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Drug Updates

Subcategories:AnalgesicsBiologics/DMARDs

The FDA Denies Approval for Remoxy Extended Release; Plus Knee OA Pain Treatment Moves into Phase 3 Trials

Michele B. Kaufman, PharmD, BCGP  |  September 6, 2018

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 Staff  |  August 31, 2018

(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

Thomas R. Collins  |  August 29, 2018

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

Deena Beasley  |  August 23, 2018

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…

Study Says 1 Biosimilar Switch Is OK; Jury Still Out on Multiple Switches

Thomas R. Collins  |  August 17, 2018

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…

Atacicept Shows Promise in Lupus Treatment Trials

Mary Beth Nierengarten  |  August 17, 2018

A new biologic agent for treatment of systemic lupus erythematosus (SLE) being tested in clinical trials is showing promise as a safe and effective new treatment, particularly in patients with more severe disease or serologically active disease. Recently published results of a study that examined the safety and efficacy of atacicept for SLE showed the…

Tanezumab Promising for OA Pain; Plus, Filgotinib Investigated for Psoriatic Arthritis

Michele B. Kaufman, PharmD, BCGP  |  August 15, 2018

New research shows tanezumab may be safe and effective for patients with osteoarthritis pain…

Adalimumab Appears Safe for Treating Pediatric Patients with Autoimmune Disease

Reuters Staff  |  August 8, 2018

NEW YORK (Reuters Health)—Adalimumab appears to be safe for treating pediatric patients with polyarticular juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), psoriasis and Crohn’s disease (CD), according to data from company-sponsored clinical trials. Adalimumab is an anti-tumor necrosis factor monoclonal antibody with demonstrated efficacy in these conditions, but pediatric safety data remains limited. Dr. Gerd…

EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray

Michele B. Kaufman, PharmD, BCGP  |  August 8, 2018

In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…

Long-Term Apremilast Promising for Psoriatic Arthritis

Michele B. Kaufman, PharmD, BCGP  |  July 27, 2018

In a long-term study, apremilast was well tolerated by patients with psoriatic arthritis, who showed sustained improvements for up to five years…

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