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…
AstraZeneca Lupus Drug Fails to Meet Main Goal in Study
(Reuters)—AstraZeneca’s experimental drug anifrolumab failed to meet its main target in a late-stage clinical study treating patients with moderate to severe lupus, the British drugmaker said on Friday. AstraZeneca said the drug did not meet the main goal in the final-stage of one of the two clinical trials under the TULIP program, failing to show…
Investigators Assess Infection Risk with RA Biologics
Due to a range of factors, determining the precise infection risk posed by new biologic therapies to RA patients is difficult. But progress has been made and health registries may be helpful, said Olivier Lortholary, MD, PhD, during the 2018 EULAR: Annual European Congress of Rheumatology…
Oklahoma Medicaid Tests New Tactic to Curb U.S. Drug Costs
LOS ANGELES (Reuters)—A new front in the battle over the cost of expensive medicines in the United States is opening up in Oklahoma, the first state where the government’s Medicaid program is negotiating contracts for prescription drugs based on how well they work. In June, Oklahoma received approval from the U.S. Centers for Medicare and…
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