Actavis plc on Friday said it filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) seeking approval to market Ambrisentan Tablets, a generic version of Gilead Sciences, Inc.'s Letairis®, a treatment for pulmonary arterial hypertension.
Patients diagnosed with deep vein thrombosis (DVT) and treated with rivaroxaban (Xarelto) were admitted to the hospital less frequently than those treated with the standard treatment of low-molecular-weight heparin (LMWH) and warfarin, according to real-world data presented at the Hospital Medicine 2015 Congress.
FDA actions in brief, priority review, breakthrough therapy designation, fast-track designations, orphan drug designations, first-time generic approvals
Coverage of specialty pharmaceuticals varies widely among health insurers, according to a new report from Atlantic Information Services in Washington, D.C.
The oral arguments in King v. Burwell will determine the viability of a central mechanism of the ACA-tax credit subsidies for economically-eligible citizens.
Health plans and providers are working with tech companies to make sure that the digital experience is as smooth and engaging as online shopping.
As the Medicare program and the healthcare industry at large begins the transition from fee-for-service to value-based reimbursement models, health plans are responding by ramping up collaboration with providers to improve health outcomes, especially for medically-complex Medicare members.
Hospital rankings provide consumers with valuable information, but they're not always in agreement.
Controversy surrounds the 340B Drug Discount Program, and many industry leaders agree that the healthcare law plays a large part.
Independence Blue Cross and other Blue providers have partnered together to purchase a real-time secure communication network for physicians and hospitals to be on the leading edge of big data.
Consumer advocacy group Public Citizen said this week that the Food and Drug Administration (FDA) must stop direct-to-consumer advertisements that market several “dangerous” diabetes medications for weight loss or blood pressure reduction.
Sarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with the Food and Drug Administration (FDA) over the approval process for its new drug, according to The Wall Street Journal.
FDA has granted marketing clearance for Alere I Strep A Rapid Molecular Test (Alere). The Alere I molecular test initially received marketing clearance in June 2014 for the detection and differentiation of influenza A and B virus, and in January 2015, the test became the first-ever molecular test to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA.
A significant and growing performance gap exists between dual eligible and non-dual eligible members that cannot be attributed to a health plan's quality of service, a new study by Inovalon has found.
After the first year of Medicaid expansion under the Affordable Care Act (ACA), some healthcare providers and plans on the front lines are confronting operational-as well as political-challenges.
Change has proliferated how health insurance is offered in recent years, and experts predict that private exchanges will now seek to emulate the e-commerce format that public exchanges have embraced.
After several years of uneven progress, the pace of healthcare payment reform shifted into high gear in January when the U.S Department of Health and Human Services (HHS) announced plans to tie 30% of traditional, or fee-for-service, Medicare payments to quality or value alternative payment models by the end of 2016, and 50% by the end of 2018.
Indiana Governor Mike Pence declared rural Scott County a public health disaster after it realized a spike in HIV cases linked to intravenous prescription drug abuse.
Roflumilast, a drug recently approved in the U.S. to treat severe chronic obstructive pulmonary disease (COPD), increases the production of a protein that causes inflammation – which possibly results in patients developing a tolerance to the drug after repeated use and renders it ineffective, according to a new study.
FDA has issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.
Aetna and Coventry Health Care of Florida are reclassifying certain HIV/AIDS medications labeled as specialty drugs to either generic or non-preferred brand drugs, according to Florida Insurance Commissioner Kevin M. McCarty.
The overwhelming majority of state health insurance marketplace plans are not providing required coverage for smoking cessation, according to a new report from the American Lung Association.
There might be a reprieve if the Supreme Court overturns the ACA's tax subsidies offered on federally-facilitated exchanges.
FDA has approved a new administration option for ticagrelor (Brilinta, AstraZeneca) in acute coronary syndrome patients.
FDA has approved label update for abiraterone acetate (Zytiga, Janssen) in chemotherapy-naïve men with metastatic castration-resistant prostate cancer.
On March 31, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, N.C., for the advanced development of a promising experimental drug for Ebola.
UnitedHealth Group’s announcement that its free-standing pharmacy care services business, OptumRx, will merge with Catamaran Corp., the fourth largest pharmacy benefit manager in the U.S., makes sense, according to industry experts.
The cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies is likely to place a tremendous economic burden on the country’s healthcare system, according to a study published in the March 17 issue of the Annals of Internal Medicine.
Pharmaceutical manufacturer Novo Nordisk, based in Denmark, said it will re-submit its new insulin drug, Tresiba, to the Food and Drug Administration (FDA) for approval. The company could approval as early as this fall, which would signal a 2016 launch, according to Reuters.
A combination of medications effectively produced a sustained virologic response (SVR) in Hepatitis C virus (HCV) patients also infected with HIV, according to two new studies.