(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…
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…
Study Says 1 Biosimilar Switch Is OK; Jury Still Out on Multiple Switches
AMSTERDAM—As more biosimilar drugs for rheumatic diseases make their way to market, evidence is growing that switching from the originator drug to a biosimilar tends to be effective, while the questions of switching back and forth, and switching multiple times using several different biosimilars, remain to be answered, an expert on the topic said at…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
Phase 3 Trial Results: Blisibimod for Lupus Shows Possible Efficacy
A phase 3 clinical trial in which researchers treated lupus patients with blisibimod, a biologic treatment that inhibits B cell activating factor (BAFF), did not meet its primary endpoint, but did demonstrate evidence of possible efficacy. Researcher Joan T. Merrill, MD, a member of the Oklahoma Medical Research Foundation (OMRF) and OMRF professor of medicine…
Guselkumab May Best Adalimumab for Psoriasis on the Scalp, Palms & Soles
NEW YORK (Reuters Health)—The interleukin 23 inhibitor guselkumab is associated with more improvement in psoriasis on the scalp, palms and/or soles compared with adalimumab, a new analysis suggests. Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center in Portland conducted a secondary analysis of data from the international VOYAGE 1 and VOYAGE 2 studies, double-blind,…
FDA Update: Committee Recommends 2 mg Baricitinib Approval; HLH Identified as Serious Adverse Event for Lamotrigine
The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…
International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…
Upadacitinib Proves Superiority to Adalimumab in Phase 3 RA Study
Initial results from an ongoing trial show that upadacitinib outperforms adalimumab in achieving ACR20 in patients with rheumatoid arthritis…
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