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AmeriLife’s HIPE Financial Welcomes Legacy Senior Benefit to Amplify Value Within the Final Expense Marketplace

AmeriLife

HIPE Financial, an ORCA Life company and an affiliate of AmeriLife Group, LLC (“AmeriLife), announced today that it has partnered with Legacy Senior Benefit, a Kentucky-based final expense-specific insurance company with distribution networks throughout the southern U.S. Per the agreement, the terms of the deal were not disclosed. “HIPE is focused on high performance, and we are thrilled to welcome Legacy Senior Benefit to our team,” said David and Lindsey Curry, principals of HIPE Financial. “The final expense market offers significant growth potential, especially given the power of our distribution channels with ORCA Life and AmeriLife. We look forward to continuing consumer awareness, customization, and value-added services for people looking to secure end-of-life expenses.” In 2016, ORCA Life entered the final expense market to address a significant gap by adopting a unique personal and in-home service approach. Since then, this strategy has set ORCA Life and its companies, such as HIPE Financial, apart, enabling its agents to develop deeper connections with their clients and enhance their support to seniors for their end-of-life insurance needs. “David and Lindsey continue to push the bar higher, strengthening our distribution and working to accelerate both business and producer success,” said Glenn Crabtree, founder and president of ORCA Life. “Our partnership with Legacy Senior Benefit is no different. Powered by a servant-leadership approach and value-based service offering, this collaboration has all the hallmarks of high performance, client trust, and care as we continue to achieve industry excellence as a final expense market leader.” Legacy Senior Benefit’s network of agents will continue under the leadership of owner and founder Corey Price. “Legacy Senior Benefit was built through a network of close friends and family,” said Price. “With a solid network of trusted agents, and now powered by one of the strongest distribution channels in the industry, we are ready for this next chapter of growth as we continue to serve our customers with end-of-life planning with trust and dignity.” AmeriLife’s distribution platform offers partners a best-in-class business culture that boasts efficiency, value, and access to professional marketing services to increase productivity and bottom-line revenue. This is particularly beneficial in the final expense sector, where consumers look to provide peace of mind and tailored financial security solutions to meet their end-of-life expenses. “We are thrilled to see our partnership with ORCA Life and HIPE flourish with the addition of Legacy Senior Benefit,” said Scotty Elliott, Chief Distribution Officer of Health for AmeriLife. “This collaboration will expand our holistic distribution capabilities and enhance our ability to serve our beneficiaries more effectively and set new standards in the industry.” ### About ORCA Life ORCA Life’s roots go back to the late ‘90s. Over the last two decades, it has expanded its footprint through grassroots marketing. The company was officially founded in 2016 to fill a glaring void in the final expense industry. It emphasizes an in-home, face-to-face service model, allowing its agents to cultivate meaningful relationships with their clients and better support seniors’ insurance needs for their final days. Today, ORCA Life boasts a growing roster of writing agents throughout and beyond the Midwest and Southeast. We continue to set the standards for client trust, care, and excellence, helping it achieve industry recognition as a final expense market leader. For more information, visit ORCA Life. About HIPE Financial Lindsey and David Curry are dynamic and dedicated to service. Their journey as successful entrepreneurs has led to the foundation of HIPE Financial, which is focused on high performance. Whether the senior market has life, health, and wealth or young professionals seek their next level of performance, HIPE is focused on the solution. For more information, visit HIPE Financial. 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 served through a distribution network of over 300,000 insurance agents and 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. Contact Details Media Jeff Maldonado media@amerilife.com Partnership Inquiries Patrick Nichols corporatedevelopment@amerilife.com Company Website https://amerilife.com/

June 12, 2024 09:00 AM Eastern Daylight Time

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Therma Bright’s Investment Case Just Got Stronger As Approval On Permanent Insurance Codes Gets Closer

TBRIF

Therma Bright (TSXV:THRM) (OTCQB:TBRIF), a developer of a wide range of leading edge, proprietary diagnostic and medical device technologies that address some of today's most important medical and healthcare challenges, appears to be positioned for major growth based on one important upcoming catalyst. For some background, Therma Bright (TSXV:THRM) (OTCQB:TBRIF) sells Venowave, a compact, battery operated peristaltic pump that generates a wave-form motion. When worn below the knee and strapped to the calf, the resulting compression of the calf causes an increased upward volumetric displacement of venous and lymph fluid. The Venowave is FDA approved for 10 indications, including: Management of Post Thrombotic Syndrome, Prevention of Deep Vein Thrombosis (DVT / blood clots), treatment of Chronic Venous Insufficiency, as well as other conditions related to poor circulation in the extremities.It seems that the company is set to receive a newly issued, HCPCS Level II code to identify it’s Venowave device,which will be instrumental in driving revenue growth. HCPCS codes are a set of health care procedure codes used in the United States to standardize the reporting of medical procedures, services and devices. These codes are essential for billing and reimbursement purposes within the Medicare and Medicaid programs, and are also used by other healthcare insurers in the United States, including private insurance companies. Additionally, a preliminary Medicare Payment determination will be made for this new HCPCS code. If the Venowave is purchased outright, Medicare and Medicaid will reimburse $1,199 USD. If the unit is rented to the patient, Medicare and Medicaid will pay $78.05 USD / month for up to 13 months, for a total of $819.55 USD. These are very favourable numbers for Therma Bright when taking into account the manufacturing cost of Venowave. Additionally, private insurers such as blue cross blue shield, UnitedHealth Group, etc., also use these codes as guidelines to determine reimbursement payouts. Why is this so important? Previously, Venowave was placed into the E0676 HCPCS code. E0676 is a miscellaneous code with no set reimbursement, meaning that when Venowave is billed for under this code, Medicare and Medicaid, as well as private insurance companies will default to a $0 reimbursement. While it is possible to submit a package of medical necessity under this code, with a detailed explanation of the patients’ condition and why it should be reimbursed, the reality is that most physicians or prescribing parties will not go through this exercise as they are not reimbursed for the time and trouble it takes. Therma Bright experienced a similar situation with the temporary codes it was approved to sell Venowave under in 2023 – Without the prescribing party submitting a package of medical necessity, Venowave by default will not be paid for. Additionally, these reimbursement issues are a barrier to prescribing parties recommending Venowave, as they are not able to tell their patients if the device will be paid for. Physicians tend to shy away from prescribing devices in these categories, as they could leave their patient with a large unexpected medical bill, reflecting badly on the prescribing party. This new HCPCS code combined with the preliminary payment determination establishes a fixed payout for Venowave across public and private insurers in the United States, eliminating friction in payments as well as hesitancy by the prescribing parties in recommending the device. Therma Bright expects to receive this new HCPCS code and payment determination after the biannual CMS meeting which was held at the end of May, 2024. Venowave differentiates itself from other available compression products in a number of ways. Currently, pneumatic devices and simple products that squeeze the leg make up the majority of the compression market. Inexpensive portable compression devices simply squeeze and release the calf, and do not actively move fluid upwards towards the heart. Sequential compression devices are proven very effective, however they are not portable. Sequential compression devices have tubes attached to an air compressor which inflates chambers in sequence, providing sequential compression. Typically these devices can only be used while lying in bed, on a couch or in a similar position, and do not allow the patient to remain ambulatory. Venowave combines the best of both worlds, providing sequential compression without the use of tubes or wires, allowing the patient to remain completely ambulatory while receiving treatment. Additionally, Venowave is quiet, so patients can continue to receive treatment while they are sleeping or otherwise resting. Currently in the United States an estimated 25 million people are living with some form of Chronic Venous insufficiency. Most go untreated or rely on simple compression stockings for some form of minor relief, as proper treatment via sequential compression devices is too cumbersome and expensive. The issuance of this new HCPCS code and payment determination opens up these patients to the Venowave, a new and portable form of treatment that will not cost them anything out of pocket. This market alone, along with the management of Post Thrombotic Syndrome and prevention of primary thrombosis is potentially huge. Additionally, Therma Bright is working towards securing reimbursement for DVT prevention. While Medicare and Medicaid do not pay for DVT prevention, private insurers do. Therma Bright is confident that the issuance of this new HCPCS code and payment determination will help patients access Venowave for DVT prevention via their private health insurance, which is another huge addressable market in the United States. During the last year, Therma Bright has been meeting with potential distributors across the United States. Many have indicated interest in the Venowave pursuant to a positive outcome with regards to the HCPCS coding. Therma Bright currently has over 2000 Venowave units in inventory, which they expect can be moved right away upon the issuance of the HCPCS code. After these initial 2000 units are sent to distributors, placed on patients, and reimbursement received, Therma Bright conservatively estimates moving 500-1000 units / month. Given the high margin on Venowave, this will fare well for the company. As Venowave is a high margin product, the company is looking at the possibility of setting up a manufacturing operation in either the U.S, Canada or Mexico which would allow it to sell to the VA in the US. This would open up yet another large market for Venowave in the United States. For investors who may be interested in Therma Bright, it is important to note that Venowave isn’t its only product. The company also has respiratory health and consumer health product portfolios. The respiratory health product portfolio features the Digital Cough Test (DCT) app created by Therma Bright (TSXV:THRM) (OTCQB:TBRIF) and AI4LYF. The app uses artificial intelligence to detect multiple respiratory diseases by analyzing a person’s cough sound and has shown a high accuracy rate. The app is currently in the process of securing a 513g FDA clearance, which will allow the company to charge for Remote Therapeutic Monitoring (RTM) and be used for patient reimbursement. The consumer health product portfolio features devices designed for pain relief, cold sore prevention and insect bite relief. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investors investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and expects to be compensated by Therma Brite to assist in the production and distribution of content related to TBRIF. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 mark@razorpitch.com Company Website http://RazorPitch.com

June 12, 2024 06:00 AM Eastern Daylight Time

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AGC Biologics & Chief Executive Officer Patricio Massera Announce Plans for Him to Step Down

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced that its Chief Executive Officer (CEO), Patricio Massera, will be stepping down from his role effective June 30. Patricio Massera joined the company in 2012, as General Manager of the Copenhagen site at CMC Biologics A/S. He later served as Chief Operating Officer of CMC Biologics at its Seattle headquarters. He held the same role after CMC Biologics was acquired by AGC Inc. and formed AGC Biologics. Mr. Massera was appointed CEO in 2019. He also served as an Executive Officer of the AGC Life Science Company, the Life Science Division of AGC Inc. During his tenure as CEO, Mr. Massera spearheaded several initiatives that elevated AGC Biologics' global business and brand. His work and achievements include key milestones such as navigating the COVID-19 pandemic, acquiring Molecular Medicine S.p.A. (“MolMed”) in Milan to create AGC Biologics’ Global Cell and Gene business, and acquiring facilities in Boulder and Longmont, Colorado to establish new large-scale commercial mammalian capacity and cell and gene services in North America. Mr. Massera also directed the company’s long-standing commitment to investing in single-use technology to ensure AGC Biologics could address the evolving needs of pharmaceutical companies using any platform process to develop new drug candidates. “Over the past 12 years, I have had the privilege of experiencing the most vibrant and remarkable professional position of my life. CMC Biologics, and later AGC Biologics, have provided me with countless opportunities. I have met incredible individuals driven by the desire to build a better world, all sharing the common purpose of enabling our partners to cure life-threatening diseases and bring hope to life.” Massera said. “During this journey, we have managed to grow the business multiple times. However, like all great stories, every book has an end. In this case, it is just a chapter that finishes. AGC Biologics has a long and brilliant journey ahead, but it is time for someone else to write the next chapter.” The new CEO search process is underway. In light of this transition, AGC Biologics is pleased to share Tadashi Murano, President of the AGC Life Science Company, will serve as interim CEO. He brings several decades of experience in global leadership roles within AGC Inc. across various business entities. For more information on AGC Biologics, visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 Team Members worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is a part of AGC Inc.’s Life Science Company. The Life Science company runs more than 10 global facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

June 12, 2024 12:00 AM Pacific Daylight Time

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Lava Cake is the top cannabis strain on the market, new poll finds

NuggMD

Lava Cake is the cannabis strain whose effects are most popular with consumers, according to new consumer polling and analysis conducted by NuggMD, the leading telehealth platform for cannabis. The poll asked cannabis users their main goal for using cannabis, desired flavor/aroma, and desired effect. More than 6,500 randomized cannabis users responded. As a representative sample of all U.S. cannabis consumers, the poll’s margin of error is 1.2%. The top preferences respondents cited were: the goal of pain relief (25%), anxiety relief (23%), and stress relief (18%); a flavor profile of fruit (27%), sweetness (19%), and earthiness (18%); and the effects of relaxation (30%) and euphoria (24%). The full poll results are available here. The company then used its database of cannabis strains to identify popular strains that fit those preferences. While strains like Georgia Pie, Cheetah Piss, Mendo Breath, and GMO Cookies rank highly, Lava Cake is the only strain that meets all of those preferences, suggesting it is both the most durable strain on the market and the one that offers the most effects that consumers want. The poll also finds nearly half of all cannabis users hit it whenever they feel like it—the poll asked respondents when they prefer to consume cannabis, with a plurality, 48 percent, saying “anytime.” “Since the onset of the Covid-19 pandemic, Americans have become much more stressed out and anxious than previous generations, and I don’t think it’s a coincidence to see everyday Americans doing whatever they can to manage it all,” said Deb Tharp, head of legal and policy research at NuggMD. “Our polling data suggests that more Americans are using cannabis to mentally and emotionally handle the world around them than to escape from it.” NuggMD.com used first-party data to conduct this poll. It was a questionnaire sent via email to a random list of opt-in respondents, all of whom consume cannabis regularly. The poll was conducted in May 2024. The sample contained no NuggMD customers. About NuggMD NuggMD is the nation’s leading medical marijuana technology platform, serving patients in Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Iowa, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Texas, Vermont, Virginia, Washington, and West Virginia. They’ve connected over 1,300,000 patients face-to-face with their new medical marijuana doctors via their state-of-the-art telemedicine platform. They believe every human being has the right to explore the potential benefits of medical cannabis and are fully committed to helping each patient explore every option in their journey to wellness. For further information, visit https://www.nuggmd.com. Contact Details Andrew Graham +1 646-385-0189 andrew.g@getnugg.com Company Website http://www.nuggmd.com

June 11, 2024 03:47 PM Eastern Daylight Time

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Voyageur Pharmaceuticals and Rain Cage Carbon Partner to Develop Advanced Radiology Contrast Agents

Voyageur Pharmaceuticals Ltd

Voyageur Pharmaceuticals CEO Brent Willis joined Steve Darling from Proactive to announce that the company and Rain Cage Carbon are advancing their collaboration following the first commercial creation of a V@C60 endohedral fullerene or Vanadium atom inside a C60 molecule. Rain Cage is now embarking on the next phase of radiology drug development using their cutting-edge technology. Willis told Proactive that Rain Cage will begin working to create on a commercial scale, the encapsulation of gadolinium, bismuth, and iodine within endohedral fullerenes. This pioneering work, set to begin later this month, aims to develop a process to create Gd@C60, Bi@C60, and I@C60 endohedral fullerenes, targeting the development of highly advanced radiology contrast agents for Magnetic Resonance Imaging (MRI) and CT scans. These novel compounds, known for their rarity and complex synthesis, hold the promise of transforming medical imaging by significantly enhancing the precision and clarity of radiological scans. Endohedral fullerenes are a class of fullerenes that enclose an additional atom, ion, or cluster within their inner sphere, exhibiting superior physical and electronic characteristics compared to regular fullerenes. In the context of radiology drugs, endohedral metallofullerenes offer distinct advantages through exceptional stability and bioavailability, an amplified signal that leads to better image clarity and resolution, targeted delivery, and reduced toxicity. These properties have garnered interest in applications such as MRI contrast agents Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

June 11, 2024 12:50 PM Eastern Daylight Time

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Busting the Myths Around Weight Loss Medication

YourUpdateTV

Obesity is one of the most common chronic health issues in the U.S. today, and can lead to or exacerbate many other significant physical and mental health challenges, including type 2 diabetes, heart disease and depression. But GLP-1 injections are an impactful new tool that can help people on their weight loss journey. Recently, Dr. Craig Primack, the Senior Vice President of Weight Loss at Hims and Hers, participated in a nationwide satellite media tour to discuss the impact of obesity, common myths surrounding weight loss medications, and personalized options that can help. A video accompanying this announcement is available at: https://youtu.be/NGNz92bi7nY Research shows that even just 5-10% of body weight loss can improve blood pressure, blood sugar, cholesterol, joint pain, sleep apnea, and other weight-related conditions. Weight loss drugs like GLP-1 medication are not only an exciting tool in the weight loss tool belt but can help to address the challenges associated with obesity. GLP-1 injections can support healthy weight loss along with a reduced calorie diet and increased exercise. Some common myths regarding weight loss medications, include: ● Many people assume that weight loss medications are magic. Weight loss drugs can be excellent tools for decreasing hunger and therefore reducing overall calorie intake, but their effects are not instant and should be combined with a healthy lifestyle approach, including a balanced diet and regular exercise. ● People also assume that the injections are painful. The injection is a very small needle that goes just under the skin. It feels like a small pinch, and is quite painless. For the most part, people do great with self-administering GLP-1 injections. ● Lastly, many people think that weight loss drugs come with dangerous side effects. Like all medications, there is a risk of side effects, but there are really only three common side effects associated with GLP-1’s, and they are generally mild: nausea, heartburn, and constipation. The benefits of these drugs far outweigh the risks for many, especially when compared to the health risks associated with being overweight. Hims & Hers’ personalized approach means custom treatment for individual needs to minimize these side effects. Known for its holistic, personalized approach to health and wellness, Hims & Hers is now offering access to GLP-1 injections designed for affordability and effectiveness. These are the four things you should know. ● Hims & Hers’ weight loss program is tailored to an individual’s needs and includes customized medication kits or GLP-1 medication, as determined appropriate by the healthcare provider. ● The science-backed and doctor-developed program is available 100% online for as little as $199 a month. ● Through the app, a licensed healthcare provider will work with you to decide the recommended treatment, plus provide realistic nutritional tips with easy to follow snack and meal ideas. ● Hims & Hers takes the safety of each customer very seriously. The pharmacies the brand works with provide sterile, single-use syringes with each GLP-1 shipment, and products are made with active ingredients from FDA regulated suppliers. And, injection medications are shipped in cold packs for temperature control in transit in the summer weather. For more information, visit hims.com/glp1 or forhers.com/glp1 About Dr. Craig Primack MD, FACP, FAAP, MFOMA Dr. Craig Primack is the Senior Vice President of Weight Loss at Hims & Hers. He completed his undergraduate studies at the University of Illinois and subsequently attended medical school at Loyola University — The Stritch School of Medicine. He completed a combined residency in Internal Medicine and in Pediatrics at Banner University- Phoenix, and Phoenix Children's Hospital. He received post-residency training in Obesity Medicine and is one of about 7,000 physicians in the U.S. certified by the American Board of Obesity Medicine. In 2006, Dr. Primack co-founded Scottdale Weight Loss Center in Scottsdale, Arizona, where he began practicing full-time obesity medicine. Scottsdale Weight Loss Center has grown since then to six obesity medicine clinicians in four locations around the greater Phoenix Metropolitan area.From 2019–2021, he served as president of the Obesity Medicine Association (OMA), a society of over 5,400 clinicians dedicated to clinical obesity medicine. He proudly served on the OMA board from 2010-2024, most recently as ex-officio trustee. Dr. Primack routinely does media interviews regarding weight loss and regularly speaks around the country educating medical professionals about weight loss and obesity care. He is co-author of the book, “Chasing Diets.” Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 11, 2024 11:37 AM Eastern Daylight Time

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Tonix Pharmaceuticals Nears Market Entry with Tonmya for Fibromyalgia Management

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr. Seth Lederman joined Steve Darling from Proactive to announce the completion of the initial phase of an assessment conducted by EVERSANA® Life Science Services, LLC on the U.S. market opportunity for Tonmya. Tonmya represents a potential groundbreaking first-line therapy for fibromyalgia management, positioning itself as a non-opioid, centrally-acting alternative in a market dominated by opioids. Lederman highlighted the concerning dominance of opioids in the fibromyalgia prescription market, despite well-documented risks of dependency. Tonmya aims to address this gap by offering a safer, non-addictive option for fibromyalgia patients. EVERSANA's primary market research indicates promising interest from physicians, with a median interest rating of 4.0 on a 5-point scale and an intended use of Tonmya in 40% of fibromyalgia patients upon approval. The analysis also noted that approximately 50% of fibromyalgia patients in the U.S. are on Medicare. The Inflation Reduction Act, effective in 2025, will cap out-of-pocket prescription drug costs for Medicare patients, which could improve access to Tonmya if approved. With the submission of the New Drug Application (NDA) for Tonmya slated for the second half of the year, Tonix Pharmaceuticals anticipates an FDA decision on approval by 2025. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

June 11, 2024 10:26 AM Eastern Daylight Time

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NOVUS INK Advisors and Solidus Capital Group Team-up to Serve Growing Transatlantic Commercial Interests of Mid-Market Enterprises

NOVUS INK Advisors

NOVUS INK Advisors and Solidus Capital Group signed a services agreement today to provide integrated senior advisory and execution services to small-and mid-market enterprises amid thriving commercial interests between the United States and Europe. The two firms aim to accelerate client services by combining expertise and resources to support growth into new markets, encompassing management counsel, valuation, performance tracking, board advisory, marketing, communication, public and government affairs. The collaboration will enable NOVUS INK Advisors and Solidus Capital Group to meet the unique needs of global small-and mid-market enterprise clients operating across business-to-consumer, business-to-business, and business-to-government segments. The transatlantic economy is proving remarkably robust in the face of global economic and geopolitical disruptions. No two other regions in the world are as deeply integrated as the United States and Europe, according to the 2024 Transatlantic Economy Report from the U.S. Chamber of Commerce, AmCham EU, Johns Hopkins SAIS and the Transatlantic Leadership Network. The report states: "the $8.7 trillion transatlantic economy employs more than 16 million workers in mutually onshored jobs on both sides of the Atlantic. It is the largest and wealthiest market in the world, accounting for half of total global personal consumption and close to one-third of world GDP in purchasing power. Ties are solid in foreign direct investment, portfolio investment, banking claims, trade and affiliate sales in goods and services, digital links, energy, mutual R&D investment, patent cooperation, technology flows, and sales of knowledge-intensive services." The services agreement will be overseen by a committee chaired by Pia De Lima and Daniel Diaz, NOVUS INK Advisors' Managing Partners, and Andreas Dal Santo, Solidus Capital Group's Managing Director. NOVUS INK Advisors is based in Miami. Solidus Capital Group, affiliated with Atlantic Business Labs, is based in New York. NOVUS INK Advisors is a communication, public and government affairs lobbying firm. NOVUS INK Advisors' practice areas include Corporate, Band and Product Reputation, Business Strategy, Crisis and Reputation Risk, Financial Services, Investor Relations, Mergers & Acquisitions, Brand and Product Marketing Communications Strategy, and Public and Government Affairs. NOVUS INK Advisors is a registered lobbying firm. To learn more, visit: www.NovusInk.com. Solidus Capital Group specializes in management consulting, business valuation, and board advisory services for firms expanding into North America, Latin America, and Europe. It is spearheading an ecosystem of companies, consultants, and subject matter experts with experience from different industries and regions to support corporate and institutional clients' global strategies and growth into new markets. To learn more, visit www.solidus-capital.com. CONTACTS: NOVUS INK Advisors: client.services@NovusInk.com Solidus Capital Group: client.services@Solidus-Capital.com Contact Details NOVUS INK Advisors Client Services client.services@NovusInk.com Company Website https://www.novusink.com/about

June 11, 2024 09:30 AM Eastern Daylight Time

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Surging Biotech M&A Reaffirms Massive Opportunity In Rare Disease Drug Development

RazorPitch CRDL NVO AZN SNY

Compared to their non-orphan counterparts, orphan drugs have consistently outpaced growth and have become a major part of pharma’s mainstream business. The U.S. FDA's orphan drug designation, established under the Orphan Drug Act of 1983, encourages the development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. by providing incentives to offset the small market size. Last year, sales from orphan drugs soared to $168 billion, accounting for about 17% of the industry’s total and just shy of the entire oncology therapeutic category at $194 billion. This year, these drugs are on track to generate an impressive $185 billion and are projected to hit around $270 billion by 2028. For such a large cohort of drugs to still be growing at a double-digit pace is impressive and shows that continued investment into the unmet need of rare diseases is warranted. That explains why there has been a surge in M&A activity among orphan drug developers over the past couple of years. For instance, when novel cannabidiol-based drug Epidiolex successfully treated rare forms of child onset epilepsy, GW Pharmaceuticals more than doubled its market value. The 120-patient trial showed patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%. GW Pharmaceuticals went on to be acquired by Jazz Pharmaceuticals for $7.2 billion in 2021, representing a premium of approximately 50% over GW's closing stock price at the time. Clearly, there is a significant opportunity in orphan drug development, which is why these four stocks have been generating substantial investor interest. Cardiol Therapeutics (NASDAQ:CRDL) is a Canadian biotech drug developer focused on developing their novel ultrapure cannabidiol formulation, CardiolRx™, for rare inflammatory heart diseases, specifically recurrent pericarditis and acute myocarditis. Pericarditis is characterized as inflammation of the pericardium, layers of tissue that surround the heart, that affects about 165,000 people in the U.S. annually and has no first-line FDA-approved treatment. Among those treated for acute pericarditis, 15% to 30% may experience recurrent pericarditis. Currently, anti-inflammatory drugs such as colchicine are prescribed for pericarditis treatment in cases of chronic or recurrent pericarditis. If the patient with pericarditis disease does not respond to anti-inflammatory medications, corticosteroids such as prednisone are prescribed. More recently, Kiniksa Pharmaceuticals’ ARCALYST® (rilonacept) became the first and only FDA-approved treatment indicated for the treatment of recurrent pericarditis and the reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is a weekly subcutaneous injection, whereas CardiolRx™ is an oral drug taken twice daily which is a major advantage as the idea of weekly injections could not be as appealing to patients. Cardiol Therapeutics’ (NASDAQ:CRDL) pre-clinical models showed that by inhibiting activation of the NLRP3 inflammasome pathway, cannabidiol may help resolve the symptoms of pericarditis. This approach has already demonstrated incredible potential, as the company was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of pericarditis, which includes recurrent pericarditis. Cardiol Therapeutics followed this major achievement with completing enrollment in its Phase 2, open-label MAvERIC-Pilot study investigating the tolerance, safety, and effect of CardiolRx™ in patients with recurrent pericarditis. The primary endpoint of the trial is the change in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS) from baseline to week 8 with topline results expected in early June. Not only that, Cardiol Therapeutics recently presented its concurrent Phase II ARCHER trial design at the annual congress of the Heart Failure Association of the European Society of Cardiology. This demonstrated the high level of interest from the cardiology community in novel approaches to treat acute myocarditis, for which there are currently no therapies approved by European and US regulatory authorities. The ARCHER trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. Patient recruitment has been accelerating due in large part to the growing global awareness of myocarditis, and ARCHER has already exceeded 85% of target enrollment. Cardiol Therapeutics (NASDAQ:CRDL) expects that results from the ARCHER trial will assist in furthering its understanding of the therapeutic potential of CardiolRx™ and will complement the more advanced MAvERIC-Pilot Phase II study in patients with recurrent pericarditis. Just to put the opportunity here in context, Future Market Insights expects that the worldwide pericarditis treatment market is likely to be worth $ 6 billion by 2032. ARCALYST’s sales further reaffirm this considering that the drug’s 2023 net revenue grew 90% year-over-year to $233.1 million. Several analysts have maintained their positive outlook on the company and have high hopes that the June data will further prove CardiolRx™ efficacy in treating recurrent pericarditis. In fact, Joe Gantoss of Chimera Research Group notes, “I won’t be surprised to see the price breaking out the 3-year high at $4.96 if the recurrent-pericarditis data show a clear success and open the path to move to the next stage with Phase-3 trial,” while analysts at H.C Wainwright & Co. issued a $9 price target for the stock. Novo Nordisk (NYSE:NVO) announced that it was buying Phase II-stage heart failure drug developer Cardior Pharmaceuticals (private) for up to $1.11 billion as it moves to strengthen its pipeline of drugs to treat cardiovascular disease and expand into areas outside of its core diabetes and weight-loss markets. The Denmark-based pharmaceutical giant is enjoying blockbuster success for its Wegovy and Ozempic obesity and diabetes treatments, which aren’t only proving highly effective at regulating blood sugar and helping patients lose weight, but are also yielding extra health benefits such as cutting the risk of stroke and heart attacks and slowing the progression of kidney disease. Based on these findings, the company recently unveiled plans to build a portfolio of therapies in areas like cardiovascular diseases and emerging-therapy areas while strengthening its progress in the rare-disease pipeline. CDR132L, Cardior’s lead compound, is designed to halt and reverse detrimental cardiac remodeling following myocardial infarction (MI) as the first-ever ncRNA-based therapy to enter clinical trials in heart disease. It is currently being investigated in the Phase 2 HF-REVERT clinical trial in 280 post-MI patients with cardiac dysfunction at more than 60 locations across Europe. AstraZeneca (NASDAQ:AZN) also announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases for $800 million. The deal also features $250 million in milestones tied to a regulatory event. The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase 3 investigational therapeutic peptide with a novel mechanism of action designed to treat hypoparathyroidism. In patients with hypoparathyroidism, a deficiency in parathyroid hormone (PTH) production results in significant dysregulation of calcium and phosphate, which can lead to life-altering symptoms and complications, including chronic kidney disease. It is one of the largest known rare diseases, affecting an estimated 115,000 people in the US and 107,000 people in the EU, approximately 80% of whom are women. Eneboparatide is designed to produce sustained and stable levels of calcium, which falls to low levels in patients with hypoparathyroidism, while preventing kidney disease and restoring bone turnover. Sanofi (NASDAQ:SNY) earlier this year agreed to buy the U.S. biotech Inhibrx Inc. for as much as $2.2 billion, giving the French drugmaker a potential therapy for a genetic disorder that affects the lungs and liver. Inhibrx shareholders will get $30 per share as part of the deal, along with the right to receive $5 in cash if the experimental drug meets a regulatory milestone. “The addition of INBRX-101 as a high potential asset to our rare disease portfolio reinforces our strategy to commit to differentiated and potential best-in-class products,” said Houman Ashrafian, Sanofi’s head of research and development. “With our expertise in rare diseases and growing presence in immune-mediated respiratory conditions, INBRX-101 will complement our approach to deploy R&D efforts in key areas of focus.” Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. 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June 11, 2024 06:00 AM Eastern Daylight Time

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