(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…
Comment Period Open for FDA Draft Guidance on Osteoporosis Treatments; Plus FDA Rejects Abuse-Deterrent Apadaz
The FDA is currently accepting comments on a draft guideline for osteoporosis treatments, which calls for more research into the long-term effects of drugs on bone quality. Also, the FDA has rejected an application for approval of Apadaz in its current form…
FDA Seeks Suspension of 4,402 Illegal Prescription Drug Websites
(Reuters)—The U.S. Food and Drug Administration said on Thursday it, along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers. The move is part of a global effort being led by the INTERPOL, the world’s largest police organization, to identify the…
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…
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…
Tofacitinib Promising for Psoriatic Arthritis & FDA Issues Alert for Warning for Saxagliptin & Alogliptin Diabetes Treatments
A recent Phase 3 study found tofacitinib safe and effective for treating psoriatic arthritis at both 5 mg and 10 mg doses compared with placebo. And the FDA has added label warnings to saxagliptin and alogliptin for an increased risk of heart failure in individuals taking the drugs, particularly in those with heart and kidney disease…
OA Knee Pain Treatment Enters Clinical Trials, Ixekizumab Receives FDA Approval & Belimumab Promising for SLE Patients
Clinical trials have begun to determine if disodium zoledronate tetrahydrate is safe and effective for treating pain in patients with knee osteoarthritis. The FDA has approved the use of ixekizumab for the treatment of plaque psoriasis. And a study has shown that patients with SLE treated with belimumab may be able to decrease steroid use…
Infliximab Biosimilar Receives FDA Approval
The FDA has officially approved an infliximab biosimilar for the treatment of multiple autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Prescribing information is now available…
Remicade Antibodies Cross-React to Biosimilars
NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance…
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