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Tonix Pharmaceuticals finish Phase 3 trial of TNX-102 SL for management of Fibromyalgia

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman recently joined Steve Darling from Proactive to shed light on the latest developments in their research efforts. The company has successfully concluded the clinical phase of a Phase 3 registration-quality study for TNX-102 SL, a drug developed for the management of fibromyalgia. This study, which is double-blind and placebo-controlled, saw the enrollment of 457 patients across various sites in the United States. Lederman conveyed to Proactive that the topline results from this study are anticipated by late December. Should the results be favorable, this trial is expected to be the conclusive well-controlled efficacy trial needed for the submission of a New Drug Application to the U.S. Food and Drug Administration. The urgency and importance of this development are underscored by the fact that an estimated 6-12 million individuals in the US are afflicted with fibromyalgia, a condition that predominantly affects women. In addition to the TNX-102 study, Lederman also discussed another significant milestone: the enrollment of the first participant in a Phase 2 study, supported by the Department of Defense, focusing on TNX-1900 for the improvement of bone health in children with autism spectrum disorder. This investigator-initiated trial represents a foray into addressing the complex needs of children with autism, potentially offering a new therapeutic avenue to enhance their quality of life. Contact Details Proactive Studio +1 347-449-0879 na-editorial@proactiveinvestors.com

November 20, 2023 01:53 PM Eastern Standard Time

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Oxford Cannabinoid Technologies strengthens board with CMO Dr. Tim Corn

Oxford Cannabinoid Technologies Holdings PLC

Oxford Cannabinoid Technologies Holdings PLC (LSE:OCTP, OTC:OCTHF) CEO Clarissa Sowemimo Coker and CMO Dr Tim Corn speak to Thomas Warner from Proactive after the pharmaceutical group announced the appoint of Corn to its board of directors. The move follows his appointment as Chief Medical Officer in June 2023. Sowemimo-Coker highlights the importance of having a clinician on the board of a biopharmaceutical company. The appointment follows the successful announcement of Phase I single ascending dose results in October, reflecting OCT's commitment to addressing unmet medical needs with novel therapeutic approaches. Dr. Corn cites the combination of addressing unmet medical needs and the use of a novel cannabinoid approach as key factors that have attracted him to the business. He outlines his dual focus in the role, continuing as CMO to ensure efficient clinical programs aligned with regulatory requirements and bringing a physician's perspective to the board. He suggests that his expertise in clinical development and board work positions him well to balance patient interests and financial considerations. Discussing the company's cash runway, Sowemimo-Coker says the company is funded into April 2024. She assures stakeholders that the board is actively exploring various funding options, and updates will be provided as progress unfolds. While the details remain confidential, she hints at potential updates before the end of the year. The interview showcased OCT's commitment to advancing cannabinoid-based therapies, building a strong leadership team, and maintaining transparency in financial matters. Stakeholders are eagerly anticipating further developments as OCT continues its journey towards clinical and financial success. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 20, 2023 10:24 AM Eastern Standard Time

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Cardio Diagnostics Establishes A New Partnership To Facilitate Global Footprint And Expansion Beyond North America With India-Based Aimil Ltd.

Cardio Diagnostics Holdings, Inc

By Jeremy Golden, Benzinga Aimil Ltd., one of the companies at the forefront of India’s instrumentation industry, is a leader in introducing innovative technologies to their extensive healthcare network in India. A new Supply and Distribution Agreement with Cardio Diagnostics (NASDAQ: CDIO) has the potential to further these efforts and transform global cardiovascular healthcare in the process. As the leading cause of death in India – and the rest of the world – cardiovascular disease contributes to 282 deaths per 100,000 people in the country. This new strategic partnership aims to address this alarming prevalence by utilizing Cardio Diagnostics’ PrecisionCHD clinical test for the personalized management of coronary heart disease. In the partnership’s first phase of pre-marketing, Cardio Diagnostics will lay the groundwork for product introduction to Aimil’s healthcare network. There are plans to expand the Supply and Distribution Agreement following phase one. “Heart disease is a global problem, and Cardio Diagnostics’ expansion to India underscores our commitment to combat heart disease globally,” Cardio Diagnostics CEO Meesha Dogan Ph.D. said. “This expansion is possible because Cardio Diagnostics’ clinical tests are developed with scalability in mind with respect to operations and cost, enabling deployment across diverse healthcare landscapes worldwide, to play a transformative role in mitigating heart disease globally.” Even as Cardio Diagnostics expands to India, the company continues to grow its footprint in the U.S, including a targeted vertical expansion into innovative employers, brokers, providers and risk-bearing organizations serving Medicaid and Medicare populations Formed to improve cardiovascular disease detection by leveraging artificial intelligence-driven technology, Cardio Diagnostics seems poised for growth after partnering with Family Medicine Specialists and Vizient, Inc. After finalizing an Innovation Technology contract with Vizient, Inc. – the nation’s largest provider-driven healthcare performance improvement company – Cardio Diagnostics will have access to a customer base that it reports encompasses 60% of hospitals and 97% of academic medical centers in the United States. Similarly, Vizient provider customers will have access to Cardio Diagnostics' state-of-the-art tests at negotiated pricing, thereby increasing access to the next generation of cardiovascular disease detection technology. The contract, effective Nov. 1, signifies to Vizient hospital and health system customers a shift toward unique technology that has the potential to bring improvement to the healthcare industry. Vizient’s diverse customer base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers. The company transacts more than $130 billion in annual purchasing volume. This new contract with Cardio Diagnostics demonstrates Vizient’s confidence in the company’s heart attack risk assessment test, Epi+Gen CHD and coronary heart disease detection test, PrecisionCHD, which utilize a proprietary AI-driven algorithm to analyze objective epigenetic and genetic biomarkers from a patient's blood sample. Epi+Gen CHD is a pillar of a new partnership with Family Medicine Specialists (FMS), a leading Illinois primary care provider with eight locations and tens of thousands of patients across the state. With the launch of FMS’s “Heart Attack Prevention” initiative, Cardio Diagnostics’ advanced and highly sensitive blood-based epigenetic-genetic tests will be leveraged to risk stratify FMS’s patient population. FMS is implementing Epi+Gen CHD in at least 1,200 patients with CHD risk factors across its BlueCross BlueShield Medicare, Medicaid, HMO and PPO health plans. The initiative demonstrates the cost-effective benefits of early heart attack risk intervention and has the potential to help mitigate the financial and human ramifications associated with unknown heart attack risk. This benefits both patients and providers, offering significant value to health plans. By leveraging Cardio Diagnostics’ technology, clinicians at FMS will better understand their patients’ risks. Armed with more knowledge, they will be equipped with enhanced insights into the drivers of patients’ risks to aid in personalizing care. Ultimately, the initiative’s goal is to avert severe cardiac events and circumvent avoidable treatment costs, which can spiral up to hundreds of thousands of dollars for heart attacks, in addition to downstream complications like heart failure. With an eye toward the future, Cardio Diagnostics is changing the way we think about detecting and treating cardiovascular disease. These momentous partnerships underscore the company’s recent progress. Cardio Diagnostics is an artificial intelligence-powered precision cardiovascular medicine company that makes cardiovascular disease prevention, detection, and management more accessible, personalized, and precise. The Company was formed to further develop and commercialize clinical tests by leveraging a proprietary Artificial Intelligence (AI)-driven Integrated Genetic-Epigenetic Engine (“Core Technology”) for cardiovascular disease to become one of the leading medical technology companies for improving prevention, detection, and treatment of cardiovascular disease. Certain statements and information included in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. When used in this press release, the words or phrases “will”, "will likely result," "expected to," "will continue," "anticipated," "estimate," "projected," "intend," “goal,” or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to certain risks, known and unknown, and uncertainties, many of which are beyond the control of the Company. Such uncertainties and risks include but are not limited to, our ability to successfully execute our growth strategy, changes in laws or regulations, economic conditions, dependence on management, dilution to stockholders, lack of capital, the effects of rapid growth upon the Company and the ability of management to effectively respond to the growth and demand for products and services of the Company, newly developing technologies, the Company’s ability to compete, regulatory matters, protection of technology, the effects of competition and the ability of the Company to obtain future financing. An extensive list of factors that can affect future results are discussed in the Current Report on Form 10-K for the period ended December 31, 2022 and Form 10-Q for the period ended March 31, 2023, under the heading “Risk Factors” in Part I, Item IA thereof, and other documents filed from time to time with the Securities and Exchange Commission. Such factors could materially adversely affect the Company's financial performance and could cause the Company's actual results for future periods to differ materially from any opinions or statements expressed within this press release. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Investor Relations +1 855-226-9991 investors@cardiodiagnosticsinc.com Company Website http://www.cardiodiagnosticsinc.com/

November 20, 2023 09:00 AM Eastern Standard Time

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AGC Biologics to Prepare Late Phase and Commercial Runs for Immunocore

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new late-stage clinical and process performance qualification (PPQ) project at its Heidelberg, Germany site with Immunocore Holdings Plc (Nasdaq: IMCR). Immunocore intends to use the Heidelberg site to complete late-stage manufacturing and prepare for commercialization for IMC-F106C, Immunocore’s PRAME-targeted bispecific therapy. Under the agreement, AGC Biologics will leverage its microbial fermentation and manufacturing experience to perform bench-scale qualification and process characterization, and other required studies to support phase III manufacturing, as well as PPQ runs. Pending a successful PPQ campaign and regulatory approvals, the Immunocore project is expected to move into commercial stages at the AGC Biologics Heidelberg site. This is the next step in the partnership for this candidate between the two companies, with AGC Biologics providing early-phase support for this same project. Immunocore and AGC Biologics previously worked together on commercial manufacturing readiness for KIMMTRAK® (tebentafusp-tebn) at the CDMO’s Copenhagen site. “This is a great example of the power of the AGC Biologics network and our ability to collaborate at our global sites to support important client projects,” said Dieter Kramer, General Manager, AGC Biologics Heidelberg. “I am extremely proud of our team here in Heidelberg and the work they’ve done to support this project. We are pleased Immunocore has agreed to work with us on these next important steps in their product’s lifecycle, as our team has the late-stage and commercial expertise to deliver what is needed.” AGC Biologics runs multiple cGMP microbial fermentation lines at its Heidelberg facility. The AGC Biologics Heidelberg site has produced biologics products for 40 years and has built a track record for navigating clients through the early clinical phases and into later stages to help prepare for commercial production. In addition to fermentation, the site serves as a center of excellence for plasmid DNA (pDNA) and messenger RNA (mRNA). To learn more about AGC Biologics’ microbial system-based biologics, plasmid DNA (pDNA) and messenger RNA (mRNA) manufacturing site in Heidelberg, visit www.agcbio.com/facilities/heidelberg. For more information on the company’s Protein Biologics, pDNA, Cell Therapy, Viral Vector and mRNA drug product services go to 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 and we currently employ more than 2,500 employees 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 the partner of choice. To learn more, visit www.agcbio.com. Contact Details AGC Biologics Nick McDonald +1 425-419-3555 nmcdonald@agcbio.com

November 20, 2023 05:08 AM Eastern Standard Time

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Breaking ground in vision restoration: Kiora Pharmaceuticals reveals promising results with KIO-301

Kiora Pharmaceuticals

Kiora Pharmaceuticals CEO Brian Strem joined Steve Darling from Proactive to share news the company's plan to broaden the clinical development of KIO-301, a treatment designed for various inherited retinal diseases. The expansion includes initiating a Phase 2 trial which will be controlled, double-masked, randomized, and will involve an ascending dose. This trial is set to include up to 20 patients suffering from Retinitis Pigmentosa (RP), who will receive doses monthly over a span of 90 days. Strem explained that this move is propelled by encouraging topline results from a Phase I/II clinical trial, which indicated that KIO-301 is a first-in-class small molecule with significant potential to improve vision for patients with RP, even those with extremely low vision or complete blindness. Moreover, Kiora Pharmaceuticals has plans to engage with the FDA in the fourth quarter of 2023. The goal of this meeting is to achieve consensus regarding the study designs, endpoints, and additional requirements necessary to conduct further studies in the United States and Europe. These studies would not only target RP but also extend to other inherited retinal diseases such as Choroideremia (CHM) and Stargardt disease. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:54 PM Eastern Standard Time

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MTL Cannabis road to success is based on flower first philosophy

MTL Cannabis

MTL Cannabis CEO Mike Perron joined Steve Darling from Proactive to to discuss the ethos and operations of their family-founded company, which places a high value on the quality and potential of the cannabis plant. The company's focus is primarily on flower-based products, including dry flower and pre-rolls. However, Perron notes that they are also venturing into hash production, leveraging their in-house knowledge and capabilities to broaden their product portfolio. Perron highlighted to Proactive the significant growth MTL Cannabis has experienced, attributing it to organic business development strategies. Remarkably, until January last year, the company's sales efforts were spearheaded by a single, highly dedicated sales representative. This individual not only worked with provincial boards but also took personal initiatives to promote the brand to dispensaries and budtenders during weekends. Furthermore, Perron provided insights into MTL Cannabis’s agreement with Canada House Wellness Group, a company deeply rooted in clinics and medical cannabis, originally established by veterans for veterans. The veteran community constitutes a crucial segment of their business, accounting for about 96% of their medical cannabis sales. Canada House operates 12 clinics across the country, including virtual ones, with a strategic presence near military bases to best serve the veteran population. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:44 PM Eastern Standard Time

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Medicus Pharma sees appointment of Dr Huma Qamar as key to company’s future

Medicus Pharma

In an exclusive interview with Dr Huma Qamar, chief scientific officer for Medicus Pharma Ltd, exciting developments in skincare and oncology are discussed. Dr Qamar shares her passion for addressing unmet medical needs, particularly in the field of basal cell carcinoma. The focus is on SkinJet, a flagship company acquired by Medicus Pharma, utilizing revolutionary microarray needles. The needles, transdermally delivering the chemotherapeutic agent doxorubicin, show promising data in preventing relapse and remission of basal cell carcinoma. Looking ahead, Dr Qamar outlines the company's goals for 2024, emphasizing the resumption of clinical development activities and recruitment efforts. The aim is to complete the phase two trial and present promising data. Dr Qamar, driven by a dedication to oncology and patient well-being, discusses the emotional impact of cancer and the hope that Medicus Pharma's contributions will bring positive changes to the lives of patients. Contact Details Proactive Investors +1 604-688-8158 na-editorial@proactiveinvestors.com

November 17, 2023 01:21 PM Eastern Standard Time

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Xeris Biopharma CEO unveils game-changing drug innovations and record financial success

Xeris Biopharma Holdings

Xeris Biopharma CEO Paul Edick joined Steve Darling from Proactive to share insights on the company's focus on innovative drug formulation technology after reporting strong third-quarter results. With three growing products addressing severe hypoglycemia, Cushing's Syndrome, and periodic peripheral paralysis, the company's core lies in commercial success. Edick discussed a promising drug in development—levothyroxine—in a once-weekly subcutaneous injection format, targeting consistency and reduced side effects. Despite being in phase two, the drug could revolutionize current prescription norms. Additionally, partnerships with industry giants like Regeneron and Amgen are underway, emphasizing Xeris' position as a formulation leader. Financially robust, Xeris reported a record quarter and anticipates cash flow breakeven by the fourth quarter. Edick affirmed the company's self-sustainability and projected ending 2024 with ample cash. Despite market challenges, Xeris' growth and strategic focus signal confidence in its trajectory, positioning it as a force in biopharmaceutical innovation. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

November 17, 2023 01:07 PM Eastern Standard Time

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Arecor Therapeutics takes major step with first commercial sale of AT220

Arecor Therapeutics PLC

Arecor Therapeutics PLC CEO Sarah Howell speaks to Thomas Warner from Proactive after the biopharmaceutical group announced the first commercial sale of a product that incorporates its proprietary Arestat technology, known as AT220. Part of a licence agreement with an unnamed global pharma partner initiated in 2017, the milestone has triggered a payment to Arecor. It will also receive royalties on sales. Howell explains the significance of the news, emphasising its importance for patients and the business. She says the achievement aligns with Arecor's vision of building a large, self-sustaining biopharmaceutical company focused on improving patient care. While the partner involved in this achievement remains undisclosed, Howell shed light on Arecor's appeal to pharmaceutical collaborators and says the Arestat technology enables the company to enhance biosimilar products, providing more benefits to patients and giving partners a competitive edge in a high-value market. She says the financial impact is significant, with the milestone triggering licensed payments and initiating recurring royalty streams for Arecor. As the year approaches its end, Howell hints at potential updates. The partnered portfolio shows promising progress, with recent announcements of licensed milestones and positive developments in clinical studies. Ongoing partnerships with pharmaceutical and biotech companies are expected to expand, contributing to Arecor's growth. The company is actively developing its proprietary products, focusing on specialty hospital medications and diabetes treatments. One of their lead diabetes products, AT278, targets patients with high insulin needs, presenting a disruptive solution in a growing market segment. Results from the clinical study are anticipated in Q1 2024. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

November 17, 2023 12:47 PM Eastern Standard Time

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