News Wire

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…
Novoclem Therapeutics, Inc., has announced that its inhaled antimicrobial drug candidate BIOC51 has been designated a qualified infectious disease product (QIDP) by the FDA. The QIDP designation, granted for treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic…
For the first time, scientists have found a connection between abnormalities in how the brain breaks down glucose and the severity of the signature amyloid plaques and tangles in the brain, as well as the onset of eventual outward symptoms, of Alzheimer’s disease. The study was supported by the National…
A new study to assess the effects of FDA regulations and guidance that sought to encourage greater inclusion of women and minorities in clinical drug trials found appropriate levels of female participation based on the estimated sex ratio of people affected by a particular disease. In contrast, some…
The FDA has approved vemurafenib (Zelboraf, Genentech) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of white blood cells called histiocytes, which can invade normal tissues and organs in the body. The approval…
Nivolumab (Opdivo, Bristol-Myers Squibb) showed a three-year survival benefit over everolimus (Afinitor, Novartis) in advanced renal cell carcinoma (RCC) in a phase 3 study, reducing the risk of death by 26%. The three-year overall survival (OS) update from the CheckMate -025 study, evaluating previously…
Canagliflozin (Invokana, Janssen) improved renal outcomes and demonstrated potential renal protective effects in patients with type-2 diabetes mellitus (T2DM) who have heart disease or are at risk for it, new analyses from the CANVAS clinical trial program show. The data were presented at the American…
California’s Medicaid health plans have made a nifty profit partly as a result of the state increasing payments to Medicaid insurers in anticipation that expansion of the program under the ACA would lure many sicker beneficiaries. But that didn’t happen, reports Kaiser Health News. The…
The details remain murky about just what’s going on regarding a possible merger of CVS and Aetna, news of which broke last week, but experts say that such a corporate entity could challenge the sweet position occupied by UnitedHealth Group and its PBM affiliate OptumRX. OptumRX is just one of the…
The drug approval process should include an only-in-research (OIR) step that would gauge real-world effectiveness. That’s the argument put forth by Anirban Basu, a professor at the University of Washington, in a Health Affairs blog post. Basu says that at the completion of phase 2 trials, the manufacturer…

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