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Fullintel Shortlisted For Five 2022 AMEC Awards

Fullintel, LLC

Fullintel, a leading media monitoring services company that specializes in human curation combined with powerful predictive intelligence, is pleased to announce it has been shortlisted for five 2022 AMEC Awards: Best use of social media measurement (2) Best crisis communications measurement and reporting Best use of measurement for a single event or campaign Best use of integrated communication measurement and research “As media becomes more fragmented and difficult to track, awards programs like AMEC’s are even more significant because they showcase how industry leaders like Fullintel are able to cut through the noise and find the content that matters,” said Fullintel President Andrew Koeck. “Our award-winning media analysis builds on this, providing our clients with strategic advice and customizing our reporting to address their specific objectives, resulting in actionable insights to drive their PR strategy to improve business results.” In the last two years, Fullintel has won four AMEC Awards including Gold for Best Multi-Market Reporting for their client at HelloFresh. The news comes on the heels of Angela Dwyer, a former senior vice-president at NYC-based PR agency Lippe Taylor and senior project manager at PRIME Research (now Cision), joining Fullintel as Head of Insights to further accelerate its media analysis program. As a member of the IPR Measurement Commission, Angela contributes to the development and promotion of standards and best practices for research, measurement, and analytics with a recognized global group of professionals in the industry. Her best-in-class measurement experience with solid research approaches will continue to elevate Fullintel’s work to help clients measure impact and make smarter business decisions – leading to better, award-quality results for clients. The 20th annual AMEC Awards is a global awards program for communications measurement held by the International Association for the Measurement and Evaluation of Communication (AMEC). The program highlights exceptional work while highlighting the vital importance of measurement, research, and analytics. Fullintel works with the world’s largest brands to offer daily executive news briefs, real-time media monitoring, and award-winning media analysis covering all traditional and social media platforms. Our real-time media monitoring service monitors every media source available, and Fullintel Hub's PredictiveAI™ engine will alert your team up to 48 hours in advance of trending stories that will become viral. You can view the full 2022 AMEC Awards shortlist here. About Fullintel: Fullintel offers a unique combination of talent, tools and technology for PR professionals looking for media monitoring and PR analysis services. We’re not just an app with canned reports - we tailor custom experiences for each client. Our reports feature easy-to-understand analysis that our clients leverage for continuous improvement, and are delivered with the accuracy, speed, relevancy and intuition that only trained industry analysts could provide. Contact Details Fullintel Samuel Chen +1 339-970-8005 schen@fullintel.com Company Website https://fullintel.com/

October 06, 2022 08:52 AM Eastern Daylight Time

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Fortress Bio’s Portfolio Of Marketed Drugs Could Soon See Three Additions

Fortress Biotech, Inc.

Fortress Biotech Inc. (NASDAQ: FBIO) is a biopharmaceutical company focused on developing a range of high-potential treatments on its own and through its growing portfolio of subsidiaries and partner companies. With nine products already on the market and more than 30 programs in development, the biopharmaceutical company helps deliver innovative drug therapies to patients who have a wide range of diseases and disorders. Here are three of the most significant breakthrough developments it achieved this year. Checkpoint’s Cancer Immunotherapy Aims To Add Second Treatment Indication Checkpoint Therapeutics Inc. (NASDAQ: CKPT) announced positive interim results in June from a registration-enabling clinical trial of its anti-PD-L1 checkpoint inhibitor. The novel cancer immunotherapy is being studied as a possible treatment for advanced cutaneous squamous cell carcinoma (cSCC), a difficult-to-treat skin cancer. The current first-line treatment for cSCC is surgery to remove the tumor or radiation therapy to destroy the tumor. However, some patients aren’t candidates for surgery or radiation, either because of poor health or because cancer has spread or become too advanced. Cosibelimab is an immunotherapy drug that works by blocking the PD-L1 inhibitor, an immune checkpoint inhibitor on the surface of cells that tells the body’s immune system not to attack that particular cell. Cancer uses those same checkpoint inhibitors to trick the immune system into believing the cancerous cell is a normal healthy cell that it should not attack. By blocking PD-L1, cosibelimab can remove cancer’s ability to escape detection and allow the patient’s own immune system to better identify and attack cancerous cells. In the registration-enabling clinical trial, cosibelimab achieved a response rate of 54.8% — far exceeding the minimum 25% target. Checkpoint plans to discuss the potential of adding locally advanced cSCC as a second indication in addition to metastatic cSCC with the Food and Drug Administration (FDA) as it prepares its biologics license application for submission around year-end. Checkpoint provides a 4.5% royalty on net sales and a 2.5% annual equity dividend to Fortress Bio in exchange for its operational, strategic, administrative, financial, and legal support. A First-Of-Its-Kind Menkes Disease Treatment Edges Closer To FDA Approval Last year, Cyprium Therapeutics Inc., a Fortress Bio partner company, announced the initiation of rolling submission of its new drug application (NDA) with the FDA for its novel treatment for Menkes disease. The company presented additional data in March at the 2022 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting. Cyprium continues to progress toward the completion of its NDA submission. Menkes disease is a rare but fatal genetic condition that impairs the ability to transport copper through the body. This results in abnormally low levels of copper in the brain and liver along with abnormally high levels in the kidney and intestines. Symptoms include poor muscle development, low weight, and cognitive difficulties. The difficult-to-diagnose progressive disease has no approved treatments, and most children with Menkes disease will die within the first three years of life. CUTX-101 is a copper histidinate (CuHis) injection that can be administered directly into the body to restore copper levels. Because Menkes disease affects the body’s ability to absorb copper through the gastrointestinal tract, direct injections are meant to bypass the GI tract and deliver copper straight to the bloodstream. Clinical data showed that CUTX-101 improved neurodevelopmental outcomes and survival in treated patients, including a nearly 80% reduction in the risk of death. If approved, CUTX-101 has the potential to be the first FDA-approved treatment for Menkes disease. As with Checkpoint, Fortress Bio receives a 4.5% royalty and 2.5% annual equity dividend from Cyprium. A More Potent Oral Rosacea Antibiotic May Offer Lower Risk Of Treatment Resistance Journey Medical Corp. (NASDAQ: DERM) is a dermatology biopharmaceutical company founded by Fortress Bio. Journey announced 50% enrollment in its Phase 3 clinical trial of a novel rosacea treatment in August. DFD-29, the drug candidate being studied in the clinical trial, is a minocycline-based compound meant to treat rosacea using its anti-inflammatory and antimicrobial properties. Minocycline is already used to treat other inflammatory conditions ranging from acne to rheumatoid arthritis because it can block pro-inflammatory cytokines and other inflammatory processes that cause flare-ups. It’s typically administered as a topical treatment, which can help with milder symptoms but doesn’t provide enough relief for severe cases. Doctors typically prescribe a course of doxycycline for rosacea patients with severe flare-ups. But the clinical data on DFD-29 showed that it was almost twice as effective as doxycycline at reducing lesions and overall symptom improvement. DFD-29’s modified release capsule is also meant to counter the bacterial resistance that often develops with frequent antibiotic use. Rather than immediate release, the capsule slowly releases small doses of minocycline over time. The subantimicrobial dose is meant to be low enough to avoid triggering selection pressure for bacterial resistance while still offering the anti-inflammatory benefits of the treatment. Topline data from this latest Phase 3 clinical trial is expected in the first half of 2023, and the company expects to file a new drug application by the end of that year. Fortress Bio currently owns a controlling stake in Journey Medical. Fortress Biotech, Inc. ("Fortress") is an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company's portfolio of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca plc, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children's Research Hospital, Nationwide Children's Hospital and Sentynl Therapeutics, Inc. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Jaclyn Jaffe and Bill Begien +1 781-652-4500 ir@fortressbiotech.com Company Website https://www.fortressbiotech.com/

October 06, 2022 08:00 AM Eastern Daylight Time

Understanding the Importance of Lowering Your Cholesterol to Help Decrease Your Risk for Heart Disease

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/_EQumoCuW6U High cholesterol is the single biggest cause of illness and death in America affecting more than 94 million adults in the United States, according to the Centers for Disease Control and Prevention. For some people, it is their genes that lead to very high LDL (“bad”) cholesterol. One of the most common causes of genetically high cholesterol is familial hypercholesterolemia (FH). FH impacts 1 in 250 individuals worldwide, and if untreated it leads to early heart attacks and strokes. There are already decades of research showing that high LDL cholesterol is a major risk factor for heart disease. And recent data has shown that having lower LDL for longer is one of the best things people can do to reduce your risk for heart disease. While a healthy diet and exercise are important for many reasons, diet and exercise alone cannot lower many people’s cholesterol to a safe level, especially if they have a genetic cholesterol-related disorder. There are medications that can significantly reduce the level of cholesterol in the bloodstream. Statins are the first line of defense when it comes to getting your LDL-cholesterol to a safer level. A new study on the safety and effectiveness of statins shows the vast majority of people do not have side effects from statins, and they not only reduce the LDL cholesterol, they also reduce the risk for heart attacks and cardiac death. The American College of Cardiology also just updated its expert guidance for medical experts treating patients and suggested an LDL target of less than 55 mg/dL for individuals with established cardiovascular disease. The Family Heart Foundation has a variety of resources for understanding treatment options for lowering high cholesterol and treating FH. Visit MoreFamiliesMoreHearts.org to learn more. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

October 04, 2022 03:00 PM Eastern Daylight Time

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Industrial Defender Appoints Gabe Authier as Chief Product Officer

Industrial Defender

Industrial Defender, a leader in operational technology (OT) cybersecurity solutions, today announced the appointment of Gabe Authier as CPO. This addition strengthens the company’s bench of technical executives and positions it for success in 2023 and beyond. Authier has held product management roles at both Tripwire and Belden, and his comprehensive knowledge of the industrial cybersecurity space and cloud-native solutions will further enrich Industrial Defender’s product development roadmap. “Industrial Defender continues to add incredible new talent to the team. Gabe’s experience architecting customer-centric product roadmaps, building cloud-native technologies and creating innovative solutions for the industrial space aligns well with our organizational goals,” said Jay Williams, CEO of Industrial Defender. “I am confident he will be an essential contributor to our continued success as a global leader in OT cybersecurity solutions.” “We see a massive opportunity right now to help critical infrastructure companies mature their cybersecurity programs beyond basic visibility solutions. Identifying, monitoring and managing asset data from a single tool is the next generation of OT security,” said Authier. “I couldn’t be more excited about the opportunity to shape Industrial Defender into the go-to OT data platform for the future.” Authier brings over 20 years of experience in product management and information technology and is passionate about customer-centric software development. He holds a BS in Systems Engineering from University of Arizona and an Executive MBA from the University of Oregon. About Industrial Defender Industrial Defender protects the world’s critical infrastructure from cyberattacks. As a leader in OT cybersecurity innovation, the company’s scalable platform is used by organizations around the world to empower security stakeholders with actionable data from their OT and IIoT infrastructure, enabling them to make informed risk management decisions and manage their OT cybersecurity program in a concise, single vendor dashboard. Learn more at www.industrialdefender.com. Contact Details Industrial Defender Erin Anderson +1 617-675-4206 eanderson@industrialdefender.com Company Website https://www.industrialdefender.com

October 04, 2022 09:09 AM Eastern Daylight Time

Development of New Drugs to Target Lyme and Other Infectious Diseases Subject of a New Webinar Now Available From Quidel Corporation

Quidel Corporation

Lyme disease is the fastest-growing vector-borne disease in the United States, and its increased prevalence is challenging the scientific community to look for new ways to diagnose and treat this worrisome infection. One answer is found in the discovery of novel drugs; and the breakthrough efforts taking place in this arena are the subject of a new webinar made available by Quidel Corporation, the California-based diagnostic health care manufacturer known for successfully developing rapid diagnostic health solutions. The 90-minute webinar, available free at https://education.quidel.com/category/lyme-disease, will explain what a small molecule drug is and how it works, identify the methods used to unearth a new drug by high-throughput screening, and discuss how to recognize the complexities involved in developing a new drug for infectious disease in general. It will also provide an overview as to the current antibiotics used for treating Lyme disease and explore how powerful new drugs—novel inhibitors—can selectively target Borrelia burgdorferi (the bacterium that causes Lyme disease). The webinar is PACE-accredited and sponsored in collaboration with Global Lyme Alliance. Conducting the webinar is Timothy Haystead, Ph.D., professor of pharmacology and cancer biology at Duke University School of Medicine. Dr. Haystead’s current research is focused on the use of chemical biology approaches to define novel drug targets. These drug targets are focused on the treatment of hypertension, obesity, cancer, inflammatory and infectious disease. Dr. Haystead received his Ph.D. from the University of Dundee, Scotland; and he completed post-doctoral work in pharmacology at the Howard Hughes Medical Institute, University of Washington, Seattle. The new webinar is the latest in an ongoing series sponsored by Quidel that has featured noted scientists, researchers and physicians discussing issues surrounding the prevalence of Lyme disease in America, including ways to reduce the chances of infection, early detection and treatment options. The timing and relevance for these webinars is particularly important as Lyme disease is on the rise to record numbers with approximately 476,000 new cases annually in the United States alone. Quidel is the diagnostic health care manufacturer behind the industry’s most rapid and reliable in-office test for Lyme disease, Sofia ® 2 Lyme FIA. It is the only FDA-cleared rapid point-of-care test on the market, which provides the patient and physician with indicative results in as few as three minutes, as opposed to days, which has historically been the norm (and during which time organisms can spread and become systemic). It can be performed in the privacy of a doctor’s office or local clinic; and it is the only test that can get results from a simple finger prick of blood. About Quidel Corporation Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. Under trusted brand names, Sofia®, Solana®, Lyra®, Triage® and QuickVue®, Quidel’ s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. With products made in America, Quidel’ s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. For more information about Quidel, visit quidel.com. Contact Details Jim Yeager +1 818-264-6812 jim@breakwhitelight.com Company Website http://Quidel.com

October 04, 2022 06:00 AM Pacific Daylight Time

United Network for Organ Sharing Names New Interim CEO

United Network for Organ Sharing

Maureen McBride, Ph.D. assumed the role of interim CEO of United Network for Organ Sharing (UNOS) on Saturday, October 1. UNOS is the mission-driven non-profit serving as the engine powering the nation’s organ donation and transplant system, under contract with the federal government. McBride is the first woman and the first person with a Ph.D. to hold this position. Prior to this role, McBride served for 27 years in a variety of senior leadership roles at UNOS, most recently as the Chief Operating Officer. McBride has already re-shaped her senior leadership team, naming patient engagement as a high priority. “As the nation’s organ donation and transplant system reaches a crucial turning point, I am incredibly honored to undertake this important role,” McBride said. “Our community has seen lifesaving success over the previous decades and together, we just surpassed the historic milestone of 1 million transplants thanks to so many generous donors and their families. From increasing transplants to expanding equity, we are proud of everything our community has accomplished, but we also believe that we can and must do more.” In her new position, McBride is committed to working with the UNOS Board, federal partners, Congress, and members of the donation and transplant system to pursue projects and initiatives that build on ongoing successes while addressing community needs and concerns. “I and my team share a bold vision for a more equitable, inclusive, and responsive UNOS,” McBride continued. “The field is constantly evolving and we are evolving with it. Our community is both innovative and forward-looking, and working together, we will challenge ourselves to reach even higher heights.” Key areas of focus identified by McBride for system-wide advancement include patient engagement and empowerment, advocating for holistic, evidence-based, patient-centered policy solutions at the federal level, and optimizing the requirements of the OPTN Contract, including opportunities to better support research into equitable access to care and the national waitlist. McBride will seek support from both the Board of Directors and the community for these and other improvement opportunities. The Congressionally-mandated report from the National Academies of Sciences, Engineering and Math (NASEM), as well as the report from the Senate Committee on Finance, will continue to inform efforts to improve, expand and engage. “Dr. McBride has the know-how, the experience, the relationships and the integrity to lead UNOS into an even brighter future,” said Jerry McCauley, M.D., President of the UNOS Board of Directors. “From her robust working relationship with the Health Resources and Services Administration (HRSA) to her decades of experience managing, leading and serving at UNOS, Dr. McBride is uniquely qualified to serve as interim CEO and to help lead the community during this unprecedented moment.” The Board of Directors has begun a national search for a permanent UNOS CEO. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

October 03, 2022 10:17 AM Eastern Daylight Time

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EF Hutton Reiterates Buy Rating On HCTI, Second Time in 2022

Healthcare Triangle, Inc.

On September 28, 2022, Healthcare Triangle Inc (NASDAQ: HCTI) received a Buy rating with a price target of $2.00 in an analyst report by EF Hutton. EF Hutton analyst Constantine Davides, CFA, said “We are reiterating our Buy rating on HCTI. We continue to like the risk-reward of shares here, as HCTI continues to scale its proprietary Platform offerings while expanding its Managed Services business.” This is the second Buy rating report released by EF Hutton on HCTI in 2022. On March 14, 2022, Davides initiated coverage with a Buy rating on Healthcare Triangle and a price target of $4.00. Here are the key points from the report: Platform Services We view the continued adoption of HCTI's Platform offerings as a key component of potential share appreciation (multiple expansion) and an improved financial profile (predictable/recurring revenue mix and long-term margin expansion). We believe that HCTI has approximately six Platform customers, up from four at the end of 1Q, and we would expect that total to expand steadily across the next several quarters. We are projecting $4.7 million in Platform revenue in 2022 (10% of revenue), growing to $8 million by 2024 (13% of revenue). Managed Services Along with the focus on Platform, we continue to expect HCTI to focus on the growth of this recurring revenue stream. We note that YTD Managed Services revenue growth has been negatively impacted by a change in the way HCTI reports partner pass-through revenue, which has had an optically negative impact on 2022 GAAP revenue with no impact on gross profit. Cash and cash flow A recent (July 2022) equity financing provided HCTI with $5.8M in net proceeds. Although HCTI has been opportunistically repurchasing its own shares, we would prefer that management allow cash to build on its balance sheet rather than deploy capital more aggressively toward repurchases, given the challenging macro backdrop. Free cash flow (FCF) was positive in 1Q and 2Q and we expect FCF generation to remain sound across the next several quarters. Updating target and initiating 2024 estimates Our target moves to $2.00 from $4.00 (2.3x 2023 revenue) given recent multiple compression in the space (our target multiple goes to 1.5x 2023 revenue) and other model adjustments (projected cash and share count). We are initiating our 2024 revenue estimate of $61.3M (+10%). HCTI recently traded at 0.3x our 2023 revenue estimate. Risks HCTI is capital-constrained and has above-average customer concentration risk; its largest customer generated 39% of 2Q revenue. The company’s CEO and CFO also serve as officers of another publicly traded company, SecureKloud Technologies, Inc., which owns 65% of HCTI’s common equity. HCTI has a relatively small float and is thinly traded. View the original report by EF Hutton here. Analyst Certification I, Constantine Davides, CFA, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressed in this research report. Company-Specific Disclosures EF Hutton, division of Benchmark Investments, LLC managed or co-managed a public offering of securities for Healthcare Triangle, Inc during the past 12 months. EF Hutton, division of Benchmark Investments, LLC or its affiliates received compensation from Healthcare Triangle, Inc for investment banking services within the past twelve months, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report General Disclosure This report has been produced by EF Hutton, division of Benchmark Investments, LLC and is for informational purposes only. It does not constitute solicitation of the sale or purchase of securities or other investments. The information contained herein is derived from sources that are believed to be reliable. Prices, numbers, and similar data contained herein include past results, estimates, and forecasts, all of which may differ from actual data. These prices, numbers, and similar data may also change without prior notification. This research report does not guarantee future performance, and the information contained herein should be used solely at the discretion and responsibility of the client. Neither EF Hutton nor its affiliates accept any liability or responsibility for any results in connection with the use of such information. This research report does not consider specific financial situations, needs, or investment objectives of any client, and it is not intended to provide tax, legal, or investment advice. Clients are responsible for making final investment decisions and should do so after a careful examination of all documentation delivered prior to execution, explanatory documents pertaining to listed securities, etc., prospectuses, and other relevant documents. EF Hutton and its affiliates may make investment decisions based on this research report. In addition, EF Hutton and its affiliates, as well as employees, may trade in the securities mentioned in this research report, their derivatives, or other securities issued by the same issuing companies in this research report. This research report is distributed by EF Hutton and/or its affiliates. The information contained herein is for client use only.EF Hutton holds the copyright on this research report. Any unauthorized use or transmission of any part of this research report for any reason, whether by digital, mechanical, or any other means, is prohibited. If you have any questions, please contact your sales representative. Additional information is available upon request.Certain company names, product and/or service names that appear in this research report are trademarks or registered trademarks of EF Hutton or other companies mentioned in the report. Copyright 2022 EF HUTTON, division of Benchmark Investments, LLC. Contact Details Healthcare Triangle, Inc. Michael Campana michael.c@healthcaretriangle.com Company Website https://www.healthcaretriangle.com

October 03, 2022 09:28 AM Eastern Daylight Time

Biotech Company Pleased With Results Of Early Testing Demonstrating Vaccine Potential For Multiple Sclerosis

Pasithea Therapeutics Corp.

Learn More about Pasithea Therapeutics by gaining access to the latest research report Vaccines that boost the body’s immune system against foreign proteins are different than those that are an inverse vaccine fighting an autoimmune disease. The latest study from Pasithea Therapeutics Corp. (NASDAQ: KTTA) focuses on the latter. Pasithea is a biotechnology company focused on discovering, researching and developing new and effective treatments for psychiatric and neurological disorders. Pasithea recently announced encouraging preclinical results that support the efficacy of a tolerizing DNA vaccine for multiple sclerosis (MS). Based on its experiments conducted with Hooke Laboratories Inc., Pasithea reported that intramuscular injections of the candidate vaccine (PAS002) delayed the onset of paralysis and reduced peak disease severity. Prophylactic administration also reduced the incidence and severity of relapse in the mouse model. According to the National MS Society, nearly 1 million people are living with MS in the United States, which is more than twice the original estimate. “The results of this study show that this technology has the potential to tolerize GlialCAM, a myelin molecule that has molecular similarity to the Epstein Barr virus (EBV) that triggers MS,” Pasithea Chairman and National Academy of Sciences Professor Lawrence Steinman said. Steinman is a globally recognized authority in MS, and his research led to the development of the drug Tysabri, which is approved to treat patients with MS and Crohn's disease. “Remarkably, the piece of GlialCAM protein shared between EBV and white matter in the brain is also found in the pox viruses, including monkeypox,” Steinman said. “Monkeypox is rarely associated with brain inflammation, and this new technology may prove useful for brain inflammation caused by certain viral infections.” GlialCAM Molecules Mimic Epstein Barr Earlier this year, a study in the leading science journal Nature showed that a molecule called GlialCAM found in the brain’s white matter is attacked in MS. GlialCAM shares a component of its protein structure that mimics an identical component of the Epstein Barr virus Nuclear Antigen-1, which plays a critical role in triggering MS. In Pasithea’s proof of concept study, relapsing paralysis was established in a mouse model of relapsing-remitting experimental autoimmune encephalomyelitis (EAE), the standard animal model of MS. In three groups, a proprietary DNA cassette was engineered to encode GlialCAM and injected to block acute disease and its relapse. Pasithea reported that these DNA molecules were designed to protect against paralytic disease by tolerizing the immune system so it would not attack myelin in the brain and spinal cord. The engineered DNA molecule created tolerance and worked as an inverse vaccine. There are currently 15 vaccines actively under development for Epstein-Barr virus, most in preclinical stages. The vaccine is a recombinant vector vaccine that uses the same technology that AstraZeneca plc (NASDAQ: AZN) and Johnson & Johnson (NYSE: JNJ) used in their COVID-19 vaccines. Moderna Inc. (NASDAQ: MRNA), meanwhile, has started testing the vaccine mRNA-1189 in Phase I studies but does not indicate MS, though the company believes it could potentially assist in prevention. Pasithea’s data showed that the engineered DNA plasmids provide a high level of efficacy in reducing disease severity and incidence of relapse when administered prophylactically in the EAE model, a widely used relapsing-remitting model of MS. "Although early stage, we believe these results demonstrate the promise and validity of our tolerizing approach, which is built on recent data on the biological mechanism linking infection with EBV with the development of MS,” Pasithea CEO Dr. Tiago Reis Marques said. “We have filed a provisional patent application, and we will continue to rapidly pursue the PAS002 drug development program.” The study was conducted at Hooke Laboratories, an independent full-service contract research organization with deep experience in the EAE animal model of MS. At future international conferences, Pasithea plans to present its study data, including histology data and plasma inflammatory markers. The company will also submit complete data for peer-review publication. For more information on Pasithea Therapeutics, visit www.pasithea.com. Pasithea Therapeutics Corporation is a biotechnology company focused on the discovery, research and development of new and effective treatments for central nervous system (CNS) disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders, including Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS). Pasithea addresses the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details TraDigital IR- Camille Baptiste camille@tradigitalir.com Company Website https://www.pasithea.com/

October 03, 2022 09:09 AM Eastern Daylight Time

MedMira provides Progress Update

MedMira Inc.

Today, MedMira Inc. (MedMira) (TSXV: MIR) announces the appointment of Dr. Sam Ratnam as MedMira’s Director of Scientific & Regulatory Affairs and provides an update on its regulatory progress in the U.S. market. U.S. Regulatory Update on COVID-19 Products The recent announced recommendation by the U.S. FDA to IVD manufacturers to apply for the traditional regulatory path 510(k) approval outlines the continuous need for quality COVID-19 rapid test. While the Emergency Use Authorisation (EUA) is continuing, the regulators prepare for the future endemic situation and initiate the standard transition protocol for prevailing diseases. In contrary to the EUA application where manufacturer does not require to meet high quality standard, traditional approval process such as the 510(k) requires full compliance with the FDA Quality System Regulation (21 CFR Part 820). It is the most important mandate for all regulators including FDA and Health Canada to approve the highest quality product to serve the public need. Such requirements may include an existing FDA establishment license and the Medical Device Single Audit Program (MDSAP) certification. MedMira’s product lines REVEALCOVID-19 ® and VYRA™ have the data supporting such an application and can provide additional data if such may be required. At the same time, MedMira’s quality system has been certified for the MDSAP and the Company holds both the FDA and Health Canada establishment license for its North-American based facility. The Company continues with its dual strategy to receive the EUA(s) and the 510(k). This enables MedMira and its distributors to offer the highest regulatory approved products when available to market. While MedMira is in the EUA process, the Company is preparing the 510(k) pre-submission. MedMira will provide further updates on both applications when available. U.S. Regulatory Update on Hepatitis C Product The Company has previously announced the intention of seeking FDA approval for its Point of Care Reveal ® Rapid Hepatitis C (HCV) Antibody Test. According to US Centers for Disease Control and Prevention (CDC), the incidence rate of acute hepatitis C in 2020 has more than doubled since 2013, a 124% increase. MedMira has taken immediate steps and a Q-submission (Q220148) was made to FDA and has received positive feedback. The submitted clinical and non-clinical protocols have been reviewed, and the Company has received clear instructions towards obtaining approval for this greatly demanded product in the USA and other parts of the world. Growth of Scientific and Regulatory Support MedMira has eight regulatory applications pending and is aiming to add three additional regulatory submission in the coming months to our three key markets. Therefore, the management has appointed Dr. Sam Ratnam as Director Scientific & Regulatory Affairs to support MedMira in its growth by introducing more products into the North-American and European markets. Dr. Ratnam brings over 40 years of experience in public health, regulatory affairs and has been the principal in a number of important regulations set forward by the health authorities such as the guidelines on Syphilis, Hepatitis C and HPV. His invaluable expertise and intrinsic knowledge of the regulatory and clinical trial framework in Canada and the United States, will provide the Company even further momentum to push forward on its current and future applications. Trademark REVEALCOVID-19 ® MedMira is delighted to announce the receipt of the United States of America Trademark for its REVEALCOVID-19 brand. The trademark complements the MedMira’s portfolio of trademarked brands and further strengthen its uniqueness. Additional trademarks are currently in the final process which includes VYRA™ (Virus based antigen tests), BYRA™ (Bacteria based antigen/antibody tests) and PYRA™ (Parasite based antigen/antibody tests). About Dr. Sam Ratnam Dr. Sam Ratnam, MSc (Medical Microbiology; Madras), PhD (Medical Microbiology; Delhi), MPH (Johns Hopkins), FCCM (Fellow of Canadian College of Microbiologists), is Clinical Professor at Memorial University, St. John's, and Adjunct Professor, McGill University, Montreal, Canada. He was Director of Public Health Laboratory, Government of Newfoundland, St. John's, and served as Advisor to the National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, and Interim Advisor to the Public Health Laboratory, St. John's. He has served as chair or member of many Canadian federal and provincial advisory committees and working groups and as temporary advisor to the WHO. His research interests are clinical and public health microbiology with focus on STI diagnostics (200 scientific articles and abstracts). Next Updates MedMira will provide further updates on its CE and Health Canada progress in a separate announcement. About MedMira MedMira is a leading developer and manufacturer of Rapid Vertical Flow® diagnostics. The Company’s tests provide hospitals, labs, clinics and individuals with instant disease diagnosis, such as HIV, Syphilis, Hepatitis, and SARS-CoV-2, in just three easy steps. The Company’s tests are sold globally under the REVEAL®, REVEALCOVID-19®, Multiplo® and Miriad® brands. Based on its patented Rapid Vertical Flow® Technology, MedMira’s rapid HIV test is the only one in the world to achieve regulatory approvals in Canada, the United States, China and the European Union. MedMira’s corporate offices and manufacturing facilities are located in Halifax, Nova Scotia, Canada. For more information visit medmira.com. Follow us on Twitter and LinkedIn. This news release contains forward‐looking statements, which involve risk and uncertainties and reflect the Company’s current expectation regarding future events, including statements regarding possible regulatory approval, product launch, future growth, and new business opportunities. Actual events could materially differ from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company quarterly filings. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Contact Details MedMira Inc. Markus Meile ir@medmira.com Company Website https://medmira.com

October 03, 2022 07:04 AM Eastern Daylight Time

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