The FDA accepted for review a supplemental biologics license application for denosumab to treat patients with glucocorticoid-induced osteoporosis…
U.S. Judge to Review Trump Healthcare Payments Cut
SAN FRANCISCO (Reuters)—A U.S. judge is set to hear arguments on Monday about whether to block President Donald Trump’s decision to terminate controversial payments to health insurance companies under Obamacare. U.S. District Judge Vince Chhabria in San Francisco federal court has said he would quickly issue a ruling following the hearing. Several U.S. states sued…
GSK Wins U.S. Shingles Vaccine Approval, U.K. Nod for Gene Therapy
LONDON (Reuters)—GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three key products for which the British drugmaker expects approval this year. It also secured a recommendation from U.K. cost authorities for a $700,000 gene therapy for so-called “bubble boy” disease—a step forward for the field of fixing faulty…
Potential Biomarker for APS Identified
New research examines the role of factor Xa in the pathology of antiphospholipid syndrome (APS) and systemic lupus erythematosus-associated APS. Researchers found that FXa stimulation was mediated by protease-activated receptors and enhanced by IgG from FXa reactive antibody positive patients, which may make IgG FXa reactivity a novel biomarker for future research…
More Republican U.S. Senators Back Bipartisan Obamacare Deal
WASHINGTON (Reuters)—A bipartisan deal to stabilize Obamacare by restoring billions of dollars of federal subsidies to health insurers picked up Republican support in the Senate on Thursday despite President Donald Trump’s opposition but still faced an uphill battle. Republican Senator Lamar Alexander and Democratic Senator Patty Murray formally introduced legislation to shore up the insurance…
FDA Teams with Medical Companies in Puerto Rico to Tackle Shortages
(Reuters)—The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the U.S. as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.1 Drugmakers are working to get…
Obamacare Whiplash Leaves States, Insurers with Dueling Price Plans
NEW YORK (Reuters)—President Donald Trump’s reversals in the past week on maintaining Obamacare subsidies to insurers are sowing new confusion over what kind of health insurance will be available to consumers, and at what price, when enrollment for 2018 begins in two weeks. Trump said last week his administration would stop paying billions of dollars…
Biosimilar Infliximab Appears Safe, Effective in Pediatric IBD
NEW YORK (Reuters Health)—A biosimilar version of infliximab appears as effective as the original for treating pediatric inflammatory bowel disease (PIBD), and less costly, new research shows. “These baseline data have now enabled us to confidently switch patients from originator to biosimilar, adopting the same prospective methodology to monitor effectiveness, safety and cost,” Dr. Lisa…
Where OA & Depression Intersect
Pain, limited mobility and lower quality of life—these aspects of living with osteoarthritis may result in severe depression. New research from Alan Rathbun, PhD, MPH, may enable physicians to better understand the intersection of physical and mental health so they can improve overall patient care…
Novartis to Shut U.S. Generics Plant, Cut 450 Jobs
ZURICH (Reuters)—Swiss drugmaker Novartis is to cut 450 jobs in the United States over the next two years as it gradually shuts a generics manufacturing plant in Colorado and discontinues some products in the face of intense price pressures. “To remain competitive in the U.S., Novartis will discontinue or divest limited growth products in saturated…
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