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…
(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…
LONDON (Reuters)—GlaxoSmithKline, AstraZeneca and Johnson & Johnson have joined with three leading British universities to create a new 40 million pounds ($57 million) fund backing early drug research. The Apollo Therapeutics Fund, which aims to improve the speed and potential of university research being translated into new medicines, is a further example of a trend…
REUTERS—Five people, including two former GlaxoSmithKline researchers, were charged with a scheme to steal trade secrets from the British drugmaker for potential sale in China, according to indictments announced by the U.S. Attorney’s Office in Philadelphia on Wednesday. The indictments include charges of conspiracy to steal trade secrets, conspiracy to commit wire fraud, conspiracy to…
NEW YORK (Reuters Health)—Women with rheumatoid arthritis (RA) are at increased risk for cervical intraepithelial neoplasia (CIN), and those taking a tumor necrosis factor (TNF) inhibitor are at increased risk of cervical cancer, according to a study from Sweden. “Whether this (the increase in invasive cancers) was due to the TNF inhibitors, disease severity, or…
The FDA approved secukinumab (Cosentyx) this past week for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis. These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA…
In Phase 2 trials, the oral opioid, CR845, has proved promising in treating pain in patients with hip and knee osteoarthritis. Olokizumab is being investigated to treat RA, and in Canada, adalimumab has been approved to treat polyarticular JIA in 2–4 year-olds…
RENNES, France (Reuters)—A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week. In total, 90 people took part in the trial of the drug made…
FDA Updates Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.1 The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths…
PARIS (Reuters)—One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug company, the French health ministry said on Friday, Jan. 15. The ministry did not say what the medicine was intended to be used…