News Wire

The American Urological Association (AUA) and the Society of Urologic Oncology (SUO) have released a new clinical practice guideline for non–muscle-invasive bladder cancer (NMIBC). The new document outlines guidance on a variety of topics, including diagnosis and treatment, as well as a risk-stratified clinical framework for postsurgical management of the disease.

Positive results have been reported from the sixth and last global phase 3a study (SUSTAIN 6) of semaglutide (Novo Nordisk), an investigational glucagon-like peptide-1 (GLP-1) analogue, which was administered subcutaneously once weekly in the SUSTAIN trials.

Positive results have been reported from the phase 3 clinical trial program for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist (LAMA), delivered via the investigational eFlow nebulizer system (SUN-101/eFlow, Sunovion Pharmaceuticals), for patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

The Department of Health and Human Services (HHS) has issued a final rule on managed care in Medicaid and the Children’s Health Insurance Program (CHIP). The rule is the first overhaul of Medicaid and CHIP managed-care regulations in more than a decade.

The Campaign for Sustainable Rx Pricing, a coalition of hospitals, insurers, and businesses, has released a policy proposal that aims to increase drug-pricing transparency and promote competition. The coalition includes the Federation of American Hospitals, the American Hospital Association, the Blue Cross Blue Shield Association, Kaiser Permanente, and the AARP.

Xtampza ER (oxycodone) extended-release (ER) capsules CII (Collegium Pharmaceutical, Inc.) has won full marketing approval from the FDA. The drug was awarded tentative approval in November 2015, but full approval was contingent on the outcome of a lawsuit filed by Purdue Pharma against Collegium.

The FDA has issued a complete response letter for Digital Medicine (Otsuka Pharmaceutical/Proteus Digital Health), a drug/device combination product that combines the atypical antipsychotic drug aripiprazole (Abilify, Otsuka) with the FDA-cleared Proteus ingestible sensor embedded in a single tablet at the point of manufacture.

In people with osteoporosis, one fracture often leads to more fractures and potentially to a future of pain, disability, and poor quality of life.

The FDA has approved cabozantinib tablets (Cabometyx, Exelixis, Inc.) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults.

The FDA is evaluating the results of a Danish study that concluded there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan, Pfizer, and generics) for the treatment of yeast infections. The agency says it will communicate its final conclusions and recommendations when the review is complete.

The Leapfrog Group, a nonprofit organization based in Washington, D.C., has announced its Spring 2016 Hospital Safety Score update, assigning letter grades to more than 2,500 U.S. hospitals, assessing medical errors, accidents, injuries, and infections.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has concluded that the investigational medication eteplirsen (Sarepta Therapeutics) is not effective for treating Duchenne muscular dystrophy, a fatal muscle-wasting disease that affects approximately 13,000 children, mostly boys. The panel voted 7 to 3 against the drug, with three abstentions.

The FDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol (AstraZeneca) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Hospital officials should be aware of an unusual bacterial outbreak taking place in Wisconsin that has yet to be explained and could pose a threat elsewhere, according to an article posted on the Hospitals & Health Networks website.

People taking proton pump inhibitors (PPIs) for heartburn are at increased risk of severe kidney disease, according to a Reuters report. A new study of hundreds of thousands of patients in Department of Veterans Affairs (VA) databases has found that new users of PPIs without kidney disease were 30% more likely to develop chronic kidney disease (CKD) over the course of five years.