К основному контенту

Сообщения

Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose

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...
Отправить комментарий
Далее...
Недавние сообщения

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...
4 комментария
Далее...

A healthy diet may trigger a better response to a certain kind of melanoma treatment. How?

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 ...
4 комментария
Далее...

Diet and nutrition

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...
1 комментарий
Далее...

Eating out could put you and your kids at risk

 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...
1 комментарий
Далее...

Overweight preschoolers have twice the odds...

 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...
2 комментария
Далее...

Do you worry a lot?

 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...
2 комментария
Далее...