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PathAI Announces Collaboration with the Crohn’s & Colitis Foundation to Advance Novel IBD Research and Development

PathAI

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced a partnership with the Crohn’s & Colitis Foundation. The collaboration will empower academic and biopharmaceutical researchers to unlock insights into inflammatory bowel disease (IBD) through the unique combination of quantitative histopathology data and well-characterized multi-modal clinical and molecular data. Quantitative histopathology data will be derived from the deployment of PathAI's IBD Explore ™ and AIM-HI UC ™ algorithm products 1 on digitized histology images from the Crohn’s and Colitis Foundation’s IBD Plexus ​Ⓡ dataset. The parties will also pursue collaborative research using their complementary assets aimed at advancing the field of IBD research.​ Despite the current array of treatment options in ulcerative colitis and Crohn’s disease, remission rates in induction trials are still less than 50%, revealing a therapeutic ceiling in the treatment of both diseases and potential challenges that need to be addressed 2-5. PathAI’s IBD Explore algorithm utilizes AI-powered histopathology analysis to provide detailed insights into the tissue’s inflammatory microenvironment. IBD Explore has the potential to lead to the discovery of novel biomarkers 6,7, disease subtypes, and treatment targets. Meanwhile, AIM-HI UC is the only AI-powered Geboes scoring tool that provides automated subgrade-level scores to accurately and reproducibly measure histological stage and improvement for ulcerative colitis research and clinical trials. “We are thrilled to collaborate with the Crohn’s & Colitis Foundation, the leading nonprofit organization in the IBD space, as a preferred partner to meaningfully advance our understanding of IBD through this unique combination of datasets,” said Andy Beck, MD, PhD, co-founder and CEO of PathAI. “By partnering with PathAI, we aim to uncover valuable insights from well-characterized pathology images, enhancing our understanding of IBD at the microscopic level and paving the way for novel biomarkers, refined disease subtypes, and potential therapeutic targets,” said Angela Dobes, SVP IBD Plexus, Crohn’s & Colitis Foundation. By combining IBD Plexus’ deeply curated multimodal data, including its large-scale digitized pathology archive, with advanced AI analysis by PathAI, this collaboration aims to enhance researchers’ understanding of the histological factors of IBD to drive novel discoveries that improve quality of life for the millions of Americans living with these diseases. For more information on licensing a joint dataset from PathAI and the Crohn’s and Colitis Foundation, please reach out to bd@pathai.com. Register for a free demo of PathAI’s algorithm products here. Footnotes IBD Explore and AIM-HI UC are For Research Use Only. Not for use in diagnostic procedures. Danese S. et al. Unmet medical needs in ulcerative colitis: an expert group consensus. Dig. Dis. 2019;37(4):266–283. doi: 10.1159/000496739. https://www.ncbi.nlm.nih.gov/pubmed/30726845 Colombel J.F. et al. Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC. Gut. 2017;66(12):2063–2068. doi: 10.1136/gutjnl-2016-312307. https://www.ncbi.nlm.nih.gov/pubmed/27590995 Colombel J.F. et al. Effect of tight control management on Crohn's disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2017;390(10114):2779–2789. doi: 10.1016/S0140-6736(17)32641-7. Alsoud D. et al. Breaking the therapeutic ceiling in drug development in ulcerative colitis. Lancet Gastroenterol Hepatol. 2021;6(7):589–595. doi: 10.1016/S2468-1253(21)00065-0. Shamshoian et al. 2024. United European Gastroenterology Week. ePoster PP0375. Griffin et al. 2024. European Crohn’s and Colitis Organisation. P008. About PathAI PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and laboratory use. Rigorously trained and validated with data from more than 15 million annotations, its AI-powered models can be leveraged to optimize the analysis of pathology samples, with the potential to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI is headquartered in Boston, MA. For more information, please visit www.pathai.com. About the Crohn’s & Colitis Foundation The Crohn’s & Colitis Foundation is the leading nonprofit organization focused on both research and patient support for inflammatory bowel disease (IBD), with the mission of curing Crohn’s disease and ulcerative colitis and improving the quality of life for the millions of people living with IBD. The Foundation’s work is dramatically accelerating the research process, while also providing extensive educational and support resources for patients and their families, medical professionals, and the public. To learn more about the IBD Plexus program, visit www.crohnscolitisfoundation.org/research/plexus. Contact Details SVM Public Relations and Marketing Communications +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

October 03, 2024 10:00 AM Eastern Daylight Time

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This Company Is Taking An Innovative, Non-Opioid Approach To Pain Management For Pancreatic Cancer

Autonomix Medical, Inc.

By Austin DeNoce, Benzinga Pancreatic cancer is one of the most aggressive and painful forms of cancer, often leaving patients with limited options for effective pain management. Traditional treatments like opioids and nerve blocks offer only temporary relief, and their side effects can further diminish the quality of life. This underscores the urgent need for innovative solutions that can provide sustainable pain relief for those battling this debilitating disease. Autonomix Medical (NASDAQ: AMIX) is working to address this critical gap with a novel, non-opioid approach designed to significantly reduce pain in pancreatic cancer patients. The company recently shared promising preliminary data from its ongoing human clinical trial, showcasing the potential of its precision nerve-targeted treatment. This minimally invasive method aims to deliver lasting pain relief, offering hope to patients who have struggled to find effective alternatives to around-the-clock opioids. “We are encouraged by the significant, sustained pain reduction demonstrated from the lead-in patients in our ongoing first-in-human trial. These are very sick individuals, who up until this point primarily relied on opioids to help mitigate their pain, which our baseline data shows were not effective,” said Autonomix CEO Brad Hauser. Overview Of Preliminary Results In early September, Autonomix announced positive outcomes from its proof-of-concept trial. The results indicated that 60% of patients in the initial cohort experienced a substantial reduction in pain. Using the Visual Analog Scale (VAS), patients reported a dramatic drop in pain scores from an average of 8.0 to just 1.33 within 4 to 6 weeks post-procedure — an 83% reduction. Significantly, patients in the responder group felt pain relief as early as one day after the procedure, highlighting the potential for rapid and meaningful impact. The trial also identified a key factor that may factor in treatment success: the access point used during the procedure. Patients treated through femoral access showed significant improvements, while those with brachial access did not. These findings suggest that the method of delivery may play a crucial role in optimizing outcomes. Innovative Technology Behind The Treatment Autonomix reports that its groundbreaking technology employs a catheter-based microchip sensing array capable of detecting and differentiating nerve signals with extraordinary precision – up to 3,000 times greater than existing methods. The company says this advanced platform not only identifies overactive nerve signals but also targets them with radiofrequency (RF) ablation, providing precise pain relief without the common drawbacks of conventional treatments. Looking Ahead: Expanding The Possibilities The trial is expected to complete patient enrollment by the end of 2024, with plans to incorporate additional biomarkers to refine the correlation between nerve ablation and pain relief. The success of this trial could pave the way for a new standard in pain management, extending beyond pancreatic cancer to other conditions characterized by severe nerve-related pain. A Potential Game-Changer, Non-Opioid Approach In Pain Therapy Autonomix Medical could be poised to help revolutionize pain management, not only for pancreatic cancer patients but for a broader range of chronic pain conditions. As their technology evolves and clinical trials progress, the company says its approach could transform the landscape of pain therapy, offering hope and improved quality of life to countless individuals. By developing cutting-edge solutions, Autonomix is not just addressing a critical unmet need but also potentially setting the stage for a new era in precision pain management. With the potential to impact a significant segment of the multi-billion-dollar pain management market, this breakthrough could mark a turning point in the way we treat pain in complex medical conditions. Featured photo by Ousa Chea from Unsplash. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class technology platform includes a catheter-based microchip sensing array that has the ability to detect and differentiate neural signals with approximately 3,000 times greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.We are initially developing our technology for pancreatic cancer pain, a condition that can cause debilitating pain and needs an effective solution. However, our technology constitutes a platform with the potential to address dozens of indications, including in cardiology, renal denervation and chronic pain management across a wide disease spectrum. Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the timing of the completion of patient enrollment in the trial and the Company’s ability to successfully meet the milestones set forth in this press release on a timely basis, if at all. Such forward-looking statements can be identified by the use of words such as ‘should,’ ‘may,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘projects,’ ‘forecasts,’ ‘expects,’ ‘plans,’ and ‘proposes.’Although Autonomix Medical, Inc. (or Autonomix) believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the offering circular filed with the U.S. Securities and Exchange Commission (“SEC”) on January 26, 2024. Forward-looking statements speak only as of the date of the document in which they are contained and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details JTC Team, LLC autonomix@jtcir.com Company Website https://autonomix.com/

October 03, 2024 08:35 AM Eastern Daylight Time

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Breakthrough Therapies And Novel Treatments - This Biopharma Is Out To Change The Game

Benzinga

By Johnny Rice, Benzinga Erez Aminov, CEO & Chairman of the Board, and Dr. Itzchak Angel, Chief Scientific Advisor for MIRA Pharmaceuticals (NASDAQ: MIRA), were recently interviewed by Benzinga. MIRA is a pre-clinical biopharma focused on developing treatments for neurologic and neuropsychiatric disorders. It holds exclusive rights to Ketamir-2, an oral ketamine analog being studied for neuropathic pain, treatment-resistant depression, major depressive disorder with suicidal ideation and PTSD. The company’s other primary asset, MIRA-55, is a novel pharmaceutical marijuana analog that could provide enhanced therapeutic effects over THC. Watch the full interview here: Featured photo by Jeremy Bishop 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

October 03, 2024 08:25 AM Eastern Daylight Time

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Psilocybin's Potentially Revolutionary Ability To Treat Depression Hinges On FDA Approval – AJNA BioSciences Is Standardizing Raw Materials To Meet Guidelines

Benzinga

By Anthony Termini, Benzinga Results of research conducted at Emory University, the University of Wisconsin-Madison and UC Berkeley estimate that more than five million Americans suffering from depression could benefit from psilocybin-assisted therapy. This first-of-its-kind peer-reviewed study is scheduled to be published in the scientific journal Psychedelics on September 24, 2024. How Psilocybin Can Deliver Rapid And Sustained Antidepressant Effects This latest research report is not the first to look into the use of psilocybin to treat depression. There is a body of research showing that it can potentially deliver quick and continuous antidepressant effects. For example, results of randomized clinical trials have been published in the Journal of the American Medical Association and by the University of California San Francisco. In fact, psilocybin’s therapeutic properties had been researched as early as the 1950s by Swiss drugmaker Sandoz Group (OTC: SDZNY) as part of specific psychiatric studies. A Pioneering Drug Development Company Focused On Botanical Therapies All of this seems to support the work of AJNA BioSciences, based in Littleton, Colorado. The company could be strategically poised to lead and create value in this emerging category of pharmaceuticals. AJNA is currently developing a full-spectrum psilocybin “novel antidepressant.” AJNA believes that a standardized botanical medicine made from psilocybin will be in high demand. It reports that in 2020, doctors prescribed nearly $19 billion worth of drugs to treat depression. Researchers have estimated that the market for psychedelic drugs will grow annually by more than 12% through at least 2027. AJNA believes it can capture a high single-digit percentage of that market. What is significant about AJNA’s drug development work is that it is standardizing botanical materials to meet strict FDA guidelines. AJNA reports that it is the first biotech company working with botanicals under a DEA Schedule-1 license. AJNA is developing a daily-use anti-depression treatment through what it intends to be a fully characterized and FDA-approved formulation. AJNA has advanced the development of two prescription drug candidates: its CBD-based Autism Spectrum Disorder drug is anticipating a phase 2 trial in late 2024, and its psilocybin-based antidepressant drug has a phase 1 trial scheduled for early 2025. The company’s research team, led by scientists from Harvard, Johns Hopkins and New York University, is conducting clinical trials in the same manner as large drug manufacturers. However, AJNA is working to transform the pharmaceutical industry by pioneering a new regulatory pathway to produce drugs from plants. Why AJNA Is Focused On FDA Approvals Authors of the research to be published by Emory University, the University of Wisconsin-Madison and UC Berkeley say that their “projections are highly contingent on…precise FDA approval parameters.” In other words, how broadly or narrowly the FDA defines this new class of drugs. AJNA seems to have anticipated some of this. It reports that it has distinguished itself as one of the leaders in the evolving field of botanical drug development and has paid strict attention to how the FDA is defining the pathways for botanical drugs to get approved. Joel Stanley, AJNA’s CEO, says that FDA approval is a critical component of bringing new drugs to market. Federal law requires that a manufacturer show that the drugs they produce are safe and effective. Stanley also notes that without the FDA’s stamp of approval, a drug is unlikely to be considered for reimbursement by health insurance carriers. For botanical drugs to be an accepted component of a physician’s and patient’s routine treatment options, they must be approved by the FDA. AJNA is committed to producing natural botanical drugs that have undergone rigorous laboratory and clinical scrutiny to demonstrate that they deliver “nature, backed by science.” AJNA is currently raising capital in a crowdfunding round through Wefunder. Stanley says that “by investing in AJNA, you’re helping to change the healthcare paradigm to include optionality that none of us have ever had.” With less than a week before the current financing/investment opportunity closes, interested investors can find more information on the Wefunder website. Featured photo by Monika Schröder on Pixabay. 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

October 02, 2024 08:25 AM Eastern Daylight Time

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Market Alert: Silexion Therapeutics (NASDAQ: SLXN) Sees Record Volumes Following Breakthrough Preclinical Data for SIL-204

Global Markets News

Shares of Silexion Therapeutics (NASDAQ:SLXN) are seeing significatnly today after the company announced promising new preclinical data for its next-generation siRNA candidate, SIL-204. The stock saw a significant initial of price spike of over 50% in pre-market activity as investors responded to the latest developments in Silexion's RNA interference (RNAi) platform, which targets KRAS-driven cancers. As of now, volume is at record highs, currently standing at over 50 million shares today. The company revealed that SIL-204, an extended-release microparticle formulation, demonstrated substantial tumor reduction and necrosis in mouse models of pancreatic cancer bearing the KRAS G12D mutation—one of the most common mutations found in pancreatic cancer patients. This latest data builds on a string of recent successes for Silexion, including its September 24 announcement of results from the Phase 2 trial for its first-generation product, LODER™, which showed significant improvements in tumor resectability among non-resectable pancreatic cancer patients. Alongside the new preclinical results, Silexion has recently reported plans to begin toxicology studies for SIL-204 in preparation for Phase 2/3 clinical trials expected to commence in the first half of 2026. The company is also expanding the application of its siRNA technology to colorectal cancer models, reflecting its broader ambitions to target multiple KRAS-driven cancers, which are notoriously difficult to treat with conventional therapies. While stock price has pulled back since premarket, The spike in Silexion’s market activity as marked by these record high volumes (according to market data) may highlight the growing market interest in the company’s novel approach to tackling cancers with high unmet medical needs, particularly its focus on KRAS mutations, which are common across a variety of aggressive cancers, including pancreatic and colorectal cancer. Silexion’s continued momentum in the precision oncology space potentially positions it as a leading player in the development of next-generation RNAi therapies. With its promising pipeline and recent positive developments, the company seems to be gaining attention as it advances toward clinical trials that could offer new hope for patients battling some of the deadliest cancers. Click here to read Silexion's full announcement *** This update is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. [https://justpaste.it/ab9dn/pdf]. Global Markets News Network is a commercial digital brand compensated to provide coverage of news and developments related to innovative companies as detailed in the full documentation and it is thus subject to conflicts of interest. Contact Details News Coverage ronald@futuremarketsresearch.com

October 01, 2024 11:47 AM Eastern Daylight Time

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Velocity Global Named a Leader in NelsonHall’s Global Employer of Record (EOR) Evaluation for the Fourth Time in a Row

Velocity Global

Velocity Global, the world’s expert on work, announced today that it was positioned as a leader in the 2024 Vendor Evaluation & Assessment Tool (NEAT) for global EOR services by NelsonHall. The report recognizes Velocity Global for both its ability to deliver immediate customer benefits as well as its capabilities to meet future customer needs. This marks the fourth time in a row that Velocity Global has earned this distinction, solidifying its position as a trusted partner for companies expanding their global presence. "Deploying a global workforce is extremely complex, as companies need to navigate a maze of varying regulations, compliance needs, and talent expectations in different countries," said Jeanine Crane-Thompson, Principal Analyst at NelsonHall’s HR & Talent Transformation practice. "Velocity Global’s blend of strategic R&D investments and compliance expertise has transformed them into a critical partner for companies looking to accelerate global growth. Their comprehensive EOR solution allows organizations to focus on their expansion goals without the burden and potential risks of logistical and legal complexities." As a trailblazer in global workforce solutions, Velocity Global empowers companies to hire, manage, pay, and retain talent, anywhere in the world. Over the years, Velocity Global has evolved from offering a point solution to being a strategic partner to its customers as they execute on their global growth plans. Velocity Global’s powerful combination of its self-service Global Work Platform and its deep legal and HR expertise ensures seamless compliance, no matter how complex the jurisdiction. Both employers and employees benefit from a frictionless, user-friendly experience. In its 2024 report, NelsonHall highlights several strengths that contributed to Velocity Global’s positioning as a leader, including: Mature EOR market provider: Velocity Global offers a compliant, integrated EOR solution that enables multinational companies to confidently hire across borders. Technology roadmap: Velocity Global’s roadmap is centered on AI-driven enhancements, expanded platform integrations, and robust self-service functionality. Competitive service offerings beyond EOR: Velocity Global offers an array of services beyond EOR, including global benefits, immigration support, pensions, equity management, and office space logistics. ”The ability to hire anyone, anywhere is a huge differentiator as companies expand across geographies and tap into underutilized talent pools,” says Francoise Brougher, CEO of Velocity Global. “To simplify and streamline this process for customers, we invest in our technology. This, coupled with our extensive in-country and compliance expertise, means customers can have peace of mind and focus on growing their business.” This latest recognition reinforces Velocity Global’s unwavering commitment to empowering businesses with the tools and expertise to navigate the complexities of the global workforce landscape and drive sustained growth. To learn more about what sets us apart, download the report [ here ]. For more information on how Velocity Global makes opportunity borderless for people everywhere, visit www.velocityglobal.com. About Velocity Global Velocity Global gives you the power to build your team everywhere—combining seamless technology and local expertise in 185+ countries. We make it simple to compliantly hire, pay, manage, and retain talent anywhere. With Velocity Global, the world is yours. About NelsonHall NelsonHall is the leading global analyst firm dedicated to helping organizations understand the 'art of the possible' in digital operations transformation. With analysts in the U.S., U.K., Continental Europe, and Asia, NelsonHall provides buy-side organizations with detailed, critical information on markets and vendors (including NEAT assessments) that helps them make fast and highly informed sourcing decisions. And, for vendors, NelsonHall provides deep knowledge of market dynamics and user requirements to help them hone their go-to-market strategies. NelsonHall's analysis is based on rigorous, primary research, and is widely respected for the quality and depth of its insight. Media Contact: press@velocityglobal.com Contact Details Media contact +1 720-650-4348 press@velocityglobal.com Company Website https://velocityglobal.com/

October 01, 2024 07:47 AM Pacific Daylight Time

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How Cosmos Health’s Acquisition Of Almost 100-Year-Old Company, Adding To Capabilities Like Contract Manufacturing, Could Generate Over $10 Million In Annual Gross Profit

Benzinga

By James Blacker, Benzinga Global healthcare group Cosmos Health (NASDAQ: COSM) has potentially positioned itself for growth through its acquisition last year of Cana Laboratories, a Greek pharmaceutical company with nearly a century of expertise. As Cosmos’ new manufacturing arm, Cana brings a wealth of synergies, potentially enabling the company to control its own production, from pharmaceuticals to nutraceuticals. Cana Laboratories: A Century Of Expertise Founded in 1928, Cana Laboratories has earned its name in the pharmaceutical industry over nearly a century, having partnered with companies such as AstraZeneca (NASDAQ: AZN), Merck (NYSE: MRK), Janssen, Nestlé (OTC: NSRGY), Unilever (Unilever), Viatris (NASDAQ: VTRS) and Procter & Gamble (NYSE: PG). In recent years it has also worked with major firms in the medtech space, namely Medtronic (NYSE: MDT) and Stryker (NYSE: SYK). Cosmos acquired Cana in July of last year for around $1.67 million – a heavy discount compared to Cana’s $10 million valuation at the time, according to the company. As such, Cosmos expects to record a substantial gain on the purchase of what it now considers to be its crown jewel asset. The acquisition of Cana equips Cosmos with in-house manufacturing capabilities, bringing significant vertical integration and providing greater control over quality and costs. Cosmos can now use Cana’s facilities to manufacture its portfolio of generic medicines, including treatments for diabetes, cholesterol, respiratory and cardiac conditions, as well as its proprietary nutraceutical brand, Sky Premium Life. The acquisition has moreover added several brands to Cosmos’ portfolio, including antiseptics like C-Sept, the organic infant care line biobebe and dermocosmetics such as Eleon Cosmetics. New Facility To Scale Production Furthermore, Cosmos now owns Cana's 54,000 sq. ft. production facility in Athens. Certified by the European Medicines Agency and with a Good Manufacturing Practice license, this facility enhances Cosmos’ production capabilities, creating opportunities for potentially lucrative contract manufacturing agreements. Cosmos has invested some $5.5 million in Cana since the acquisition. The investment includes upgrading the Athens facility with new machinery, equipment, IT infrastructure and quality management systems. These investments will enable the company to manufacture a wide range of pharmaceuticals at scale, such as tablets, capsules, syrups, sprays, creams, gels and ointments. The company announced in July this year that it completed the first phase of this upgrade. At full capacity, which Cosmos says will be reached by the end of 2025, the facility is expected to generate over $10 million in annual gross profit. This stands in contrast to Cosmos’ current market cap of about $15 million as of Sept. 27. Contract Manufacturing: A High-Margin Growth Driver With its enhanced manufacturing capacity, Cosmos aims to accelerate the growth of its contract manufacturing business. In July, the company announced that it signed agreements with Provident Pharmaceuticals and Humacology to manufacture 5,020,000 units of medicines and up to 500,000 CBD units. Cosmos says its contract manufacturing business has very high margins thanks to minimal costs, most of which are borne by clients. The company, therefore, expects the newly signed deals to be highly profitable. Moreover, with less than 20% of its production capacity being utilized, there is plenty of room to sign additional contracts. Further down the line, if the facility reaches full capacity, Cosmos is prepared to initiate a second phase of the expansion to further boost capacity and gross profits beyond the projected $10 million from phase 1. Cosmos Health says it is confident that the acquisition of Cana Laboratories positions it for substantial growth. With its new in-house production capabilities, the company can boost efficiency and secure high-margin contract manufacturing agreements. Interested investors may want to watch for announcements of further contract manufacturing agreements as Cosmos seeks to fully utilize its production capacity. Featured photo by Testalize.me 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 not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

October 01, 2024 09:30 AM Eastern Daylight Time

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MediVera Compounding Pharmacy™ Expands into 18 States Across Five Regions in 2024, Now Offers Dozens of Personalized Medicine Options

MediVera

MediVera Compounding Pharmacy™, a leader in personalized medicine since 1999, announced today that it has officially been licensed to serve residents in 18 new states across the West, Southwest, Southeast, Midwest, and Northeast regions in 2024. The licenses allow MediVera to fill compounding prescriptions—including semaglutide and tirzepatide—throughout these states. This expansion broadens the company’s geographical reach, reflecting its commitment to providing personalized compounding services to prescribers and patients nationwide. The new states include: West Region: Colorado, Idaho, Montana, Utah, Washington, Wyoming Southwest Region: Arizona, New Mexico, Oklahoma Southeast Region: Georgia, North Carolina, South Carolina, Tennessee, Virginia, West Virginia Midwest Region: South Dakota Northeast Region: Connecticut, Maine The licenses were issued between January 24, 2024, and August 13, 2024, by the respective State Boards of Pharmacy following rigorous application and compliance processes that require MediVera to meet or exceed governmental regulations and recommendations. MediVera is PCAB Accredited in both sterile and non-sterile compounding, certifying ethical and quality standards met by only 1% of compounding pharmacies nationwide. Prescribers and patients in these states are now welcome to use MediVera’s services, effective immediately. “We are absolutely thrilled with the opportunity to do business in these new states,” said MediVera CEO Bradley McCloskey, PharmD. “MediVera has been dedicated to changing lives with the industry standard in personalized medicine since it was founded by my father over 20 years ago. Bringing that simple mission to states across the country—and now to these additional 18 states—is a dream come true.” This growth coincides with an increased interest in compounded medications, including hormone replacement therapy and solutions for men’s and women’s health. MediVera has responded with an ongoing nationwide expansion effort, growing its footprint to include 37 states, with more licenses expected before the end of the year. About MediVera Since its inception in 1999, MediVera Compounding Pharmacy™ (formerly University Compounding Pharmacy) has been dedicated to providing personalized medicine. With a focus on quality and innovation, MediVera Compounding Pharmacy™ continues to set industry standards, offering tailored solutions to meet the unique needs of healthcare providers and patients. MediVera Compounding Pharmacy™ is currently licensed in and ships to the following 33 states: AZ, CN, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NY, OH, PA, RI, SC, SD, TN, VA, VT, WA, WI, WY. Contact Details MediVera Compounding Pharmacy™ Laurie Malseed +1 937-242-0430 laurie@mediverarx.com Company Website https://mediverarx.com/

September 26, 2024 09:00 AM Eastern Daylight Time

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CompleCure Partners with AGC Biologics’ Chiba Site to Develop Advanced Anti-Cancer Therapeutic Using Pioneering AMDC Technology

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today the company entered into a strategic service agreement with CompleCure. The partnership focuses on developing the manufacturing process for a novel anti-cancer therapeutic, which uses Antibody Mimetics Drug Conjugate (AMDC) technology—a groundbreaking advancement in cancer treatment. AGC Biologics is developing the manufacturing process for the protein component of this new therapeutic at its facility in Chiba, Japan. The AMDC technology represents a significant evolution of Antibody Drug Conjugate (ADC) therapy, offering a potentially promising new approach to cancer treatment by combining a mimetic protein structure with a chemically synthesized drug specifically designed to target and destroy cancer cells. The therapeutic being developed by CompleCure aims to revolutionize breast cancer treatment. It is designed to achieve complete remission with minimal side effects, significantly improving patient outcomes. The protein component, which is the focus of AGC Biologics' efforts, features a complex tetrameric structure that demands advanced technologies in microbial expression for successful process development and manufacturing—an area where AGC Biologics Chiba has unparalleled expertise. “AGC Biologics Chiba and our scientists are experts in working with complex proteins and the latest technologies. For this reason, we are an ideal CDMO site to partner with CompleCure on this innovative treatment,” said Jun Takami, General Manager, AGC Biologics Chiba Facility. “We look forward to working side by side with the CompleCure team to develop this new therapeutic that could have a revolutionary impact on breast cancer patients across the globe.” CompleCure selected AGC Biologics as its partner based on the company’s 30-year track record as a leading CDMO, its ability to rapidly propose innovative development solutions, and its flexible production capabilities. The two companies plan to continue manufacturing the protein component at AGC Biologics' Chiba site, ensuring a seamless transition to production for further steps once the process development is completed. This collaboration marks a significant milestone in the path toward the commercialization of AMDC-based therapeutics. By combining AGC Biologics’ development and manufacturing capabilities with CompleCure's innovative therapeutic approach, the two companies hope to bring this promising treatment to market, ultimately contributing to the improvement of quality of life (QOL) for cancer patients worldwide. For more information about AGC Biologics Chiba, visit www.agcbio.com/facilities/chiba. To learn more about AGC Biologics’ global CDMO services go to www.agcbio.com. About CompleCure CompleCure is a start-up developing innovative pharmaceuticals by utilizing cutting-edge biotechnology. We own the intellectual property rights to the “Cupid-Psyche System,” utilizing the high affinity and strong binding of proteins and vitamins. Cupid-Psyche System is one of the outcomes of the “Molecularly Designed Antibody Project,” a cutting-edge R&D support program led by the Cabinet Office and involving Japan Bioindustry Association, the University of Tokyo, Osaka University, Chugai Pharmaceutical Co., Ltd. and Fujifilm Corporation. The new breast cancer treatment for which AGC would develop manufacturing process under the announced strategic service agreement is the most advanced in development among the AMDC based therapeutics utilizing the Cupid-Psyche system. This therapeutics is being developed in cooperation with the University of Tokyo, Tohoku University, and Chiba University. We will open up new possibilities for fundamental treatment of cancer. 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 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com Company Website https://www.agcbio.com/

September 23, 2024 04:58 PM Pacific Daylight Time

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