- CMS appoints ICD-10 ombudsman (healthcareitnews.com)
William Rogers, MD, director of the Physicians Regulatory Issues Team at the Centers for Medicare and Medicaid Services, will act as ICD-10 ombudsman to the federal agency, He will work out of an ICD-10 coordination center in Baltimore.. Implementation of ICD-10 is only 34 days away… CMS has said it will not deny claims as long as the right code family is used, the agency will not send back a message if the wrong code is used.
- MHRA (Medicines and Healthcare products Regulatory Agency) uncovers 1m illegal ED drug haul? (in-pharmatechnologist.com)
A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation. Sundeep Amin, 57, pled guilty to 21 counts of importing, possessing and supplying unlicensed medicines. Officers from the UK medicines regulator seized nearly £900,000 ($1.4m) of unlicensed medicines… As well as illegal importation, Amin admitted possession of a large amount of the Class C, Schedule II benzodiazepine Phenazepam, and to laundering money from his crimes..
- Las Vegas trial centers on diabetes drug Actos (reviewjournal.com)
Billions of dollars are at stake in a Las Vegas trial that centers on two men who were diagnosed with bladder cancer after taking the diabetes drug Actos… Robert Eglet… represents Mary Iorio, the widow of Maurice Iorio.. filed a product liability case… against Takeda Pharmaceutical Co… Thousands of plaintiffs across the country have filed product liability lawsuits against Takeda. The company is accused of failing to inform consumers and medical professionals about the risk of bladder cancer...
- CDC and Sepsis Alliance Team Up for Sepsis Awareness Month (sepsisalliance.org)Sepsis Alliance (sepsisalliance.org)
Sepsis Alliance and… Centers for Disease Control and Prevention will mark Sepsis Awareness Month in September by collaborating on a variety of efforts and new resources. Throughout the month of September, CDC will release a new series of fact sheets, host a twitter chat to engage the public in a conversation about sepsis, and host a blog series on its Safe Healthcare Blog to share first-hand experiences of doctors, first responders, patients, and family members coping with the devastating effects of sepsis.
- Amgen wins approval for second biotech cholesterol drug (cnbc.com)
Amgen has won federal approval for the second medicine in a new class of pricey biotech drugs that reduce artery-clogging cholesterol more than older statin drugs that have been used for decades…Repatha (evolocumab) could eventually help millions of Americans who face increased risks of heart disease because they cannot control their cholesterol with existing drugs and methods. .. medication's price tag—$14,100 per year
—patients with extremely high levels of LDL, or bad cholesterol, due to inherited conditions
—patients with persistently high LDL levels and a history of heart attack, stroke and other cardiovascular problems
….designed to be self-injected on a monthly or bi-monthly dosing schedule.
- Metro’s top cop says he wants to keep medical pot businesses safe (reviewjournal.com)
Clark County's top law enforcement officer told a room full of marijuana business owners Thursday that he wants to work with them…Sheriff Joe Lombardo,...made light of the historic nature of his appearance at a lunch meeting of the Las Vegas Medical Marijuana Association…sheriff's in a marijuana (meeting)," he said to laughter…. his two biggest concerns are the prospect of people driving under the influence and the potential for robberies or thefts given the cash-heavy nature of the business…
- Millions in the red, a Nevada Obamacare insurer has failed (reviewjournal.com)
Nevada's health insurance exchange is losing its only locally based carrier. Nevada Health CO-OP, a nonprofit insurer created by the Affordable Care Act and federally funded to offer health coverage through the Nevada Health Link marketplace, said Wednesday that it cannot make enough money to stay in business after Jan. 1…second year of high claims costs and limited growth projections for enrollment made it "clear" the insurer would have a hard time providing "quality care at reasonable rates" in 2016.
- Cholesterol drug wars (video.cnbc.com)
After Regeneron and Sanofi got FDA approval for their cholesterol drug last month, today is Amgen's turn. CNBC's Meg Tirrell reports. (video)
- EDITORIAL: Finally, a new kind of pharmacy (reviewjournal.com)
Clark County's first marijuana dispensary opened for business Monday. Legal retail sales of pot commenced… Euphoria Wellness…the first medical marijuana… was commercially grown…More than 6,000 registered medical marijuana patients live in Clark County. There still isn't enough supply for all of them…considering Nevada dispensaries are allowed to sell to registered marijuana patients from other states, buyers can expect a limited supply for the near future.
- The FDA has spoken on biosimilar names. But will its hybrid proposal work? (fiercepharma.com)Naming and Biological Products (blogs.fda.gov)
After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. ..it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy… both branded meds and biosims would share a "core drug substance" name… Each product would also carry a four-letter suffix….individualized product-by-product,..








