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FDA Approves First-Of-Its Kind Drug to Ease Menopause Symptoms

An Astellas Pharma drug that treats hot flashes and night sweats from menopause is now approved by the FDA, a regulatory decision that makes the therapy the first one that hits a particular central nervous system target to ease the symptoms of this change in life. The Friday approval of the drug, fezolinetant, covers the treatment of moderate-to-severe vasomotor symptoms caused by menopause. Tokyo-based Astellas will market the once-a-day pill under the brand name Veozah. In an email, the company said the new drug will carry a wholesale price of $550 for a 30-day supply. Astellas expects Veozah will become available within three weeks. Menopause brings a decline in the production of estrogen and progesterone. The resulting hormonal imbalance can affect the way the body regulates body temperature, leading to hot flashes, the sudden and intense feelings of warmth. While hormone therapy is standard treatment for such vasomotor symptoms, ...
- Source: drugdu
- 150
- May 16, 2023
Abbott expands initiative to increase diversity in clinical trials

May 12, 2023 By Sean Whooley Leave a Comment Abbott (NYSE:ABT) announced a new series of programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care in under-represented populations. The additions to Abbott’s “Diversity in Clinical Trials” initiative build on partnerships, scholarships and the focus on diversified patients. Abbott applied these to its own clinical trials throughout the initiative’s first year. Within that first year, the company established a Diversity in Clinical Trials Medical Advisory Board. Through $5 million in grants, it also sponsored more than 300 scholarships at four historically black colleges and university (HBCU) medical schools, plus the National Black Nurses Association and National Association of Hispanic Nurses. Within this program expansion, Abbott launched a new initiative with the Norton Healthcare Foundation. It aims to build and implement new models of sustainable clinical research alongside the Institute for Health Equity in Louisville, Kentucky. ...
- Source: drugdu
- 141
- May 16, 2023
FDA greenlights a new type of drug for menopausal hot flashes

By Brenda Goodman, CNN CNN — The US Food and Drug Administration on Friday approved a new type of drug to treat hot flashes and night sweats during menopause. Veozah, or fezolinetant, made by Astellas Pharma, is the first approved neurokinin 3 (NK3) agonist. It blocks receptors in the brain that play a role in the regulation of body temperature. It’s an alternative to traditional hormone replacement therapies to manage hot flashes, which are a common symptom of menopause that can be disruptive if they become severe. Women at higher risk of stroke, heart attacks or some kinds of cancer are sometimes advised against using hormone replacement therapies because they increase the risk of blood clots and cancers. “Hot flashes as a result of menopause can be a serious physical burden on women and impact their quality of life,” said Dr. Janet Maynard, director of the FDA’s Office of ...
- Source: drugdu
- 120
- May 16, 2023
Researchers discover novel ‘Shanghai APP’ mutation in late-onset Alzheimer’s disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder affecting tens of millions of people worldwide, and it is the most common cause of dementia. Early-onset AD is typically associated with mutations in the genes APP, PSEN1, and PSEN2, leading to a more aggressive form of the disease with atypical symptoms. In contrast, the newly discovered “Shanghai APP” mutation has been linked to LOAD, which affects a larger population of AD patients. In a study published in Genes & Diseases, researchers from Ruijin Hospital, affiliated to Shanghai Jiao Tong University School of Medicine and other three teams detected the Shanghai APP mutation in a Chinese patient who developed memory decline in his mid-70s. Neuroimaging techniques confirmed the presence of widespread amyloid β deposition, a key hallmark of AD. Using molecular dynamics simulation and in vitro experiments, the team found that the E674Q mutation led to increased processing of APP and production of amyloid β, ...
- Source: drugdu
- 149
- May 16, 2023
Ahead of high-stakes California trial, GSK notches Zantac win in Canada

As GSK’s July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit. The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users. A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK. But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement. Zantac is ranitidine’s brand name and much of the Zantac cases revolve around reports of N-nitrosodimethylamine (NDMA) contamination in the products. Health Canada started investigating the potential impurity in ...
- Source: drugdu
- 120
- May 16, 2023
Study shows AI chatbot provides quality and empathetic answers to patient questions

A study published in JAMA Internal Medicine indicates that artificial intelligence assistant-generated responses to patients’ questions are better than physicians’ responses regarding quality and empathy. Background Due to social restrictions, virtual healthcare systems have significantly increased during the coronavirus disease 2019 (COVID-19) pandemic. This has led to a 1.6-fold increase in electronic patient messages and a concomitant increase in workload and stress among healthcare professionals. All these factors can collectively give rise to a situation where most patients’ messages will be ignored or answered unsatisfactorily. Current strategies to reduce virtual healthcare burdens include restricting electronic message notifications, billing for responses, or delegating messages to less trained medical staff. However, these strategies limit patients’ access to quality healthcare support. Currently, healthcare systems are considering artificial intelligence (AI) assistants to reduce the workload of healthcare professionals. In the current study, scientists have explored the ability of an AI ...
- Source: drugdu
- 118
- May 16, 2023
Steroids linked to long-lasting heart disease risk and worse quality of life

Anabolic steroids not only can cause serious side effects during use, such as heart failure and depression, but can continue being harmful years after stopping, according to two studies presented at the 25th European Congress of Endocrinology in Istanbul. These studies were carried out by researchers from the Copenhagen University Hospital Rigshospitalet who investigated the impact of anabolic steroids in former users. Anabolic steroids—synthetic hormones that mimic the naturally-occurring sex hormone testosterone—are used to increase muscle mass and boost athletic performance. These performance-enhancing drugs have harmful side effects, for instance in men these include breast growth, hair loss, lower testosterone levels, erectile dysfunction, and an increased risk of heart disease, stroke, and liver or kidney failure. However, not much is known about the effects years after stopping their use. In one study, the researchers examined 64 healthy men, between the ages of 18 and 50, who did recreational strength training ...
- Source: drugdu
- 112
- May 16, 2023
After costly setback, Astellas’ menopause drug crosses FDA finish line

After Astellas’ shot at a speedy FDA approval for its menopause drug was derailed in February, the therapy has finally crossed the FDA finish line. The drug, branded as Veozah, won FDA approval to treat moderate to severe menopause-related vasomotor symptoms. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat the condition. It’s been a bit of a bumpy road to the green light. After shelling out 13.1 billion Japanese yen ($97 million) to secure a priority review voucher and speed up the regulatory timeline, the FDA extended its review just days before the drug’s prior regulatory decision date. Vasomotor symptoms, or hot flashes and night sweats, are the hallmark of menopause. Some 60% to 80% of women experience the symptoms during or after menopausal transition, Astellas said in its release. The drug’s nonhormonal aspect is key because some people with menopause can’t take hormone therapies, the ...
- Source: drugdu
- 111
- May 16, 2023
MyFitnessPal and Google Health Connect announce integration between two platforms to help people with diabetes

MyFitnessPal, the No. 1 global nutrition and fitness tracking app, and Google Health Connect today announced an integration between the two platforms at this year’s Google I/O developer conference. Individuals diagnosed with Type 1 and 2 diabetes who use select continuous glucose monitoring (CGM) tools integrated with Google’s Health Connect can now see their glucose data directly within the MyFitnessPal app. ”Our community will now have the critical capability to understand and visualize how the foods they eat affect their blood glucose levels throughout the day. Prior to this, someone could see spikes in their glucose, but not make the connection to what caused them. Our collaboration with Google builds on our innovation and commitment to bringing the latest technologies to consumers as they navigate their health and wellness journeys, particularly those with diet-related diseases.” Tricia Han, CEO, MyFitnessPal MyFitnessPal Android users with select glucose monitors now ...
- Source: drugdu
- 152
- May 15, 2023
Swiss researchers identify plastic-degrading microbial strains in the Alps and Arctic region

Finding, cultivating, and bioengineering organisms that can digest plastic not only aids in the removal of pollution, but is now also big business. Several microorganisms that can do this have already been found, but when their enzymes that make this possible are applied at an industrial scale, they typically only work at temperatures above 30 °C. The heating required means that industrial applications remain costly to date, and aren’t carbon-neutral. But there is a possible solution to this problem: finding specialist cold-adapted microbes whose enzymes work at lower temperatures. Scientists from the Swiss Federal Institute WSL knew where to look for such micro-organisms: at high altitudes in the Alps of their country, or in the polar regions. Their findings are published in Frontiers in Microbiology. “Here we show that novel microbial taxa obtained from the ‘plastisphere’ of alpine and arctic soils were able to break down biodegradable plastics at 15 ...
- Source: drugdu
- 211
- May 15, 2023

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