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NAVEX 2024 Global Incident Management Benchmark Study Reveals Significant Third-Party Reporting to Companies

NAVEX Global

NAVEX, the global leader in integrated risk and compliance management software, has released its 2024 Whistleblowing & Incident Management Benchmark Report. The annual benchmark report offers valuable insights into workplace culture, analyzing trends from 1.86 million global reports spanning thousands of organizations that together employ more than 50 million employees. Amid a record number of tips to the SEC and a burgeoning DOJ whistleblowing program, NAVEX’s comprehensive analysis sheds a critical light on the state of workplace environments worldwide, guiding organizations toward program improvement. "NAVEX remains the gold standard in risk and compliance data analytics, continually innovating our benchmarks to enhance corporate compliance programs and offer business leaders insights into the trending risk areas for their organizations," says NAVEX Chief Risk and Compliance Officer Carrie Penman. "This year's report introduces crucial third-party reporting insights, highlighting an organization’s need to adopt internal and external reporting avenues to bolster integrity, foster accountability and equip the organization to tackle emerging challenges effectively.” This year’s analysis of the data revealed several key themes and notable findings, including: Report volume and case substantiation reach milestones. Internal reporting programs saw a record level of use as measured by NAVEX’s Reports per 100 Employees metric. In addition, the Substantiation Rate metric reached an all-time high, meaning more reports were received and more were found to be true. Report volume, and the substantiation rates of the reports received, are two of the most highly watched metrics in the annual NAVEX publication. To see both reach the highest levels ever is good news. For those with trusted and effective internal reporting programs, this added up to greater visibility into the trends of risk, ethics and culture playing out in their organizations’ operations – real-time intelligence to inform business decision-making. In 2023, organizations received a median 1.57 Reports per 100 Employees across their internal reporting systems, exceeding the previous record of 1.47 set in 2022. More organizations (23%) received five or more Reports per 100 Employees, making this population the largest in the NAVEX data set. And while year-over-year values fluctuated, every size of organization – from the smallest companies to enterprises with over 100,000 employees – has seen report volumes rise comparing 2021 and 2023. At 45%, the overall median share of substantiated or founded reports in 2023 reached an 11-year high. Third parties more likely to report business integrity and financial misconduct issues. In a first for this report, NAVEX analyzed its database by both employees and third-party reporters. Its analysis shows these two groups are distinct across several metrics, highlighting the insight organizations see by promoting their reporting programs internally and externally. Third parties as a group delivered a far greater median share of reports related to Business Integrity matters than employees in 2023 (50% versus 17%). Encompassing topics like conflicts of interest, vendor issues, fraud, global trade and human rights, this category of issues can manifest in various elements of a supply chain. Third-party reporters also showed twice the median share of Accounting, Auditing & Financial Reporting reports as employees in 2023 (10% versus 4.5%). Story emerging on accounting-related reporting – internally and externally. Accounting-related reports -- while lower in overall percentage of reports received internally by organizations at a median of 4.3.% in 2023 -- often receive an outsized share of attention due to potential for regulatory action and the well-publicized bounty program offered by the SEC and its Office of the Whistleblower. The SEC's program is witnessing unprecedented growth in tips and generously rewarding valuable information. Now, the U.S. Department of Justice is launching a similar initiative. Specifically, reports related to Accounting, Auditing, and Financial reporting: Showed the longest time between when an incident was observed and when it was reported to the organization By a large margin, were least likely to be reported anonymously Comprised an outsized share of cases for organizations that receive very few Reports per 100 Employees – meaning while these organizations received well below the benchmark number of reports, they had a much more significant percentage of accounting-related reports Experienced the longest time to investigate and close the case Had among the highest median Substantiation Rates, at 50% Were most likely to cause an employment separation event as a result of a substantiated case Accounted for twice as many of the reports submitted by third parties than those submitted by employees Small increase in report volume shows big payoff in healthy report mix. A diverse array of topics, inquiries, and allegations in internal reporting indicates a robust program. NAVEX’s findings reveal that even minor efforts to promote internal reporting significantly improve the mix of report types received. For instance, in organizations with the lowest report volume, only 8.7% of reports pertain to HR, Diversity, and Workplace Respect. However, in the next tier, this proportion jumps to 36.3%. This trend persists across different report volumes, emphasizing the importance of fostering a reporting culture. A varied mix of report types signifies trust in internal reporting to address a broad spectrum of issues. Even a slight increase from minimal reporting yields a more comprehensive and insightful flow of reports. "With NAVEX's integrated data platform, companies gain unparalleled risk signal data that empowers them to foster healthier workplace cultures, helping them achieve outcomes that matter most,” explains NAVEX Chief Product Officer A.G. Lambert. "Data isn't just numbers; it's the compass guiding organizations toward success and ensuring they stay ahead in the ever-evolving landscape of risk and compliance." Additional notable findings include: Workplace behaviors and discord were clearly visible in the data as more organizations return to office environments. As is always the case in these reports, workplace behaviors and other human resources related matters are by far the highest percentage of reports received by organizations. Workplace Civility matters continued to increase in prominence in 2023, representing a median of 18% of reports and the highest median reporting rate in 2023. This was followed by Discrimination, at a median 12%, Harassment, at a median 7.1%, then Retaliation at a median of 2.0%. The HR, Diversity and Workplace Respect category overall has seen a multi-year increase in its median share of all reports (from 50% in 2021 to 55% in 2023). These figures underscore the growing importance of fostering a respectful and inclusive work environment. Highlighting the seriousness with which organizations are taking reports received, more substantiated reports (18%) resulted in separation from employment in 2023, up significantly from 14% in 2022 and 12% in 2021. The share of reports resulting in no action – effectively the opposite end of the outcome spectrum – fell from 17% in 2022 to 14% in 2023. Nearly nine out of 10 reports of Imminent Threat to a Person, Animals or Property were substantiated in 2023 highlighting the importance that reporters possess the training, knowledge, tools and trust that promote rapid reporting of dangerous issues. This need is made even greater by a new California workplace violence prevention law expected to take effect this year that includes requirements for reporting, incident management and training around this issue. For more insights on the 2024 Whistleblowing & Incident Management Benchmark Report, join Jane Norberg, Arnold & Porter partner and former chief of the SEC Office of the Whistleblower, Keith Thomas, FedEx corporate integrity & compliance lead counsel, Carrie Penman, NAVEX chief risk & compliance officer, and Anders Olsen, NAVEX senior data scientist, for an informative webinar where they will discuss the results of this year’s analysis in detail. Watch the webinar here. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Navex Global scott.levesque@navex.com Company Website https://navex.com

March 26, 2024 06:00 AM Eastern Daylight Time

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An Inherited Condition Could be the Cause of Your Early Heart Disease or Stroke, But Your Doctor is Probably Not Testing for It

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/Y_mu9ZpIO88 Heart disease is still the single biggest threat to American health today. Family Heart Foundation research shows that less than 5% of Americans are being screened for the most common, life-threatening genetic condition that causes early strokes and heart attacks – elevated Lipoprotein(a) or Lp(a) for short. Elevated lipoprotein(a) is the most common genetic cause of early heart disease and stroke. One in 5 people worldwide have inherited high Lp(a), and most don’t know it. You inherit your Lp(a) level from your parents. Because elevated Lp(a) isn’t screened for, the first sign of this condition may be a stroke or a heart attack. Elevated levels of Lp(a) increases the risk of blood clotting and plaque buildup inside the blood vessels, which can block the flow of blood and oxygen to your heart and brain. Compared to the general population, people with elevated Lp(a) have 2-3 times the risk for a heart attack and stroke at a young age. The higher your Lp(a), the higher your risk. Lp(a) is not measured in the standard cholesterol panel. It’s important to understand if you have elevated Lp(a). Multiple therapies are in development but in the meantime, there are things you can do to manage your other cardiovascular risk factors, such as keeping your LDL cholesterol levels very low. The Family Heart Foundation can help you find a healthcare provider near you and connect you to others living with elevated Lp(a). The Family Heart Foundation is the only patient-centered, research and advocacy organization focused on addressing the lack of screening and care for people born and living with this common life-threatening condition. On March 20 th a nationwide media tour was conducted featuring Dr. Amit Khera, Professor and Director of Preventive Cardiology UT Southwestern Medical Center and Misty Votaw. Topics they discussed included: Who should have their Lp(a) measured and when. Misty’s story and how the Family Heart Foundation provided resources. If you have elevated Lp(a), what can you do to reduce your risk of heart disease and stroke. What the Family Heart Foundation is doing to address gaps in care for 60 million Americans at risk. For more information and to find out if you have elevated Lp(a), contact the Family Heart Foundation’s Care Navigation team at FindLpa.org. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

March 25, 2024 01:13 PM Eastern Daylight Time

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AGC Biologics Strengthens Executive Leadership with Appointment of Dr. Christoph Winterhalter as Chief Business Officer

AGC Biologics

AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the promotion of Dr. Christoph Winterhalter to Chief Business Officer and a new member of the executive leadership team. Winterhalter, who has three decades of experience in the biopharmaceutical industry, will oversee corporate strategy, business development, new business initiatives and global marketing for the AGC Biologics CDMO network. He has a strong track record of success within the Life Science industry, including creating strategies for sustainable and profitable business growth, building and maintaining highly motivated and skilled global teams, leading business development and marketing initiatives and developing strategic partnerships with large pharma and biopharmaceutical companies. Winterhalter previously served as the Senior Vice President Business Development EMEA for AGC Biologics. “Throughout his career, Christoph has developed a unique combination of technical knowledge and the ability to create business growth for life science organizations. I am pleased to appoint him to this new position,” said Patricio Massera, CEO, AGC Biologics. “He is a proven leader with a vision that knows how to create value for our business through corporate development, strategic partnerships, and sales and marketing initiatives. This experience will be crucial for AGC Biologics’ growth, and I am confident he will positively impact our global teams as we strive to achieve our purpose: to bring hope to life by enabling life-changing therapies for patients around the globe.” Winterhalter joined AGC Biologics in 2018 and contributed significantly to the company’s growth over the past six years. Before that, he served as the Senior Vice President of Global Business Development for the CDMO Rentschler Biopharma. Reporting directly to the CEO, he guided the company’s global sales and development strategy and created strategic manufacturing alliances with leading global biopharmaceutical companies. While at Rentschler, he was instrumental in tripling the top-line sales numbers for the company. Before that, Winterhalter worked at Wacker Chemie AG supporting its Life Science businesses for nearly 20 years, most recently serving as Vice President of Biosolutions for the Americas. At Wacker he managed teams focused on Research and Development (R&D), Project Management, GMP Production, Business Development, and Marketing. Winterhalter received a degree in Microbiology and his Doctorate from the Technical University of Munich. "I am enthusiastic to be taking more responsibility with this position at a company dedicated to supporting biopharmaceutical companies developing important treatments to help patients worldwide," said Christoph Winterhalter, CBO, AGC Biologics. "I look forward to partnering with the rest of the executive team, contributing my expertise to advance AGC Biologics’ business goals, and working side-by-side with our partners to bring their innovative biopharmaceuticals all the way to market." To learn more about AGC Biologics and its global CDMO services visit www.agcbio.com. About AGC Biologics: AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan 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 a part of AGC Inc.’s Life Science Company. The Life Science company runs ten different 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/

March 25, 2024 01:09 PM Eastern Daylight Time

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Immunic CMO discusses complexities of multiple sclerosis to mark MS Awareness Month

Immunic Inc

Immunic Inc (NASDAQ:IMUX) Chief Medical Officer Dr Andreas Muehler discusses the complexities of multiple sclerosis (MS) during an interview with Proactive's Stephen Gunnion to mark MS Awareness Month, highlighting the disease's impact, development, and the unmet medical needs of patients. MS, a lifelong autoimmune disease more prevalent in women than men, begins typically in early adulthood. It manifests in various forms, starting with relapsing-remitting MS, characterized by relapses and MRI lesions, affecting 80-85% of patients. Another form, primary progressive MS, occurs in 10-15% of patients, starting with a progressive phase without typical relapses. As the disease advances, Muehler explained that it transitions into secondary progressive MS, marked by a decrease in relapses but an increase in disability, which is a significant concern for patients. Despite the availability of treatments focusing on inflammation, there remains a significant gap in addressing the disability progression, a key area of concern for patients. Muehler introduced Immunic Inc's approach to tackling MS through their drug, vidofludimus calcium (IMU-838), which possesses dual mechanisms: anti-inflammatory and neuroprotective. The neuroprotective aspect, in particular, is believed to address the critical unmet need of slowing disability progression by protecting neurons. This differentiation, especially in progressive MS where current therapies fall short, positions vidofludimus calcium as a promising candidate in the MS treatment landscape. Clinical trials for vidofludimus calcium are underway, with a notable Phase 2 study, CALLIPER, fully enrolled and expected to read out in April 2025. Additionally, Phase 3 studies in relapsing MS are actively recruiting, with outcomes anticipated in 2026. These developments are keenly awaited by the medical community and potential partners, given the drug's potential to significantly impact MS treatment, particularly for forms of the disease currently lacking effective therapies. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 21, 2024 12:14 PM Eastern Daylight Time

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PainChek leads innovation in AI-based pain assessment

PainChek Ltd

PainChek Ltd (ASX:PCK), a medical device company, is pioneering the use of an app, leveraging artificial intelligence (AI) for pain assessment in vulnerable individuals unable to communicate their pain due to conditions such as dementia, cognitive impairments, or in pre-verbal children. In and interview with Proactive's Stephen Gunnion CEO and managing director Philip Daffas highlighted that PainChek's app is the world's first regulatory-cleared medical device for this purpose. It utilises AI for facial analysis to detect nine micro facial features indicative of pain, assisting carers in aged care and hospitals to document and score the severity of pain. PainChek has achieved a first mover advantage with patents in the US, Europe, Japan, and the UK, protecting its technology until 2038. The company has regulatory clearance in Australia, New Zealand, Canada, the UK, the EU, Singapore, and Malaysia, with ongoing clinical studies in the US aimed at FDA clearance. PainChek reported its fifth consecutive quarter of double-digit growth in the December quarter, with 85,000 licences across 1,400 aged care facilities on three continents. With an annual recurring revenue of around $4 million, the company sees a significant growth opportunity in aged care, home care, and the hospital sector. Key milestones for investors include expansion in regulatory-cleared markets, entry into the US market upon FDA clearance, and the launch of an infant app for pain assessment in the home. Contact Details Proactive Australia Pty Ltd Proactive Australia Pty Ltd +61 431 597 771 writers.australia@proactiveinvestors.com

March 21, 2024 12:07 PM Eastern Daylight Time

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Tissue Regenix unveils growth strategy and positive EBITDA milestone

Tissue Regenix Group PLC

Tissue Regenix Group PLC (AIM:TRX) CEO Danny Lee and CFO David Cocke discussed the company's 2023 operational and financial performance in an interview with Proactive's Stephen Gunnion. Tissue Regenix is a global leader in regenerative medicine, focusing on tissue-based scaffold technologies derived from both human and animal tissues. These technologies are critical for regenerative therapies, enhancing the body's natural healing processes across various surgical fields, including orthopaedics, sports medicine, general surgery, urogynecology, and ophthalmology. For the first time, the group reported a positive EBITDA, attributed to a 20% increase in sales revenue, reaching £29.5 million. Growth was primarily driven by the BioRinse and DermaPure divisions, with notable success in specialised bone and birth tissue products, particularly the ConCelltrate product for bone formation and the amniotic membrane product for wound care. The company outlined its strategic focus, known as the "four Ss": Supply, Sales, Revenue, Sustainability, and Scale, which form the foundation of its growth strategy. This strategy is further supported by four growth pillars: expanding the base business, enhancing tissue partnerships, evolving regulatory status to become a device company, and expanding market reach globally. Notably, Tissue Regenix has signed new distribution partnerships in Spain, Australia, and China, with plans to enter additional markets based on strategic opportunities. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

March 21, 2024 11:53 AM Eastern Daylight Time

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Benevolent AI CEO discusses 2023 highlights and 2024 outlook as it pioneers AI in drug discovery

BenevolentAI

BenevolentAI (OTC:BAIVF) CEO Dr Joerg Moeller outlines the company's operational and corporate milestones for 2023, categorising achievements into five key areas: clinic operations, proprietary pipeline progress, platform enhancement, organisational growth, and financial management. Moeller noted that BAI secured a significant deal with Merck KGaA worth up to $594 million for developing three clinical drug candidates in immunology and oncology. Collaborations with AstraZeneca have also advanced, focusing on target selection for diseases such as systemic lupus. Progress was noted in Benevolent AI's proprietary pipeline, especially with a lead asset in ulcerative colitis expected to deliver Phase 1a study data. Additionally, advancements in glioblastoma treatment and ALS research were highlighted. Organisational developments included key executive appointments and an extended financial runway until mid-next year. Moeller underscored the validation of the BAI platform through collaborations with the major pharmaceutical companies, positioning the company as a leader in AI-augmented drug discovery. The imminent release of data for a leading program in ulcerative colitis aims to introduce a new treatment with fewer side effects. For 2024, the company plans to extend its financial runway, forge additional collaborations, and partner on pipeline assets, with expectations for another year of significant achievements. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 21, 2024 11:50 AM Eastern Daylight Time

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Immunic secures key patent, boosting MS drug exclusivity and global IP strategy

Immunic Inc

Immunic Inc CEO Dr Daniel Vitt joins Proactive's Stephen Gunnion with news the company has received a Notice of Allowance from the US Patent and Trademark Office for a new patent application, marking a significant step in the company's intellectual property (IP) strategy. This latest patent is distinct from two others granted last year, focusing on the composition of matter protecting a specific polymorph of vidofludimus calcium. The company aims to ensure broad protection and exclusivity for vidofludimus calcium, especially as it approaches the final development stage. Vitt highlighted Immunic's global patent strategy, aiming to cover all important territories and build multiple protection layers around their inventions. The strategy includes securing patents not only for the medical use of their discoveries but also for the materials themselves. The newly allowed patent extends until 2039, with potential for extension. For the use of vidofludimus calcium in MS, Vitt estimates exclusivity extending into 2041, Vitt estimates exclusivity extending into 2041, ensuring a significant period for exclusive marketing in major markets, particularly the US. Immunic now has eight families of patents in the US, with three major patents granted or allowed in the past three months, significantly enhancing their IP portfolio for vidofludimus calcium. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

March 21, 2024 11:37 AM Eastern Daylight Time

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Quantum Pathology Enhances Digital Pathology Capabilities with the Adoption of PathAI's AISight Image Management System

PathAI

Quantum Pathology, LLC, an independent pathology service provider in the United States, today announced the adoption of the AISight[i] Image Management System, a leading end-to-end workflow and image management solution by PathAI. This strategic decision marks a significant step forward in Quantum Pathology's transition to digital pathology, leveraging the advanced capabilities of AISight to revolutionize its operations. In a rapidly evolving landscape where competition for pathologists and pathology services is intensifying, the integration of digital pathology and artificial intelligence emerges as a crucial differentiator for players in the independent pathology market. After evaluating several image management systems, Quantum Pathology identified the AISight Image Management System as the most compelling solution to streamline its workflow, enhance case prioritization, and facilitate TC/PC use cases. By embracing AISight, Quantum Pathology aims not only to expedite turnaround times for referring physicians but also to harness AI overlays for delivering next-generation insights on patient pathology. "As the demand for pathology services grows, embracing digital pathology and AI-driven solutions becomes imperative for staying ahead. AISight emerged as the frontrunner among image management systems, offering the versatility and robustness needed to manage our caseload effectively as well as the full menu of algorithms we require to drive efficiencies in our workflow both in-house and amongst our professional clients,” said Dr. May Azar, Chief Medical Officer and Medical Director of Quantum Pathology. AISight, a cloud-native intelligent enterprise workflow solution, stands as a cornerstone in the digital pathology ecosystem, trusted by hundreds of pathologists worldwide. Serving as a centralized platform for case management, workload balancing, and image management, AISight integrates best-in-class artificial intelligence tools from PathAI and third-party partners. This comprehensive approach enables Quantum Pathology to address a wide spectrum of histopathology use cases with efficiency and precision. "The adoption of digital pathology represents a pivotal moment in healthcare, and we are witnessing a surge in laboratories embracing innovative image management systems. AISight stands out as a versatile solution that not only delivers high-quality images promptly but also empowers pathologists with a suite of AI algorithms for unparalleled workflow efficiency,” said Eric Walk, MD, FCAP, Chief Medical Officer of PathAI. “We are thrilled to partner with Quantum Pathology and support their journey towards digital transformation." [i] AISight is For Research Use Only. Not for use in diagnostic procedures. About Quantum Pathology Quantum Pathology is an independent, nationally renowned, fully accredited pathology laboratory committed to providing the best in class in patient care, latest technology, turnaround time and customer service. Quantum’s highly trained team of medical professionals and client relations specialists provide fast, accurate, personalized laboratory services, as well as a full range of ancillary support and practice management solutions. About PathAI PathAI is the leading precision pathology company providing software and AI-enabled solutions to all pathologist stakeholders including laboratories, research institutions, and the biopharma industry. Developed with the input of hundreds of pathologists, PathAI’s digital pathology Image Management System, AISight, is the solution of choice for laboratories transitioning to digital workflows. 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 to improve efficiency and accuracy of pathology interpretation, as well as to better gauge therapeutic efficacy and accelerate drug development for complex diseases. For more information, please visit www.pathai.com. ### Contact Details SVM Public Relations and Marketing Communications Maggie Naples +1 401-490-9700 pathai@svmpr.com Company Website https://www.pathai.com/

March 21, 2024 10:00 AM Eastern Daylight Time

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