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Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved,..should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside. Food and Drug Administration rulings can make or break these companies…. big FDA decisions coming up on the calendar for the month of September..

1. Opko Health - expecting a rolapitant PDUFA (Prescription Drug User Fee Act ) action date on September 5. (prevention of chemotherapy induced nausea and vomiting)
2. Tesaro - tag along with Opko, has a New Drug Application for oral rolapitant under review by the FDA with the same PDUFA goal date.
3. Zosano Pharma - completed its enrollment for the Phase 2 trial for ZP-Glucagon. (significant improvement over the currently marketed products for treatment of severe hypoglycemia)
4. Xenoport - completed enrollment in its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis..
5. Apricus Biosciences - enrolled its last patient in its RayVa Phase 2a proof-of-concept study, (Raynaud’s phenomenon secondary to scleroderma)

All 11,000 workers, retirees and family members insured by the Washoe County School District are being put on health plans with Renown Health starting in January, but their coverage won’t be restricted to Renown-branded facilities and providers, company representatives emphasized this week following concerns about the new contract.

Two NIH institutes join forces to educate teens about the risks of using drugs and alcohol…An annual, week-long observance that brings together teens and scientific experts to shatter persistent myths about substance use and addiction will feature information about alcohol in addition to drug use. Now called National Drug and Alcohol Facts Week, the observance will be held Jan. 25-31, 2016, and is sponsored by the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism, both part of the National Institutes of Health. The institutes often work together on research and prevention initiatives.

A 12-hospital health system is notifying hundreds of its current and former patients that their protected health information has been compromised after discovering an employee was involved in identity theft…Merit Health system based in Jackson, Miss., only learned of the breach after local law enforcement notified them that one of their employees…was under investigation for identity theft,..The employee was allegedly swiping patient files for more than a year undetected,..swiped records containing patient names, Social Security numbers, medical diagnoses data, health plan data and also payment information.

Dutch public employees' pension fund, the world's third largest, has sold all its shares in pharmaceuticals maker Mylan after it emerged that one of the company's products is in stock at a U.S. prison where death sentences are carried out…European companies are barred from selling drugs for use in executions, forcing states that still impose the death penalty to scrabble for alternative substances, some of which have led to widely publicized and gruesome botched executions.

Department of Health and Human Services has no plans to curtail use of enterprise social network Yammer, despite a scathing report detailing serious security risks associated with that platform at the Department of Veterans Affairs…VA’s Office of Inspector General issued a report calling Microsoft-owned Yammer "unapproved," … we found that it had vulnerable security features, recurring website malfunctions, and users engaged in a misuse of time and resources,"..

Pfizer has no problem keeping sales for Viagra flying high in China,… But the company has gotten in hot water for its efforts, as Chinese marketing authorities slapped Pfizer with a fine for paying local drugstores to promote its blockbuster ED med. Pfizer inked deals with four Shanghai pharmacies to display the drug… violating China's drug management rules...

An independent pharmacy will pay a $46,000 settlement over an alleged lack of break times for its employees…Three former employees,..filed small claims lawsuits with California’s labor commissioner against Point Reyes Station-based West Marin Pharmacy…Deputy Labor Commissioner…ruled that the pharmacy owed the 3 ex-employees rest-period premium wages and waiting-time penalties.

…. proponents of e-prescribing have achieved their goal of electronic prescribing of controlled substances becoming legal nationwide, as Vermont has become the last holdout to change its rules… years of protests from law enforcement over concerns that drug diversion would increase, the federal Drug Enforcement Agency in 2010,legalized e-prescribing of Schedule II-V drugs,

Treatment has complementary actions that help control blood glucose. A new type 2 diabetes treatment for adult patients, empagliflozin and metformin (Synjardy), was approved by the FDA…(from Boehringer Ingelheim and Eli Lilly)… is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. The 2 medicines…have complementary actions that help control blood glucose,…Empagliflozin removes excess glucose through urine by blocking glucose reabsorption in the kidney, while metformin lowers glucose production by the liver and absorption in the intestine,…