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.
Discontinuing statin use in patients with late-stage cancer and other terminal illnesses may help improve patients’ quality of life without causing other adverse health effects, according to a study published in JAMA Internal Medicine.
Don’t use a kitchen spoon to give children liquid medications; instead use metric milliliter-only dosing, urges a statement, published online March 30 in Pediatrics.
Plaque psoriasis patients treated with secukinumab (Cosentyx) over ustekinumab (Stelara)-a widely used biologic-can achieve clearer skin, according to a late-breaking research session at the 73rd Annual Meeting of the American Academy of Dermatology (AAD), in San Francisco.
The Food and Drug Administration (FDA) is approving new drugs – especially those to treat cancer – at a near record pace this year.
FDA has approved use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV (Quadracel, Sanofi Pasteur, the vaccines division of Sanofi) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4 through 6 years.
The Affordable Care Act’s medical loss ratio provision yielded more than $5 billion in benefits to consumers from 2011 through 2013, either through the rebates that insurance companies have paid to them or through reduced health plan spending on overhead, according to a new Commonwealth Fund report.
People who take more than 4 doses of medicine a day appear more likely to crush tablets or open capsules potentially reducing their effectiveness, according to a study published in the Journal of Pharmacy Practice and Research.
Health and Human Services (HHS) recently launched a widespread initiative – including increasing the use of naloxone to reverse opioid overdoses – aimed at reducing prescription opioid and heroin related overdose, death and dependence.
Pfizer and Eli Lilly and Company said they will resume Phase 3 clinical studies for tanezumab for chronic pain, after the Food and Drug Administration (FDA) lifted a partial hold on trials.
Both the Food and Drug Administration (FDA) and Harvoni and Sovaldi maker Gilead are warning Hepatitis C patients about serious bradycardia when the drugs are combined with certain other medications.
FDA has approved Anthrax Immune Globulin Intravenous (Human) (Anthrasil, Emergent BioSolutions) also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.
Restrictive Medicaid prior authorization policies are leading to substitution of potentially inappropriate, off-label psychotropic medication use and other problems in prescribing antipsychotic medications for children, according to a recent research letter.
