Monday, September 10, 2018
Krystal Biotech initiated at Cantor Fitzgerald
Krystal Biotech initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Elemer Piros initiated Krystal Biotech with an Overweight and $28 price target Piros said Kyrstal is developing off-the-shelf dermatological gene therapy treatments for severe monogenic diseases and expansion into chronic skin conditions, and believes shares are positioned well well ahead of Q4 interim clinical data.
https://thefly.com/landingPageNews.php?id=2788189
Integra LifeSciences selected for Healogics iSupply program
Integra LifeSciences Holdings announced it has been selected as a primary provider for cellular-based tissue products within Healogics new iSupply program. This program is exclusively available to Healogics’ hospital partners and is focused on ensuring hospitals and patients receive the best value from wound care products commonly used in Wound Care Centers and other sites of care. Under Healogics new iSupply program, Integra will be a lead provider for cellular-based tissue products, including AmnioExcel Amniotic Allograft Membrane, AMNIOMATRIX.”We are excited to be a primary provider of cellular-based tissue products for the iSupply program,” said Robert T. Davis, Jr., corporate vice president and president, Orthopedics and Tissue Technologies. “Integra’s products were selected through a rigorous analysis of published data and reviewed by Healogics’ value analysis committee of leading wound care clinicians. This partnership with Healogics reinforces Integra’s commitment to broader access to our advanced wound care products and improving outcomes for patients with chronic wounds.”
https://thefly.com/landingPageNews.php?id=2788209
Tai chi may work best to prevent falls in old age
The ancient practice of tai chi may beat strength training and aerobics for preventing falls among seniors, a new trial shows.
A modified senior-centered tai chi program reduced falls nearly a third better in a head-to-head comparison with an exercise regimen that combined aerobics, strength training and balance drills, the researchers reported.
“This tai chi program better addressed the deficits that were contributing to fall risk,” said senior researcher Kerri Winters-Stone, a professor with the Oregon Health & Science University School of Nursing.
Tai chi is a centuries-old Chinese tradition that involves a graceful series of movements. People performing tai chi flow between different postures in a slow and focused manner, keeping their body in constant motion and frequently challenging their balance.
Researchers have long suspected that tai chi can help reduce risk of falling, said co-researcher Peter Harmer, a professor of exercise and health science with Willamette University in Salem, Ore.
Annually, about 28 percent of U.S. seniors report falling, and 2 out of 5 falls result in injuries leading to an ER visit, hospitalization or death, researchers said in background notes.
“Falling in adults age 65 and older is significantly associated with loss of independence, premature mortality and big health care costs,” Harmer said.
The movements of tai chi require people to move in all directions, while traditional exercise programs focus more on forward and backward motion, Winters-Stone and Harmer said.
“The reality of how falls happen tends to be quite varied and a bit unpredictable. In tai chi, the movements are in these multiple planes,” Winters-Stone said. “You’re moving your body outside of your center of gravity and then you’re pulling it back. There’s a lot of postural responses.
“If you accidentally started to fall, if you had been trained in tai chi you would probably be better at starting to counteract that movement and regain your balance,” Winters-Stone continued.
But classical tai chi can involve upwards of 100 different movements, which can be challenging for seniors to learn, Harmer said.
So, the research team for this clinical trial developed a pared-down form of tai chi that focuses on eight fundamental movements most related to fall prevention, Harmer said. The trademarked program is called Tai Ji Quan: Moving for Better Balance.
To see how well the program works, researchers tested it against both a traditional exercise program and a control group that only performed stretching exercises.
Researchers recruited 670 Oregonians with an average age of nearly 78 and assigned them to one of the three programs. “This was a more at-risk group than we’ve worked with before,” based on both their age and screening for fall risk, Harmer said.
After six months, the tai chi group was 58 percent less likely to have a fall than the stretching group, and the traditional exercise group was 40 percent less likely to fall than people who only stretched.
Compared against each other, the tai chi program outperformed traditional exercise. People taking tai chi suffered 31 percent fewer falls than those who took strength training and aerobics courses.
“Not falling is a pretty complex physiological behavior,” Harmer said, noting that you combine muscle strength with feedback from muscles and joints, eyesight and even hearing to regain your balance. “Tai chi directly challenges the integration of all those things.”
Although tai chi did work better, people following a traditional exercise program still gain a benefit, noted Nathan LeBrasseur, a physical medicine and rehabilitation researcher with the Mayo Clinic in Rochester, Minn.
“I would not discourage people who are actively participating in a strength and aerobic exercise program to throw in the towel and say, ‘Now I need to do tai chi,'” said LeBrasseur, who wasn’t involved in the study. “The real challenge is getting people to adopt and stick to an exercise program.”
Harmer said tai chi not only improves balance, but also improves confidence.
“We’ve found a major risk factor for people falling is fear of falling,” Harmer said. “People might have had a fall. They’re scared then of falling again, so they start doing fewer physical things so they don’t fall. It kind of becomes a self-fulfilling prophecy.”
The modified tai chi program requires people to push themselves out of their comfort zone, breaking the negative cycle, Harmer said.
LeBrasseur agreed that whatever the exercise, more should be asked of seniors if they want to protect their health.
“I do think we tend to hold back across multiple exercise interventions in terms of really challenging and pushing older adults with the notion it will lead to harm and injury, when in fact it probably will drive beneficial adaptations,” LeBrasseur said.
The new study was published Sept. 10 in the journal JAMA Internal Medicine.
Explore further: Strength training might help prevent seniors’ falls
More information: Kerri Winters-Stone, Ph.D., professor, Oregon Health & Science University School of Nursing, Portland; Peter Harmer, Ph.D., M.P.H., professor, exercise and health science, Willamette University, Salem, Ore.; Nathan LeBrasseur, Ph.D., physical medicine and rehabilitation researcher, Mayo Clinic, Rochester, Minn.; Sept. 10, 2018, JAMA Internal Medicine
The U.S. National Center for Complementary and Integrative Health has more about tai chi.
Zika virus strips immune cells of their identity
Macrophages are immune cells that are supposed to protect the body from infection by viruses and bacteria. Yet Zika virus preferentially infects these cells. Researchers at University of California San Diego School of Medicine have now unraveled how the virus shuts down the genes that make macrophages function as immune cells.
The study is published the week of September 10 in Proceedings of the National Academy of Sciences.
In pregnant women, Zika virus can stunt neonatal brain development, leading to babies born with abnormally small heads, a condition known as microcephaly. Adult brain cells may also be vulnerable to the virus.
“We know Zika virus destroys a number of cell types, particularly in the brain, but we don’t yet understand how it causes cells to die or malfunction,” said first author Aaron Carlin, MD, Ph.D., associate physician at UC San Diego School of Medicine. “So this loss of general gene transcription and identity we saw in macrophages could also be crucial when a neural stem cell is trying to develop into a new neuron.”
Carlin led the study with Christopher K. Glass, MD, Ph.D., professor in the departments of Medicine and Cellular and Molecular Medicine at UC San Diego School of Medicine, and Sujan Shresta, Ph.D., professor at La Jolla Institute for Allergy and Immunology.
Carlin and team first developed a method for tagging the Zika virus inside live cells, and a mechanism for sorting tagged (infected) and untagged (uninfected) human macrophages. Many previous viral studies relied on dishes of cells that had been exposed to the virus, but not necessarily all cells were infected. As a result, the cellular effects measured in a laboratory “infection” are often a mixture of what’s going on inside both infected and uninfected cells.
“If your goal is to see what a virus is doing to a cell, you need to focus on only infected cells to get true representation,” Carlin said.
The difference they found with the new technique was startling.
“We were surprised at just how different infected and uninfected cells looked, in terms of the genes they had turned on or off, even two cells next to each other,” Glass said. “What’s amazing is that even though they are exposed to the same environment, their responses are completely different. And now we know those differences are truly due to the virus, not any of the other events going on around the cells during an immune response.”
This approach provided a more accurate account of Zika’s effect on macrophages and revealed that the virus suppressed gene production in the cells by two methods. First, the virus specifically blocks hundreds of macrophage genes that should be stimulated by interferon, a molecule that triggers an immune response. For example, the IFITM1 gene, which inhibits Zika virus, is expressed 73-fold less in Zika-infected cells than in neighboring uninfected cells. Second, Zika infection leads to general suppression of gene production because the virus targets RNA Pol II, a crucial part of the cell’s gene transcription machinery. The loss of RNA Pol II is especially notable at genes responsible for macrophage function and identity.
Collectively, these approaches allow Zika virus to stop macrophages from making many genes involved in immune cell recruitment and anti-viral defense.
Moving forward, Carlin, Glass and team are interested in applying their new sorting technique to cells infected by other viruses. They also hope to examine other cell types infected by Zika virus, such as neural stem cells.
Explore further: Zika suppresses virus-fighting cells: study
More information: Aaron F. Carlin el al., “Deconvolution of pro- and antiviral genomic responses in Zika virus-infected and bystander macrophages,” PNAS (2018). www.pnas.org/cgi/doi/10.1073/pnas.1807690115
1 year after Irma, watchdog addresses nursing home preparedness concerns
Despite enhanced guidance from CMS, nursing homes hit by disaster often struggle to execute emergency plans and protect residents, according to testimony (PDF) from the HHS Office of Inspector General to lawmakers last week.
Addressing the Energy and Commerce Committee's oversight subcommittee, OIG's Regional Inspector General Ruth Ann Dorrill said officials went in and looked at deficiencies in nursing homes following Hurricane Katrina in 2005 and found 94% were in compliance.
However, she said: "When we visited a sample of homes actually affected by the hurricanes, we found the plans weren’t practical and up-to-date; in many cases the nurses would pull out a pad and pen when they saw the hurricane coming as opposed to looking at the binder on the shelf."
More than half of those adverse events were considered preventable had the facilities provided better care.
"Most of the events weren’t the big dramatic events you think about when you think about adverse harm events. They were incremental. They were small. They were surrounding the daily, hourly care provided by nurse assistants and staffing throughout the nursing home," Dorrill said. "This low-level substandard care harms a tremendous amount of people."
These conditions might have been preventable with better guidance and government oversight, she said.
Her comments to lawmakers were echoed by the Government Accountability Office, which also raised concerns about gaps in reporting in its latest report on nursing home oversight. During the same time period, consumer complaints about nursing home care quality increased while data collected by CMS indicated quality improvements.
The GAO also pointed out that different states use different data-collection methods, which makes it difficult for CMS to make accurate quality comparisons.
The GAO recommended CMS establish and implement a clear plan for ongoing auditing to ensure the reliability of data self-reported by nursing homes, including payroll-based staffing data and data used to calculate clinical quality measures. CMS concurred with this recommendation and said it has begun to take steps to address it.
https://www.fiercehealthcare.com/hospitals-health-systems/oig-offers-recommendations-oversight-nursing-homes
Addressing the Energy and Commerce Committee's oversight subcommittee, OIG's Regional Inspector General Ruth Ann Dorrill said officials went in and looked at deficiencies in nursing homes following Hurricane Katrina in 2005 and found 94% were in compliance.
More than half of those adverse events were considered preventable had the facilities provided better care.
These conditions might have been preventable with better guidance and government oversight, she said.
Her comments to lawmakers were echoed by the Government Accountability Office, which also raised concerns about gaps in reporting in its latest report on nursing home oversight. During the same time period, consumer complaints about nursing home care quality increased while data collected by CMS indicated quality improvements.
The GAO also pointed out that different states use different data-collection methods, which makes it difficult for CMS to make accurate quality comparisons.
The GAO recommended CMS establish and implement a clear plan for ongoing auditing to ensure the reliability of data self-reported by nursing homes, including payroll-based staffing data and data used to calculate clinical quality measures. CMS concurred with this recommendation and said it has begun to take steps to address it.
https://www.fiercehealthcare.com/hospitals-health-systems/oig-offers-recommendations-oversight-nursing-homes
FDA flags lingering patient safety concerns over feeding tubes
The Food and Drug Administration on Friday issued new guidance to hospital purchasing departments and healthcare providers warning them to use enteral devices with connectors to avoid misconnections—a known risk for patient injury.
The guidance, which was also directed to manufacturers of enteral feeding tubes, said the FDA is “concerned” by continued reports of misconnections. The FDA pointed to enteral connectors that meet the proper standard under the trade name ENFit as a solution.
Misconnections may occur when one type of medical device is mistakenly attached to another device that performs a different function.
“Misconnections between enteral devices and other medical devices, such as tracheostomy tubes, have been associated with patient death and serious injuries,” the FDA said in the warning (PDF).
Since 2011, the FDA has received reports of two deaths, 24 serious injuries and 32 device malfunctions related to enteral misconnections, but officials said they are also concerned many misconnections are not reported or are reported as medication errors.
This is far from the first time this sort of warning has been issued.
In 2015, the FDA published a guidance document recommending manufacturers design and test enteral connectors based on the ISO 80369 standard, which was developed to prevent deadly medical mistakes. The standard would make the tubes incompatible with other tubing systems that deliver medicines, gases or fluids.
The FDA also issued a letter to manufacturers and health providers about the danger of misconnections in 2010.
Citing the Global Enteral Device Supplier Association, PlasticsNews reported in February that adoption has been slow at U.S. hospitals due to concern over the limited supply of ENFit components. Manufacturers have also raised patient safety concerns, they said.
The ECRI Institute named “slow adoption of safer enteral feeding connectors” among its top 10 list of technology hazards for hospitals to prepare against in 2018.
Editas ‘pleased’ U.S. appeals court affirmed favorable USPTO decision
Editas Medicine announced that the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. Patent and Trademark Office decision that ended the U.S. patent interference between the University of California, the University of Vienna, and Emmanuelle Charpentier and the Broad Institute, Inc. concerning certain CRISPR/Cas9 patents Editas Medicine exclusively licenses from Broad. This favorable action by the CAFC upholds the USPTO decision issued in February 2017, granting Broad’s motion for no interference-in-fact. “We are pleased with the Federal Circuit’s decision affirming the Patent Trial and Appeal Board decision on the patents that were granted to the Broad Institute for its innovative and fundamental work on CRISPR/Cas9 genome editing,” said Katrine Bosley, President and Chief Executive Officer, Editas Medicine. “This decision is highly favorable for Editas and for the Broad as it reaffirms the strength of our intellectual property foundation and has profound implications for making CRISPR medicines.”
https://thefly.com/landingPageNews.php?id=2788141
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