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A roundup of the week's most newsworthy health industry press releases from PR Newswire, including the FDA approval of Eli Lilly's drug to treat obesity. NEW YORK, Nov. 10, 2023 /PRNewswire/ -- With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help journalists covering the healthcare industry stay on top of the week's most newsworthy and popular releases, here's a roundup of stories from the week that shouldn't be missed. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Weekly Health Press Release Roundup, Nov. 6-10, 2023. Photo provided by quip. FDA Approves Lilly's Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Option for the Treatment of Obesity or Overweight with Weight-Related Medical Problems "Far too many hurdles continue to prevent people living with obesity from accessing obesity treatments that could lead to significant weight loss," said Mike Mason, executive vice president and president, Lilly Diabetes and Obesity. "Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it." 90% of Women aren't prepared for menopause. Knix wants to change that. Conceptualized by Knix Founder and President, Joanna Griffiths, The Invisible Period is an artistic manifesto style campaign created to shine light on perimenopause - the invisible period that more than half the world's population experiences but don't talk about. NYU Langone Health Performs World's First Whole-Eye and Partial Face Transplant The surgery included transplanting the entire left eye and a portion of the face from a single donor, making this the first-ever human whole-eye transplant in medical history and the only successful combined transplant case of its kind. Emory Healthcare collaborates with Andor Health to provide virtual inpatient monitoring using AI technology ThinkAndor® harnesses generative AI to unlock data stored in various systems including ambient listening and real-time visualization -- to detect common safety risks, such as falls, self-harm and elopement. New Hospital Safety Grades from The Leapfrog Group Find Improved Infection Rates Following Major Spike During COVID-19 Pandemic This cycle, nearly 30% of hospitals earned an "A," 24% earned a "B," 39% earned a "C," 7% earned a "D" and less than 1% earned an "F." Utah is the state with the highest percentage of "A" hospitals in the country this fall. St. Joseph's Hospital to Open First Proton Radiation Therapy Center in Tampa Bay Area Proton therapy delivers precise radiation treatments to cancerous tumors, using protons instead of X-rays to better target cancer and reduce the amount of radiation exposure to healthy tissue. As a result, patients report few side effects and have a lower risk of secondary malignancies. quip Launches Custom-Fit Mouth Guards and Whitening Solutions Users will simply take their detailed impressions at home, mail them back, and quip will send the user a custom Night Guard, custom Sports Guard, or Whitening Kit (with custom trays + 14-day treatment), with a protective storage case. Eko Health Announces Large-Scale Deployment of AI Heart Disease Detection Technology The current gold standard to detect heart failure is a blood test (NT-proBNP) that when ordered alone, initiates a long pathway that often fails to achieve early diagnosis and treatment in those who need it most. This novel deployment can potentially improve heart disease outcomes for millions of people in communities across the UK. The Arab International Women's Forum and Pfizer launch 'DEI by Design' report with recommendations on embedding diversity into MENA health "We believe that the recommendations delivered by the 'DEI by Design' series will pave the way for tangible change, ensuring that women at every level of healthcare – from grassroots workers to senior executive leadership – are empowered, recognised, and celebrated for their growing role at the forefront of health innovation, research and discovery," said AIWF President & Founder Dr. Haifa Al Kaylani. On/Go Launches Sniffles™: A First-of-its-Kind Solution to Take Care of Whatever's Got You Sniffling On/Go's Sniffles™ helps users sleep better, reduce fever, get congestion relief, soothe an itchy throat, calm dry and chapped lips, relax, and even boost the immune system with an all-in-one solution of medication, at-home testing, and immediate access to 24/7 expert medical care, anytime anywhere. Aplos Medical Achieves a Major Milestone in GERD Treatment with Omega PF™ The Omega PF™ device heralds a paradigm shift in GERD treatment. Being the first of its kind, the device seamlessly combines a dual-modality treatment; it not only controls reflux but ensures a natural, uncompromised swallowing process for the patient. Designs for Health Launches Innovative Probiotic Toothpaste, PerioBiotic™ Silver Similar to the role of probiotics in the gastrointestinal tract, beneficial oral bacteria may help maintain dental and oral health. Purified silver may support overall oral wellness, CoQ10 may help support gum health, and grape seed extract may help healthy inflammatory support. Read more of the latest health-related releases from PR Newswire and stay caught up on the top press releases by following @PRNhealth on Twitter. Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers and freelancers have access to the following free features: Customization: Create a customized newsfeed that will deliver relevant news right to your inbox. Customize the newsfeed by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include with your next story. Subject Matter Experts: Access ProfNet, a database of industry experts to connect with as sources or for quotes in your articles. Related Resources: Read and subscribe to our journalist- and blogger-focused blog, Beyond Bylines, for media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire

Sniffles™ is a quick and effective fix to diagnose and treat cough, the common cold, flu, RSV, COVID, and other upper respiratory conditions - all from the comfort of home, or on the go. MIAMI, Nov. 8, 2023 /PRNewswire/ -- On/Go™, the leading health technology platform known for award-winning at-home rapid COVID-19 test-to-treat solutions, expanded its offerings today with the launch of Sniffles™, a quick fix for whatever gets you sniffling. Now anyone can easily get diagnosed, treated, and obtain medical solutions for cough, cold, sore throat, headache, flu and a variety of other upper respiratory conditions. On/Go's Sniffles™ helps users sleep better, reduce fever, get congestion relief, soothe an itchy throat, calm dry and chapped lips, relax, and even boost the immune system with an all-in-one solution of medication, at-home testing, and immediate access to 24/7 expert medical care, anytime anywhere. Continue Reading When needed, Sniffles™ also offers 24/7 telehealth services (no health insurance required), seamless integration with CVS MinuteClinic for in-person support, and $75 worth of remedies, medications, and devices – all for only $39.99. No more scrambling to find remedies, rushing to the pharmacy, or looking for a doctor. Sniffles™ is packed with everything needed to feel better faster - wherever you are. At launch, Sniffles™ is available through leading rapid delivery retailers such as DoorDash, Amazon, and Walmart.com and directly through On/Go app and snifflesfix.com. "Over the past few years, Americans have been plagued by a sea of upper respiratory illness while the Flu, RSV, and COVID Tridemic continues to periodically overwhelm the healthcare systems," said Ron Gutman, Co-Founder and CEO of Intrivo and the inventor of On/Go. "With learnings we've accumulated from serving more than 100 million people and years of research and development, we've created the most accessible all-in-one solution to rapidly tackle upper respiratory ailments. Through a combination of trusted essential medications, top-of-the-line devices, and 24/7 telehealth access, we're helping Sniffles™ users get diagnoses and have their symptoms treated rapidly, efficiently, and cost effectively." There are more than a billion cases of colds reported each year in the U.S. and only 10 percent of patients get treatment. Sniffles™ aims to solve the ever recurring cold and flu epidemic that puts a strain on families, doctors, employers, and government by providing a rapid fix that's convenient, easily accessible, and highly effective. "As a father of three, keeping everyone safe and healthy is always top of mind - especially leading into cold and flu season," said Reeve Benaron, Co-Founder and CEO of Intrivo. "I've experienced first hand how time consuming and costly it can be to purchase medicine and remedies for an entire family when sick. It is our hope that Sniffles™ will make its way to homes across the country and provide the care and peace of mind families and individuals need without having to spend hundreds of dollars at the pharmacy. We're extremely pleased with the initial feedback and feel strongly that Sniffles™ will be integral for keeping families healthy this Winter and beyond." Intrivo, On/Go's parent company, is also offering special programs for employers and government agencies to help reduce employee sickness and unnecessary suffering, as well as unplanned PTO, which result in up to $700 savings per employee each year. Employers can calculate their cost savings by using Sniffles™' savings calculator. In fact, 40 percent of all sick days in the U.S. each year (150 million total) are due to the common cold, which results in $25 billion in lost productivity. Additionally, the average consumer will shop for over-the-counter medicine up to 26 times a year, resulting in $338 spent per household on cold and flu remedies. Sniffles™ aims to reduces the risk of spreading illness and the high costs associated with it. To learn more about Sniffles™, visit . About On/Go On/Go is a leading health and technology platform that delivers delightful digital health and care solutions for health and wellness-related conditions such as respiratory care, and weight management. Built on a scalable, extensible platform, On/Go's award-winning digital and physical products harness the power of AI and delightful user experience and design to create solutions that have helped over 100 million people worldwide live healthier, happier lives. About Intrivo Intrivo is a global healthcare technology company committed to delivering highly effective, comprehensive, and delightful population health & care solutions. Its platform features fully integrated, highly scalable, and extensible digital health infrastructure that is engineered to easily connect healthcare partners with speed, quality, and delight. Intrivo is the parent company of On/Go. Media Contact Kylee Kaetzel [email protected] SOURCE Intrivo

REDWOOD CITY, Calif., Nov. 06, 2023 (GLOBE NEWSWIRE) -- Soleno Therapeutics Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced publication of one-year results from the Phase 3 DESTINY PWS study and the open-label extension period of Study C602 evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS). The paper, entitled “Diazoxide Choline Extended-Release Tablet in People with Prader-Willi Syndrome: Results from Long-Term Open-Label Study,” was published in the peer-reviewed journal Obesity and can be found online here. “We are pleased to publish results from the long-term study of DCCR demonstrating significant, sustained reductions in hyperphagia,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Together with positive results from our recently completed randomized withdrawal period of Study C602, DCCR has shown significant and clinically meaningful benefits for the most burdensome symptoms of PWS. We believe it has the potential to be a safe and effective therapy for patients with PWS. We anticipate submitting an NDA to the FDA for DCCR in mid-2024.” The publication features results from 52-week administration of DCCR in participants with PWS enrolled in DESTINY PWS and/or Study C602, the long-term open-label extension study of participants who completed DESTINY PWS. The primary efficacy endpoint was change in hyperphagia total score from baseline, as measured using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT). Other endpoints included behavioral assessments using the PWS Pro (PWSP), body composition, hormonal and metabolic measures, disease severity and safety. Key Highlights from the Publication: Primary Endpoint: Hyperphagia Statistically significant, clinically meaningful decreases in HQ-CT total score (mean [SE]) from baseline in overall population after receiving DCCR for 52 weeks (-9.9 [0.77]; p<0.0001). Highly significant, clinically meaningful decreases in HQ-CT total score from baseline were also observed after receiving DCCR for 13, 26, and 39 weeks (all p<0.0001). In participants with severe hyperphagia at baseline, 52-week DCCR treatment resulted in significantly greater reduction in HQ-CT score compared to the overall population (-15.2 [1.39]; p<0.0001). Other Endpoints PWS related behaviors: Statistically significant improvements in all behavioral domains of the PWSP, which consist of aggressive behaviors, anxiety, compulsivity, depression, disordered thinking, and rigidity/irritability (all p<0.0001). Body composition: Significant improvements in lean body mass:fat mass ratio were seen (p=0.0005), consistent with increases in lean body mass (p<0.0001) and no significant changes in body fat mass. Hormonal and metabolic measures: Significant reductions in serum leptin (p<0.0001) and insulin (p=0.0004) and improvement in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (p=0.0033), consistent with the proposed mechanism of action of DCCR in PWS. In addition, a significant increase in adiponectin was observed (p<0.0001). Disease severity: Significant reduction in disease severity as assessed by both clinicians and caregivers using Clinical Global Impression of Severity and Caregiver Global Impression of Severity scores, respectively (both p<0.0001). Safety: DCCR was well-tolerated overall. Safety results are consistent with the safety pro DCCR, with the most common drug-related treatment-emergent adverse events of hypertrichosis, peripheral edema, and hyperglycemia, the majority of which were grade 1 and infrequently resulting in study drug discontinuation. DCCR has orphan designation for the treatment of PWS in the U.S. and EU and Fast Track designation from the U.S. FDA. Soleno recently announced positive topline results from its randomized withdrawal phase of Study C602. The U.S. Food and Drug Administration (FDA) previously acknowledged that data from this study has the potential to support an NDA submission for DCCR. Soleno anticipates submission of an NDA to the FDA in mid-2024. About PWS The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births in the U.S. The hallmark symptom of this disorder is hyperphagia, a chronic feeling of insatiable hunger that severely diminishes the quality of life for PWS patients and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant morbidities (e.g., obesity, diabetes, cardiovascular disease) and mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior). In a global survey conducted by the Foundation for Prader-Willi Research, 96.5% of respondents (parent and caregivers) rated hyperphagia and 92.9% rated body composition as either the most important or a very important symptom to be relieved by a new medicine. There are currently no approved therapies to treat the hyperphagia/appetite, metabolic, cognitive function, or behavioral aspects of the disorder. Diazoxide choline has received Orphan Drug Designation for the treatment of PWS in the U.S. and E.U., and Fast Track Designation in the U.S. About DCCR (Diazoxide Choline) Extended-Release Tablets DCCR is a novel, proprietary extended-release dosage form containing the crystalline salt of diazoxide and is administered once-daily. The parent molecule, diazoxide, has been used for decades in thousands of patients in a few rare diseases in neonates, infants, children and adults, but has not been approved for use in PWS. Soleno conceived of and established extensive patent protection on the therapeutic use of diazoxide and DCCR in patients with PWS. The DCCR development program is supported by data from five completed Phase 1 clinical studies in healthy volunteers and three completed Phase 2 clinical studies, one of which was in patients with PWS. In the Phase 3 DESTINY PWS study, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters. After one-year of open-label DCCR, participants experienced significant, clinically meaningful reductions from baseline in hyperphagia and other common PWS behaviors. In a randomized withdrawal period of Study C602, participants who were randomized to placebo had highly statistically significant increases from baseline in HQ-CT total score compared to those randomized to continue on DCCR (p = 0.0022). About Soleno Therapeutics, Inc. Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS), is currently being evaluated in a Phase 3 clinical development program. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact: Brian Ritchie LifeSci Advisors, LLC 212-915-2578