STOCKHOLM/LONDON (Reuters)—Two Americans and a Briton won the 2018 Nobel Prize for Chemistry on Wednesday for harnessing the power of evolution to generate novel proteins used in everything from environmentally friendly detergents and biofuels to cancer drugs. The fruits of this work include the world’s top-selling prescription medicine – the antibody injection Humira sold by…
FDA Expands Safety Measures for Immediate Release Opioids
The FDA has expanded the new Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to include immediate release opioids. The program, which also includes extended release and long acting opioids, will provide education to prescribers and healthcare professionals…
TNFi Exposure in Utero
Vinet et al. evaluated the risk of serious infections in children of women with RA exposed to TNFi’s in the gestational period compared with unexposed offspring of women with RA, as well as with children from the general population. Although the research did not demonstrate a marked excess risk for serious infections, the authors could not exclude a differential risk according to specific TNFi, with infliximab potentially resulting in a threefold increase in the risk of serious infections compared with other TNFi’s. More studies are needed…
FDA Issues Safety Warning
The FDA is warning that patients with type 2 diabetes taking SGLT2 inhibitors may be at risk of developing a rare, serious infection, Fournier’s gangrene…
California Insurance Commissioner Sues AbbVie over Humira
(Reuters)—On Tuesday, Insurance Commissioner Dave Jones filed a complaint on behalf of the State of California against AbbVie Inc., alleging the drugmaker gave illegal kickbacks to healthcare providers to prescribe its blockbuster drug, Humira. The regulator alleged that AbbVie engaged in a far-reaching scheme including cash, meals, drinks, gifts, trips and patient referrals, as well…
Rheumatoid Arthritis Patients on Biologics Remain At Risk of Infection
AMSTERDAM—With new therapies coming into the marketplace, researchers are working to tease out the risk of infection for rheumatoid arthritis (RA) patients. Existing data suggest the risk of infections—even fatal ones—is real. But over time, improvements have taken hold, particularly for tuberculosis, according to an infectious disease expert at EULAR: the Annual European Congress of…
Placebos: Their Underappreciated Impact in Pharmaceutical Trials
Sir William Osler, the father of modern medicine, said “the desire to take medicine is perhaps the greatest feature that separates man from animal.” Determination of the benefit of a medication can be challenging and includes a number of factors, such as pharmacologic activities on the disease pathophysiology, pharmacokinetic properties and patient characteristics.1,2 An additional,…
Immune Checkpoint Inhibitors & Immune-Related Adverse Events
Immune checkpoint inhibitors (ICIs) are at the forefront of advances in cancer therapy and have shown promising results for progression-free survival. Checkpoint signaling pathways, such as cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death protein 1 (PD-1), normally regulate the immune response to promote self-tolerance and prevent tissue damage and inflammation. PD-1 is a…
Piclidenoson in Trials for Psoriasis & RA; Plus Duzallo Approved in Europe
New clinical trials are underway to determine the safety and efficacy of piclidenoson for patients with plaque psoriasis and rheumatoid arthritis…
The FDA Denies Approval for Remoxy Extended Release; Plus Knee OA Pain Treatment Moves into Phase 3 Trials
The FDA has not approved extended release Remoxy, a gel capsule formulation of oxycodone, concluding that its potential benefits do not outweigh its risks…
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