News Wire

The FDA is adding a boxed warning to obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) in an effort to prevent incorrect dosing of the liver-disease medication in patients with moderate-to-severe primary biliary cholangitis (PBC). Obeticholic acid has been incorrectly dosed daily instead of…
Sarah Kliff at Vox had the best tweet about this morning’s announcement that Amazon, Berkshire Hathaway, and JPMorgan Chase were forming a new health care company. “Alexa, what is this new Amazon health care company?" https://t.co/oAAI0R4JQH — Sarah Kliff (@sarahkliff) January 30, 2018 The lack…
Increased reimbursements under Medicare Part B overall could offset potential losses for hospitals under changes to the 340B discount program, according to a new analysis. FierceHealthcare reports that consulting firm Avalere Health analyzed hospital-level data from the Centers for Medicare and Medicaid…
The FDA has awarded a breakthrough therapy designation to the investigational oral drug balovaptan (previously known as RG7314, Roche), a vasopressin 1a (V1a) receptor antagonist for individuals with autism spectrum disorder (ASD). Balovaptan has shown the potential to improve social interaction and…
The National Institutes of Health (NIH) is teaming with government, biopharmaceutical, life science, and nonprofit organizations to overcome obstacles and increase success for advancing promising treatments for Parkinson’s disease (PD). Part of the NIH Accelerating Medicines Partnership (AMP), AMP…
A new study at Columbia University Irving Medical Center (CUIMC) challenges the popular notion that psychiatric medications are overprescribed in U.S. children and adolescents. When the researchers compared prescribing rates with prevalence rates for the most common psychiatric disorders in children,…
Amazon.com, Inc., Berkshire Hathaway, and JPMorgan Chase & Co. will form a health care company aimed at cutting costs for their U.S. employees, the three partners have announced. Reuters reports that the news sent shares in the broad health care sector sharply lower. The independent company will be…
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…
President Donald Trump said prescription drug prices will come “rocketing down” under the leadership of the new secretary of Health and Social Services (HHS), according to a report from The Hill. “We have to get the prices of prescription drugs way down and unravel the tangled web of special interest…
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…
Emicizumab (Hemlibra, Roche Holding AG), a costly new drug to treat the bleeding disorder hemophilia A, could significantly reduce health care expenses for certain patients, according to a draft report from an independent U.S. nonprofit organization that evaluates clinical and cost effectiveness of…
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…
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…
The 340B Drug Pricing Program, a 25-year-old discount plan aimed at boosting resources for hospitals treating low-income patients, has not delivered on its promise to enhance care for the needy, according to research from Harvard Medical School and the NYU School of Medicine. The federal program was…
Solanezumab, a monoclonal antibody-based treatment for Alzheimer’s disease developed by Eli Lilly that targets amyloid plaques, did not significantly slow cognitive decline, according to a report published in The New England Journal of Medicine. Researchers have proposed that Alzheimer’s disease…

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