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Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla PRINCETON, N.J., May 17, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug Administration (FDA) the NDA for its lead product candidate, Twirla®, an investigational low-dose combined hormonal contraceptive patch (AG200-15).  Agile resubmitted the NDA in response to a December 2017 Complete Response Letter (CRL) from the FDA, which identified deficiencies relating to (i) quality control adhesion test methods for the Twirla manufacturing process, (ii) observations identified during an inspection of a facility of our third-party manufacturer for the Twirla NDA that must be resolved, and (iii) questions on the in vivo adhesion properties of Twirla and their potential relationship to the SECURE clinical trial results. The resubmitted NDA includes the results from a...

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...

New research suggests that a diet that's full of fiber appears to lead to more diverse intestinal bacteria (microbiome). In turn, a thriving gut microbiome is linked to a stronger response to an immune therapy for the aggressive skin cancer. "We found that patients eating a high-fiber diet at the start of therapy were about five times more likely to respond to the anti-PD-1 immunotherapy," said study author Christine Spencer. She's a research scientist with the Parker Institute for Cancer Immunotherapy in San Francisco. Anti-PD-1 immunotherapy helps the immune system recognize cancer cells as dangerous cells that need to be destroyed, according to the American Cancer Society (ACS). The cancer drugs Keytruda and Opdivo are examples of this type of immunotherapy. Melanoma is a type of skin cancer. It only accounts for about 1 percent of all skin cancers, but is responsible for most skin cancer deaths, the ACS says. Several recent studies have suggested that a ...

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 pu...

 You know that too much salt contributes to high blood pressure, but you might not realize how easily eating out could put you and your kids at risk. Many entrees at leading restaurants and fast food places contain almost a full day's allotment of salt, according to the U.S. Centers for Disease Control and Prevention. Remember, that's 2,300 milligrams, or about one teaspoon. With many Americans eating out an average of five times a week, all that salt adds up. And the more salt you eat, the greater the odds for high blood pressure (hypertension), a major contributor to heart disease and stroke. By some estimates, the average American takes in 50 percent more salt than the daily limit, and this excess starts in childhood. Kids between 6 and 10 years of age take in 2,900 mg a day, while teens top out at about 3,700 mg. Studies done around the world have looked at salt consumption and high blood pressure. A study of 500 people, aged 18 to 40, found that the more restaura...

 Overweight preschoolers have twice the odds of developing high blood pressure by age 6, putting them at risk of heart attack and stroke later in life. And those odds begin building as early as age 4, a new study reports. "The myth that excess weight in children has no consequences hampers the prevention and control of this health problem," said study author Dr. Inaki Galan, from Carlos III Health Institute in Madrid, Spain. "Parents need to be more physically active with young children and provide a healthy diet," Galan added. "Women should shed extra pounds before becoming pregnant, avoid gaining excess weight during pregnancy, and quit smoking, as these are all established risk factors for childhood obesity." For the study, Galan and his team looked at the weight and blood pressure of nearly 1,800 4-year-olds. The children were tested again at age 6. Compared with kids who maintained a healthy weight throughout the study, those who were obes...

 Do you worry a lot? Besides the anxiety it's causing you emotionally, it can threaten your health. Whether you worry over actual problems or the fear of future ones, it interferes with sleep and quality of life. And, according to research done at Case Western Reserve University, it can be so intrusive that it harms your important relationships, too. Here's what you can do to ease your worries and protect your mental and physical health. Take action for true concerns. For instance, if you're worried about money for retirement, learn more about investments. Work with a certified financial planner to help you meet goals. If you're nervous about a health condition or an upcoming medical test, bone up on the procedure, experts at the University of California, Berkeley, suggest. Don't be afraid to ask your medical providers questions so you understand what you've read and how it applies to you. On the other hand, if you find that you look for things to worry ab...

 The risk of a pregnancy-related type of heart failure is five times higher for women who undergo fertility treatment than those who conceive naturally, a new study says. The condition is called peripartum cardiomyopathy (PPCM). It affects about 1 in 1,000 pregnant women worldwide and is life-threatening to the mother and baby. This study included 111 women with PPCM and was presented Saturday at a meeting of the European Society of Cardiology, in Athens. "It is very difficult to distinguish normal pregnancy discomfort from heart failure symptoms," study co-author Dr. Tobias Pfeffer said in a society news release. He's a cardiologist at Hannover Medical School in Germany. "Our study shows that the risk of PPCM is five times higher in women who have fertility treatment, so they should be aware that this discomfort may not be benign. PPCM is often diagnosed much too late, with direct consequences on prognosis," Pfeffer said. Shortness of breath, swollen legs...

 Whether you grow it yourself or buy it at your farmers' market or grocery store, zucchini is a great way to add variety to traditional dishes and even increase portion sizes of favorite recipes without extra calories. Love cool cucumber salad? For a tasty variation, use thin strips of peeled zucchini, cut on a mandoline. (Note: Mandoline blades are sharp. Always use the gripper to hold the food you're prepping.) Toss with lemon juice, chopped dill, salt and olive oil, then refrigerate for one hour before serving. Next, try zucchini "noodles" in place of white pasta. Grate zucchini with the shredder attachment of the mandoline. Heat 1 tablespoon of olive oil in a large skillet over medium heat, then cook the zucchini for one minute until it begins to soften. Toss with your favorite marinara. Want to get more creative? These easy zucchini fritters taste great hot or cold. Zucchini Fritters 2 eggs lightly beaten 1/4 cup parsley, chopped 1/2 cup grated Parmesan c...

 A new analysis suggests the Trump administration should have considered how unchecked climate change might harm U.S. citizens before it pulled out of a pact aimed at slowing down the pace of global warming. In the study, researchers calculated that tens of thousands of lives in major U.S. cities would be saved annually if rising temperatures were curtailed. "Extreme heat is related to higher human morbidity and mortality in cities," explained study author Y.T. Eunice Lo. She is a research associate with the Bristol Research Initiative for the Dynamic Global Environment at the University of Bristol, in England. But, "by limiting the amount of warming, U.S. cities' exposure to extreme heat would decrease," Lo said. That conclusion follows her team's examination of the public health impact that rising temperatures might have on these 15 metropolitan areas: Atlanta, Boston, Chicago, Dallas, Detroit, Houston, Los Angeles, Miami, New York City, Philadelphia,...

-- About 1 in 5 teens has some degree of hearing loss, says the American Osteopathic Association. Experts think many instances could be linked to headphone use. To avoid headphone-induced hearing loss, the association suggests: Listen to music at less than 60 percent of maximum volume. Listen to music for less than 60 minutes. Choose over-the-ear headphones over earbuds. If you have ringing, hissing or buzzing in the ear, visit a doctor immediately, the association says.

 Millions of tons of nitrate from industrial farming find their way into America's drinking water each year, causing thousands of cases of cancer and other health problems, an environmental advocacy group says. In a new report, researchers from the Environmental Working Group (EWG) quantify the risk. They say nitrate is responsible for nearly 12,600 cases of cancer a year. "Industrialized farming relies heavily on nitrate fertilizers that can run off into the water table used by drinking water utilities," said Sydney Evans, a science analyst at EWG. The risk varies from region to region, she said, noting that many small farming communities have the highest nitrate levels in their water -- and the highest risk. Iowa and California, two heavily agricultural states, were found to have the most nitrate-related cancer cases. A Yale University researcher who reviewed the report said the danger it highlights is clear and exists throughout the country. "An immedi...

More Women Should Be On Scientific Panels, NIH Head Says The head of the U.S. National Institutes of Health, Dr. Francis Collins, has vowed not to speak at conferences where women are not given a prominent speaking role. Men have typically dominated the platform at scientific meetings, the New York Times reported. In a statement, Collins said: "I want to send a clear message of concern: It is time to end the tradition in science of all-male speaking panels." "Starting now, when I consider speaking invitations, I will expect a level playing field, where scientists of all backgrounds are evaluated fairly for speaking opportunities," he said. Collins urged others to follow his lead.

"While both men and women are reluctant to seek professional help for their abuse, there is an added barrier for men voiced in these studies, that they may be falsely accused of being the perpetrator. The men also raised wider concerns about masculinity," said study co-author Dr. Gene Feder, a professor of primary care at the University of Bristol. He and his colleagues reviewed studies of men in heterosexual and gay relationships. They found that fears of not being believed or being accused of abuse were factors in not seeking help. Embarrassment and feeling "less of a man" were reported to be other barriers. Men also worried about their partner and damaging their relationship as well as losing contact with their children. Still others were afraid of telling their family or friends, or getting professional help. Many men didn't know that professional help was available, the study found, or thought that support services were for women only. Some men ...

The study, of nearly 20,000 adults in England, found that people who spent at least two hours outdoors in the past week gave higher ratings to their physical health and mental well-being. There could, of course, be many reasons that nature lovers were faring better than people who preferred the great indoors, according to lead researcher Mathew White. White said his team tried to account for as many alternative explanations as possible: They asked study participants about any disabling health problems that might keep them homebound, as well as their exercise habits. The researchers also looked at factors such as people's age, occupation, marital status and the characteristics of their neighborhood -- including poverty and crime rates. In the end, outdoor time itself still seemed beneficial. People who spent two to three hours per week in nature were 59% more likely to report "good health" or "high well-being." In fact, White said, even when people had heal...

"Your neighborhood shouldn't influence your odds of seeing your grandchildren grow up," said lead researcher Dr. Marc Gourevitch, chairman of the department of population health at NYU Langone Health System. His colleague, co-author Benjamin Spoer, said researchers have known for a while that conditions from neighborhood to neighborhood can have "profound influence" on how long and how well people live. "But we were surprised to see just how large the gap in life expectancy can be between neighborhoods, and how strong the link was between life expectancy and segregation, across all different kinds and sizes of cities," Spoer said in an NYU news release. Chicago had the biggest gap in life expectancy between neighborhoods at 30.1 years. That was followed by Washington, D.C., at 27.5 years; New York City, 27.4; and New Orleans and Buffalo, N.Y., both at 25.8 years. Scores on measures of racial and ethnic segregation in these cities were more than do...

These gaps can mean people in one neighborhood live 20 to 30 years longer than those just a mile away -- and the inequalities are prevalent in cities with high levels of racial and ethnic segregation, according to New York University researchers. They said their findings should be a wake-up call for city leaders nationwide. "Your neighborhood shouldn't influence your odds of seeing your grandchildren grow up," said lead researcher Dr. Marc Gourevitch, chairman of the department of population health at NYU Langone Health System. His colleague, co-author Benjamin Spoer, said researchers have known for a while that conditions from neighborhood to neighborhood can have "profound influence" on how long and how well people live. "But we were surprised to see just how large the gap in life expectancy can be between neighborhoods, and how strong the link was between life expectancy and segregation, across all different kinds and sizes of cities," Spoer sai...

The new study is the first to document how facial bones change as black adults age, and may help guide plastic surgeons' work. "It is important for plastic surgeons to understand how the facial aging process differs among racial and ethnic groups to provide the best treatment," said study author Dr. Boris Paskhover. He is an assistant professor at Rutgers New Jersey Medical School, in Newark. For the study, his team looked at medical records of 20 black adults from 1973 and 2017. The study patients had at least two face scans taken 10 years apart. Although all of the faces changed over time, they showed only minor changes, compared to similar studies on the aging white population. "This finding reflects other studies that show black adults have higher bone mineral density, decreased rates of bone loss and lower rates of osteoporosis as compared to the general population," Paskhover said in a university news release. Facial aging results from a combination ...

Researchers found a complete response rate of 40 percent with Polivy plus bendamustine and rituximab compared with 18 percent with bendamustine and rituximab alone. Twenty-five patients achieved a partial or complete response with Polivy plus bendamustine and rituximab; 64 percent of these patients had a duration of response of six months or longer and 48 percent achieved a duration of response of at least one year. The most commonly reported side effects of the combination of Polivy plus bendamustine and rituximab included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite, and pneumonia. Patients should be closely monitored for infusion-related reactions, low blood counts, fatal or serious infections, tumor lysis syndrome, hepatotoxicity, and progressive multifocal leukoencephalopathy. The FDA noted that women of reproductive age should be advised to use effective contraception during treatment and for three months following ...

Erectile dysfunction — the inability to get and keep an erection firm enough for sex — is a common problem. You've likely seen advertisements for erectile dysfunction herbs or supplements to "increase your sexual performance." Could they work for you? Erectile dysfunction supplements and other natural remedies have long been used in Chinese, African and other cultures. But unlike prescription medications for erectile dysfunction, such as sildenafil (Viagra), vardenafil (Levitra, Staxyn), tadalafil (Cialis, Adcirca) and avanafil (Stendra), erectile dysfunction herbs and supplements haven't been well-studied or tested. Some can cause side effects or interact with other medications. And the amount of the active ingredient can vary greatly from product to product. Here's a guide to erectile dysfunction herbs and supplements: DHEA Some evidence shows that dehydroepiandrosterone (DHEA) increases libido in women and helps erectile dysfunction in men. DHEA app...