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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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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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BenevolentAI and AstraZeneca collaborate on new lupus target

BenevolentAI

BenevolentAI chief scientific officer Dr Anne Phelan speaks to Proactive's Stephen Gunnion about the addition of a novel systemic lupus erythematosus (SLE) target to AstraZeneca's discovery portfolio. Phelan discussed the collaboration between BenevolentAI and AstraZeneca, which began in 2019 focusing on idiopathic pulmonary fibrosis and chronic kidney disease and later expanded to include heart failure and lupus. She highlighted the benefits of this collaboration, stating, "We can really leverage the power of the interconnectivity of the data foundations to pull through potential target hypotheses irrespective of the disease." Phelan explained how BenevolentAI's data-driven approach, combined with AstraZeneca's disease expertise, facilitates the identification and validation of new therapeutic targets. She also provided insights into lupus, describing it as a debilitating autoimmune disease where the body's immune system attacks its own tissues, leading to chronic fatigue and damage to vital organs. The BenevolentAI platform's ability to handle complex data and generate explainable hypotheses is pivotal in identifying new therapeutic targets for such complex diseases. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 26, 2024 08:01 AM Eastern Daylight Time

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atai Life Sciences co-CEO says initial results from ELE-101 show promise in treating depression

atai Life Sciences

Atai Life Sciences co-founder and co-CEO Florian Brand discussed initial results from Beckley Psytech’s phase 1 trial of its patent-protected psilocin ELE-101 in patients with major depressive disorder. Brand explained that ELE-101 is an intravenous (IV) formulation of psilocin, the active metabolite of psilocybin, developed for depression treatment. The IV formulation aims to reduce treatment duration to two hours, compared to the longer sessions required by traditional psilocybin and LSD treatments. Phase one trials in healthy participants showed that ELE-101 was well tolerated with no serious safety concerns and had a predictable pharmacokinetic profile, supporting dose selection for phase two trials. Brand highlighted the commencement of phase 2 trials with the first patient already dosed. This study involves 6 to 12 patients, with data expected in the second half of this year. atai Life Sciences is optimistic about the shorter treatment duration, potentially making it more convenient for patients and less burdensome for the healthcare system. Additionally, Brand mentioned their involvement with Compass Pathways, which is developing psilocybin therapy, and noted the importance of the two-hour treatment paradigm established by the intranasal esketamine spray, Spravato. This paradigm could be leveraged for their other compounds, such as BPL-003 and DMT, also being developed for depression treatment. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

June 26, 2024 06:09 AM Eastern Daylight Time

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Superlab Suisse opens state-of-the-art facility in Basel, fostering new spaces for scientific breakthroughs

Superlab Suisse

For life sciences and biotech companies, access to affordable dedicated lab spaces is hard to come by. Labs are prohibitively expensive to build and operate, posing significant financial barriers to innovation and research. A cutting-edge new alternative is being offered by Superlab Suisse, a leading provider of innovative laboratory and research spaces that today announces the grand opening of its newest facility in Basel. With this new facility, Superlab Suisse becomes the largest private lab space in Switzerland. Opening in July 2024, following the success of the Lausanne location supported by Biopôle Lausanne and InnoVaud, the expansion marks a significant milestone in Superlab Suisse's mission to provide research infrastructure to Switzerland's dynamic life sciences sector. Forging ahead with its successful partnership with Swiss Prime Site, Superlab Suisse is set to open the door for huge commercial opportunities in the ideally suited location of Basel, a booming biotechnology hub and home to over 700 companies including pharmaceutical giants like Novartis and Roche. The new facility, nestled within the bustling Stücki Park with neighbours like Tech Park Basel, Lonza, Medartis, NBE, and Boehringer Ingelheim, offers ready-to-use laboratory spaces equipped with the latest technology and essential operational support services, allowing teams to channel their resources into scientific research rather than lab operations. Spanning over 4770 square metres, it promises to be a nucleus of scientific collaboration and breakthrough, redefining laboratory services in Basel. "We are thrilled to bring Superlab Suisse's innovative platform to Basel, the city of Pharma," says Xi Zhang, CEO of Superlab Suisse. “Our holistic solution frees scientists from operations headaches, so they can save time and focus on science. We service, you discover”. Life sciences and biotech companies have until now lacked the widely accepted lab solutions that have benefitted industries such as tech and finance. Universities have typically been the only viable option, with lab construction and operation requiring significant upfront investments — costs which redirect attention away from research and delay progress in getting products to market. Superlab Suisse's serviced BSL1 and BSL2 labs provide a new industry standard of lab solution. Users in one location such as Basel also gain access to facilities in Lausanne and other locations. By delivering ready to move in lab solutions for life science companies of all sizes, including startups, scale-ups, and corporates, Superlab Suisse eliminates the hurdles of lab construction and operation. One of the first companies to secure their space at the opening is Skyhawk Therapeutics, which has recently announced a research collaboration with Ipsen focusing on RNA targeting in rare neurological diseases. In addition to the Basel location, Superlab Suisse continues its commitment to innovation with plans for a third site in Zurich Schlieren. This new facility, scheduled to open in March 2025, will cater to the diverse needs of start-ups, spin-offs, and established companies in the life sciences sector, further solidifying Superlab Suisse's position as a leader in laboratory-as-a-service solutions. This one-stop solution not only solves the true problems of life science companies but also attracts like-minded innovators to meet and collaborate. Superlab is expanding this year to more cities in Europe, the US, and Asia, embodying a borderless lab concept because life science benefits humanity as a whole. Dr. Rajwinder Lehal, CEO of biotech business Cellestia commented: “Superlab is exactly the place which the scientific community needs, where we can concentrate on our work without being distracted by construction or operation. Superlab provided us with state of the art infrastructure and equipment that we needed to hit the ground running from day 1.” Emmanuel Savioz, CEO & Chairman, Tigen Pharma commented: “Superlab is a great place to work in a vibrant scientific community. Our team at Tigen can focus on growth, supported by state-of-the-art facilities, latest equipment and a competent and fun Superlab team to support on-site”. About Superlab Suisse AG Superlab Suisse AG offers innovative laboratory solutions through its "Lab as a Service" business concept. With state-of-the-art facilities, professional services, and financing support, Superlab Suisse empowers companies in the biotech, pharma, and medtech sectors to focus on research and innovation. About Swiss Prime Site AG Swiss Prime Site is the largest real estate company in Switzerland and one of the leading commercial property companies in Europe. The real estate portfolio spanning across densely populated areas is valued at approximately CHF 26 billion and includes own properties – with about CHF13 billion commercial properties and development projects – as well as ones managed on behalf of third parties with about CHF 13 billion AuMs invested in residential and commercial buildings. Contact Details Superlab Suisse Bilal Mahmood +44 7714 007257 b.mahmood@stockwoodstrategy.com Company Website https://superlabsuisse.com/

June 25, 2024 07:00 AM Eastern Daylight Time

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Botanical Remedies LLC Introduces Enhanced Kratom Feature for Customized Potency

Rev Up Marketers

Botanical Remedies LLC, a leading provider of premium, lab-tested kratom products, is proud to announce the launch of its innovative Enhanced Kratom Feature, designed to offer customers a tailored experience with customized potency. This new feature marks a significant advancement in the kratom industry, underscoring the company's commitment to quality, safety, and customer satisfaction. The Enhanced Kratom Feature allows customers to select kratom products with customized potency levels, catering to individual preferences and needs. This feature leverages advanced processing techniques and rigorous lab testing to ensure each product meets precise potency specifications. By offering customizable options, it empowers users to fine-tune their kratom experience for optimal wellness benefits. Botanical Remedies LLC is dedicated to providing the highest-quality kratom products. The company meticulously sources its kratom from reputable farmers and suppliers who prioritize ethical practices and sustainability. Each batch of kratom undergoes rigorous third-party testing to verify its purity, potency, and safety. This comprehensive testing process ensures that products are free from contaminants, heavy metals, and adulterants, offering customers peace of mind and a superior product. The Enhanced Kratom Feature is available across Botanical Remedies LLC’s extensive range of kratom strains, including popular varieties such as Green Maeng Da, Gold Vein, and Hippie Dip. Customers can now choose their preferred strain and customize the potency to match their specific requirements. Whether seeking relaxation, focus, or energy, users can select the precise potency that best suits their needs. Ordering from Botanical Remedies LLC, is a seamless process. Customers can browse the extensive collection of premium kratom products on the company’s website, select their preferred strain and potency, and proceed to a secure checkout. The company prioritizes the safety of customer information, ensuring a secure transaction process. The company ensures prompt and discreet delivery of orders through fast and discreet shipping. Botanical Remedies LLC prides itself on providing exceptional customer support. The knowledgeable and friendly team is available to assist with any questions or concerns, offering guidance on product selection and usage. The company is committed to ensuring customer satisfaction and building long-lasting relationships with its valued clients. Confident in the quality of its products, Botanical Remedies LLC offers a satisfaction guarantee. If customers are not entirely pleased with their purchase, the company’s customer service team will work diligently to resolve any issues and ensure complete satisfaction. Customers who choose Botanical Remedies LLC join a thriving community of kratom enthusiasts. The company engages with its community through social media and newsletters, providing updates on new products, exclusive offers, and kratom-related information. About Botanical Remedies LLC is a veteran-owned company dedicated to providing premium, lab-tested kratom products. The company combines its dedication to quality with a profound respect for ethical practices, guaranteeing the sustainable sourcing and rigorous testing of all products. With a focus on customer satisfaction, it continues to set the standard in the kratom industry. For more information about Botanical Remedies LLC and the Enhanced Kratom Feature, please visit www.botanicalremediesllc.com. Contact Details Botanical Remedies LLC Shelly Hughes +1 305-393-4847 support@bremediesllc.com Company Website http://www.botanicalremediesllc.com/

June 24, 2024 10:13 AM Eastern Daylight Time

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Select Sector SPDR ETFs: A Focused Approach for Sector-Specific Portfolio Management

Select Sector SPDR

In the ever-changing landscape of the financial markets, Select Sector SPDR ETFs present a method for investors looking to engage in sector-specific investments. By breaking down the S&P 500 into distinct sectors, these ETFs provide a pathway for both individual and institutional investors to craft more targeted and strategic investment portfolios. The Select Sector SPDR ETFs encompass a range of sectors, each represented by a dedicated ETF. This structure allows investors to focus their investments on specific areas of the economy, depending on their investment objectives, risk tolerance, and market outlook. Overview of Select Sector SPDR ETFs: Communication Services Select Sector SPDR Fund (XLC): Focuses on telecommunications and media companies. Consumer Discretionary Select Sector SPDR Fund (XLY): Targets companies focused on non-essential goods and services such as luxury items, travel, and leisure. Consumer Staples Select Sector SPDR Fund (XLP): Concentrates on essential consumer goods and services like food, clothing, and personal products. Energy Select Sector SPDR Fund (XLE): Dedicated to the energy sector, focused on oil and natural gas. Financials Select Sector SPDR Fund (XLF): Encompasses banking, investment, and insurance industries. Health Care Select Sector SPDR Fund (XLV): Focuses on pharmaceuticals, healthcare equipment, and services. Industrials Select Sector SPDR Fund (XLI): Includes manufacturing, construction, and logistics firms. Materials Select Sector SPDR Fund (XLB): Covers the chemicals, construction materials, and packaging industries. Real Estate Select Sector SPDR Fund (XLRE): Targets commercial real estate services and REITs. Technology Select Sector SPDR Fund (XLK): Concentrates on the information technology, semiconductor, and electronics sectors. Utilities Select Sector SPDR Fund (XLU): Dedicated to electric and gas utility companies. By offering a straightforward and transparent approach to investing in specific sectors, Select Sector SPDR ETFs enable investors to adapt their investment strategies in response to changing market conditions. The Select Sector SPDR ETFs offer a focused approach to investment, allowing for detailed sector analysis and strategic portfolio management. As the financial landscape continues to evolve, these ETFs provide a valuable tool for investors looking to refine their investment strategies through sector-specific allocations. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007597 EXP 8/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

June 24, 2024 05:00 AM Eastern Daylight Time

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