WASHINGTON (Reuters)—Two U.S. lawmakers have called on privately held Marathon Pharmaceuticals LLC to explain how it came to price its newly approved drug to treat Duchenne muscular dystrophy at $89,000 a year when patients have for decades been able to acquire it overseas for as little as $1,000. The drug, Emflaza, known generically as deflazacort,…
U.S. Senators Question Kaleo’s $4,500 tag on Opioid Overdose Treatment
(Reuters)—U.S. Sen. Claire McCaskill (D-Mo.) on Thursday asked Kaleo Pharmaceuticals to justify the more than 550% surge in the price of its device to treat opioid overdoses, becoming the second senator to question Evzio’s $4,500 price tag. Evzio contains the overdose-reversing drug naloxone and can be used in emergencies by people without medical training. Privately…
Insights into Drug-Related Interactions in Older Adults
A study showed that prior hospitalization and the use of multiple medications are risk factors for drug and drug–disease interactions…
Biosimilar Update: ACR Says FDA Draft Guidance Is Promising & Biosimilar to Humira (Adalimumab) Enters Regulatory Review
The ACR has released a statement, responding positively to the release of the latest U.S. Food and Drug Administration (FDA) draft guidance on biosimilar drug development. Also, BI 695501, a biosimilar to Humira (adalimumab) made by Boehringer Ingelheim, has been accepted for regulatory review in both the U.S. and Europe. ACR Responds to FDA Biosimilar…
Baricitinib Is Effective in Patients Treated with DMARDs & Methotrexate
A recent analysis has examined the effectiveness of baricitinib in treating RA patients who suffer from comorbidities and the effect of concomitant use of steroids. Baricitinib proved effective, particularly in patients who had exposure to cDMARDs and corticosteroids…
FDA Update: FDA Delays Baricitinib Review & Removes Bupropion & Varenicline Warnings
FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…
Updated EULAR Recommendations for Early Arthritis; Plus FDA Approves New Abuse-Deterrent Morphine Sulfate
EULAR has updated its recommendations for the management of early arthritis, outlining aspects of diagnosis and drug treatments…
Rheumatology Drug Updates: Giant Cell Arteritis Relapse Possible if Tocilizumab Discontinued; Plus Updates on Rituximab, Etanercept
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
FDA Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
Benefits of Secukinumab in Ankylosing Spondylitis May Persist at 2 Years
NEW YORK (Reuters Health)—Secukinumab appears to improve clinical and radiographic outcomes of ankylosing spondylitis (AS) through two years of therapy, according to new results from the MEASURE 1 study. Secukinumab is a fully human monoclonal antibody against interleukin-17A, which is implicated in various pathophysiological features of spondyloarthritis. In a report online Dec. 13 in the…
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