Friday, December 21, 2018
Health Insurance Innovations should be bought aggressively, says Canaccord
Canaccord analyst Richard Close said he would be an aggressive buyer of Health Insurance Innovations shares following its significant pullback. The analyst cited the company’s recently updated guidance and his management meeting, which reassured him about the company’s focus on compliance and the potential for accelerating growth given industry tailwinds. Close reiterated his Buy rating and $62 price target on Health Insurance Innovations shares.
https://thefly.com/landingPageNews.php?id=2840527
Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol
Jazz Pharmaceuticals plc JAZZ, -0.82%today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User Fee Act (PDUFA) goal date is now March 20, 2019.
The FDA determined that an NDA submission made by Jazz during the course of discussions regarding draft labeling for solriamfetol constitutes a major amendment to the NDA, resulting in a three-month extension of the PDUFA goal date to provide time for a full review of the submission.
“We appreciate the opportunity to work with the FDA to complete the review process as soon as possible,” said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. “We are committed to addressing unmet needs in sleep medicine and look forward to offering solriamfetol as a meaningful treatment option for patients living with excessive daytime sleepiness associated with narcolepsy or OSA.”
Jazz Pharmaceuticals will host a brief investor conference call and live audio webcast on Friday, December 21, 2018 at 8:30 a.m. EST (1:30 p.m. GMT) to discuss the PDUFA goal date extension and a business update. The live webcast may be accessed from the Investors section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 6766127.
A replay of the conference call will be available through December 28, 2018 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 6766127. An archived version of the webcast will be available for at least one week in the Investors section of the company’s website at www.jazzpharmaceuticals.com.
Thursday, December 20, 2018
E-bandage generates electricity, speeds wound healing
Skin has a remarkable ability to heal itself. But in some cases, wounds heal very slowly or not at all, putting a person at risk for chronic pain, infection and scarring. Now, researchers have developed a self-powered bandage that generates an electric field over an injury, dramatically reducing the healing time for skin wounds in rats. They report their results in ACS Nano.
Chronic skin wounds include diabetic foot ulcers, venous ulcers and non-healing surgical wounds. Doctors have tried various approaches to help chronic wounds heal, including bandaging, dressing, exposure to oxygen and growth-factor therapy, but they often show limited effectiveness. As early as the 1960s, researchers observed that electrical stimulation could help skin wounds heal. However, the equipment for generating the electric field is often large and may require patient hospitalization. Weibo Cai, Xudong Wang and colleagues wanted to develop a flexible, self-powered bandage that could convert skin movements into a therapeutic electric field.
To power their electric bandage, or e-bandage, the researchers made a wearable nanogenerator by overlapping sheets of polytetrafluoroethylene (PTFE), copper foil and polyethylene terephthalate (PET). The nanogenerator converted skin movements, which occur during normal activity or even breathing, into small electrical pulses. This current flowed to two working electrodes that were placed on either side of the skin wound to produce a weak electric field. The team tested the device by placing it over wounds on rats’ backs. Wounds covered by e-bandages closed within 3 days, compared with 12 days for a control bandage with no electric field. The researchers attribute the faster wound healing to enhanced fibroblast migration, proliferation and differentiation induced by the electric field.
Story Source:
Materials provided by American Chemical Society. Note: Content may be edited for style and length.
Journal Reference:
- Yin Long, Hao Wei, Jun Li, Guang Yao, Bo Yu, Dalong Ni, Angela LF Gibson, Xiaoli Lan, Yadong Jiang, Weibo Cai, Xudong Wang. Effective Wound Healing Enabled by Discrete Alternative Electric Fields from Wearable Nanogenerators. ACS Nano, 2018; DOI: 10.1021/acsnano.8b07038
Mortality rates rising for Gens X and Y, too
Declining life expectancies in the U.S. include Gen X and Y Americans, in addition to the older Baby Boomers. But the causes of premature mortality vary by race, gender and ethnicity, according to a new study from Duke University.
“We identified late-Gen X (38- to 45-year-olds) and early-Gen Y (27- to 37-year-olds) as age cohorts with elevated mortality patterns, particularly for non-Hispanic whites, said study co-author Emma Zang, a Ph.D. candidate at the Sanford School of Public Policy. “That is in addition to the rise among the already much-discussed Baby Boomer generation.”
To study cause of death for Americans born from 1946 to 1992, the researchers used data from the Centers for Disease Control and Prevention Mortality Multiple Cause Files for the years 1990-2016.
Late Gen X and early Gen Y Americans were aged 25 to 43 during the Great Recession and faced greater difficulty finding jobs, which may have contributed to greater health impacts.
“Social scientists and policymakers are aware of the financial burden for the younger generation, but the elevated mortality rate among them has largely been ignored,” the authors say in a paper that appears in the December issue of the International Journal of Epidemiology.
The study examined death rates in five different age cohorts, comparing men and women, as well as whites, blacks and Hispanics.
“Few studies have looked at Hispanics when considering disparities in mortality,” Zang said.
The researchers examined nine leading causes of death for each age cohort, finding that the underlying causes for increased mortality vary for the different ethnic groups and also between genders in the cohorts and ethnicities.
For Baby Boomers, five causes of death drove the rising mortality rates.
“Drug overdoses, external causes — such as traffic accidents and homicides, suicides, COPD (chronic obstructive pulmonary disease) and HIV/AIDS have contributed to the increase in mortality trends among Baby Boomers across all race, ethnic, and gender groups,” Zang said.
For the late Gen X (born 1973-1980) and early Gen Y (born 1981-1991) age cohorts, leading causes of death vary by ethnicity:
- For Hispanics, overdoses and suicides are the leading causes of death.
- For non-Hispanic whites, both men and women, overdoses and alcohol-related diseases appear to drive increased mortality.
- For non-Hispanic black women, diabetes-related mortality is increasing.
- For non-Hispanic black men, leading causes are cancer, alcohol-related diseases and external causes, such as traffic accidents.
The time period of the study spans the opioid abuse crisis and the Great Recession. Some of the disparities may reflect different access to opioid prescriptions among blacks, whites and Hispanics, Zang said.
Story Source:
Materials provided by Duke University. Note: Content may be edited for style and length.
Journal Reference:
- Emma Zang, Hui Zheng, Yang Claire Yang, Kenneth C. Land. Recent Trends in U.S. Mortality in Early and Middle Adulthood: Racial/Ethnic Disparities in Inter-Cohort Patterns. International Journal of Epidemiology, 2018 DOI: http://dx.doi.org/10.1093/ije/dyy255
Six Months of Aerobic Exercise Cuts Mild Cognitive Impairment Risk
Six months of aerobic exercise can improve executive functioning in patients with mild cognitive impairment (MCI), new research suggests.
In the Exercise and Nutritional Interventions for Cognitive and Cardiovascular Health Enhancement (ENLIGHTEN) study, researchers assessed 160 older adults who reported some cognitive impairment but no dementia.
Results showed significant improvements in executive functioning after six months of regular aerobic exercise. In contrast, participants randomly assigned to the Dietary Approaches to Stop Hypertension (DASH) diet did not demonstrate comparable improvements.
The patients who received a combination of both interventions showed the largest improvement compared with those who only received health education.
“The ‘take home’ message is that it is not too late for older adults with subtle cognitive impairments to adopt healthy lifestyle habits and to benefit from exercise and diet,” principal investigator James A. Blumenthal, PhD, JP Gibbons Professor of Psychiatry, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, told Medscape Medical News.
“Our data show that exercise improves executive functioning and also provide suggestive evidence that combining regular exercise with a heart-healthy diet reduces risk for heart disease and produces greater improvement in executive cognitive functioning compared to controls,” he said.
The findings were published online December 19 in Neurology.
Good for the Heart, Good for the Brain?
“We were surprised to find that participants who engaged in regular aerobic exercise and who consumed the DASH diet…obtained greater improvements in executive functioning compared to participants who just received health education and did not exercise or modify their diets,” Blumenthal said.
An overlap in risk factors for cardiovascular disease (CVD) and dementia means that strategies designed to reduce risk for CVD “also may be effective in improving neurocognition and reducing the risk of developing dementia,” the investigators write.
“We believe that the benefits of diet and exercise have the potential for improving both heart and brain health,” Blumenthal said.
“Our working hypothesis is that a healthier vascular system maximizes the brain’s overall functioning and cognitive reserve,” he added.
As reported by Medscape Medical News, American Academy of Neurology guidelines updated in 2017 support the cognitive benefits of exercise among people with MCI.
Individual studies in the literature also suggest aerobic exercise could improve neurocognitive function among healthy adults. However, relatively few studies include individuals with cognitive impairment, a meta-analysis revealed.
ObsEva SA Completes Patient Recruitment in Phase 3 Fibroid Trial
ObsEva SA (NASDAQ: OBSV), a clinical- stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today reported completion of patient recruitment of its Phase 3 clinical trial PRIMROSE 2 evaluating oral gonadotropin releasing hormone (GnRH) receptor antagonist OBE2109 for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).
PRIMROSE 2 is being conducted at 102 sites, in the United States and Europe, randomizing approximately 500 patients with a diagnosis of HMB associated with UF. Eligible patients are receiving once daily either 100 mg or 200 mg of linzagolix or placebo. Active treatment arms are being tested with and without low doses of hormonal add-back therapy (ABT). Patients are treated for up to 52 weeks to evaluate the safety of long-term treatment.
“We are evaluating long term administration of linzagolix in two dosing regimens: primarily, we are assessing the efficacy of a lower-dose of linzagolix without add-back therapy, and of a higher dose option in association with add-back therapy for patients requiring higher levels of estrogen suppression. This strategy will potentially allow us to offer the broad patient population the personalized options needed for symptom relief with fewer side effects” said Ernest Loumaye, Chief Executive Officer and Co-Founder of ObsEva. “Patient recruitment completion is an important step in this pivotal trial for the lead indication of linzagolix, a potential best-in-class oral GnRH antagonist. We anticipate the primary endpoint read out of PRIMROSE 2 in Q4 2019, in line with our development plan.”
Microsoft, CVS to review executive pay levels, official says
Microsoft Corp., CVS Health Corp., Macy’s and two other companies have agreed to review their policies on executive compensation at the request of the New York state pension fund and Comptroller Thomas DiNapoli.
DiNapoli announced the agreements on Friday. Under the terms, the companies agree to consider what they pay all levels of employees as a factor when setting CEO salaries, instead of simply looking at what other CEOs earn.
Similar agreements were reached with Salesforce.com and TJX Companies Inc., the parent company of TJ Maxx.
The changes were sought by the state’s $207 billion pension fund, which DiNapoli oversees. The fund’s sizeable investments give DiNapoli significant leverage over publicly traded companies.
DiNapoli says the agreements are intended to address the rising disparity between typical worker wages and CEO salaries.
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