The FDA has rejected the new drug application (NDA) for Linhaliq (Aradigm Corporation) as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients who have chronic lung infections with Pseudomonas aeruginosa. Aradigm said it received a complete response letter (CRL) stating that the agency…
Researchers at Massachusetts Institute of Technology (MIT) and Brigham and Women’s Hospital have developed a capsule that can deliver a week’s worth of human immunodeficiency virus (HIV) drugs in a single dose. This advance could make it much easier for patients to adhere to the strict schedule…
The FDA’s bid to shut down an Arkansas drug compounder over allegations of “serious deficiencies” is drawing a heated response from the company owner, who says he’s fighting “a bureaucracy that makes broad claims against us, gives little feedback, and ignores independent third-party experts.”…
More children than previously thought may suffer from the health effects that can result when women drink alcohol while pregnant, according to researchers at the University of California San Diego School of Medicine. Their study, published online in the Journal of the American Medical Association, found…
Prices for each of the 20 most-prescribed brand-name drugs for seniors have increased dramatically every year for the past five years, according to a new report released by U.S. Senator Claire McCaskill (D- Missouri). The cost of the drugs, which include brands like Advair (fluticasone propionate and…
Biogen Inc. says it will not develop natalizumab (Tysabri) for the treatment of acute ischemic stroke after the medication failed a phase 2b trial. Natalizumab, which made nearly $2 billion in 2017 sales, is part of Biogen’s franchise of multiple sclerosis (MS) drugs, a Reuters report noted. Biogen’s…
Mylan N.V. and Revance Therapeutics, Inc., are teaming up to develop and market a biosimilar to Allergan’s Botox (onabotulinumtoxinA), the market-leading product in a neuromodulator market with overall sales estimated at $4 billion. The two companies announced a global collaboration and license agreement…
Despite the threat of a global health crisis in antibiotic resistance, worldwide use of antibiotics in humans soared 39% between 2000 and 2015, fueled by dramatic increases in low-income and middle-income countries (LMICs), according to a new study in the Proceedings of the National Academy of Sciences…
Taking a once-daily tablet of semaglutide led to “significant and superior improvements” in long-term blood sugar levels for people with diabetes in the phase 3a PIONEER1 trial, Novo Nordisk announced. PIONEER 1 is the first phase 3a trial of oral semaglutide, a new GLP-1 analogue for the treatment…
The FDA has approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications S.A.) for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutathera, which received…
Just how bad a flu season are we having? Without a crystal ball, it’s impossible to predict the final toll. But just about any way you crunch the numbers, the prognosis is grim. “Most people with influenza are being infected with the H3N2 influenza virus. And in seasons where H3N2 is the main cause…
Two phase 3 studies evaluating a fixed 110-mg subcutaneous dose of reslizumab (Cinqair, Teva Pharmaceutical Industries Ltd.) failed to meet their primary endpoints: reducing exacerbations in patients with uncontrolled asthma in one trial, and reducing oral corticosteroid doses in asthma patients dependent…
The FDA has approved a second indication for plecanatide (Trulance, Synergy Pharmaceuticals Inc.): the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Plecanatide was already approved for the treatment of adults with chronic idiopathic constipation (CIC). The 3-mg…
Far more people than previously thought can benefit from an emergency procedure for acute ischemic stroke, according to a 38-center clinical trial sponsored by the National Institutes of Health and led by researchers at the Stanford University School of Medicine. The improved outcomes were achieved…
Scientists in Japan and Australia have developed a blood test that can identify people who have high levels of a protein associated with Alzheimer's disease. If confirmed by further research, this long-sought test could help in the increasingly desperate search for therapies that halt the progression…
