News

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.

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).

Data from the largest clinical trial of myelofibrosis patients treated with ruxolitinib (Jakavi, Novartis) support its safety profile and efficacy benefit, as measured in primary and secondary end points, according to a study presented at the 56th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.

MP Diagnostics HTLV Blot 2.4 (MP Biomedicals) has been approved by FDA as the first FDA-licensed supplemental test for human T-cell lymphotropic virus-I/II (HTLV-I/II). It is a qualitative enzyme immunoassay test, which is to be used to confirm the presence of HTLV antibodies as well as to differentiate between HTLV-I and HTLV-II infection.

On the 1-year anniversary of the first G8 summit on dementia, new funding has been announced for a study to research the use of tadalafil (Adcirca, Cialis; Eli Lilly), an erectile dysfunction drug, for the treatment of vascular dementia.

Providers and care teams working to improve the health of overweight and obese patients must keep hypertension detection and management top of mind for this population.

Formulary managers should be alert to the use of opioid painkillers by special populations, such as people with epilepsy, according to findings during a poster session at the American Epilepsy Society annual meeting in Seattle.

Including more nurse practitioners in a greater number of health plans can improve the experiences of patients as well as the bottom line.

Looking to capitalize on California’s decision to expand Medicaid, Blue Shield of California has purchased Care 1st of Monterey Park, which will add 473,000 Medicaid managed-care members to its rolls.

Dr OvbiageleFor recent ischemic stroke patients, using an optimal combination of evidence-based secondary prevention medication classes, compared to not doing so, was associated with 61% lower odds of experiencing a recurrent stroke, according to a study published online in Neurology.

FDA approved a new use for ruxolitinib (Jakafi, Incyte) to treat patients with polycythemia vera (PV), a chronic type of bone marrow disease. Jakafi is the first drug approved by FDA for this condition.

Narrow networks have sparked concern that they will unduly limit patient care and lead to increased patient use of out-of-network providers with higher out-of-pocket costs.

Recently, accountable care organization's aims have broadened to include overseeing patients with cancer, end-stage renal disease and certain other diseases and chronic conditions.

Now that the ACA has eliminated pre-existing conditions, payers have taken on many unknowns when evaluating the massive population of new members coming in from the state and federal exchanges.

Providers, owners and suppliers who owe Medicare money, have been convicted of felonies or have a history of billing abuse will be excluded from enrollment under new rules adopted by the Centers for Medicare and Medicaid Services (CMS).

Drug shortages and manufacturer consolidation are leaving their imprint on the price of some generic drugs.

Researchers generally agree that intense, highly-coordinated care, with an emphasis on changing patient behavior is a key to improving outcomes and reducing costs for complex morbidities.

Nilotinib (Tasigna) should be considered as a leading option for front-line therapy in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), according to data presented at the 56th ASH Annual Meeting and Exposition in San Francisco.

Actavis Plc has announced that the Infective Drugs Advisory Committee, which makes recommendations to the FDA concerning the safety and effectiveness of drug products for use in the treatment of infectious diseases, has voted to recommend approval of its New Drug Application for ceftazidime-avibactam.

Patients taking statins may be at an increased risk for cataracts, according to a study published in the Canadian Journal of Cardiology.