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This Biotech Just Cleared A Big FDA Hurdle In Its Quest To Improve ADHD Treatment

Benzinga

By Johnny Rice, Benzinga Dr. Ann Childress and Shane Schaffer, Chairman & CEO of Cingulate (NASDAQ: CING), were recently guests on Benzinga’s All Access. Cingulate is a biotechnology company developing drugs for a range of underserved conditions. The company has developed a proprietary technology called Precision Timed Release™ (PTR™). The technology allows a single pill to contain multiple doses of a drug, relieving the pill burden many people with chronic conditions suffer. Cingulate was just given clearance by the FDA to seek full approval for its lead candidate, CTx-1301. Watch the full interview here: Featured photo by Hal Gatewood on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

July 03, 2024 08:30 AM Eastern Daylight Time

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Vivos One Step Closer To Transforming Cancer Treatment With FDA Application To Start Human Trials For Pioneering Injectable Brachytherapy Device

Vivos Inc.

By Meg Flippin, Benzinga In what could prove to be a transformational development in cancer treatment, Vivos (OTCQB: RDGL), the maker of the Radiogel™ Precision Radionuclide Therapy, submitted an application to the U.S. Food and Drug Administration (FDA) to initiate human clinical trials. The Investigational Device Exemption (IDE) application is an amendment addressing the FDA’s comments about the company’s previous application. Once it's granted approval, Vivos can begin testing its therapy on humans to treat solid metastatic tumors, particularly in lymph nodes associated with papillary thyroid cancer. How RadioGel Works RadioGel, a pioneering Yttrium-90-based injectable brachytherapy device, represents what the company says is a groundbreaking approach to cancer treatment. It is designed for patients who are either not eligible for surgery or have chosen not to undergo the procedure, particularly those with non-radioiodine avid disease and limited burden regional nodal disease. The therapy involves directly injecting a hydrogel containing Yttrium-90 phosphate microparticles into the tumor. This method allows for a more localized and potent radiation treatment compared to traditional external-beam radiation therapies. First Filing Since Breakthrough Device Designation The application marks Vivos’ first filing with the FDA since being granted FDA Breakthrough Device Designation for the Radiogel ™ Precision Radionuclide Therapy. The Breakthrough Devices Program by the FDA is designed to accelerate the development and review of innovative technologies that show potential for more effective treatment options. The program's support is instrumental in hastening patient access to promising medical advancements like RadioGel. The technology behind RadioGel allows for the safe delivery of higher doses necessary for treating non-resectable and radiation-resistant cancers. The product also boasts a short half-life, delivering over 90% of its therapeutic radiation within ten days. That will be welcome news to cancer sufferers, given other treatments can require up to six weeks for a full course of radiation therapy. Additionally, the outpatient nature of the RadioGel therapy means patients can return home without concerns about radiation exposure to family members. Vivos Is Ready Since receiving that status, Vivos said the communication with the FDA has improved further, which is important to ushering this treatment along. The IDE filing includes reports on two studies – RadioGel genotoxicity and the retention of RadioGel at the injection site in VX2 tumors in rabbits. Vivos said the IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, the company repeated underlying testing to strengthen its answers with current data. “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly,” said Dr. Michael Korenko, President and CEO of Vivos. “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.” Vivos, in collaboration with the Mayo Clinic, is working hard to develop treatments to fight challenging cancer types, offering hope and potentially more effective treatment options to people around the globe. The IDE application puts it one step closer to realizing that dream. Featured photo by National Cancer Institute on Unsplash. Vivos Inc. has developed a Yttrium-90-based injectable Precision Radionuclide Therapy brachytherapy device to treat solid tumors in animals (IsoPet®) and humans (RadioGel™). Using the company's proprietary hydrogel technology, brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows the safe delivery of higher doses needed for treating non-resectable and radiation-resistant cancers. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Michael K. Korenko info@vivosinc.com Company Website http://www.vivosincusa.com

July 02, 2024 09:00 AM Eastern Daylight Time

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AmeriLife Expands Wealth Distribution Portfolio with Acquisition of WerksGroup

AmeriLife

AmeriLife Group, LLC (“AmeriLife”), a national leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions, announced today a strategic partnership with WerksGroup, LLC and its primary business line, MyFedRetirementWerks, helping Federal Employees optimize their retirement and benefit options. This partnership will enhance the retirement and life insurance guidance available to federal employees, offering a more comprehensive range of solutions to help them achieve their long-term financial goals. Per the agreement, the terms of the deal were not disclosed. “Our company began with a simple phrase: ‘One big purpose,’” said Richard and Karen Wolfe, principals of WerksGroup, LLC. “We believe that financial guidance is more than just selling products. It is the pursuit of helping clients create and implement a plan to achieve their long-term life goals. Partnering with AmeriLife strengthens that mission, broadens our reach, and merges our core values seamlessly.” With over 60 years of combined retirement planning and life insurance expertise, WerksGroup, LLC has built its business on the idea that relationships are more important than sales. As such, the company has focused on nurturing a client base of those who serve the American people, including employees of the U.S. Postal Service, the Department of Veteran Affairs, the Central Intelligence Agency, and various other federal agencies and departments. “Our success and this partnership would not have been possible without the dedication of our management team and minority partners, Patrick Shehan from our sales division in the postal and federal market, and Mark Ross, who was critical in expanding our annuity market. Their contributions were exemplary in bringing our vision to fruition and building WerksGroup into a great organization,” added Richard and Karen. As part of AmeriLife Wealth Group, WerksGroup will gain access to a best-in-class platform that delivers efficiency, value, and access to diverse resources and services to increase their productivity and grow their bottom line. “We are immensely impressed with Richard and Karen and their dedication and expertise while growing WerksGroup,” said AmeriLife Chief Distribution Officer of Wealth Distribution Mike Vietri. “Their exceptional work in the life insurance and annuity sectors has played a pivotal role in ensuring the retirement comfort of their federal employee clients. We are excited to integrate their strengths into our portfolio and continue building on their success.” About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities, and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For over 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers through a distribution network of over 300,000 insurance agents, financial professionals, and over 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com and follow AmeriLife on Facebook and LinkedIn. About WerksGroup, LLC Founded on a simple yet profound principle, WerksGroup, LLC is committed to assisting clients nationwide in preparing for their immediate needs and future aspirations. With over 60 years of combined expertise in retirement and life insurance, our team understands that trustworthy financial guidance involves more than just offering products—it requires a deep, comprehensive understanding of each client's financial, familial, and estate planning goals. Contact Details Media Inquiries Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

July 01, 2024 09:00 AM Eastern Daylight Time

Shedding Light on Cystic Fibrosis

YourUpdateTV

Cystic fibrosis (CF) is a rare, progressive, and genetic disease that currently affects about 40,000 people in the United States. CF is the result of a defective gene, inherited from each parent, and the disease can impact people of all races and ethnicities. Recently, KC White, Board Chair of the Cystic Fibrosis Foundation, participated in a nationwide satellite media tour to discuss the disease, her personal journey, and how the Foundation is helping progress care and treatment options. A video accompanying this announcement is available at: https://youtu.be/8wj8u0JEqLU CF is a life-shortening disease that prevents our bodies from clearing mucus. This can lead to lung infections, poor nutrition, lung disease, and a host of unique challenges that can impact every aspect of a person’s life. When it was first discovered, it was considered a fatal pediatric disease. But due to transformative advancements in treatments and high-quality care, the life-expectancy for someone born with CF today is 56. While that number is climbing there is still a long way to go and unfortunately, not all people with CF equally benefit from this progress. KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood and is the first person with CF to serve as board chair. When she was diagnosed, she wasn’t expected to live past high school age, but her family refused to accept that fate, which prompted their dedication to the Foundation’s work. Because of recent treatments known as modulators, about 90% of the CF population (including KC) experienced an incredible transformation in their health. With this though, comes navigating unplanned challenges including careers, finances, family, and more. In addition to fueling the research, particularly in genetic therapies, that will lead to transformative treatments for the entire CF population, the CF Foundation works to support the CF community in all aspects of their lives through support programs and fostering connection opportunities. The CF Foundation is committed to finding a cure and providing all people with CF the opportunity to lead long, fulfilling lives. The Foundation is aggressively funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. For more information, visit CFF.ORG About KC White KC White was elected chair of the Cystic Fibrosis Foundation’s Board of Trustees in 2022 after serving on the Board since 2005. Diagnosed with cystic fibrosis at age 3, White has been a committed volunteer and inspiring advocate for the Foundation since childhood, speaking at her first Foundation event when she was only 9 years old. She is the first person with CF to serve as board chair. White received her Master of Applied Positive Psychology from the University of Pennsylvania in 2022 and currently serves as an assistant instructor in the program. She is also the Head Varsity Women’s Lacrosse coach for the Chagrin Falls, Ohio, Tigers. She and her husband, Justin, have one son, Mac. About the Cystic Fibrosis Foundation The Cystic Fibrosis Foundation is a donor-supported nonprofit organization leading the relentless pursuit of a cure for cystic fibrosis. The Foundation is committed to providing all people with CF the opportunity to lead long, fulfilling lives by funding research and drug development, advancing high-quality, specialized care, and partnering with and advocating for the CF community. The Foundation funds more CF research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. The organization supports and accredits a national network of over 130 CF care centers recognized by the National Institutes of Health as a model of care for a chronic disease. Also, the Foundation manages support programs and fosters connection opportunities for the CF community. Based in Bethesda, Md., the Foundation’s impact is made possible by the work of nearly 70 local chapters across the country. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 28, 2024 12:45 PM Eastern Daylight Time

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Tiziana Life Sciences adds to treasury with $3.4 million in non-dilutive funding

Tiziana Life Sciences Ltd

Tiziana Life Sciences Ltd (NASDAQ:TLSA) chairman and CEO Gabriele Cerrone joined Proactive's Stephen Gunnion with more details of the company's recent advancements and news. Tiziana Life Sciences is developing a fully human CD3 monoclonal antibody, delivered intranasally, specifically targeting neurodegenerative diseases such as multiple sclerosis (MS) and Alzheimer's disease. Cerrone discussed the company's progress in MS treatments, highlighting its expanded access trial at Harvard University's Brigham and Women's Hospital. Notably, 70% of patients in the trial showed improvement in fatigue scores, while 80% experienced reduced brain inflammation. The company is also preparing to dose the first Alzheimer's patients in a new trial approved by the FDA. Furthermore, Tiziana Life Sciences is exploring the combination of its drug with GLP-1 antagonists to target obesity-related diseases. Cerrone shared the exciting news of securing $3.4 million in non-dilutive funding, emphasising its commitment to protecting shareholder investments. "We have seen extraordinary improvements in patients, and we are thrilled about the potential impact of our treatments on neurodegenerative diseases," he remarked. Visit Proactive's YouTube channel for more videos, and don't forget to give the video a like, subscribe to the channel, and enable notifications for future content. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 28, 2024 07:53 AM Eastern Daylight Time

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Flash Appoints Chris Donus as President

Flash Parking

Flash, the leading end-to-end parking technology platform, today announced that Chris Donus, the current CFO, has been appointed president of the organization. In the newly established role, Donus will expand his focus on day-to-day operations, working closely with the leadership team to execute transformative strategies that include the expansion of Flash’s burgeoning digital demand network, EV charging and parking platform scale, and driving the company’s regionalized branch organization to deliver unmatched partner experiences. Dan Sharplin will continue in his role as Chairman and CEO, focusing on international growth, strategic transactions, and ecosystem partnerships. “This promotion reflects Chris’s exceptional leadership and expertise at this time of tremendous momentum for Flash as we rapidly scale our industry-leading parking and EV charging digital ecosystem," said Flash CEO Dan Sharplin. “In the next 24 months, we anticipate more transformation in the parking industry than we’ve seen in several decades prior. Chris has the relevant experience to ensure we execute on our priorities that allow us to drive this industry transformation.” “We are building a parking and EV charging ecosystem where a seamless driver experience benefits everyone,” said Donus. “There is an incredible amount of innovation and hard work being done across Flash to build the platform and partnerships that further our position as the leader in parking and EV Charging technology. I look forward to ensuring the value we create is incomparable in my role as President of Flash.” Before Flash, Donus served as COO and CFO at Wheel Health, a venture-backed telehealth platform developer designed to connect companies and clinicians to deliver virtual care. He also served in senior leadership roles at Lyft as VP and Business Unit leader of Express Drive, the customer-facing fleet line of business, generating over $400 million in rental revenue and over $2 billion in Lyft rides. Prior to that, he was president of Silvercar from 2015 to 2018 alongside roles as COO, from 2017 to 2018, and CFO from 2012 to 2015. He has also served in leadership roles at Freescale Semiconductor, Hertz Global Holding, and Lucent Technologies. About Flash Flash is a pioneering technology company bringing seamless parking and EV charging experiences to drivers through a first-of-its-kind digital ecosystem. Flash’s platform connects reservable parking and charging in the apps drivers use every day with garage, surface lot, event, and valet parking locations—connected and controlled via a cloud-based operating system with unrivaled intelligence. Customer-obsessed brands partner with Flash to deliver digital, easy-to-use, reliable, and increasingly frictionless experiences to drivers eager to pay for a solution that eliminates wasted time, excess emissions, and stress. The solution has arrived. Contact Details Razor Sharp PR Ray Young +1 512-694-6097 ray@razorsharppr.com Company Website https://www.flashparking.com/

June 27, 2024 10:00 AM Central Daylight Time

FeedSpot Recognizes Take Pride in Retirement Podcast as a Leading LGBTQ+ Voice for Pride Month 2024

Retirement.Radio

Retirement.Radio, a premier network dedicated to providing essential retirement planning information, announced today that its Take Pride in Retirement podcast has been recognized as a must-follow Pride-related podcast by FeedSpot, one of the web’s foremost aggregators of the “best of” across the internet. This recognition not only underscores the podcast’s commitment to sharing diverse voices and stories from the LGBTQ+ community but also highlights the importance of empowering and representing this community as it navigates its unique challenges during the golden years of retirement. “I am humbled and honored to receive this recognition,” said Matt McClure, founder and host of Take Pride in Retirement. “I started Take Pride in Retirement because I saw a need in my community for retirement planning, education, and assistance. Knowing that the podcast is reaching its intended audience and making a difference in their lives is extremely fulfilling.” The Take Pride in Retirement Podcast, a one-of-a-kind platform, focuses on financial issues relevant to the LGBTQ+ community. It has had the privilege of hosting distinguished guests such as Gabrielle Claiborne, Co-Founder and CEO of Transformation Journeys Worldwide, who has shared invaluable insights on the unique challenges the trans community faces in retirement planning. The podcast has also featured Katie Leikam, a licensed therapist, who has underscored the importance of living wills and estate plans for the LGBTQ+ community. These unique and insightful perspectives testify to the podcast's importance and relevance. Matt reiterates in every episode that the Take Pride in Retirement Podcast remains steadfast in its mission that everyone, regardless of their background, identity, or who they love, deserves a retirement they can be proud of. This commitment to diversity and inclusivity is at the heart of our podcast. It is a testament to our dedication to ensuring that all voices are heard, and all needs are met, making our audience feel valued and included. “The Retirement.Radio team is deeply committed to amplifying these crucial conversations on our radio shows and affiliated podcasts,” said Sam Davis, executive producer for Retirement.Radio. “Our unwavering mission is to provide essential information, ensuring that every senior citizen and retiree, regardless of their background or identity, has the information they need to navigate retirement confidently and clearly. This recognition by FeedSpot is a testament to our dedication to inclusivity and our ongoing efforts to serve all communities.” FeedSpot’s ranking of the Best Pride Podcasts results from a rigorous evaluation considering podcast popularity, content quality, update frequency, and audience engagement. This recognition places the Take Pride in Retirement podcast in an exclusive league of content creators leading the way in celebrating and advocating for LGBTQ+ rights and stories. Other podcasts are available through the Retirement.Radio Network, including the Peak Financial Freedom Hour, Retirement Results, Guaranteeing Your Retirement, and the Federal Retirement Show. For more information, visit TakePrideInRetirement.com and subscribe to the show wherever you listen to podcast. ### About Take Pride in Retirement Take Pride in Retirement is Retirement.Radio podcast dedicated to retirement planning solutions for the LGBTQ community. During uncertain economic times, the safety of your principal is critical to planning a successful retirement. Our goal is to help educate you about ways to protect your hard-earned money while experiencing market-like growth at the same time. LGBTQ people face unique challenges when planning for their retirement future. Everyone's situation differs from legal barriers to a potential lack of family support. Tune in each week as we explore these obstacles and give you tips on overcoming them so you can get on the road to success. For more information, visit TakePrideInRetirement.com and subscribe to the show wherever you listen to podcasts. About Retirement.Radio Retirement.Radio is dedicated to providing essential retirement planning information to listeners across the United States. Our licensed financial professionals and insurance agents host weekly radio shows and podcasts, offering expert advice on various topics, including smart tax planning, retirement income strategies, and health care planning. Retirement.Radio is powered by national insurance distribution and marketing leader AmeriLife and features wide-reaching and impactful broadcasts. Our commitment is to help listeners invest wisely, plan effectively, and achieve successful retirement outcomes. Contact Details Retirement.Radio Sam Davis sdavis@amerilife.com Company Website https://retirement.radio/

June 26, 2024 11:00 AM Eastern Daylight Time

News Release

NanoViricides Reports Promising Results for NV-387 in Influenza A H3N2 Mouse Model

Nanoviricides Inc

NanoViricides CEO Dr Anil Diwan joined Steve Darling from Proactive to share promising news about the company's ultra-broad-spectrum antiviral, NV-387. The antiviral was found to be effective in protecting lungs from damage in a lethally infected Influenza A H3N2 mouse model. Dr. Diwan explained that the lung protection provided by NV-387 is particularly important, as severe cases of respiratory viral infections, which often lead to hospitalization and fatalities, typically involve extensive lung damage. In the study, NV-387 oral treatment resulted in only about 31% lung infiltration by immune system cells, while NV-387 intravenous treatment showed an even lower infiltration rate of about 22%. In comparison, the lungs of infected untreated animals exhibited a high infiltration rate of 68%. These findings indicate that NV-387 significantly protects the lungs of Balb/c mice lethally infected with the Influenza A H3N2 virus. Moreover, NV-387 treatment resulted in a significantly greater survival improvement compared to three approved influenza drugs. This remarkable outcome highlights the potential of NV-387 as a powerful therapeutic option for treating severe influenza infections and possibly other respiratory viral infections. Further, in this study, NV-387 was also found to protect the lungs of the infected animals from viral damage as well as immune system damage, supporting a strong antiviral effect. These results have arrived just as the bird flu H5N1 threat potential has increased significantly due to its spread into several mammalian species. While dairy cattle have suffered relatively mild infections, some other mammals, particularly cats on farms, have died of brain infection with this virus. Only four human cases have occurred so far, with one person dying in Mexico, while the three other cases, all in the USA, have recovered. This highlights the urgency and potential impact of NV-387 in addressing not only current viral threats but also emerging ones, making it a critical development in the field of antiviral therapies. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

June 26, 2024 10:34 AM Eastern Daylight Time

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News Release

Promising Developments from OKYO Pharma on Dry Eye Disease and Neuropathic Pain Treatment

OKYO Pharma Ltd

OKYO Pharma Ltd CEO Gary Jacobs joined Steve Darling from Proactive to share additional key findings from the Phase 2 clinical trial evaluating the safety and efficacy of OK-101 (0.05%) ophthalmic solution in patients with dry eye disease (DED). This trial involved 240 patients in a randomized, double-masked, placebo-controlled study. OK-101, developed using a membrane-anchored-peptide technology, is a novel long-acting drug candidate designed to treat dry eye disease. It has shown anti-inflammatory and pain-reducing efficacy in mouse models of dry eye disease and corneal neuropathic pain. Jacobs highlighted that the findings include a statistically significant and durable reduction in ocular pain and a statistically significant improvement in Tear Film Break-Up Time throughout the study, which is a clinically important endpoint. Additionally, multiple symptomatic improvements were observed through both data obtained from patient clinic visits and daily symptom diaries. Jacob explained that OK-101 targets a receptor called Chemerin 23, present on both immune and nerve cells, including those in the spinal cord and ocular nerves. Preclinical animal studies indicated that OK-101 could reduce neuropathic pain, which can be particularly severe and debilitating in affected patients. The company is preparing to launch a Phase II trial for OK-101 specifically targeting neuropathic corneal pain. This trial will be a placebo-controlled, randomized study involving 48 patients diagnosed with ocular nerve damage through confocal microscopy, with top-line data anticipated by mid-2025.The significance of this development is underscored by the lack of FDA-approved treatments for neuropathic corneal pain, a condition recognised by the National Organization of Rare Diseases. The upcoming trial aims to fill this therapeutic gap, potentially offering relief to patients suffering from this excruciating condition. Contact Details Proactive North America +1 604-688-8158 na-editorial@proactiveinvestors.com

June 26, 2024 10:29 AM Eastern Daylight Time

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