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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 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.

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.

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.

The FDA has given the nod to a supplemental new drug application (sNDA) for the use of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child–Pugh class A). The application was previously granted a priority review.

A new infection alert system in catheters could prevent serious infections in millions of hospital patients worldwide, according to a paper published in Biosensors and Bioelectronics. The system changes the color of the urine so caregivers and patients can see whether bacteria are starting to block the catheter.

The FDA has accepted for review the resubmission of a new drug application for Carnexiv (Lundbeck), an intravenous (IV) formulation of the antiepileptic drug carbamazepine. An action letter is anticipated before the end of 2016.

More dialogue between drug-makers and insurers would ease the pain for both insurers and patients when expensive new drugs hit the market, representatives from the pharma and insurance industries told Morning Consult

The long-held approach to predicting seasonal influenza vaccine effectiveness may need to be revisited, new research suggests. Currently, seasonal flu vaccines are designed to induce high levels of protective antibodies against hemagglutinin (HA), a protein found on the surface of the influenza virus that enables the virus to enter a human cell and initiate infection.

The FDA has announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling.

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