According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.
FDA approved the first intravenous influenza treatment, peramivir (Rapivab, BioCryst).
Some anti-inflammatory drugs, including ibuprofen have the potential to prevent the second most common type of skin cancer, according to a study published in the Journal of Investigative Dermatology.
Despite known risks of confusion and falls associated with benzodiazepine use in elderly patients, a study published in JAMA Psychiatry, finds that prescription of benzodiazepines increases as people age. The research offers the first estimates of use patterns in the United States.
Employers are increasingly utilizing level-funding, a hybrid self-insurance model, to gain flexibility and control costs.
Eighty-nine new accountable care organizations will join the Medicare Shared Savings program in 2015, bringing the total number of participants to 405.
The Affordable Care Act has ushered in a new era of convergence among healthcare payers and providers.
One medical center is urging parents to seek non-medical solutions for their children’s anxiety or insomnia, after a recent study found that teens prescribed anti-anxiety or sleep medications are up to 12 times more likely to abuse prescription drugs than those who had never been prescribed them.
The Southeastern Pennsylvania Transportation Authority (SEPTA) recently filed a class action suit in federal court against Gilead Sciences, Inc. over the high cost of its hepatitis C drug, Sovaldi.
FDA approved ceftolozane/tazobactam (Zerbaxa, Cubist Pharmaceuticals, Inc.) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.
More than half of all Medicaid beneficiaries nationwide were enrolled in a managed care organization as of September 2014, according to a new analysis by the Kaiser Family Fund.
FDA has approved finafloxacin (Xtoro, Alcon) otic suspension for the treatment of otitis externa.
FDA has approved olaparib (Lynparza, AstraZeneca) for the treatment of women with advanced ovarian cancer associated with defective BRCA genes, as determined by an FDA-approved test.
FDA has allowed marketing of the EnLite Neonatal TREC kit (PerkinElmer), the first newborn screening test for detection of Severe Combined Immunodeficiency (SCID).
FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
The ACA has had a significant impact on uninsurance rates for racial and ethnic minorities, according to a new study by the Urban Institute.
In a shift from fee-for-service to value-based care, UnitedHealthcare has launched a pilot bundled payment model with the University of Texas MD Anderson Cancer Center for head and neck cancers.
Hospitals with high rates of certain hospital-acquired conditions (HACs) will have their Medicare payments cut by 1% for the 2015 fiscal year.
FDA has approved lanreotide (Somatuline Depot, Ipsen) Injection, 120 mg (referred to as Somatuline) for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
The FDA has granted breakthrough therapy designation for Lucentis (ranibizumab, Genentech) for the treatment of diabetic retinopathy.
FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
FDA has cleared a new screening test for the prediction of future coronary heart disease (CHD) events, such as myocardial infarction. It is cleared for use in all adults who have no history of CHD.
FDA has granted the first-ever CLIA waiver for the Syphilis Health Check test, a rapid screening test for syphilis.
The number of states deciding to pursue some form of Medicaid expansion continues to grow, with Alabama, Alaska, Florida, Tennessee and Wyoming moving forward or indicating intent to pursue an alternative plan.
Customers at 7-11 stores who use a bill-paying system will receive information promoting the Affordable Care Act’s open enrollment period on their printed receipts, allowing HHS to reach financially underserved consumers.
A price increase for a popular form of the medication, naloxone, threatens the ability of non-profit programs and organizations, including police departments around the country, to provide a medical antidote for drug overdoses.
Medicare Advantage (MA) members in Humana’s accountable care programs in 2013 had 7% fewer emergency room visits and 4% fewer inpatient hospital admissions than members in traditional, fee-for-service settings.
Almost 2.5 million consumers signed up for health insurance through December 15 as part of open enrollment, and 48% were new consumers.
FDA has approved Cyramza (ramucirumab, Eli Lilly) in combination with docetaxel to treat aggressive non-small cell lung cancer.
A new vaccine, human papillomavirus (HPV) 9-valent vaccine, recombinant (Gardasil 9, Merck Sharp & Dohme), has been approved by FDA for the prevention of diseases caused by 9 HPV types. It is effective against 5 additional strains of the virus than is the previous FDA-approved version of the vaccine (Gardasil).
