis and Crohn’s disease and had third-quarter sales of $1.12 billion….
Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis
In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…
New Jersey Sues OxyContin Maker, Links Marketing to Opioid Crisis
(Reuters)—New Jersey on Tuesday sued Purdue Pharma LP, accusing the OxyContin maker of contributing to the state’s opioid crisis through deceptive marketing to doctors and patients, including the elderly and the “opioid-naive.” Christopher Porrino, the New Jersey attorney general, faulted what he called a decade-long marketing campaign of “almost inconceivable callousness and irresponsibility, and said…
Trump Declares Opioids a U.S. Public Health Emergency
WASHINGTON (Reuters)—U.S. President Donald Trump declared the opioid crisis a public health emergency on Thursday, stopping short of a national emergency declaration he promised months ago that would have freed up more federal money. Responding to a growing problem wreaking havoc in rural areas, Trump’s declaration will redirect federal resources and loosen regulations to combat…
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