NEW YORK (Reuters Health)—Aggregated results from three studies of patients with moderate to severe plaque psoriasis show that Eli Lilly’s injectable drug ixekizumab can completely resolve the plaques in about one third of cases after 12 weeks of treatment. And with continued therapy every four weeks, at least half maintained or attained complete resolution of…
Patients with OA Respond to Low-Dose SoluMatrix Meloxicam; Off-Label Use of Ketoconazole Results in Death
In a clinical trial, patients with osteoarthritis taking low-dose SoluMatrix meloxicam used less rescue medication to manage pain. Also, the FDA has issued a new warning against using oral ketoconazole off label to treat onychomycosis and fungal skin infections…
FDA Panel Backs Teva’s Abuse-Resistant Opioid Painkiller
(Reuters)—A U.S. Food and Drug Administration (FDA) advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties. The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have…
Immunotherapy Largely Untested in Patients with Autoimmune Disease
(Reuters Health)—The safety and effectiveness of cancer immunotherapy is largely unknown in patients with autoimmune diseases, researchers say—and that might account for up to a quarter of individuals with lung cancer. Patients with autoimmune diseases, such as rheumatoid arthritis, ulcerative colitis or psoriasis, have been mostly excluded from clinical trials testing immunotherapies over fears that…
Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…
FDA Restricts Use of Systemic Fluoroquinolones Due to Side Effects & Will Review Application of Apadaz for Pain
The FDA has issued new safety guidelines for systemic fluoroquinolones, restricting their use to patients with no alternative treatment options…
Roche & Novartis Face Off in Biosimilar Drug Battle
ZURICH (Reuters)—Switzerland’s biggest drugmakers are clashing over cheaper copies of pricey biotech drugs—one reason why Novartis is considering selling its $14 billion stake in cross-town rival Roche. With a copycat of Roche’s blood cancer drug Rituxan (rituximab) pending European approval, Novartis aims to muscle in on a share of sales that last year hit 7…
Lilly Says New Type of Pain Drug Could Reduce Need for Opioids
(Reuters)—Eli Lilly and Co. on Tuesday said it and partner Pfizer Inc. aim to seek approval by 2018 for a new type of pain drug that could be an alternative to opioids for osteoarthritis, chronic back pain and cancer pain. The Indianapolis drugmaker said tanezumab, given by injection every eight weeks, could be a far…
Not Junk Mail: Social Security Letter Can Cut Medicare Costs
CHICAGO (Reuters)—A letter arrives in the mail with this opening line: “We are writing to let you know how you can get help paying your Medicare costs.” Your fraud detector probably goes on high alert—the mailboxes of retirees routinely are stuffed with bogus come-ons. But this letter is no scam. More than 2 million seniors…
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