News Wire

The FDA has expanded the indication for dasatinib tablets (Sprycel, Bristol-Myers Squibb Company) to include the treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. Approval was based on data from 97 pediatric patients with chronic phase CML evaluated…
Cariprazine (Vraylar, Allergan PLC) has received FDA approval for the maintenance treatment of adults with schizophrenia. Cariprazine was previously approved for adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder. "Schizophrenia is one…
Testing of C-reactive protein (CRP) may offer a quick and reliable way to identify the patients most likely to achieve the greatest benefits from long-term treatment with canakinumab (Novartis), according to a new analysis of the phase 3 CANTOS study. The results, presented by Dr. Paul Ridker, MD, at…
It’s not easy being an insurance broker these days, as they try to cope with the many challenges involved with the most complicated enrollment season for the ACA since the first enrollment season in 2014. It’s ironic in a way, as Kaiser Health News reports, because Obamacare was meant to be so consumer-friendly…
The FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)––the most common subtypes of cutaneous T-cell lymphoma––who have received prior systemic…
Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted], Dynavax Technologies Corporation) has received FDA approval for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Heplisav-B is the first new hepatitis B vaccine in the United States…
The FDA has approved letermovir (Prevymis, Merck) for the prevention of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT). The medication will be available as once-daily tablets for oral use and as an injection…
More than 600,000 consumers signed up for individual insurance plans under the Patient Protection and Affordable Care Act (PPACA) during the first week of enrollment for 2018, Reuters reports––a positive sign for insurers who take part in the health care program that Republicans are trying to undo.…
Brexanolone (formerly SAGE-547, Sage Therapeutics) helped ease the severity of women’s postpartum depression in two phase 3 clinical trials. Sage has announced positive top-line results from Study 202B in severe postpartum depression (PPD) and Study 202C in moderate PPD. Its proprietary intravenous…
One in four Americans personally knows someone who has overdosed or died from an opioid overdose, knows someone who has become addicted to opioids, or has become addicted themselves, according to a new poll from the National Safety Council (NSC). The opioid crisis is the worst drug epidemic in recorded…
A mixture of two non-addictive, over-the-counter drugs relieves pain just as well than a trio of opioid pain medications for patients who showed up in the emergency department, according to a study in JAMA. “For patients presenting to the ED with acute extremity pain, there were no statistically significant…
A growing number of consumers in the ACA market will be able to get coverage for 2018 without paying any monthly premium, according to health insurers and an analysis of federal data. Some consumers in the 2,722 counties included in the analysis will be able to obtain no-premium insurance thanks to…
Florida Blue wants to do its part to help stem the opioid crisis; a notable exception to what has been a lackluster response to the problem on the part of the insurance industry. When FDA chief Scott Gottlieb issued a call this summer for PBMs and insurers to help solve the opioid crisis, it was mostly…
The World Health Organization (WHO) is urging farmers worldwide to stop using antibiotics to promote growth and prevent disease in healthy animals because the practice fuels dangerous drug-resistant superbug infections in people. Describing a lack of effective antibiotics for humans as “a security…
The FDA has granted regular approval to alectinib (Alecensa, Hoffmann-La Roche, Inc./Genentech, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015, alectinib received…

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