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Tonix Pharmaceuticals releases positive results from Proof-Of-Concept Study on TNX-102 SL

Tonix Pharmaceuticals

Tonix Pharmaceuticals CEO Dr Seth Lederman joined Steve Darling from Proactive to share significant news regarding the Phase 2 proof-of-concept PREVAIL study of TNX-102 SL 5.6 mg for the management of fibromyalgia-type Long COVID. Dr Lederman provided an overview of the study's topline results and the implications for future development. Dr Lederman announced that the study showed a robust effect size in improving fatigue, a key symptom of Long COVID. The results also demonstrated consistent activity trending towards improvements across secondary endpoints, including sleep quality, cognitive function, disability, and patient global impression of change. However, Dr Lederman noted that TNX-102 SL did not achieve the pre-specified primary endpoint of improving Long COVID pain intensity scores at Week 14. Despite this, the proposed mechanism of TNX-102 SL, which aims to improve sleep quality, aligns with recent announcements from the National Institutes of Health (NIH) that sleep quality is a target for future clinical trials in Long COVID. Dr Lederman highlighted that there is currently no approved drug for the treatment of Long COVID, making these findings important for potential future treatments. The company's plan is to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the possibility of a Phase 3 program. They intend to propose a primary outcome measure using the PROMIS Fatigue scale, which is widely recognized and validated for assessing fatigue across various conditions. Dr Lederman also told Proactive the company is committed to meeting potential increased demand for its Tosymra nasal spray 10 mg following GlaxoSmithKline’s planned discontinuation of Imitrex nasal spray 5 mg and 20 mg products after January 2024. This move by Tonix is to be ready in case of possible drug shortages for patients who suffer from migraines. Contact Details Proactive Studio +1 347-449-0879

September 19, 2023 01:54 PM Eastern Daylight Time

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PathAI Announces Expansion of BioPharma Lab to Provide End-to-End Central Pathology and Histology Services


PathAI, a global leader in AI-powered pathology, today announced the expansion of its BioPharma Laboratory Services. Capitalizing on the 30-year history of delivering high quality pathology services in the PathAI Diagnostics clinical laboratory (formerly known as Poplar Healthcare), PathAI offers biopharma partners a comprehensive, GCP/GCLP compliant histology and digital pathology lab to support prospective clinical trials across oncology, liver, and gastrointestinal indications. The lab offers pharmaceutical companies access to unparalleled histological laboratory services and comprehensive operational support, encompassing the full end-to-end tissue processing from kitting and logistics management, tissue processing and staining across H&E, IHC, and special stains; local and remote pathology tapping into PathAI’s network of >500 US board-certified pathologists; and AI-driven analysis from PathAI’s menu of algorithms and clinical trial software. This integrated approach enables the streamlined, proficient, and regulatory-compliant implementation of controlled clinical trials, all within a single facility. PathAI’s BioPharma Lab has a unique combination of capabilities to enable clinical trials where pathology-based endpoints, biomarker classification, and/or superior histology quality are critical to the success of their pharma partners. Over the last two years, the company has already supported Phase 2 clinical trials in NASH, IBD, and breast cancer, as well as oncology neoadjuvant trials. Based on successfully meeting key milestones on quality and turnaround times, PathAI is expanding and scaling its services to new trial indications and partners. The lab adheres to all relevant quality, regulatory, and compliance standards including CAP/CLIA and GCP/GCLP. In addition to full laboratory support for clinical trials, PathAI’s BioPharma Lab supports trials through its AI products and expertise with AI-powered endpoint assessment and patient enrollment. “We don’t just create algorithms, we stay in lock step with our pharma partners to ensure our AI products are integrated into trials appropriately, based on regulatory criteria, to enhance trial quality and efficiency,” said Andy Beck, MD, PhD, CEO of PathAI. The BioPharma Lab’s expertise helps reduce the impact of many challenges associated with clinical trials, including unreliable turnaround times, variable histology, stain or scan/digitization quality, and challenging assessment of histological endpoints. In addition, the lab allows pharma partners the ability to use AI without a heavy lift to implement. The lab offers most major types of instrumentation, with flexible workflows across different scanners, stains, and biopsy types, which improves the quality of clinical trials. Importantly, the services include access to PathAI’s extensive network of over 500 US Board Certified pathologists to perform high quality reading with rapid turnaround time in a cost-effective manner. “During my time running translational sciences in a Top 10 pharma company, I witnessed a strong need for high quality, scalable, and flexible pathology services that can further be combined with the state-of-the-art technology in digital pathology and AI,” said Mike Montalto, PhD, Chief Scientific Officer, of PathAI. “We took a pharma-first approach when establishing this lab and its offerings.” The BioPharma Lab will physically expand in 2024 to allow an increase in sample throughput to accommodate larger scale global phase 3 studies, as well as additional equipment to support a wider range of clinical studies. Learn more about how PathAI’s BioPharma Lab can power your next clinical trial by contacting or visiting PathAI will be at several upcoming conferences with representatives available to speak about the lab’s capabilities, including ESMO, SCOPE Europe (booth #4), and SCOPE Orlando (booth #206). 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 diagnostic 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 patient samples to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. PathAI, which is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN, is proud to have a team of 600+ innovative thinkers from around the globe. For more information, please visit Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 Company Website

September 19, 2023 10:00 AM Eastern Daylight Time

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One Year Into Kabir Nath’s Leadership, Compass Pathways’ (NASDAQ: CMPS) Phase 3 Trial For Innovative Treatment Resistant Depression Progressing

COMPASS Pathways

By Faith Ashmore, Benzinga Treatment-resistant depression, also referred to as TRD, is a subset of depression that poses significant challenges for clinicians, patients and those closest to patients. It is characterized by persistent symptoms of depression that do not respond adequately to at least two different standard antidepressant treatments. This debilitating condition often leaves individuals grappling with feelings of despair, hopelessness and a diminished quality of life. Unlike some forms of depression that may improve with pharmacological interventions or talk therapies, TRD tends to persist, leading to a multitude of negative consequences. The unyielding nature of this condition can contribute to increased rates of disability, higher suicide risk and significant financial burden due to the need for repeated treatments. Psilocybin treatment is emerging as a potentially effective approach to the treatment of TRD. Although further research is still needed to establish its efficacy and safety, initial findings are promising. While there are a number of companies developing psilocybin treatments, Compass Pathways (NASDAQ: CMPS) is setting itself apart from its contemporaries with its phase 3 program in TRD. The company’s innovative approach has received FDA Breakthrough Therapy designation in the U.S. and Innovative Licensing and Access Pathway designation in the U.K. for their investigational COMP360 psilocybin. Moreover, in late 2021, Compass Pathways announced the completion of a randomized, controlled double-blind phase 2b study of COMP360 psilocybin treatment involving 233 patients with TRD in 22 sites across Europe and North America. In August of 2022, Compass Pathways brought on Kabir Nath as CEO to help navigate its transition from a start-up to an established phase 3 biopharma company. Nath is a seasoned healthcare executive with over two decades of experience leading global pharmaceutical companies. He has held several leadership positions at multinational corporations, including Bristol Meyers Squibb (NYSE: BMS), GlaxoSmithKline (NYSE: GSK) and Otsuka Pharmaceutical (OTCMKTS: OTSKY). Nath has a track record of success in developing new products and creating commercial strategies to make medicines available to patients on a global scale. He is skilled in identifying unmet patient needs and working collaboratively with stakeholders to develop targeted and effective treatment options. He also has considerable experience in psychiatric drug development. Under Nath’s leadership, Compass Pathways has made significant progress in advancing the development of its investigational drug, COMP360 psilocybin. One notable accomplishment was the initiation of their phase 3 clinical trials, which are pivotal in determining the safety and efficacy of the treatment. These trials consist of two key studies: Pivotal Trial 1 (COMP005) and Pivotal Trial 2 (COMP006). COMP005 is studying a single dose (25mg) of COMP360 psilocybin as monotherapy, comparing it with a placebo. The aim of this trial is to replicate the positive treatment response observed in the company’s phase 2b study, which included 233 patients with treatment-resistant depression. COMP006 is a fixed repeat dose monotherapy study that examines the effects of three different dose arms: 25mg, 10mg and 1mg. The objective of this trial is to investigate whether a second dose can enhance the number of responders and further improve the response observed in the phase 2b study. Additionally, this trial explores the potential for a meaningful treatment response from the repeat administration of COMP360 10mg. Both pivotal trials have the change from baseline in MADRS (Montgomery-Åsberg Depression Rating Scale) total score at week six as their primary endpoint. This measure allows researchers to evaluate the effectiveness of COMP360 psilocybin in reducing depressive symptoms compared to baseline. In addition to driving the company forward into phase 3, Nath has supported the development of the company’s digital platforms that accompany its psilocybin treatment, has led a successful private placement fundraising that extends the company’s runway into late 2025, and claims to have one of the most talented and experienced leadership team among psychedelic companies in the space. Nath's global experience in the pharmaceutical industry and his expertise in developing and commercializing treatments for unmet needs uniquely position him to lead Compass Pathways toward the successful development and commercialization of their investigational drug COMP360 psilocybin, subject to FDA approval. Company BioCOMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomised, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also conducting phase 2 clinical studies of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD) and anorexia nervosa. COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. This post contains sponsored content. This content is for informational purposes only and not intended to be investing advice. Contact Details Stephen Schultz

September 19, 2023 09:25 AM Eastern Daylight Time

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Genflow Biosciences CEO says human healthspan has not kept up with lifespan

Genflow Biosciences PLC

Genflow Biosciences PLC (LSE:GENF) CEO Dr. Eric Leire speaks to Thomas Warner from Proactive about the gene therapy company's work in the field of extending human longevity. He notes that the amazing advances made in advancing human lifespans over the last century have not been matched by a similar increase in people's healthspans, with many people spending the second half of their life plagued with various debilitating illnesses and conditions. "The purpose of our company is to increase the healthspan, that's the primary objective. If we can also increase the lifespan, fine... so we are a longevity company that's trying to extend healthspan and secondly maybe lifespan." The company's central asset is a centenarian version of the sirtuin six gene, which plays a crucial role in aging. They've identified a rare mutation of this gene found exclusively in centenarians, offering a promising avenue for intervention. Genflow's approach is supported by a strong team and close collaboration with a distinguished Scientific Advisory Board. He goes on to explain how Genflow Biosciences is going about its mission, revealing its most promising leads, before concluding by saying who else in the sector he admires. Contact Details Proactive UK Ltd +44 20 7989 0813

September 19, 2023 03:00 AM Eastern Daylight Time

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Avricore Health announces HealthTab now supporting first Rexall Pharmacy walk-in clinic

Avricore Health

Avricore Health CEO Hector Bremner joined Steve Darling from Proactive to share news regarding the company's flagship health-data management platform, HealthTab. The company has made a significant move by partnering with Rexall Pharmacy, one of Canada's largest pharmacy retailers, to integrate HealthTab into its walk-in clinic services. Bremner revealed that patients can now access testing through HealthTab at the first Rexall Pharmacy Walk-In Clinic located in Sherwood Park, Alberta. This collaboration enables HealthTab to offer both the Afinion 2™ blood-chemistry analyzer and the ID Now™ molecular platform by Abbott Rapid Diagnostics. This means that patients can receive rapid test results and immediate consultation with their pharmacist, facilitating timely healthcare interventions. HealthTab has played a crucial role in the last year by assisting pharmacists in screening patients for diabetes and cardiovascular conditions, as well as supporting those already diagnosed in better managing their health. With Rexall Pharmacy joining the HealthTab network, patients now have more accessible care options, empowering them to make meaningful and impactful changes to their health. This partnership underscores Avricore Health's commitment to leveraging technology to improve access to healthcare services, particularly within the pharmacy setting. The integration of HealthTab into Rexall Pharmacy's walk-in clinics not only enhances patient convenience but also contributes to early detection and management of health conditions, aligning with the broader goal of improving healthcare outcomes in Canada. Contact Details Proactive Studio +1 347-449-0879

September 18, 2023 02:03 PM Eastern Daylight Time

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Perimeter Medical Imaging new CEO makes key improvements in personnel and technology

Perimeter Medical Imaging AI

Perimeter Medical Imaging CEO Adrian Mendes joined Steve Darling from Proactive to discuss the strategic developments and innovations the company has undertaken since his appointment as CEO. Mendes highlighted several key initiatives aimed at driving Perimeter's growth and advancing its technology in the medical field. One notable addition to the team is Adam Hodges, a seasoned medtech sales executive with over 20 years of experience. Hodges has taken on the crucial role of overseeing the strategy and execution of sales-related goals, bringing valuable expertise to the company's efforts. Another significant advancement Mendes shared is the enhancement of Perimeter's AI capabilities. This involves leveraging additional training data and the latest AI advancements to improve the sensitivity, specificity, precision, and recall of their ImgAssist AI technology. This updated version is expected to significantly enhance the accuracy of image classification, reducing the incidence of false positives and negatives. Moreover, Mendes touched upon the positive interactions with the FDA in relation to the clinical development program for Perimeter's B-Series OCT medical imaging technology with ImgAssist AI. This collaborative engagement with regulatory authorities reflects the company's commitment to advancing its next-gen AI technology, ultimately aimed at improving clinical and economic outcomes in the field of breast surgical oncology. Contact Details Proactive Investors +1 604-688-8158

September 18, 2023 01:58 PM Eastern Daylight Time

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Futura Medical "on track for a profit in 2025" after strong first half

Futura Medical PLC

Futura Medical PLC (AIM:FUM, OTC:FAMDF) CEO James Barder speaks to Thomas Warner from Proactive London after the pharmaceutical company announced its interim results for the six months to 30 June 2023. Barder gives an overview of what he describes as a "pretty tremendous 2023 for Futura so far", highlighting the progress made in multiple markets with the company's topical erectile dysfunction treatment MED3000. He starts with a look at the enormously prospective US market where Futura secured both FDA approval for the product as well as a distribution deal with Haleon, who are responsible for the future launch and ongoing regulatory, development, marketing, and commercialisation of MED3000 in the USA. Barder also talks about the strides the company made in Europe during the first half and noted minimal complaints with over 200,000 packs sold. Financially, the company reported £1.7 million in revenue and a gross profit of £900,000, with Barder saying that he expects Futura to reach breakeven in 2024 and "is on track for a profit by 2025". Barder acknowledged the importance of production expansion to meet rising demand and highlighted efforts to strengthen distribution networks, particularly in Asia. Contact Details Proactive UK Ltd +44 20 7989 0813

September 18, 2023 11:20 AM Eastern Daylight Time

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September is Cholesterol Education Month


September is Cholesterol Education Month and for people with unsafe levels of high LDL (bad) cholesterol, there are many options in the treatment toolbox. Recently, Preventive Cardiologist Dr. Seth Baum participated in a nationwide satellite media tour to discuss high LDL cholesterol, best treatment options, and tips for patients navigating challenges with their health coverage. A video accompanying this announcement is available at: Heart disease remains the leading cause of death in the United States and LDL-cholesterol, what we call the “bad” cholesterol, is a major risk factor which can lead to a heart attack or a stroke. While many can lower their LDL cholesterol with a heart healthy diet, some will need medication to reach their Safe Zone. Statins are often the first-line of treatment for individuals with high LDL cholesterol, not all patients reach their recommended LDL cholesterol levels with statins alone. In these cases, lipid-lowering medications, known as PCSK9 inhibitors, are often recommended to help lower cholesterol levels. Unfortunately, individuals who are prescribed PCSK9 inhibitors are facing significant hurdles in accessing and using these potentially life-saving drugs, despite their proven efficacy in reducing LDL cholesterol. One major obstacle is insurance company denials or rejections. Data published in the November 2022 Journal of the American Medical Association found that for commercially insured patients prescribed a PCSK9 inhibitor, only 42% of initial rejections were overturned. Sadly, nearly 75% of patients rejected for a PCSK9 inhibitor ended up on no therapy, which is not a win for anyone. Research from the Family Heart Foundation shows that compared to individuals who were able to obtain their prescribed PCSK9 inhibitor, those whose prescription was rejected or abandoned experienced more heart attacks, strokes, and other cardiovascular events within 12 months. For more information and resources that can help, visit About Seth Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC Dr. Seth J. Baum is Chief Scientific Officer at Flourish Research, and clinical affiliate professor of Cardiology at FAU Medical School. He actively consults in Clinical Lipidology and Cardiovascular Disease Prevention and continues to offer lipoprotein apheresis for patients in southeast and central Florida. Dr. Baum has practiced Preventive Cardiology and Clinical Lipidology since 2000. He is a fellow of the American College of Cardiology, the American Heart Association, the American College of Preventive Medicine, the National Lipid Association, and the American Society for Preventive Cardiology. Dr. Baum is a past President of the American Society for Preventive Cardiology (ASPC). He currently serves on both the ASPC and Family Heart Foundation Advisory Boards. He has published over 100 peer reviewed papers and abstracts as well as two books. In 2013, he was awarded Cleveland Heart Lab’s “Heart Award” for lifelong dedication to Preventive Medicine. In 2019, Dr. Baum received Mended Hearts’ biennial Dwight Emary Harken Award. Dr. Baum is the Founder of Excel Medical Clinical Trials, LLC, a consortium of clinicians dedicated to the safe and professional conduct of high-level scientific trials. He has served as Principal Investigator in over 100 clinical trials covering a broad range of disease states. Dr. Baum is the Chief Scientific Officer of Flourish Research, a leading national clinical research company. Dr. Baum is a graduate of Columbia College and Columbia College of Physicians and Surgeons, and completed training in Internal Medicine, Cardiology, Interventional Cardiology, and Electrophysiology Contact Details YourUpdateTV +1 212-736-2727

September 18, 2023 10:27 AM Eastern Daylight Time

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Arecor Therapeutics expecting a busy end to the year after solid first half progress

Arecor Therapeutics PLC

Arecor Therapeutics PLC (AIM:AREC) CEO Sarah Howell speaks to Thomas Warner from Proactive after the globally-focused biopharmaceutical group released its interim results for the six months to 30 June 2023. Howell gives an overview of recent progress, highlighting the initiation of the second Phase One clinical study for their concentrated rapid-acting insulin, with positive recruitment in type 2 diabetes patients. She also highlights fruitful partnerships, such as the one with Hikma, which obtained FDA confirmation for an accelerated regulatory pathway during the reporting period. Arecor's acquisition of Tetris Pharma led to successful commercialisation of their lead product, Ogluo, for severe hypoglycemia. Looking ahead, Arecor anticipates passing some significant milestones, including the launch of a biosimilar product and pivotal study progress for a partner's novel medicine. She says she's expecting "A busy end to the year and its really testament to the great work of Arecor and the team there and also the support from our shareholders and investors that we're very grateful for." Howell attributes the company's achievements to a dedicated team and supportive investors. Contact Details Proactive UK Ltd +44 20 7989 0813

September 18, 2023 09:13 AM Eastern Daylight Time

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