An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
CVS to Make Overdose Drug Naloxone Prescription-Free in Ohio
(Reuters)—CVS Health Corp said it would make naloxone, available without a prescription at all its pharmacies across Ohio, a state with one of the highest rates of overdose-related deaths. Naloxone is already available without a prescription in CVS Health stores in more than a dozen states. Drug overdoses increased 6.5% in 2014 from a year…
U.S. Appeals Court Ruling May Clear Barrier to Generic OxyContin
(Reuters)—A federal appeals court ruled Monday that four patents related to Purdue Pharma’s painkiller OxyContin are invalid, potentially bringing Teva Pharmaceutical Industries Ltd and others a step closer to introducing generic versions of the drug. Privately owned, Connecticut-based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food…
Newly Released Documents Show Profit-Seeking Behind Price Hikes at Turing, Valeant
WASHINGTON/NEW YORK (Reuters)—A decision by Turing Pharmaceuticals to raise the price of a lifesaving drug by 5,000% drove up some patient co-pays to as high as $16,000, according to excerpts of documents that congressional committee members released on Tuesday. The excerpts, which are highlighted in memos released by Democrats on the powerful U.S. House of…
Apremilast Effective for Psoriatic Arthritis
NEW YORK (Reuters Health)—Apremilast improves clinical outcomes in patients with psoriatic arthritis and active psoriasis, according to results from the PALACE 3 randomized controlled trial. Apremilast, a phosphodiesterase 4 (PDE4) inhibitor, showed efficacy against psoriatic arthritis in the PALACE 1 trial. Dr. Christopher J. Edwards from University Hospital Southampton in the U.K. and colleagues evaluated…
Newer Biologics for RA on Par with TNF-Inhibitors for CV Risk
NEW YORK (Reuters Health)—The newer disease-modifying drugs for rheumatoid arthritis appear to offer the same or even better cardiovascular (CV) protection than older tumor necrosis factor (TNF) inhibitors, hints a large study. “We really haven’t had a good understanding on where the non-TNF biologics and CV risk stand,” Dr. Jeffrey R. Curtis of the University…
Tocilizumab Plus Methotrexate Faster Fix in Some with RA
NEW YORK (Reuters Health)—In rheumatoid arthritis (RA) patients with an inadequate response to methotrexate, adding tocilizumab to the regimen is more effective than simply switching to tocilizumab, according to Japanese researchers. Dr. Tsutomu Takeuchi told Reuters Health by email that the approach “more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical…
Theranos Lab May Pose Jeopardy to Patient Health
(Reuters)—Deficient practices at a lab operated by blood-testing startup Theranos pose “immediate jeopardy to patient health and safety,” the U.S. government’s Centers for Medicare & Medicaid Services said in a letter to the company released on Wednesday. Theranos, founded and led by Elizabeth Holmes, has been in the spotlight after reports in the Wall Street…
3 Clinical Trials Examine Sirukumab for RA; Plus TNF-α Combination & Monotherapies Are Compared for Treating PsA
Three clinical trials are evaluating subcutaneous sirukumab for safety and efficacy in treating rheumatoid arthritis. And a study found no significant difference in persistence and remission for TNF-α monotherapy when compared with TNF-α plus conventional DMARD combination therapy for treating psoriatic arthritis…
U.S. Sen. Markey Places Hold on Obama’s Nominee to Lead FDA
(Reuters)—U.S. Sen. Edward Markey (D-Mass.) said on Monday he has placed a hold on President Barack Obama’s nominee to head the U.S. Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee…
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