News Wire

Federal authorities are cracking down on 15 companies that are making unproven claims about unapproved products’ ability to help treat opioid addiction and withdrawal. The FDA and the Federal Trade Commission (FTC) jointly posted warning letters to the marketers and distributors of 12 opioid cessation…
The FDA has approved a second indication for plecanatide (Trulance, Synergy Pharmaceuticals Inc.): the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Plecanatide was already approved for the treatment of adults with chronic idiopathic constipation (CIC). The 3-mg…
For obese people with diabetes, doctors have increasingly been offering gastric bypass surgery as a way to lose weight and control blood glucose levels. Short-term results are often impressive, but questions have remained about the long-term benefits of such operations. Now, a large, international study…
Of the 30 U.S. children who have died from the flu so far this season, some 85% had not been vaccinated, said Centers for Disease Control and Prevention Director Brenda Fitzgerald, MD, who urged Americans to get flu shots amid one of the most severe flu seasons in years. “My message is, if you haven’t…
While e-cigarettes are not without health risks, they are likely to be far less harmful than conventional cigarettes, according to a congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine. The committee that conducted the study concluded that e-cigarettes…
An independent analysis of pharmaceutical industry efforts to tackle drug resistance gives high marks to GlaxoSmithKline and Johnson & Johnson among the large research-based pharmaceutical companies, while Mylan leads the generic medicine manufacturers and Entasis leads in the biotechnology group. The…
Patients with hard-to-treat episodic migraine experienced marked improvement in the phase 3B LIBERTY study of erenumab (Aimovig, Amgen), according to new trial results. The study assessed the efficacy and safety of erenumab 140 mg in patients with episodic migraine who had experienced two to four previous…
RAND Health researchers who studied how much U.S. medical practices were using electronic health records (EHRs) found only about a quarter using them to their full potential, while 39% of the practices were underusing EHRs. The study was funded under the Agency for Healthcare Research and Quality (AHRQ)…
The FDA has sent a complete response letter to Braeburn Pharmaceuticals regarding its new drug application for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD). The FDA has requested additional information in order…
ASP0113 (Astellas Pharma Inc./ Vical Incorporated), an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant recipients, did not significantly improve overall mortality and CMV end-organ disease through the first year following the transplant,…
Two phase 3 studies evaluating a fixed 110-mg subcutaneous dose of reslizumab (Cinqair, Teva Pharmaceutical Industries Ltd.) failed to meet their primary endpoints: reducing exacerbations in patients with uncontrolled asthma in one trial, and reducing oral corticosteroid doses in asthma patients dependent…
A U.S. map of flu activity issued Friday by the Centers for Disease Control and Prevention (CDC) was a sea of red: the color marking the highest levels of outpatient visits for an illness that continues to worsen this season. According to this week's CDC report, covering the week of January 7 to 13,…
In women with metastatic ovarian cancer restricted to the abdominal cavity (stage III), hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival with almost no additional side effects, according to research published in the New England Journal of Medicine. The research, led by the Netherlands…
A final analysis of the phase 3 ASPIRE trial showed that adding carfilzomib (Kyprolis, Amgen) to lenalidomide and dexamethasone reduced the risk of death by 21% versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma, Amgen announced. The analysis, published…
The U.S. Patent & Trademark Office (USPTO) has overturned the sole unexpired patent keeping generic competition at bay for the prostate-cancer medication abiraterone acetate (Zytiga, Janssen Oncology). Generic drug-maker Argentum Pharmaceuticals LLC successfully challenged all claims of a Janssen patent…

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