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…
U.S. FDA Approves First-Ever Implant to Treat Opioid Addiction
(Reuters)—The first-ever implant to fight addiction to opioids, a class of drugs that includes prescription painkillers and heroin, was approved by the U.S. Food and Drug Administration on Thursday. The matchstick-sized implant, developed by Titan Pharmaceuticals Inc. and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues…
Osteoarthritis Treatments: Monoclonal Antibody Starts Clinical Trial & Fasinumab Promising for Treating Pain
Recent clinical trials have evaluated the efficacy of GSK3196165, a monoclonal antibody, and fasinumab, a nerve growth factor antibody, in treating patients with osteoarthritis and pain…
Baricitinib Has Promising Clinical Trial Results for Treating RA
Recent clinical trials have shown that baricitinib is safe and effective for treating patients with rheumatoid arthritis who have proved non-responsive to multiple biologic treatments…
TNF Blocking Drugs Persist in Infants after Exposure In-Utero
NEW YORK (Reuters Health)—Babies born to mothers who took anti-tumor necrosis factor (anti-TNF) agents during pregnancy have detectable drug in their bodies up to 12 months of age, new findings show. These infants should therefore not receive live vaccines during their first year of life, Dr. Mette Julsgaard of Aarhus University Hospital in Denmark and…
Drug Company Gifts Linked to Doctors’ Prescribing Habits
(Reuters Health)—Doctors who receive payments or gifts from pharmaceutical companies are more likely to prescribe brand name medications, a new study suggests. Dr. James Yeh, of Brigham and Women’s Hospital in Boston, and colleagues write May 9 online in JAMA Internal Medicine that some states require doctors to report what they receive from drug companies….
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