Kiniksa Pharma up 7% premarket on Kite collaboration

Kite, a Gilead Company (NASDAQ:GILD) and Kiniksa Pharmaceuticals (NASDAQ:KNSA) have entered into a clinical collaboration to conduct a Phase 2, multicenter study of mavrilimumab, in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma.

The objective of the study is to determine the effect of mavrilimumab on the safety of Yescarta. Kite will be the sponsor of this study and will be responsible for its conduct.

Mavrilimumab is an investigational fully-human monoclonal antibody designed to antagonize GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor.

KNSA shares are up 7% premarket.

https://seekingalpha.com/news/3525490-kiniksa-pharma-up-7-premarket-on-kite-collaboration

HCA fights CNN’s subpoena in defamation suit

Nashville, Tenn.-based HCA Healthcare is refusing to comply with an “over-broad subpoena” issued by CNN seeking information on a former company executive, according to the Nashville Post.

CNN is seeking the information in a defamation lawsuit brought against the news network by David Carbone, the former CEO of St. Mary’s Medical Center in West Palm Beach, Fla., which is part of Dallas-based Tenet Healthcare. Mr. Carbone worked at HCA prior to leading St. Mary’s Medical Center, according to the report.

The lawsuit alleges CNN ran a defamatory report about Mr. Carbone in 2015 that resulted in him losing his job. The story, “Secret deaths: CNN finds high surgical death rate for children at a Florida hospital,” allegedly misrepresented St. Mary’s Medical Center’s mortality rate for pediatric open-heart surgeries. After the report ran, public backlash forced the hospital to shut down its pediatric cardiothoracic surgery program. Mr. Carbone resigned as CEO of St. Mary’s Medical Center and filed the lawsuit after the program closed.

HCA is not a party to the defamation lawsuit, but CNN is requesting records related to Mr. Carbone’s time with the company. HCA is asking the court for a protective order to avoid the cost of complying with the request.

“Despite months of negotiations, CNN takes the position that it is HCA’s burden to shoulder the costs of compliance with its over-broad subpoena,” HCA lawyers wrote in a court memo, according to the Nashville Post. “HCA has respectfully moved the court for the protection the law affords subpoenaed third parties who find themselves in a position neither deserved nor justifiable.”

https://www.beckershospitalreview.com/legal-regulatory-issues/hca-fights-cnn-s-subpoena-in-defamation-suit.html

Therapists to treat children with autism in short supply

The supply of certified applied behavior analysis (ABA) providers is insufficient to meet the needs of children with autism spectrum disorder (ASD) in nearly every state, according to a study published online today in Psychiatric Services. The new study found there is substantial variation across states and regions–for instance, the per capita supply of certified ABA providers is substantially higher in the Northeast than in any other region.

The rising prevalence of ASD underscores the importance of access to evidence-based interventions such as ABA. An estimated one in 59 children had ASD in 2014, up from one in 125 a decade earlier, according to the Centers for Disease Control and Prevention.

ABA uses behavioral learning principles to help children with ASD increase positive behaviors and social interactions and decrease problematic behaviors. It is the recommended treatment for children with autism and is supported by more than 30 years of research. ABA is most effective when it is started in early childhood and the therapy is provided between 20 and 40 hours per week.

Study authors Yidan Xue Zhang, M.C., and Janet R. Cummings, Ph.D., with the Rollins School of Public Health, Emory University, Atlanta, used 2018 data from the Behavior Analyst Certification Board. They compared the per capita supply of certified ABA providers in each state with a benchmark established using the board’s guidelines. They found that the per capita supply of certified ABA providers fell below the benchmark in 49 states. The supply was highest in the Northeast, which included the top seven states in the U.S. based on per capita ABA providers. In the Midwest, however, no state had more than one-third of the minimum number of ABA providers needed for number of children with autism.

In addition, the study found that states with higher public education spending had significantly more certified ABA providers per capita than states with lower spending. Similarly, states with higher median household income had more certified ABA providers per capita.

This study provides the first known examination of the supply and geographic variation in certified ABA providers. The authors conclude that new workforce policies are needed to increase the supply of certified ABA providers to ensure that youth with ASD have access to evidence-based interventions.

https://www.eurekalert.org/pub_releases/2019-12/apa-ns120919.php

Google’s $2.1B acquisition of Fitbit faces DOJ probe

Google’s $2.1 billion acquisition of Fitbit will face scrutiny by the Department of Justice amid data privacy fears, The Post has learned.

The controversial merger in recent days was cleared for review by the DOJ after federal law enforcement tussled with the Federal Trade Commission, which had also sought authority to investigate the deal, according to a source close to the situation.

Both agencies are concerned that a Google-owned Fitbit would give the search giant an even bigger window into people’s private data, including sensitive health information, sources said.

Under the Hart-Scott-Rodino Act, all large mergers must file proposals with both the DOJ and the FTC, but only one antitrust agency reviews the merger.

Historically, most Google deals have been reviewed by the FTC, which in February created a “technology task force” to monitor anti-competitive behavior in Silicon Valley.

But the DOJ also is presently investigating Google for broader anti-competitive issues. In September, it asked Google for documents related to past FTC antitrust investigations.

That larger investigation was the main argument the DOJ made when asking for the Fitbit review in what a source described as a real “arm wrestle” between the agencies.

“The DOJ’s handling of Fitbit will give an early read on the Google investigation,” a DC source said.

With the DOJ probing the Fitbit deal, a DC antitrust attorney also noted, “There is a more direct line from the White House.”

President Trump has criticized Google for alleged anti-conservative bias. In August, he said he was closely watching the search giant.

Earlier this month, “60 Minutes” reported that Google had taken down more than 300 ads from Trump’s re-election campaign this summer for violating the search engine’s advertising policies.

Last month, Public Citizen and the Center for Digital Democracy urged the FTC, thinking it would get the case, to block the merger, arguing it would give Google the chance to collect more personal data including sensitive health information.

“Through its vast portfolio of internet services, Google knows more about us than any other company and it should not be allowed to add yet another way to track our every move,” the groups said in a letter to the FTC.

This fall, the DOJ reviewed Google’s June $2.6 billion acquisition of cloud analytics company Looker Data and cleared it in November.

https://nypost.com/2019/12/10/googles-2-1b-acquisition-of-fitbit-faces-doj-probe-sources/

New bone healing mechanism has potential therapeutic applications

Led by researchers at Baylor College of Medicine, a study published in the journal Cell Stem Cell reveals a new mechanism that contributes to adult bone maintenance and repair and opens the possibility of developing therapeutic strategies for improving bone healing.

“Adult bone repair relies on the activation of bone stem cells, which still remain poorly characterized,” said corresponding author Dr. Dongsu Park, assistant professor of molecular and human genetics and of pathology and immunology at Baylor. “Bone stem cells have been found both in the bone marrow inside the bone and also in the periosteum — the outer layer of tissue — that envelopes the bone. Previous studies have shown that these two populations of stem cells, although they share many characteristics, also have unique functions and specific regulatory mechanisms.”

Of the two, periosteal stem cells are the least understood. It is known that they comprise a heterogeneous population of cells that can contribute to bone thickness, shaping and fracture repair, but scientists had not been able to distinguish between different subtypes of bone stem cells to study how their different functions are regulated.

In the current study, Park and his colleagues developed a method to identify different subpopulations of periosteal stem cells, define their contribution to bone fracture repair in live mouse models and identify specific factors that regulate their migration and proliferation under physiological conditions.

Periosteal stem cells are major contributors to bone healing

The researchers discovered specific markers for periosteal stem cells in mouse models. The markers identified a distinct subset of stem cells that contributes to life-long adult bone regeneration.

“We also found that periosteal stem cells respond to mechanical injury by engaging in bone healing,” Park said. “They are important for healing bone fractures in the adult mice and, interestingly, their contribution to bone regeneration is higher than that of bone marrow stem cells.”

In addition, the researchers found that periosteal stem cells also respond to inflammatory molecules called chemokines, which are usually produced during bone injury. In particular, they responded to chemokine CCL5.

Periosteal stem cells have receptors — molecules on their cell surface — that bind to CCL5, which sends a signal to the cells to migrate toward the injured bone and repair it. Deleting the CCL5 gene in mouse models resulted in marked defects in bone repair or delayed healing. When the researchers supplied CCL5 to CCL5-deficient mice, bone healing was accelerated.

The findings suggested potential therapeutic applications. For instance, in individuals with diabetes or osteoporosis in which bone healing is slow and may lead to other complications resulting from limited mobility, accelerating bone healing may reduce hospital stay and improve prognosis.

“Our findings contribute to a better understanding of how adult bones heal. We think this is one of the first studies to show that bone stem cells are heterogeneous and that different subtypes have unique properties regulated by specific mechanisms,” Park said. “We have identified markers that enable us to tell bone stem cell subtypes apart and studied what each subtype contributes to bone health. Understanding how bone stem cell functions are regulated offers the possibility to develop novel therapeutic strategies to treat adult bone injuries.”

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Story Source:

Materials provided by Baylor College of Medicine. Note: Content may be edited for style and length.

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Journal Reference:

1. Laura C. Ortinau, Hamilton Wang, Kevin Lei, Lorenzo Deveza, Youngjae Jeong, Yannis Hara, Ingo Grafe, Scott B. Rosenfeld, Dongjun Lee, Brendan Lee, David T. Scadden, Dongsu Park. Identification of Functionally Distinct Mx1 αSMA Periosteal Skeletal Stem Cells. Cell Stem Cell, 2019; 25 (6): 784 DOI: 10.1016/j.stem.2019.11.003

https://www.sciencedaily.com/releases/2019/12/191209161325.htm

Brain function abnormal in children with Type 1 diabetes

Children with Type 1 diabetes show subtle but important differences in brain function compared with those who don’t have the disease, a study led by researchers at the Stanford University School of Medicine has shown.

The study, publishing online Dec. 9 in PLOS Medicine, is the first to evaluate what happens in the brains of children with diabetes during a cognitive task. On functional magnetic resonance imaging scans, when their brains were at work, children with diabetes displayed a set of abnormal brain-activity patterns that has been seen in many other disorders, including cognitive decline in aging, concussion, attention-deficit hyperactivity disorder and multiple sclerosis.

The study also reported that the abnormal brain-activity patterns were more pronounced in children who had had diabetes longer.

“Our findings suggest that, in children with Type 1 diabetes, the brain isn’t being as efficient as it could,” said Lara Foland-Ross, PhD, senior research associate at the Center for Interdisciplinary Brain Sciences Research at Stanford. Foland-Ross shares lead authorship of the paper with Bruce Buckingham, MD, professor emeritus of pediatrics at Stanford.

“The takeaway from our study is that, despite a lot of attention from endocrinologists to this group of patients, and real improvements in clinical guidelines, children with diabetes are still at risk of having learning and behavioral issues that are likely associated with their disease,” said the study’s senior author, Allan Reiss, MD, professor of psychiatry and behavioral sciences at Stanford.

Blood sugar affects brain development

Type 1 diabetes occurs when the pancreas fails to make insulin, a hormone that helps regulate blood sugar. Patients are given insulin via injections or an insulin pump. But even with treatment, their blood levels of glucose, the main sugar in blood, fluctuate much more than in healthy individuals.

“Kids with diabetes have chronic swings in blood-glucose levels, and glucose is important for brain development,” Foland-Ross said. Brain cells need a steady supply of glucose for fuel. Earlier work revealed brain-structure changes and mild performance impairment on cognitive tasks in children with Type 1 diabetes, but the mechanism had never been studied. “It was important to capture what is going on in the brains of these kids functionally,” she said.

The researchers conducted fMRI brain scans on 93 children with Type 1 diabetes recruited at five sites: Nemours Children’s Health System in Jacksonville, Florida; Stanford; Washington University in St Louis; the University of Iowa; and Yale. An additional 57 children who did not have the disease composed the control group. All participants were 7-14 years old. Standard behavioral and cognitive tests were given to all the children before brain scanning.

Then, in the fMRI scanner, the children performed a cognitive task called “go/no-go”: Different letters of the alphabet were shown in random order, and participants were asked to press a button in response to every letter except “X.” The task is often used in brain-scanning studies to evaluate what is happening in the brain while participants are concentrating.

The study found that, although the children with diabetes performed the task as accurately as those in the control group, their brains were behaving differently. In children with diabetes, the default-mode network, which is the brain’s “idle” system, was not shutting off during the task. To compensate for the abnormal activation of the default-mode network, the brain’s executive control networks, responsible for aspects of self-regulation and concentration, were working harder than normal in the children with diabetes.

These abnormalities were more pronounced in children who had been diagnosed with diabetes at younger ages, suggesting that the problem may worsen with time.

“The longer the exposure you have to dynamic changes in blood-glucose levels, the greater the alterations in brain function with respect to the default-mode network,” Foland-Ross said. Studies in adults with diabetes suggest that in the later stages of the disease, the brain eventually loses its ability to compensate for this problem, she added.

Next: Testing effects of devices

Next, scientists want to study whether achieving better blood glucose concentrations through treatment with a closed-loop artificial pancreas benefits children’s brain function. These devices electronically couple a blood glucose sensor to an insulin pump that automatically adjusts insulin delivery.

“We hope that with improvements in devices for diabetes treatment, these findings will either decrease in severity or go away,” Reiss said, adding that with better blood sugar control, children’s brains might be able to recover normal activity. “Young brains have the most potential for plasticity and repair,” he said. “But children also have a long time to live with the consequences if problems with brain function persist.”

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Story Source:

Materials provided by Stanford Medicine. Original written by Erin Digitale. Note: Content may be edited for style and length.

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Journal Reference:

1. Lara C. Foland-Ross, Bruce Buckingam, Nelly Mauras, Ana Maria Arbelaez, William V. Tamborlane, Eva Tsalikian, Allison Cato, Gabby Tong, Kimberly Englert, Paul K. Mazaika, Allan L. Reiss. Executive task-based brain function in children with type 1 diabetes: An observational study. PLOS Medicine, 2019; 16 (12): e1002979 DOI: 10.1371/journal.pmed.1002979

https://www.sciencedaily.com/releases/2019/12/191210111722.htm

Fitbit link to WellCare of Ga. Medicaid focuses on chronic disease management

Fitness tracker company Fitbit is teaming up with a Medicaid plan in Georgia to encourage beneficiaries to better manage their chronic conditions.

Marking the company’s first partnership with a Medicaid plan, Fitbit is working with WellCare of Georgia to arm Medicaid enrollees with Type 2 diabetes with a Fitbit Inspire device.

Beginning on January 1, 2020, approximately 4,000 plan enrollees with Type 2 diabetes will be eligible to receive a device if they complete their annual diabetic retinal exam (DRE), according to Amy McDonough, senior vice president, and general manager of Fitbit Health Solutions, in a LinkedIn blog post.

Those who sign up also will receive educational materials and activity challenges through Fitbit’s platform. The goal is to help people adopt long-term behavior changes to better manage their chronic conditions.

“Nearly one in five people in the U.S. are covered by Medicaid, and this partnership is the beginning of an important connection between Fitbit and a population that has not historically had access to innovative healthcare technology,” McDonough wrote.

She notes that the partnership is a promising approach that could help an underserved population get healthier and better manage a chronic condition.

Fitbit’s collaboration with Medicaid comes as more health plans, particularly Medicare Advantage plans, have begun to include wearable devices as an embedded benefit for their members.

Next year Fitbit devices will be included in Medicare Advantage plans offered by three insurers, making them even more accessible to seniors who are increasingly interested in adopting technology that can help them be proactive about their health as they age, McDonough said.

Fitbit devices will be an embedded benefit in 59 plans offered by UnitedHealthcare across 27 states—up from 42 plans in 2019.

“As Medicare Advantage plans increasingly dedicate their focus to keeping their members out of the hospital by driving adoption of healthy behaviors, Fitbit devices and the resources they offer have become an important part of that strategy,” she wrote.

2019 has been a busy year for Fitbit as the company made several moves to expand its platform to more people. The company is in the process of being acquired by tech giant Google, which announced in November it plans to buy Fitbit for $7.25 per share in cash, valuing the company at $2.1 billion.

In August Fitbit signaled it was deepening its reach into healthcare with a new premium subscription service for users that offers coaching and personalized insights mined from the health data it collects from 27.3 million users.

The company also is working with pharmaceutical giants Bristol-Myers Squibb and Pfizer to accelerate the detection and diagnosis of atrial fibrillation to reduce the risk of life-threatening events such as stroke. The collaboration will rely on Fitbit’s afib detection software, which the tech giant plans to submit to the U.S. Food and Drug Administration (FDA) for regulatory review and approval, company executives said in October.

The wearables company also is working with Singapore’s Health Promotion Board on a population-based public health initiative. The program, called Live Healthy SG, will spur the city-state’s residents to adopt fitness trackers to encourage healthier lifestyle habits.

https://www.fiercehealthcare.com/tech/fitbit-partners-wellcare-georgia-s-medicaid-plan-focus-chronic-disease-management