Contepo

Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA

DUBLIN, Ireland, Jan. 04, 2019 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted a priority review for Contepo™ (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Contepo NDA is June 30, 2019. In addition to priority review, Contepo has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.

“The acceptance of the Contepo NDA marks another major milestone for Nabriva Therapeutics, demonstrating our commitment to bring novel anti-infective agents that address the urgent, unmet medical need in patients with serious infections,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “Contepo, if approved in the United States, represents a first-in-class intravenous antibiotic with broad spectrum activity against Gram-negative and Gram-positive organisms, including ESBL-producing Enterobacteriaceae and other contemporary multi-drug resistant (MDR) organisms.”

The NDA submission is utilizing the 505(b)(2) regulatory pathway and is supported by a robust data package, including a pivotal Phase 2/3 clinical trial (known as ZEUS™), which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.

In the NDA acceptance letter, the FDA stated that no filing or potential review issues were identified. In addition, the Agency stated that it has not referred Contepo to an advisory committee meeting at this time.

About cUTIs

Urinary tract infections (UTIs) are a significant health problem in both the community- and hospital-based treatment settings. It is estimated that 150 million UTIs occur yearly worldwide, accounting for $6 billion in health care expenditures, according to the American Urological Association. Patients who fail to respond to an initial course of antibiotics can go on to develop a cUTI, which occurs when the bacteria are embedded in the bladder wall where they can multiply more slowly and are much harder to address with antibiotics. In most cases, cUTIs occur following treatment for a normal UTI because antibiotics were given too late, for too short a period of time, at too low of a dose course or the wrong antibiotic was used and did not provide adequate spectrum of coverage. An estimated three million cases of cUTIs are treated in the hospital setting in the United States each year for Gram-negative infections. Enterobacteriaceae are the most common pathogens causing cUTIs and, currently, widespread antibiotic resistance limits the effective treatment options for cUTI. Ineffectively managed cUTI can lead to increased treatment failure rates, recurrence of infection, increased re-hospitalization, and increased morbidity and mortality.

About Contepo™

Contepo™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. Intravenous (I.V.) fosfomycin has been approved for a number of indications and utilized for over 45 years in Europe to treat a variety of infections, including cUTIs and other serious bacterial infections. Contepo utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support Contepo as a first-line treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. At least 20 percent of cUTIs are caused by MDR bacteria and limited treatment options are available in the U.S. In addition, non-clinical data have shown that Contepo acts in combination with certain other antibiotics to improve bacterial killing.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, potentially the first systemic pleuromutilin antibiotic for CABP and Contepo (fosfomycin for injection), a potential first-in-class epoxide antibiotic in the United States for complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP). For  

Zynquista

FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.

A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.

Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps.
About Lexicon Pharmaceutical.

Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
*Sotagliflozin is an investigational drug and is under regulatory review by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The EMA and FDA have conditionally accepted Zynquista™ as the trade name for sotagliflozin.
About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Lexicon Forward-Looking Statements

This press release contains “forward-looking statements,” including statements relating to Lexicon’s and Sanofi’s clinical development of and regulatory filings for Zynquista (sotagliflozin) and the potential therapeutic and commercial potential of Zynquista. In addition, this press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including the risk that the FDA and other regulatory authorities may not grant regulatory approval of Zynquista in accordance with Lexicon’s currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of Zynquista. As a result, Zynquista may never be successfully commercialized. Other risks include Lexicon’s ability to meet its capital requirements, successfully commercialize XERMELO (telotristat ethyl), successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX2761, LX9211 and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2018, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
Source: Sanofi

This Couple Did Everything Right, Then Their 3-Year-Old Drowned

Nicole and Jonathan Hughes, a teacher and a physician with three young children, were acutely aware of the dangers of swimming pools and lakes. From fenced-off pools to life jackets to constant supervision, they did everything right.

Tragedy struck anyway.

Last June, as the family was about to head to an Alabama beach for an evening crab hunt, 3-year-old Levi somehow slipped out of their vacation house and found his way to the pool. In what seemed like an instant he was face down in the water, and couldn't be revived.

"We weren't neglectful, but somehow we failed to keep him safe," Nicole said. "Everybody knows about statistics, but the reality is nobody thinks it's going to happen to them."

Nicole, who lives in Bristol, Tennessee, has channeled her grief into activism, speaking out about a leading cause of preventable death among children: drowning.

"There's such a stigma that it's even hard to say the word," she said. "People say it's about 'water safety.' No, it's about drowning. We have to stop tiptoeing around it."

According to the Centers for Disease Control and Prevention, drowning is the No. 1 cause of unintentional death between ages 1 and 4, and the No. 2 cause between ages 5 and 9. The latest national data show 702 U.S. children under age 15 drowned in 2017.

The figures are not broken down by ethnic group, but minorities may be at even greater risk. The USA Swimming Foundation reports 64 percent of African American children and 45 percent of Hispanic children have low or no swimming ability, compared to 40 percent of white children.

The American Academy of Pediatrics recently updated its recommendations for preventing drowning in children, ranging from vigilance at bath time and emptying buckets and wading pools immediately after use to teaching children to swim and encouraging teenagers to learn CPR.

"We've got to do a better job," said Dr. Sarah Denny, lead author of the new guidelines. "Drownings continue to happen. Parents must be aware of the risks and take action to prevent drowning."

Denny, a pediatrician at Nationwide Children's Hospital in Columbus, Ohio, is particularly concerned about young children.

"Toddlers are curious, they're newly mobile, they're exploring their environment and they have no concept of the risk of water," she said.

She stressed that "layers of protection" are key to avoiding tragedy. Those layers include secure fences around pools, close supervision when children are around water, risk assessment and planning for children at every age level, and education, from the pediatrician's office to public service announcements.

One current announcement features Olympic gold medal skier Bode Miller and his wife Morgan, whose 19-month-old daughter Emmy drowned in a pool in California ; on the same day that Levi Hughes died in Alabama.

"You have to be vigilant, as if it's a lion waiting to snatch your child," Morgan says in the video message.

Nicole Hughes wants to encourage that vigilance with a "Water Guardian" tag, complete with lanyard, that adults can hand off to one another to emphasize the responsibility of supervising children in the water. They're available from her new foundation Levi's Legacy.

"It's another layer of protection," she said. "But the most important goal is just awareness."

If a drowning emergency should occur, "every second makes a difference," said Dr. Vinay Nadkarni, a critical care expert at The Children's Hospital of Philadelphia.

His recommendations start with calling 911 immediately. Get the victim to a safe area "and assess for signs of life. If they're not breathing normally, start CPR."

For drowning victims, the American Heart Association recommends CPR with chest compressions and rescue breaths.

"Prevention is the best cure," but a devastating accident can still happen, Nadkarni said, which makes knowing CPR no less important than a good fence.

"If you do not know CPR," Nadkarni said, "you should not have a pool."

AHA News: Kids With Heart Defects Joined Jackie Kennedy, LBJ to Raise Awareness

WEDNESDAY, Feb. 27, 2019 (American Heart Association News) -- On Feb. 1, 1961, twins Debbie and Donna Horst arrived at the White House to fanfare. The 6-year-olds, decked out in fancy dresses and satin sashes, found themselves surrounded by a pressing crowd and a sea of blinding flashbulbs as they made their way to see Jacqueline Kennedy.
The girls -- both born with holes in their aortas -- were meeting with the first lady to kick off a national campaign to raise awareness about congenital heart defects.
"There were hundreds of reporters because this was Jacqueline Kennedy' first public act as first lady," Debbie said. She recalls being startled when the reporters asked Mrs. Kennedy if they could move in closer. "It was frightening because they all jumped at us at once."
The Pennsylvania twins, just a few weeks from turning 7, were among the first "Heart Fund Sweethearts" in the campaign to raise money as well as awareness. The month before, they'd met up with Micki and Patricia Gane, also of Pennsylvania, and Jackie and Jeri Pelletieri of New Jersey, at the U.S. Capitol Building. All but one of the six were born with a hole in their heart at the time, a devastating diagnosis.
More than 50 years later, the four surviving Sweethearts share their unforgettable childhood stories.
Debbie and Donna
When Debbie and Donna were born in 1954 in Cheltenham, Pennsylvania, they experienced seizures and turned blue, leading doctors to conclude they each had a hole in their aortas. The hole is supposed to close before birth. Otherwise, getting enough oxygen to the blood is a problem.
The condition could be repaired with surgery at age 5.
"Sixty years ago, it was major surgery," Debbie said. "We didn't go to kindergarten, because of a risk of infection from the other kids."
After their surgeries in 1959, the girls' parents were asked if the girls could be "poster sweethearts" for an American Heart Association campaign about congenital heart defects.
Fast-forward to that February day in 1961. President John F. Kennedy' inauguration was just 12 days before, and the press was clamoring to capture the first lady' first public act. Debbie and Donna remember being escorted into her office amid the chaos.
"She was so soft-spoken and kind," Debbie recalled. "She asked my mom how to tell us apart, and she told Mrs. Kennedy the story of me cutting my own hair in the front, so mine was a little shorter than Donna'."
The girls gave the first lady a gift of heart-shaped flowers and dolls wearing the same dresses they wore baby blue with red hearts to give to her daughter, Caroline. Kennedy gave Debbie and Donna heart charms with her initials and their initials.
"I still have that charm today on my charm bracelet," Debbie said.
Today, Debbie' a medical receptionist in Yardley, Pennsylvania, and is married to her high school sweetheart, John Deeney. They have three children and five grandchildren.
Donna eventually married, and she and her husband, Lenny Jachimowicz, had two children, Nicole and Raymond. The family lived in Virginia when Donna died from cardiac arrest in 1998 at age 44. It wasn't related to her congenital heart defect, but it was rooted in an undiagnosed heart problem, Debbie said.
"When I lost Donna, it was like I lost my right arm," Debbie said. "But I have a lot of faith in God."
Patricia and Micki
Patricia, whose last name is now Olekszyk, was the only one of the six Sweethearts with a normally functioning heart. But she was very involved in the world of heart disease.
"When your sibling, especially a twin, is going through something this impactful, you feel it almost as much," Patricia said.
Micki had surgery at age 5. The hospital stay was long four months. But when she got out, she had energy to spare, jumping fearlessly in piles of leaves, Patricia recalled.
While only Debbie and Donna met Jacqueline Kennedy, all six girls visited the U.S. Capitol and met then-Vice President Lyndon B. Johnson.
"He saw what all of these little girls were going through, and what their families were going through, and I guess he just couldn't let it go overlooked," Patricia said.
Today, Patricia is married with a 29-year-old son. She teaches karate and self-defense and is the Delaware state champion for powerlifting and bench press for her age group.
Micki eventually married Jim Gaffney. She was a fan of Scottish country dancing and raising funds for projects she cared about, such as heart health. But Micki struggled with health problems. She suffered from chronic pain after a car accident and died in her sleep in 2016.
"I miss her, but at the same time, I feel like she never left," Patricia said.
Jackie and Jeri
Jackie and Jeri were well-known in their town of Milton, New Jersey, even before they went to Washington.
In addition to all the concerns about their condition and the upcoming surgery, their family was trying to rally their hometown to make sure they had enough blood for the procedure. They needed 48 pints of rare O-negative. Ads were placed in the local newspaper. One headline proclaimed, "100 donors helped twins facing knife."
Their mom' reaction matched the headline' drama she was terrified.
So, she told the 5-year-old girls they were just getting their tonsils out. The girls survived the lie, the surgery and long stints cooped up at the hospital and home. From their kitchen cots, Jackie and Jeri "operated" on their dolls, crayoning scars down the plastic chests.
When they went to Washington in 1961, they too met Johnson. A photo famously shows all the Sweethearts circling him while he clutched a large heart made of flowers. They recall his kindness and the letters he sent afterward; he said meeting them had been good for his heart.
Just a few years later, in 1964, Johnson would issue the first-ever national proclamation declaring February as American Heart Month to raise national awareness about heart disease. The tradition has continued ever since.
Today the sisters both live in Milton. Jackie Meller is retired after many years of waitressing. She has been married 23 years and has three children and five grandchildren. Jeri Wyse is a board assembler for Hubble, where she' worked for 40 years.
The family has seen some health scares. Twelve years ago, Jeri needed a stent. Eight years later, a quivering heartbeat required treatment.
More recently, a cousin' young son had surgery for a hole in his heart. His hospital stay was a few days, and Jeri couldn't help but to note how much less fuss and drama there was compared to her day.
"It' amazing what they can do for your heart today," Jeri said.

Colon Cancer Usually Diagnosed Late in Under-50 Adults

 Young adults are increasingly developing colon cancer -- and it's often diagnosed at a late stage, after they've seen several doctors and been misdiagnosed, a new survey shows.
Researchers questioned nearly 1,200 colon cancer patients diagnosed before age 50. Most cases were correctly identified only after the cancer was more advanced. In fact, about two-thirds waited up to a year to see a doctor after developing symptoms, and then went on to see multiple doctors before receiving the right diagnosis.
Many said they were initially misdiagnosed with conditions like hemorrhoids or irritable bowel syndrome (IBS).
Experts said the findings are not surprising. Symptoms of colon cancer -- such as fatigue, constipation and rectal bleeding -- can be caused by many noncancerous conditions that are much more common in younger adults.
"For young people, the possibility of colon cancer wouldn't be high on their list," said lead researcher Ronit Yarden.
It's also reasonable for doctors to first suspect conditions like hemorrhoids or IBS, said Yarden, who directs medical affairs for the Colorectal Cancer Alliance, a Washington, D.C.-based patient advocacy group.
But, she said, it's critical that doctors and patients alike be aware that colon cancer can strike young people.
And it's becoming more common, Yarden stressed. Since the 1990s, colon cancer rates have risen by 0.5 to 2 percent a year among Americans younger than 55, according to the American Cancer Society. Also, rectal cancer has shown a slightly faster increase ever since the 1970s.
Last year, the cancer society changed its guidelines on colon cancer screening for people at average risk. It now advises screening starting at age 45, instead of 50.
Around the same time, Memorial Sloan Kettering Cancer Center in New York City opened a center for colon cancer patients younger than 50. One goal is to research the reasons for the rising incidence, said Dr. Robin Mendelsohn, who co-directs the program.
Obesity and type 2 diabetes are risk factors for colon cancer, said Mendelsohn. So in theory, rising rates of those conditions among young Americans could be one driving force.
But that's unlikely to be the whole explanation. According to Mendelsohn, her center sees plenty of young patients who are normal-weight, have no medical conditions and lead healthy lifestyles.
"Right now, the reasons are unclear," she said.
Mendelsohn was not surprised that many survey respondents waited to see a doctor for their symptoms, or that other diagnoses were often made first.
In her experience with young colon cancer patients, she said, rectal bleeding is usually the symptom that first got them to see their doctor. Even when there's bleeding, Mendelsohn noted, noncancerous conditions, like hemorrhoids, are more likely to be the cause.
"But if that bleeding persists for a couple weeks after the visit, patients should go back for further evaluation," Mendelsohn said.
The survey findings are based on 1,195 colon cancer patients who were diagnosed before their 50th birthday. The majority were in their 40s, but one-third were in their 30s, and 10 percent were even younger.
Overall, 63 percent said they waited three to 12 months after their first symptoms to see a doctor. Even more -- 67 percent -- saw at least two doctors before getting the right diagnosis, with some seeing four. And, Yarden added, many patients who saw only one doctor also had delays in a correct diagnosis.
In all, 71 percent were diagnosed with more-advanced stage 3 or 4 cancer.
It's not clear, though, what role the delayed diagnoses had in that, Yarden said.
Mendelsohn said the finding probably reflects the fact that younger patients are going to the doctor because of symptoms that often arise when the disease is more advanced. That's in contrast to older patients, whose cancer is often caught early through screening -- before they have symptoms.
Both Mendelsohn and Yarden said younger patients with possible colon cancer symptoms should "advocate for themselves." If the problems persist, ask for further evaluation with a colonoscopy.
"And know your family history," Mendelsohn advised.
The risk of colon cancer is higher among people with a parent, sibling or child who had the disease -- especially if it was diagnosed before age 45, the cancer society says.
Yarden is scheduled to present the results next month at the annual meeting of the American Association for Cancer Research, in Atlanta. They were released Feb. 27. Research presented at meetings should be considered preliminary until
ed in a peer-reviewed journal.

Too Much TV Might Dull the Aging Brain

 The old saying, "TV rots your brain," could have some validity for folks as they age.
In a new study, middle-aged people who watched television for more than 3.5 hours a day experienced a decline in their ability to remember words and language over the next six years, British researchers found.
What's worse, it appears that the more TV you watch, the more your verbal memory will deteriorate, researchers said.
"Overall, our results suggests that adults over the age of 50 should try and ensure television viewing is balanced with other contrasting activities," said lead researcher Daisy Fancourt. She's a senior research fellow at University College London.
For the study, researchers relied on data from a long-term study of aging involving more than 3,600 residents of England.
Participants reported the amount of hours of TV they watched daily. They also had their thinking and reasoning skills regularly tested as part of the study.
People who watched less than 3.5 hours of TV a day didn't seem to suffer any deterioration in their brain power, Fancourt said.
But more than that amount, people became increasingly apt to struggle with words or language in tests conducted six years later.
The decline in language skills is similar to that experienced by the poor as they age, Fancourt said.
"We already know from a number of studies that being of low socio-economic status is a risk factor for cognitive decline," Fancourt said. "If we compare the size of association for watching television for greater than 3.5 hours a day, it has a similar-sized association with verbal memory as being in the lowest 20 percent of wealth in the country."
The worst deficits occurred in those people who watched more than seven hours of television daily, researchers found.
While only an association was seen in the study, there are a couple of potential reasons why this might happen.
"Due to the fast-paced changes in images, sounds and action, yet the passive nature of receiving these -- i.e., television does not involve interaction as gaming or using the internet does -- watching television has been shown in laboratory studies to lead to a more alert, but less focused, brain," Fancourt explained.
Some TV viewing is also stressful, and stress has been associated with a decline in brain power, she added.
The specific effect on verbal skills indicates that avid TV viewing could be replacing other activities that would be better for the brain, said Rebecca Edelmayer, director of scientific engagement at the U.S.-based Alzheimer's Association.
"You're spending more time not engaging with your family, your friends and having social conversations, because they're specifically reporting a decrease in verbal recall," Edelmayer said. "We know engagement with others in conversation is something that supports and protects verbal recall."
People who want to protect their thinking skills need to socialize often and engage in other activities that "stretch" their brain, Edelmayer said.
In fact, a long-term study
ed just last week in the journal Neurology found that exercising both the brain and body during middle age may guard against dementia. Such mental exercise includes reading, playing music, sewing or painting, according to the report.
"The recommendation would always be to stretch yourself and stay as engaged as you can be, whatever the connection is," Edelmayer said. "We're asking you for best brain health to go outside your normal passive box."
The new study was
ed Feb. 28 in the journal Scientific Reports.

Could Invasive Lung Cancer Biopsies Be Replaced by Blood Tests?

 A blood test may one day replace invasive tissue biopsies as a pain-free way to confirm lung cancer and guide treatment, new research suggests.
According to investigators, the test is as effective as a tissue biopsy in diagnosing advanced non-small cell lung cancer, by far the leading form of the leading cancer killer.
The so-called "liquid biopsy" can also quickly identify tumor gene mutations that match targeted drug therapies -- potentially boosting patient survival.
The new findings present "a convincing argument for use of the liquid biopsy as a first option for molecular testing in advanced non-small cell lung cancer," said lead researcher Dr. Vassiliki Papadimitrakopoulou. She's professor of thoracic head and neck medical oncology at the University of Texas MD Anderson Cancer Center.
As the Houston team explained, if a CT scan suggests lung cancer, patients are typically asked to undergo a surgical tissue biopsy. It's an expensive, invasive procedure that comes with risks and inconvenience to patients.
Seeking a way around these procedures, numerous companies have been developing blood-based diagnostic tests for lung cancer. The new study focuses on one such test, called Guardant360, developed by Guardant Health, the company that funded the new study.
Blood tests like Guardant360 rely on traces of tumor DNA in blood for clues to the presence of lung cancer and the best way to treat it.
In addition to the higher accuracy found in the new study, the researchers reported that the results of the blood test can be turned around sooner than those of a tissue biopsy.
While results for a standard biopsy took 15 days to process, results of the liquid biopsy took just nine days, on average, the study found.
That means treatment could begin sooner, with potentially better outcomes, the researchers said.
Speedier genetic analysis of the tumor is crucial, the investigators explained, because 30 percent of lung cancers can now be successfully treated with new gene-targeted medicines. These drugs tend to have higher response rates than standard chemotherapy.
For the study, Papadimitrakopoulou and her colleagues used Guardant360 to identify mutant genes in the blood of nearly 300 patients.
Specifically, the tests were focused on seven "biomarkers" in blood samples -- tumor-specific gene mutations that can help identify subtypes of lung cancer.
The Guardant360 test also looked for one biomarker -- called KRAS -- that helps predict a cancer patient's prognosis, the research team said.
The blood test seemed to outperform standard tissue biopsy. While the standard surgical biopsy found at least one marker predictive of lung cancer in 60 patients, the blood test spotted it in 89 patients, the findings showed.
Drugs that target many of these lung tumor gene mutations are already approved by the U.S. Food and Drug Administration, the researchers noted.
Among the more than 190 patients who did not show the presence of one of the seven genetic tumor biomarkers, testing was often still able to spot the KRAS prognostic biomarker, the study team said.
Again, the blood test beat tissue biopsy in this regard: The Guardant360 test spotted the KRAS biomarker in 92 patients, compared with 24 patients who underwent standard biopsy.
Still, the new study was limited in two ways. First, Guardant360 results weren't compared to the results of the very latest gene-based surgical biopsy analyses. And secondly, the results apply only to the Guardant360 test -- not to other liquid biopsies already out there.
One lung cancer specialist was still heartened by the results, however.
"For years, we have been doing surgical biopsies, but over the last few years there's been a recognition that this is more a 'molecular disease,' governed by [gene] mutations," said Dr. Richard Lazzaro, chief of thoracic surgery at Lenox Hill Hospital in New York City.
It's also been known that cancer cells can shed their DNA into the blood, he said.
"If you can make diagnosis and treating decisions and save time, that's outstanding for patient care," Lazzaro said.
Effective treatment, delivered sooner after diagnosis, should improve survival, he added.
Already, liquid biopsies are often being used in tandem with surgical biopsies, Lazzaro noted.
However, "perhaps one day they will replace a surgical biopsy and may become a better therapeutical paradigm," he said.
The results of the study are to be presented March 29 at the American Association for Cancer Research meeting, in Atlanta. Findings presented at medical meetings are typically considered preliminary until
ed in a peer-reviewed journal.
According to the American Cancer Society, lung cancer remains the number one cancer killer in the United States, with nearly 143,000 deaths expected in 2019.

Smoking While Pregnant Sends SIDS Risk Soaring

 Smoking during pregnancy is never a good idea, but new research shows it might double the risk of a baby dying from sudden infant death syndrome (SIDS).
"Any maternal smoking during pregnancy -- even just one cigarette a day -- doubles the risk of sudden unexpected infant death [SUID, another term for unexplained infant deaths]," said lead researcher Tatiana Anderson. She is a fellow at Seattle Children's Research Institute, Center for Integrative Brain Research.
Doctors should strongly encourage women to give up smoking during pregnancy, or if they can't quit, to smoke less, she said. Each cigarette smoked increases the risk of SIDS, Anderson added.
If women didn't smoke during pregnancy, the rate of SIDS in the United States could be cut by 22 percent, preventing some 800 infant deaths a year, according to the new report
ed online March 11 in the journal Pediatrics.
Although 55 percent of the women in the study who smoked didn't stop or cut back during pregnancy, those who did markedly reduced the risk of SIDS, Anderson said.
Specifically, women who cut down on their smoking by the third trimester reduced the risk of SIDS by 12 percent. Women who quit by the third trimester reduced the risk by 23 percent, the researchers found.
For the study, Anderson and her colleagues collected data on more than 19,000 SUID cases. SUID cases include sudden infant death syndrome and other unknown causes of death, as well as suffocation and strangulation in bed of infants under age 1.
It's not just smoking, said Dr. Rahul Gupta, chief medical and health officer at the March of Dimes. But the more women smoke, the greater the risk for SUID becomes, he said.
Women should stop smoking before pregnancy and certainly during pregnancy, Gupta advised.
Smoking during pregnancy can impair the baby's brain development. In addition, women who smoke are depriving their baby of oxygen, as smoking decreases the amount of oxygen in the blood and, therefore, in the placenta, he explained.
"Smoking also causes preterm birth, decreases in development of the brain and respiratory system of the baby," Gupta said. "Nicotine has also been linked with an important part of the development of the brainstem in the infant."
Gupta explained that if an infant stops breathing during sleep, a mechanism in the brain senses the lack of oxygen and triggers breathing to start. This is called auto-resuscitation.
Nicotine, however, alters this response, he said. "That baby may not be able to auto-resuscitate, and as a result, we end up with sudden infant death syndrome," Gupta said.
Because e-cigarettes are a nicotine delivery device, they are not a safe alternative to cigarettes, he added.
"Nicotine is in the vaping device, so all the impacts we are talking about are still harmful when nicotine is delivered, regardless of the device," Gupta said. "Nicotine and babies do not match."
In addition, flavorings and other ingredients in e-cigarettes may be harmful to developing babies, he noted.
"Quitting smoking is one of the most effective actions you can take to protect yourself and your baby," Gupta said.

Similarly, the counseling was not effective overall, though it seemed to help prevent depression in participants who attended a recommended number of sessions.

That suggests counseling works only if people get an adequate "dose" of therapy and make significant changes in their diet, according to the study
ed March 5 in the Journal of the American Medical Association.
"Because depression is such a common problem, finding effective and widely available ways to prevent depression at a population level is an important goal," said study co-author Ed Watkins.
He's a professor of experimental and applied clinical psychology at the University of Exeter in England.
"Diet and nutrition held promise as one means to reach large numbers of people. However, this trial convincingly demonstrates that nutritional supplements do not help to prevent depression," he said in a university news release.

The study included more than 1,000 overweight or obese people in the United Kingdom, the Netherlands, Germany and Spain who were at risk for depression, but were not currently depressed.

Excess weight is often linked with depression, the researchers noted.
Half of the study participants took daily supplements containing folic acid, vitamin D, omega-3 fish oils, zinc and selenium. Half took a placebo pill.
Half were also counseled about their eating habits and urged to limit snacking and follow a healthy Mediterranean-style diet.
In a one-year follow-up, the researchers discovered that the supplements worked no better than the placebo in helping ward off depression.
Similarly, the counseling was not effective overall, though it seemed to help prevent depression in participants who attended a recommended number of sessions.
That suggests counseling works only if people get an adequate "dose" of therapy and make significant changes in their diet, according to the study
ed March 5 in the Journal of the American Medical Association.
"Because depression is such a common problem, finding effective and widely available ways to prevent depression at a population level is an important goal," said study co-author Ed Watkins.
He's a professor of experimental and applied clinical psychology at the University of Exeter in England.
"Diet and nutrition held promise as one means to reach large numbers of people. However, this trial convincingly demonstrates that nutritional supplements do not help to prevent depression," he said in a university news release.

1 in 3 Young Adults Suffers From Loneliness in U.S.

 For young adults, drugs and distracted driving are well-recognized health threats. Far less attention is paid to loneliness.
But loneliness is common -- and it is a particular problem for people aged 18 to 24, a new study suggests.
"We have this stereotype of the lonely old person in poor health, and the robust, socially active young person," said James Maddux, a senior scholar at George Mason University's Center for the Advancement of Well-Being, in Fairfax, Va.
"But that's not what this study found," added Maddux, who was not involved in the research.
The researchers found that of more than 1,200 patients at primary care offices, 20 percent said they at least sometimes felt lonely, isolated and "left out." Overall, those people gave lower ratings to their physical and mental health.
Loneliness was most common among patients younger than 25 -- with one-third reporting those feelings. In contrast, that was true for only 11 percent of adults older than 65, the investigators found.
The study is the latest to highlight what some researchers call a national "loneliness epidemic."
Last year, a study of more than 20,000 U.S. adults found that nearly half felt lonely at least sometimes. And only 53 percent said they had meaningful face-to-face interactions everyday.
Research suggests it's not only a social issue. Chronic loneliness is linked to heightened risks of conditions such as high blood pressure, heart disease, dementia and depression.
The study surveyed people at one point in time. So it's not clear whether loneliness preceded -- and possibly contributed to -- people's poorer health, said lead researcher Dr. Rebecca Mullen.
It's possible the relationship goes in "both directions" -- with loneliness and health issues feeding each other, added Mullen, an assistant professor at the University of Colorado School of Medicine.
In talking about loneliness, it's important to distinguish it from "time spent alone," said Maddux.
"People who are more introverted may be perfectly happy with their alone time," Maddux explained.
Subjective loneliness is different. It makes people feel bad. And, Maddux said, that can come with a "whole package" of issues, like poor diet, poor sleep and time spent on the couch instead of being physically active.
What's making Americans so lonely? In this study, certain people felt more alone than others -- including those living in poorer areas with high unemployment; unmarried people; and those aged 18 to 24.
The finding on young people is "interesting," Maddux said.
One obvious suspect would be social media. Does all that time on smartphones rob teenagers and young adults of meaningful face-to-face interaction?
There's some evidence of that, Maddux said. A number of studies have found correlations between young people's screen use and their likelihood of depression and loneliness.
Mullen also pointed to social media but said that, so far, research has been mixed as to whether smartphones are -- ironically -- disconnecting us.
At this point, Maddux said, "some research suggests time on social media can be psychologically unhealthy for some people."
If people are using social media to forge connections in addition to old-fashioned face time, that's one thing. But, Maddux said, if they just passively scroll through people's photos of their fabulous vacations -- or have online connections that are otherwise "unsatisfying" -- that's different.
Young people, he added, may have a harder time keeping those social media experiences in perspective -- and understanding that when other people post, they are probably trying to present their lives in the shiniest terms possible.
The findings were
ed in the March/April issue of Annals of Family Medicine. They're based on 1,235 adult primary care patients in Colorado and Virginia. All of the patients completed a standard three-question survey on loneliness -- asking how often they felt isolated, left out or lacking companionship.
One-fifth of patients scored high enough to be deemed "lonely." Those people reported an average of 10 "poor health days" a month -- versus four days among other patients.
Maddux said it's important for people to acknowledge and address their own feelings of loneliness -- and to reach out if they start seeing the signs in others.
"It can be easy for people to just gradually fade out of your life," he noted.
Loneliness, Mullen said, is a public health issue, and one people should be discussing.
"Let's work to decrease the stigma around loneliness," she said, "so that we can have open, honest conversations about it."

The finding could have implications for a huge number of vets: Roughly eight in 10 VA-covered patients have additional private or public health insurance coverage. About 51 percent have Medicare, and about one-third of those receive Medicare Part D drug benefits.

But the problem may be more about poor oversight than addicted patients trying to game the system, noted study author Dr. Walid Gellad, a researcher with the VA Pittsburgh Healthcare System.
"Only in some limited circumstances -- and we don't know how many -- is this purposeful behavior by a patient to try and get additional opioids," he explained.
"I would not think of this as 'double-dipping' or 'being caught,'" Gellad added. "In some cases, receiving opioids from both systems could have happened at different times, as veterans got care in one system first, and then in another system later, or they go back and forth between VA and the private sector. In some cases, the opioids are prescribed at the same time, sometimes unintentionally, and sometimes intentionally."
Gellad and his team found that more than 3 million veterans filled at least one opioid prescription (either through the VA or another insurer) during the time period from July 2011 through December 2013.
To see how dual health insurance coverage might influence overdose risk, the team first examined the records of 215 veterans who died from an overdose between 2012 and 2013.
Their average age was 57, most (90 percent) were male and most (84 percent) were white. All had both VA and Medicare Part D health care coverage for at least six months prior to their deaths.
For comparison, the investigators also assessed opioid prescription patterns among a "control group" of more than 800 living vets of a similar age, race, health status and gender.
About 28 percent of those who had died due to an opioid overdose had obtained their meds from both the VA and through Medicare Part D. This compared with just 14 percent of the control group, the researchers found.
Still, Gellad stressed that systemic changes that curtail getting opioids from multiple sources have been implemented by the U.S. Department of Veterans Affairs since the study ended in 2013.
For example, he noted that "the VA has instituted requirements to check prescription drug monitoring programs, which should alert physicians to instances when opioids are prescribed in different systems."
But, "for this to work to reduce the risk of overdose, clinicians have to actually check, and they have to do something with the information when they find it," Gellad added.
"Ultimately, I think we will see automated alerts that will alert clinicians to a medication prescribed in one system if it, or an interacting medication, is also being prescribed in another system," Gellad said. "But for that to have an impact, it has to alert at the point of prescribing, which is not possible yet within [the] VA or outside [the] VA."
The report was
ed online March 12 in the Annals of Internal Medicine.
Dr. Carolyn Clancy, Deputy Under Secretary for Discovery, Education and Affiliate Networks with the VA in Washington, D.C., co-authored an accompanying journal editorial.
Clancy pointed out that "because of VA's existing robust and extensive patient record system, the department has had significant success in reducing opioid use and overdose risk."
The VA has been tracking problems related to dual access to medications "for some time," she said.
"That's why the department is constantly working to improve coordination with community providers," Clancy noted. "Especially through the implementation of electronic health record modernization."
And going forward, she said, the VA hopes to augment the current screening process afforded by state prescription drug monitoring programs, by "seeking to develop [its own] electronic system to automatically check all state prescription drug monitoring programs for each veteran to further improve care coordination."

A Simple Way to Help Prevent Child Obesity

 Kids who don't drink water take in nearly 100 more calories from sugary drinks every day than those who do, according to a recent Penn State study.
About one-fifth of children fall into the no-water group.
But a multi-year experiment in the New York City public schools involving more than 1 million students found that installing water dispensers in school can change that. Having dispensers increases the amount of water the kids drink, decreases purchases of sugary chocolate milk and the number of sodas and juices brought to school, and helps prevent excess weight in both boys and girls.
But it's not enough to simply tell kids to give up soda and other sugary drinks and have water instead. It needs to be easier for kids to make this choice. Parents can follow these steps from Children's Hospital Colorado to encourage kids to choose water.
Make drinking water more fun by adding frozen berries or grapes to a clear reusable water bottle designed for small hands.
Freeze small bottles of water to pack in their afterschool sports bag. The water will thaw during the day, yet still be cold and refreshing when they reach for it.
Let your kids keep the deposit money when you recycle store-bought bottled water containers.
When eating out, choose water as the beverage -- you'll not only save calories, but you'll also save money.
Finally, set the right example by drinking water yourself.

Leonardo da Vinci May Have Had ADHD

 Leonardo da Vinci's legendary struggles to complete projects suggest he may have had attention-deficit hyperactivity disorder (ADHD), a British researcher says.
That's the latest in a series of attempts to understand the genius and work habits of an inventor and artist often considered the most creative person ever known.
The fascination with da Vinci dovetails with the 500th anniversary of his death earlier this month.
In the latest theory, Marco Catani of King's College London said ADHD may have been a factor in da Vinci's chronic procrastination as well as his exceptional achievements. Catani's theory is based on historical accounts of da Vinci's work habits and behavior.
"While impossible to make a post-mortem diagnosis for someone who lived 500 years ago, I am confident that ADHD is the most convincing and scientifically plausible hypothesis to explain Leonardo's difficulty in finishing his works," said Catani, a professor of forensic and neurodevelopmental science.
"Historical records show Leonardo spent excessive time planning projects but lacked perseverance. ADHD could explain aspects of Leonardo's temperament and his strange mercurial genius," Catani explained in a college news release.
The inability to complete tasks was seen in da Vinci from childhood.
The artist was always on the go, often switching from project to project, and he worked around the clock by taking short naps, according to Catani, who specializes in treatment of conditions such as ADHD and autism.
Along with being left-handed, da Vinci was likely dyslexic and to have a dominance for language on the right side of his brain, Catani said. All are common in people with ADHD.
"There is a prevailing misconception that ADHD is typical of misbehaving children with low intelligence, destined for a troubled life," Catani said. "On the contrary, most of the adults I see in my clinic report having been bright, intuitive children but develop symptoms of anxiety and depression later in life for having failed to achieve their potential."
Catani said da Vinci considered himself a failure.
"I hope that the case of Leonardo shows that ADHD is not linked to low IQ or lack of creativity but rather the difficulty of capitalizing on natural talents," he said. "I hope that Leonardo's legacy can help us to change some of the stigma around ADHD."
The study was outlined in a paper
ed May 23 in the journal Brain.
Earlier this month, Dr. Salvatore Mangione, of Thomas Jefferson University in Philadelphia, said dyslexia was probably behind da Vinci's genius. Like ADHD, dyslexia does not affect intelligence, and research suggests people with the condition may be highly creative.
In an article in The American Journal of Medicine, Mangione noted da Vinci was an atrocious speller -- a sure sign of dyslexia.
Other recent research suggests da Vinci may have had an eye problem called strabismus, which makes 3D vision impossible. Having 2D vision is associated with dyslexia and skill in visual art, Mangione said.

Ещё Задан пустой поисковый запрос Яндекс.Директ Скачать Яндекс.Браузер getyabrowser.com Заходите во Вконтакте и в Одноклассники с помощью обновленного Браузера Видеочат с девушками для взрослых! coomeet.com Тысячи людей онлайн! Хотите найти собеседника? С нами это просто. Заходите!18+ Ютуб без рекламы – это look.li look.li Загрузка, поиск, просмотр видео без рекламы и платных функций. Жми!0+ Электросамокаты. Ликвидация склада giroskuter.net.ua Супер низкие цены, и высокое качество товара. Прямые импортеры. не пропустите! Распознавание гос. номера авто! mallenom.ruАдрес и телефон Система распознавания гос. номеров автомобилей! Напрямую от разработчика! С обновлённым Браузером сервисы работают исправно

Ещё

Дополнительная информация о запросе

Задан пустой поисковый запрос

Яндекс.Директ

Скачать Яндекс.Браузер

getyabrowser.com

Заходите во Вконтакте и в Одноклассники с помощью обновленного Браузера

Видеочат с девушками для взрослых!

coomeet.com

Тысячи людей онлайн! Хотите найти собеседника? С нами это просто. Заходите!18+

Ютуб без рекламы – это look.li

look.li

Загрузка, поиск, просмотр видео без рекламы и платных функций. Жми!0+

Электросамокаты. Ликвидация склада

giroskuter.net.ua

Супер низкие цены, и высокое качество товара. Прямые импортеры. не пропустите!

Распознавание гос. номера авто!

mallenom.ru

Адрес и телефон

Система распознавания гос. номеров автомобилей! Напрямую от разработчика!

КрестовкаНастройкиКлавиатураПомощьОбратная связь

Rus

Для бизнесаДиректМетрикаКасса

Для душиМузыкаПогодаКоллекции

ЯндексО компанииВакансииБлогКонтакты

© 1997–2019  ООО «Яндекс»

Лицензия на поискСтатистика

Поиск защищён технологией Protect

Попробуйте быстрый Браузер

с технологией защиты Протект0+

Скачать

С обновлённым Браузером сервисы работают исправно