Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
FDA Advisory Committee Votes in Favor of Romosozumab Approval
An FDA advisory committee voted 18-1 in favor of approving romosozumab to treat postmenopausal women with osteoporosis.
Not-for-Profit to Offer 20 Generic Drugs in 2019 to Alleviate Shortages
(Reuters)—A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Since the start-up of Civica Rx spearheaded by Intermountain Healthcare was…
FDA Update: Priority Review for Non-Opioid Treatment & New Warning for Fluoroquinolones
The FDA has granted priority review to a non-opioid, postoperative pain treatment, HTX-011…
The Eliminating Kickbacks in Recovery Act of 2018—What Does It Mean?
It should not be a surprise to anyone that the U.S. is facing a national opioid crisis. It may be a surprise, however, that the federal government recently passed a law to address this crisis—a law that may have a profound impact on many healthcare facilities, some of which are not involved in the substance…
Medicare Changes Could Have Some Patients Paying More for Drugs
(Reuters Health)—A proposed shift in Medicare coverage for medicines administered by doctors may help reduce total drug spending, but a new study suggests it may also lead to higher out-of-pocket costs for some patients. Right now, drugs given by infusion or injection in outpatient settings are covered by Medicare Part B, which is part of…
U.S. Lawmaker Launches Investigation into Pharma Drug Pricing
WASHINGTON (Reuters)—A top U.S. lawmaker has launched an investigation into pharmaceutical industry pricing practices, less than a week after he and fellow Democrats introduced legislation aimed at lowering medicine prices. Rep. Elijah Cummings (D-Md.), who chairs the U.S. House Oversight Committee, sent letters to 12 drug makers seeking information on price increases, investment in research…
Results of SPIRIT: A Head-to-Head Trial of Ixekizumab vs. Adalimumab in Active PsA
In a recent study, ixekizumab proved safe and effective in treating adults with psoriatic arthritis (PsA) and plaque psoriasis compared with adalimumab…
FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients
The FDA has approved Truxima (rituximab-abbs), which is biosimilar to Rituxan (rituximab), for treating adults with CD20-positive, B-cell non-Hodgkin’s lymphoma…
Can IL-6 Predict Sarilumab Response?
Recent post-hoc analyses of two Phase 3 clinical trials show that RA patients with high interleukin 6 levels taking sarilumab experienced improved symptoms and less joint damage than those using other treatments…
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