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Thursday, September 20, 2018

Astellas Has Positive Results for Phase 3 Chronic Kidney Disease Med Trial


Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’) today announced that roxadustat, an inhibitor of hypoxia ¬inducible factor (HIF) prolyl hydroxylase activity, met its primary endpoints in the Phase 3 ALPS study by demonstrating superiority in efficacy versus placebo in terms of both hemoglobin (Hb) response rate in the first 24 weeks and Hb change from baseline at Weeks 28 to 521. The preliminary safety analysis for this trial shows an overall event profile consistent with the results seen in previous roxadustat studies in CKD patients with anemia.
‘The ALPS study adds to the growing body of evidence to support roxadustat as a potential treatment of anemia associated with CKD,’ said Salim Mujais, M.D, senior vice president and global therapeutic area head, Medical Specialties Development, Astellas. ‘This condition can have a debilitating impact on the patients affected, and we look forward to continuing our work to potentially make a new therapeutic option available to the physicians who care for them.’
The ALPS study is the first of three Astellas Phase 3 studies conducted mainly in EMEA to report. The study forms part of a wider large-scale global Phase 3 development program for roxadustat conducted in collaboration with its partner FibroGen, Inc. (NASDAQ: FGEN), and will ultimately support filing and reimbursement in Europe. The ALPS study is a randomized, double-blind, placebo-controlled study of the efficacy and safety of roxadustat for the treatment of anemia in CKD in patients not on dialysis2.
Further detailed data from this study are expected to be reported in the future.

Nestle to examine ‘strategic options’ for skin health unit


Nestle said on Thursday it was exploring strategic options for its skin health business, saying it believes the unit might be better off outside of the Swiss food maker.

Following a strategic review earlier this year, Nestle’s board decided to increase the company’s focus on food, drinks and nutritional health products.
“The Board has come to the conclusion that the future growth opportunities of Nestle Skin Health lie increasingly outside the Group’s strategic scope,” the Swiss company said. “The Board has therefore decided to explore strategic options for Nestle Skin Health.”

Wednesday, September 19, 2018

Walmart wants to bring its ‘everyday low prices’ to health care


When most people think about health care, rarely do “discounts” and “low prices” come to mind.

But Walmart is looking to change that.
The retail behemoth, which markets itself as the leader in “Everyday Low Prices,” is beefing up its presence in the health care sector. It inked a deal last month with Anthem, one of the nation’s largest insurers, to entice more Medicare enrollees to buy over-the-counter medications and health supplies at its stores. It recently tapped former Humana executive Sean Slovenski to lead its health and wellness division. And it was reportedly looking to buy PillPack before Amazon purchased the online pharmacy in June.
Walmart (WMT) is one of the latest — and largest — retailers to expand its reach into the fast-growing and lucrative health care arena, which makes up 18% of the nation’s economy and is growing. Amazon is also ramping up its health care offerings, and CVS (CVS) is purchasing Aetna (AET) to expand its services.
Walmart’s moves will help it gain a further foothold in this market and deepen its relationship with its 140 million weekly customers. It comes at a time when the mega-retailer is looking to fend off rivals, including Amazon.
“Because of its strategic importance, we’ve decided to put more focus on our Health & Wellness business in the near term,” Greg Foran, CEO of Walmart US, said when announcing Slovenski’s appointment in July, noting that Slovenski will report directly to him. The company declined to comment for this story.

Already one of the nation’s leading pharmacies, Walmart could look to provide more low-cost health services, including basic medical care through nurse practitioners, physician assistants or even doctors, experts predict.
Big discounters such as Walmart may also offer primary care, nutrition and weight counseling and chronic disease management, said Sam Glick, a partner in Oliver Wyman’s health and life sciences consulting practice. That’s one of the main advantages physical retailers have over their online competitors.
“There’s a certain amount of health that’s about laying hands,” Glick said.
Expanded care was a key motivation behind Walmart’s reported negotiations with Humana (HUM)earlier this year. The two were exploring a variety of options, including Walmart purchasing the health insurer, according to the Wall Street Journal.
What is health care’s allure for Walmart? Medical services typically have higher margins than store products. Since they are often provided in person, there is more opportunity for consumers to pick up other items while visiting the store. And usage is growing, especially as the United States’ population ages.
In particular, Walmart is eyeing both the Medicare and Medicaid markets since many of its customers are senior citizens and lower-income Americans. Its prices are generally lower than at pharmacy chains, such as CVS.
As Walmart expands its health care menu, it builds even more ties with its shoppers. Its deal with Anthem, for instance, lets the insurer’s Medicare Advantage customers use their plan benefits to purchase over-the-counter medicine, first aid supplies, support braces and pain relievers from a store.
And Walmart can market its healthy grocery items to certain Medicare Advantage enrollees since the federal government recently allowed insurers to cover such products as a supplemental benefit. This has given the company another advantage over pharmacy chains, which have much more limited food selections.

Also, the retailer’s locations blanket the nation. Many are in rural areas where there are few other health care options. Walmart often operates as a community center, with customers dropping in a few times a week. And it serves as a one-stop shop, where people could access medical services and pick up whatever other items they need.
“You have thousands of physical locations so the convenience is there,” said Charles O’Shea, a retail analyst at Moody’s.
Plus, Walmart knows its customers. It can attract those with diabetes or heart conditions, for instance, by offering them counseling services or discounts on items they need.
“Consumers of Walmart and other sophisticated retailers will begin to identify them as their trusted health care partner and use them for an increasing range of health care services,” said John Matthews, national strategy leader, healthcare and life sciences at KPMG.
Health care isn’t a new area for Walmart. The Bentonville, Arkansas, company has years of experience providing Health and wellness products, which have accounted for 11% of its merchandise sales in recent years. It’s probably best known for selling several dozen generic prescription drugs for $4 each, a program that launched in 2006.

Customers, many of whom are senior citizens, can also get eye care at roughly 3,000 in-store vision centers and free health screenings at Walmart’s 4,700 locations four times a year. They can receive hands-on help enrolling in Affordable Care Act policies, Medicare Advantage plans and prescription drug plans through the company’s partnership with directhealth.com.
The retailer also dipped a toe in the booming urgent care industry a few years ago and now operates a total of 19 Walmart Care Clinics in Georgia, South Carolina and Texas. Visits cost between $59 and $99, and customers can get routine and urgent care, as well as lab tests and immunizations, from nurse practitioners. But the effort has met with mixed success, experts said, and has not expanded nationwide.

Opioid crisis grows among seniors


Against the backdrop of an unrelenting opioid crisis, two new government reports warn that America’s seniors are succumbing to the pitfalls of prescription painkillers.
Issued by the Agency for Healthcare Research and Quality (AHRQ), the reports reveal that millions of older Americans are now filling prescriptions for many different opioid medications at the same time, while hundreds of thousands are winding up in the hospital with opioid-related complications.
“These reports underscore the growing and under-recognized concerns with opioid use disorder in older populations, including those who suffer from chronic pain and are at risk for adverse events from opioids,” said Dr. Arlene Bierman. She is the director of AHRQ’s Center for Evidence and Practice.
Bierman was part of a team that focused on trends regarding opioid-related hospitalizations and emergency department visits among U.S. seniors.
The agency’s second report analyzed opioid prescription patterns among older Americans.
Bierman and her colleagues pointed out that chronic pain is common among seniors, as eight in 10 struggle with multiple health conditions, including heart disease, diabetes, arthritis and depression.
To cope, many seniors take opioids, which inevitably raises the risk for side effects and negative drug interactions.
And in fact, the team found, opioid-driven complications were the cause for nearly 125,000 hospitalizations — and more than 36,000 emergency department visits — among seniors in 2015.
The report also uncovered other alarming trends. Between 2010 and 2015, there was a 34 percent jump in the number of opioid-related inpatient hospital admissions among seniors, even as non-opioid-related inpatient hospitalizations dropped by 17 percent.
Similarly, AHRQ investigators found that opioid-related emergency department visits among seniors shot up by 74 percent, while non-opioid related emergency department visits only increased 17 percent.
At the same time, AHRQ’s second report found that nearly 20 percent of seniors filled at least one opioid prescription between 2015 and 2016, equal to about 10 million seniors. And more than 7 percent — or about 4 million seniors — filled prescriptions for four or more opioids, which was characterized as “frequent” use.
Frequent use was found to be notably more common among seniors who were either poor or low-income, insured through Medicare or another form of public insurance, and/or residents of rural areas.
Opioid use also went up dramatically depending on a person’s perceived health status. For example, only 9 percent of seniors in “excellent” health filled out opioid prescriptions, compared with nearly 30 percent in “fair” health and 40 percent in “poor” health.
The challenge, said Bierman, “is safe-prescribing for those who need opioids for pain, while avoiding overuse or misuse.”
Clinicians, she advised, could address that concern “by using non-opioid pain medications and non-pharmacologic treatments before considering the use of opioids.” And she suggested that if and when opioids are needed, “the lowest possible dose should be used.”
Dr. Anita Everett is chief medical officer for the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA). She said that the findings shouldn’t come as a surprise.
“As a society, we don’t typically think of persons in the grandparent generation as having opioid use disorder,” she said. But when common chronic pain is paired with “the generation of physicians that were taught that opioid medication, when used for pain, was not likely to become addictive,” the result is a senior citizen opioid problem.
And, Everett said, the problem is likely more acute among the rural and the poor, who “often are in situations wherein they have fewer resources, less alternative treatments and may not know about the chances of becoming addicted to a prescription medication.”
Shame, stigma and social isolation among older people may also complicate efforts to prevent addiction or tackle it when it occurs, she added.
The solution? Everett suggested that caregivers have to be educated about the risk.
“SAMHSA supports early training for all health professionals so that addiction can be avoided, identified and treatment offered as early as possible,” she said.
More information
There’s more on opioid treatment among seniors at SAMHSA.
SOURCES: Arlene Bierman, M.D., M.S. director, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, Rockville, Md.; Anita Everett, M.D., chief medical officer, Substance Abuse and Mental Health Services Administration, Rockville, Md.; September 2018, Agency for Healthcare Research and Quality, reports

1 in 6 Americans Over 40 Has Been Knocked Unconscious: Study


 Brain injury research typically focuses on football players and military veterans, but a new study suggests head injuries are far more widespread than estimated.
About 1 in every 6 U.S. adults — roughly 23 million people aged 40 or older — have been knocked out by a head injury, researchers report.
“Those numbers are huge,” said lead researcher Dr. Andrea Schneider, a neurologist with Johns Hopkins University in Baltimore. “Head injury in the United States is much more common than we thought.”
Further, these head injuries are associated with neurological and psychological problems such as depression, sleep disorders, stroke and alcoholism, the researchers found.
For this study, Schneider and her colleagues relied on data gathered by the National Health and Nutrition Examination Survey, which is conducted by the U.S. Centers for Disease Control and Prevention.
The data showed that nearly 16 percent of U.S. adults aged 40 and older answered yes to the question, “Have you ever had loss of consciousness because of a head injury?”
Men were nearly twice as likely to have answered yes, about 20 percent compared with 12 percent among women.
This could be because men are more involved in careers and pastimes with an increased risk of head injury, such as military service or contact sports, Schneider said.
People who reported a head injury that knocked them out were 54 percent more likely to have a sleep disorder, 68 percent more likely to have had a stroke, twice as likely to be a heavy drinker, and more than twice as likely to have symptoms of depression.
However, researchers can’t say from this data which way the relationship runs between head injury and these health problems, Schneider said.
It could be that depression or sleeplessness or heavy drinking make you more likely to suffer a head injury. It also could be that a head injury increases your risk to subsequently suffer from these problems.
“More prospective studies are needed to look into the directionality of these relationships,” Schneider said.
Kristen Dams-O’Connor, co-director of the Brain Injury Research Center of Mount Sinai in New York City, suspects the relationship runs both ways. Head injuries are prompted by these neurological and psychological problems, but the injuries also can either cause new problems or make existing problems worse.
“We may be talking about people who are associated with previous risk factors, and you’ve now got a traumatic brain injury overlaid upon whatever they were suffering before,” said Dams-O’Connor, who wasn’t involved with the study.
She believes the number of people who’ve suffered a brain injury is even higher than found here.
“I think the numbers are impressive. The numbers are staggering. They certainly support the notion that we need to learn a heck of a lot more about how to prevent this injury,” Dams-O’Connor said. “But at the end of the day, I think this is definitely an undercount.”
The single question used in this survey does not capture all of the potential scenarios in which a traumatic brain injury could occur, Dams-O’Connor explained.
For example, the survey question would not reflect people who were dazed or confused by a blow to the head that did not cause them to lose consciousness, she said.
“That would meet the criteria for a mild traumatic brain injury, and none of those people are even included in this estimate,” Dams-O’Connor noted.
It’s unknown whether these 23 million or more people are at increased risk for neurological problems like dementia or Parkinson’s disease down the road, Dams-O’Connor added.
It’s widely suspected that one traumatic brain injury (TBI) doesn’t result in the kind of long-term damage caused by repeated brain injuries, she said.
“A substantial number of people sustain a TBI that heals and they return to their normal,” Dams-O’Connor said. “These are the lucky ones who go back to their baseline and they don’t have long-term symptoms that don’t go away. Overall, most people who survive a brain injury are not going to develop these terrible outcomes.”
The findings appear in a letter published Sept. 19 in the New England Journal of Medicine.
More information
There’s more from the U.S. National Institutes of Health about traumatic brain injury.
SOURCES: Andrea Schneider, M.D., Ph.D., neurologist, Johns Hopkins University, Baltimore; Kristen Dams-O’Connor, Ph.D., co-director, Brain Injury Research Center of Mount Sinai, New York City; Sept. 19, 2018, New England Journal of Medicine

Adverum gets FDA fast track for macular degeneration gene therapy


Adverum Biotechnologies announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ADVM-022. ADVM-022 is a novel gene therapy candidate for the treatment of wet age-related macular degeneration (wAMD). A Fast Track designation is intended to facilitate the development and expedite the review of drugs and biologics to treat serious conditions and fill unmet medical needs. The designation enables more frequent communication with the FDA throughout a product candidate’s development and review process. The designation also provides eligibility for Priority Review and Accelerated Approval, which may potentially result in a shorter FDA review process.
https://thefly.com/landingPageNews.php?id=2792831

Fitbit launches connected healthcare platform for insurers, employers


Fitbit launched a new connected health platform for insurance plans, employers and health systems, combining coaching, virtual care and personalized digital interventions.
Through its apps and wearable activity trackers, Fitbit aims to guide plan participants toward goals in weight management and tobacco cessation—as well as through the management of conditions including diabetes, hypertension, depression, chronic obstructive pulmonary disease and congestive heart failure.
The system, Fitbit Care, follows the company’s acquisition of health coaching company Twine Health earlier this year. A spinout from MIT’s Media Lab, Twine carried data from some small trials that showed digital approaches could help lower blood pressure and average blood sugar levels.
“Supporting patients beyond the walls of the doctor’s office is one of the most important things we can do to drive successful outcomes, and as a clinician I see great potential for Fitbit Care to help tackle some of the biggest challenges in healthcare and improve health outcomes at scale,” John Moore, M.D., Ph.D., Fitbit Health Solutions’ medical director, said in a statement.
Alongside the launch, Fitbit revealed that health insurance giant Humana will use the platform as the preferred coaching solution for its employer group plans, with its more than 5 million members gaining access through the Humana Employee Assistance Program and other avenues.
A 2015 study of Humana associates enrolled in Go365, the company’s rewards program, found that members who were actively engaged over three years had lower average claim costs and absenteeism rates. Since the companies partnered in 2013, members have used their health rewards points to redeem more than 170,000 Fitbit devices, the companies said.
The move comes as Fitbit looks to broaden its base beyond direct-to-consumer product sales. The new bundled subscription offering is aimed at the company’s more than 1,600 enterprise health customers, as well as over 100 health plans, according to Adam Pellegrini, general manager of Fitbit Health Solutions.
With a user’s consent, the Fitbit Care program will provide their real-time health data to care teams for more personalized recommendations, including guided workouts and motivations to make more healthy decisions as well as other interventions.
Coaches will be able to work with participants and providers through the new Fitbit Plus app, as well as over the phone and in person. The app will also support integration of health metrics including blood glucose, blood pressure and medication adherence, as well as data from third-party devices, the company said.