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ArisGlobal Reports | Newest Version of LifeSphere® Regulatory Platform Launches

ArisGlobal, an innovative technology company at the forefront of life sciences and creator of LifeSphere®, today announced the launch of its new LifeSphere® Regulatory platform, a unified platform for end-to-end regulatory affairs management. The platform simplifies and reinvents the regulatory workflow processes, allowing organizations to improve visibility and data quality.

The new LifeSphere Regulatory Platform ecosystem of products includes:

  • Regulatory Information Management (RIM) – Increases data quality, global oversight, and control with robust capabilities for product information management, regulatory planning, tracking, and data management.
  • Products Compliance – Manages medicinal product data submissions through submission, post-submission, and post-approval according to the IDMP requirements and operating model.
  • Documents – Establishes a single content repository for seamless document and content management, including template management, workflows, advanced rendering, and permissions.
  • Submission Management & Publishing– Consolidates submissions and publishing workflows in a single solution that makes it simple to create, compile, and publish submissions in any format.
  • Labeling – Drives greater efficiency and consistency by streamlining end-to-end labeling change management and compliance tracking workflows.
  • Regulatory Analytics – Leverages preconfigured sets of standard dashboards and reports addressing common regulatory tracking, reporting, and analytical needs.

Industry leaders utilizing LifeSphere Regulatory can further power the platforms’ capabilities with LifeSphere NavaX, ArisGlobal’s next-generation cognitive computing engine, to leverage the latest GenAI and LLM features.

Today, early adopters can leverage GenAI and LLM enhancements that are driving upwards of 50% efficiency gains, including:

  • Health Authority Interactions – Accelerate the intake of Health Authority (HA) communications and drive transparency and consistency in HA interactions.
  • Regulatory Intelligence – Monitor for regulatory updates and build an intelligence knowledgebase to facilitate up-to-date compliance amid changing regulations.

In 2023, ArisGlobal launched LifeSphere NavaX, which is now able to power LifeSphere Regulatory for GenAI functionality today – and for future roadmap use cases.

Commenting on the launch, Ann-Marie Orange, CIO & Global Head of R&D shares,

“With more than 35 years of experience in life sciences technology, ArisGlobal is the only technology company offering strong Safety, Regulatory, and Quality Management solutions powered with next-generation cognitive computing, delivering unmatched interoperability across the R&D IT ecosystem. Over the last 18 months ArisGlobal has made significant investment in the strategic acquisitions of Amplexor Life Sciences and SPORIFY, along with technology R&D – and we’re not stopping.”

She continues, “For current LifeSphere Regulatory customers, the new platform will provide an enhanced experience and the ability to deploy the latest technologies, all with simple migration. For organizations looking to drive ROI with a new technology approach to Regulatory Affairs, LifeSphere Regulatory is the most advanced option and a real game-changer for this industry. The enhanced platform truly revolutionizes critical Regulatory processes and drives better outcomes for life sciences organizations by readying organizations for GenAI and LLM use cases — we’re thrilled to relaunch LifeSphere Regulatory to the market.”

ArisGlobal, with a series of new product innovations, is the first life sciences R&D technology company to unveil targeted solutions that make impactful use of GenAI in the industry. The company continues to host the industry-leading GenAI Council, convening top pharmaceutical executives, academia, and AI thought leaders to further fuel adoption of next-generation technologies across life sciences.

 

Valencia Technologies Announces CMS Publication of 2025 Medicare Proposed Rule for eCoin® Procedure

Valencia Technologies Corporation announced today that the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), published the 2025 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule with information relevant to the eCoin® system procedure. The technology is a pioneering, leadless implantable tibial nerve stimulation (ITNS) system for treating urgency urinary incontinence (UUI).

In the Proposed Rule issued Wednesday, July 10, 2024, CMS defined that the existing Category III CPT code 0816T, which describes the eCoin ITNS procedure, will remain assigned to Hospital Outpatient Prospective Payment System Ambulatory Payment Classification (APC) 5464 for Calendar Year 2025, with a proposed unadjusted national average payment rate of US$21,063, as referenced in the Addendums A and B of the Proposed Rule.

Notably, due to the efforts of the Valencia Technologies Reimbursement Team in their dialogue with CMS, a favorable adjustment to the CY 2024 Ambulatory Surgical Center (ASC) payment rate was achieved. The proposed national unadjusted ASC payment rate for CY2025 for code 0816T is $19,464, representing a 38% increase over the CY2024 rate of $14,122.

The eCoin System is the first and only US Food and Drug Administration (FDA) PMA approved implantable medical device to target the tibial nerve for the treatment of urgency urinary incontinence.

Ann Decker, VP of Reimbursement for Valencia Technologies, stated, “The cumulative effect of the proposed 2025 continuation of APC assignment 5464, the improved ASC payment rate, and the recognition of ITNS as a minimally invasive OAB treatment option in the recently updated guidelines by the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), underscores that the eCoin ITNS system will have a strong reimbursement pathway throughout 2025 and beyond. I could not be prouder of the diligence and tenacity of the Valencia Team in building a robust, sustainable reimbursement foundation that will allow more patients suffering from UUI to access our innovative technology. Our efforts are focused on ensuring patient access to the eCoin ITNS system to find relief from their symptoms.”

The eCoin device is a coin-sized neurostimulator implanted subcutaneously in the lower leg during a minimally invasive, outpatient procedure utilizing local anesthetic. The eCoin device contains a primary battery and once activated, automatically delivers intermittent stimulation to the tibial nerve twice weekly to reduce UUI symptoms without requiring the need for patient management. The procedure is less invasive than traditional sacral neuromodulation surgery for treating UUI, which typically requires a multi-phase approach, the need for sedation or general anesthesia, and patient management of an external remote and possibly other recharging components.

The eCoin system received FDA premarket approval (PMA) in the USA in March 2022 and is currently available throughout the United States.

Physicians interested in offering eCoin ITNS therapy may register for the eCoin Physician Qualification training program using the eCoin physician website at professionals.eCoin.us. Patients are encouraged to visit Valencia’s patient website at www.eCoin.us for more information about this novel therapy for UUI.

Phage-Derived Enzyme Targets E. faecalis Biofilms to Mitigate Acute Graft-Versus-Host Disease

Acute Graft-Versus-Host Disease

Acute graft-versus-host disease (aGVHD) is a medical condition that occurs when donor immune cells attack the recipient’s tissues after an allogeneic hematopoietic stem cell transplantation (allo-HCT). The pathogenesis of aGVHD is influenced by gut dysbiosis and Enterococcus domination. Researchers from Japan recently identified a bacteriophage-derived enzyme called endolysin capable of targeting biofilms formed by Enterococcus faecalis. Their findings offer hope for tailored interventions in allo-HCT.

Allogenic haematopoietic cell transplantation (allo-HCT) involves transferring healthy donor stem cells to recipients with conditions like blood cancer, bone marrow failure, or certain genetic blood disorders. Acute graft-versus-host disease (aGVHD) is a common complication, where the donor’s immune cells attack the recipient’s tissues. Recent studies highlight the significant role of the microbiome in aGVHD, with dysbiosis contributing to its pathogenesis. Dysbiosis can lead to the emergence of pathogenic commensal bacteria including Enterococcus species, particularly E. faecalis and E. faecium, which are associated with multidrug-resistant infections in allo-HCT patients. However, there is a lack of effective therapies specifically tailored to treat dysbiosis in the context of aGVHD.

To address this gap, a multidisciplinary team led by Associate Professor Kosuke Fujimoto from Osaka Metropolitan University and The University of Tokyo, alongside Professor Seiya Imoto from The University of Tokyo, and Satoshi Uematsu from Osaka Metropolitan University and The University of Tokyo, conducted an in-depth analysis of the intestinal bacteriome of allo-HCT patients. The study aimed to investigate the prevalence and implications of Enterococcus domination in this specific patient population. Their findings, published on July 10, 2024, in the journal Nature, shed light on crucial aspects of gut microbiota dynamics in the context of allo-HCT.

Explaining the motivation behind the present research, Fujimoto says,

“During dysbiosis, some symbiotic commensal bacteria acquire pathogenic characteristics, proliferate, and become directly involved in the onset and progression of the disease. Recognizing the specificity of phage therapy and its ability to spare beneficial bacteria from adverse effects, we focused our research on phage-derived lytic enzymes.”

The team initiated their investigation by examining the intestinal microbiome of allo-HCT patients, where they noted a predominance of Enterococcus species, particularly E. faecalis. This was notably associated with acute leukemia. Despite being sensitive to several antibiotics, E. faecalis strains possessed cytolysin-associated genes, indicating high virulence. Further exploration through metagenomic analysis revealed the presence of genetic signatures associated with biofilm formation. They then proceeded with whole-genome sequencing of E. faecalis. This unveiled the presence of an intriguing bacteriophage-derived enzyme known as endolysin, exhibiting potent antibacterial activity specifically targeting E. faecalis.

Fujimoto and his team conducted rigorous in-vitro and in-vivo assays to confirm the efficacy of the endolysin. They found that it exhibited narrow-spectrum activity against E. faecalis and effectively lysed biofilms. Notably, the endolysin’s lytic activity did not affect other intestinal bacteria species. In mouse models, the efficacy of the endolysin was assessed in two experiments. Firstly, mice with induced aGVHD were treated with the endolysin, resulting in a significant reduction of E. faecalis colonization in faeces and suppression of aGVHD development. In the second experiment, mice with a gut microbiota resembling that of humans, dominated by Enterococcus bacteria, were treated with the endolysin, leading to decreased Enterococcus levels and improved survival rates.

“Bacteriophage research is gaining momentum, with advancements in phage therapy paving the way for new treatments. Our discovery of the endolysin enzyme holds promise for future applications in preventing or treating acute GVHD,” says Fujimoto, expressing his optimism regarding the potential impact and real-life applications of the research work.

Thanks to the research team for the identification of endolysin from bacteriophage, a new class of therapeutic compounds targeting highly resistant, biofilm-forming bacteria is now possible!

Check out this YouTube link for a visual explanation of the research here:

Josh Smale Appointed VP of Global Clinical and Scientific Affairs at R3 Vascular

Josh Smale

R3 Vascular Inc., a medical device company dedicated to developing and providing novel, best-in-class bioresorbable scaffolds for treating peripheral arterial disease (PAD), is pleased to announce the appointment of Josh Smale as its Vice President of Global Clinical and Scientific Affairs.

Prior to joining R3 Vascular, Johsh Smale served as Vice President of Clinical Affairs for the Peripheral Intervention business unit of Becton Dickinson (BD) where he was responsible for all aspects of clinical evidence generation and dissemination for the company’s complex and diverse device portfolio.  Prior to his tenure at BD, Smale served in roles of increasing responsibility for Bard Peripheral Vascular, Inc. (BPV) which was acquired by BD, and as Regulatory Affairs Manager for SenoRX, Inc. which was acquired by BPV.  He also served as Regulatory Affairs Manager for Endologix, Inc. and in various roles at BPV.  Josh Smale holds a Bachelor of Science in Engineering with an emphasis on Molecular and Cellular Engineering, and Biochemical Engineering from Arizona State University.  He also served on the board of the Peripheral Intervention business unit of BD, has received numerous awards, is the co-author of several publications, and holds five Vena Cava Filter patents.

Commenting on the appointment of Mr. Josh Smale, Christopher M. Ownes, President and CEO of R3 Vascular said, “On behalf of the R3 management team, I am very pleased to welcome Josh Smale as Vice President of Global Clinical and Scientific Affairs.  Josh has a proven track record and more than 20 years of relevant medical device experience specializing in clinical and regulatory affairs strategy, clinical evidence generation and dissemination, and physician education.  Among other key clinical and scientific affairs programs, Josh will lead our clinical trial efforts, including our pivotal ELITE trial for our next generation Magnitude drug eluting bioresorbable scaffold.  We look forward to his contributions as we work towards establishing R3 Vascular as the leader in the development and manufacturing of fully bioresorbable vascular scaffolds.”

Mr. Smale said, “I am very excited to join R3 Vascular and work closely with Chris Owens, Kamal Ramzipoor, and the rest of the R3 Vascular team to build upon the success of the company and support the adoption of its breakthrough technology for treating below-the-knee peripheral arterial disease (BTK PAD).  R3 Vascular’s novel next generation bioresorbable scaffolds will transform the field of peripheral interventions by providing a new standard of care and improving the health of patients around the world.”

Mr. Smale joins R3 Vascular’s leadership team which, among others, includes Christopher M. Owens, President and Chief Executive Officer and Kamal Ramzipoor, R3 Vascular’s Founder and Chief Technology Officer (CTO).  In May of 2024, R3 Vascular announced the closing of its $87 million Series B financing round.

Arnold Magnetic Technologies Highlights Custom Electromagnetic Capabilities for Medical Applications

Arnold Magnetic Technologies Corporation (Arnold), a subsidiary of Compass Diversified (NYSE: CODI) and leading global manufacturer of high-performance magnets and precision thin metals, highlights its custom electromagnetics used in medical applications. By providing critical components for oncology equipment, Arnold’s electromagnets (also known as solenoids) save lives and provide the flexibility needed in generating magnetic fields so necessary for critical waveguide applications.

Arnold manufactures a wide variety of custom electromagnets that generate uniform or proportioned magnetic field shapes and with a wide range of magnetic field intensities. These electromagnets are either made up of tape wound foil wafers or built up from coils of wire.

All Arnold tape wound electromagnets feature coils that are electrically controlled to the precise field strength desired. Depending upon specific requirements, magnetic field distribution may be uniform, or it may have peaks, plateaus, and valleys along the axial length of the electromagnet, Shaped field electromagnets can be custom-designed to specific configurations with great precision. Coils may be of various widths within the electromagnet and they can be made interchangeable.

Customers can select nominal ID and OD to meet application size requirements. Also available are special designs that use chilled oil or liquid nitrogen to allow higher than normal current, generating up to 200 percent greater field intensity than an uncooled design.

How Often Should Nurses Update Their Skills?

Nurses Update Their Skills

If you’re wondering how often nurses should update their skills, the answer is: constantly.

The benefits of continuing professional development (CPD) in nursing are vast – from keeping your finger on the pulse to staying abreast of advances in your industry, and also, ensuring your professional skillset stays fresh and relevant – the question should not be how often, but how to most effectively work on continually updating your nursing skills.

Let us take you through it.

The Benefit of Continuing Professional Development: Lifelong Learning & Upskilling

As a nurse, you must constantly build on your professional knowledge and expertise. Continuing professional development (CPD) is an integral part of this, and is instrumental in:

Broadening Your Knowledge of the Nursing Profession

Completing advanced studies in nursing can enable nurses to expand their existing knowledge of their profession and the industry. CPD can open doors to new opportunities for nurses, and inspire them to pursue advanced areas of practice – such as becoming a highly-paid family nurse practitioner (FNP), adult-gerontology nurse practitioner (AGNP), or psychiatric mental health nurse practitioner (PMHNP) – just to name a few examples. As well as improving career prospects and enhancing salary prospects, CPD in nursing facilitates a nurse’s ability to reach their full career potential.

Refreshing and Maintaining Your Existing Professional Skillset

CPD allows nurses to maintain competence in their profession. It enables them to refresh, perfect, and nurture their existing skills, while also ensuring they stay up-to-date on current and emerging best nursing practices. In an industry where it pays to stay informed, CPD is not only beneficial, it’s essential. To carry out best practices and ensure the optimal safety and care of patients, nurses’ skills need constant maintenance and refinement to remain fine-tuned, fresh, and on point – regardless of how many years of experience they have had on the job. Indeed, it could be argued that older nurses in particular can benefit from CPD the most – to ensure consistent reinforcement of their lifelong skills and knowledge.

Staying Up-to-date with Industry Advancements

In a fast-paced, ever-changing professional environment, keeping abreast of advances in the nursing industry is vital. With advancements in patient care, healthcare technology, and even AI, rendering older skills and practices virtually obsolete, it’s essential to stay up-to-date. AI in nursing in particular is an emerging concept that nurses must now familiarize themselves with. As the development of artificial intelligence-based technology and its benefits to the healthcare sector is becoming increasingly thrust into the limelight, nurses need to embrace the AI revolution and ensure they are informed about its application in their field.

How to Upskill: Pursuing Higher Education & Advanced Nursing Qualifications

CPD has many benefits for nursing, but not least, is the enhanced career prospects it can provide. In pursuing CPD as a nurse, completing DNP online programs can facilitate your pathway toward becoming an advanced nursing practitioner (APRN) in one of the following areas of advanced nursing specialization, for example:

Nurse Practitioner (NP)

Nurse Practitioner is an umbrella term that encapsulates a variety of different specialized nursing professions, including:

  • Family Nurse Practitioner
  • Adult-Gerontology Nurse Practitioner
  • Emergency or Critical Care Nurse Practitioner
  • Pediatric Nurse Practitioner
  • Oncology Nurse Practitioner
  • Neonatal Nurse Practitioner
  • Psychiatric Mental Health Nurse Practitioner

Clinical Nurse Specialist (CNS)

Another form of APRN, instead of delivering patient care and treatment, clinical nurse specialists focus more specifically on conducting medical research. In this sense, the role is more administrative and predominantly focused on nursing education.

Certified Nurse Midwife (CNM)

A CNM specializes in the areas of gynecology and reproductive care and treating women from all walks of life. They will also deliver prenatal, pregnancy, and postpartum care.

Certified Registered Nurse Anesthetist (CRNA)

A CRNA is a type of APRN whose main focus is to administer anesthesia and other medications. They are most often situated in surgical environments, as well as hospitals.

Are you still wondering how often a nurse should update their skills? As discussed today, continual learning and improvement is the only way a nurse can keep their professional skillset fresh, relevant, and up-to-date.

The best part? Continuing professional development (CPD) has many advantages for nurses. Namely, being able to broaden their professional horizons while refreshing their existing skills, and also, staying abreast of industry advancements.

 

FDA Approves Roche’s Vabysmo Prefilled Syringe for 3 Leading Causes of Vision Loss

Vabysmo Prefilled Syringe

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect close to 80 million people globally.1-4 The Vabysmo PFS will become available to United States (US) retina specialists and their patients in the coming months.

“We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, which are some of the leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”

Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial.5

Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in nAMD, DME and RVO.5-13 Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.14

To date, Vabysmo is approved in more than 95 countries for nAMD and DME, and in several countries, including the US and Japan, for RVO.5,7,15-18 Review by other health authorities across the globe is ongoing. More than four million doses of Vabysmo have been distributed globally since its initial US approval in 2022.18

About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.5-7 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.6,19 Vabysmo is approved in more than 95 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema and in several countries, including the US and Japan, for retinal vein occlusion.5,7,15-19 Review by other regulatory authorities is ongoing.

About Roche in ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes gene therapies and treatments across multiple vision-threatening conditions, including diabetic eye diseases, geographic atrophy and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.

Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant was approved by the United States Food and Drug Administration in 2021.20 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.5-7,19 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.21

References
[1] Bright Focus Foundation. Age-related macular degeneration: facts & figures. [Internet; cited July 2024]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
[2] Im JHB, et al. Prevalence of diabetic macular edema (DME) based on optical coherence tomography in people with diabetes: a systematic review and meta-analysis. Surv Ophthalmol. 2022 Jul-Aug;67(4):1244-1251.
[3] The Lancet. Diabetes: a defining disease of the 21st century. Lancet. 2023 Jun 24;401(10394):2087.
[4] Song P, et al. Global epidemiology of retinal vein occlusion (RVO): a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019 Jun;9(1):010427.
[5] United States Food and Drug Administration (U.S. FDA). Highlights of prescribing information, Vabysmo. 2022. [Internet; cited July 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
[6] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular macular degeneration (nAMD) (TENAYA and LUCERNE): two randomised, double-masked, Phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.
[7] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited July 2024]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[8] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with nAMD (TENAYA). [Internet; cited July 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT03823287.
[9] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with nAMD (LUCERNE). [Internet; cited July 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT03823300.
[10] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with DME (YOSEMITE). [Internet; cited July 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT03622580.
[11] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with DME (RHINE). [Internet; cited July 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT03622593.
[12]Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to branch RVO (BALATON). [Internet; cited July 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740905.
[13] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in participants with macular edema secondary to central retinal or hemi RVO (COMINO). [Internet; cited July 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04740931.
[14] United States National Institutes of Health – National Eye Institute. Macular edema. 2023. [Internet; cited July 2024]. Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.
[15] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited July 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[16] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited July 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[17] European Medicines Agency. Summary of product characteristics, Vabysmo. 2022. [Internet; cited July 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[18] Roche data on file.
[19] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): two randomised, double-masked, Phase III trials. The Lancet. 2022; 399:741-755.
[20] U.S. FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited July 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[21] U.S. FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited July 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.

Long-time Collaborators Botond Roska and José-Alain Sahel Win the Wolf Prize 2024 in the Field of Medicine

Long-time Collaborators Botond Roska and José-Alain Sahel Win the Wolf Prize 2024 in the Field of Medicine

Botond Roska and José-Alain Sahel have been awarded the Wolf Prize in Medicine for their pioneering work on restoring vision to blind patients using optogenetic therapy.

The Wolf Prize, considered one of the most prestigious international awards, recognizes outstanding achievements in various fields including medicine.

Botond Roska, Director at the Institute of Molecular and Clinical Ophthalmology Basel (IOB) and Professor at the University of Basel, and Sahel, Chair of Ophthalmology at the University of Pittsburgh School of Medicine and Chair of IOB’s Scientific Advisory Board, have collaborated since 2001. Their work focuses on optogenetic vision restoration, a technique that creates light-sensitive cells using genes derived from algae, to treat degenerative retinal diseases.

In 2021, they reported groundbreaking results from an early-stage clinical trial with blind retinitis pigmentosa patients. One patient who completed the full study protocol was able to detect and move objects placed before him within months of treatment. This work, which was done in collaboration with researchers from the Institut de la Vision in Paris, marked the first proof-of-concept for optogenetics in human disease. Despite initial scepticism, Roska and Sahel persevered, recognizing the potential of optogenetics for treating retinal diseases due to its mutation-independent approach and the accessibility of the eye’s optical system.

The collaboration between Roska, a basic scientist with an MD, and Sahel, an accomplished clinician and expert in translational research, has proven highly complementary. Their work represents a significant milestone in treating blinding conditions affecting millions worldwide, with promising results emerging from ongoing clinical trials. The Wolf Prize in Medicine acknowledges their exceptional contributions to the field of ophthalmology.

Medsenic, a Subsidiary of BioSenic SA, Extends Key Patent to the United States

BioSenic (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell repair therapy, today announces the filing of the continuation patent application US 18/763,376 with the United States Patent & Trademark Office (USPTO) to provide protection for the use of arsenic trioxide (ATO) for the prevention and treatment of sepsis syndrome.

The patent application seeks to cover the use of Medsenic’s ATO platform, to prevent or alleviate the cytokine storm associated with systemic infections of various origins but sharing a common set of key symptoms (such as persistent hypotension, hyperthermia or hypothermia, leukocytosis or leukopenia, and thrombocytopenia) with dramatic short-term health consequences. Similar protection may lead to the filing of further specific divisional applications, in particular at the European Patent Office (EPO).

The ever-growing intellectual property portfolio is part of a strategy to build strong and meaningful protection around its lead product, ATO, paving the way for clinical and commercial development by the company and its partners, particularly in the field of autoimmunity.

The new patent, now being extended by Medsenic in the USA, covers two main areas of immediate application. The first is in immune- and autoimmune-related diseases – specifically BioSenic’s current lead project, chronic GvHD, and later systemic sclerosis and systemic lupus erythematosus. The second is oncology, where ATO has already demonstrated exceptional results in patients, including complete remissions in acute promyelocytic leukaemia. The growing patent family will support Medsenic/BioSenic’s plans for international clinical trials in pathologies with unmet medical needs. The company’s long-term goal is to seek market access approvals for its various formulations, optimizing the original properties of arsenic salts, alone or in combination.

François Rieger, PhD, Chairman and CEO of BioSenic said: “The current effort to improve the field of indications and a broader intellectual property for the use of original formulations and composition of matter related to the extraordinary properties of arsenic salts should give a dramatic impetus to the clinical and commercial development of the company. Arsenic salts are now found to exhibit critical and very original biological properties that should help provide new ways to treat diseases of the immune system and, further, cancer conditions with no effective medical treatment. It is of great interest that pharmacological formulations containing arsenic salts are often found to redirect organisms towards normal functioning of various cells and organs and restore homeostasis. We are delighted to be opening new chapters in the continuing global effort to control chronic or fatal diseases for which there is no real cure.”

The expected availability of both an intravenous and an oral formulation combining arsenic and copper puts BioSenic in a unique position to build on preclinical successes in chosen areas of applications. Medsenic/BioSenic should be able to continue a successful clinical development involving proprietary original formulations with arsenic and new active ingredients such as metal ions- increasing the efficacy of its products and minimizing side effects.

Medsenic’s worldwide patent family already includes a patent granted by the European Union Intellectual Property Office (EP3972613) in April 2023, and others by the China National Intellectual Property Administration in August 2023, by the Australian Patent Office in December 2023 and by Canada in January 2024 (3,138,472).

The Role of Enterprise Search Software in Accessing Knowledge Bases

Enterprise Search Software: In today’s frenetic business atmosphere, having quick access to reliable data is vital. A significant amount of company data exists in knowledge bases, which are now essential business tools. However, locating and efficiently using this data can be hard. This is where work search software transforms interactions with knowledge bases.

Knowledge base software acts as a central storehouse for information. It has been created to handle, organize, and preserve knowledge within the business for easy access by customers, employees, and partners. These systems are often used for corporate records, training materials, and assistance to clients.

Software known as “enterprise search software” helps users locate data spread throughout company repositories, including knowledge bases, CRM systems, and content management systems. This program looks similar to web search engines like Google and Bing, but rather than obtaining search results from the Internet, it uses internal company data sources.

How Does Software for Enterprise Search Operate?

According to an expert investigator, enterprise search completely searches a company’s many data sources, including its website, knowledge base, intranet, and help center. To ensure a smooth flow of data to the necessary parties, the entire process is divided into three crucial steps:

1. Exploration

A business search engine utilizes a crawling robot to search through indexes and websites to find data during the exploration or collecting phase. Next, this robot takes the data so that it can index and organize it for later, simple searching.

2. Indexing 

After being built, the company’s crawling robot arranges the data into indexes. Every time you search for something, it’s simple to find the data thanks to this categorization. To enhance search effectiveness and relevancy, this process includes gathering information and extracting metadata. Also, you can use connectors or APIs to customize this procedure. By speeding up the process of syncing data from the source to the platform, these solutions maximize accessibility and ease of use of data.

3. Querying 

After being indexed, the material is made visible to users. Therefore, upon inputting a search query, the search engine examines its indexes for relevant matches. As a result, workers can search for data, files, and documents, with results tailored based on their level of exposure.

Benefits of Using Business Search Software

Here are some benefits of using business search software:

  • Enhanced Accessibility of Data 

The capacity of enterprise search software to increase access to information is one of its main advantages. No matter where information is retained, users may quickly and easily access it because it integrates with multiple data sources and a uniform search engine. As a result, the workflow becomes more efficient as less time is wasted looking for data.

  • Simplified Process 

Enterprise search software streamlines workflow by enabling data retrieval. Users can do a single search to find the information they need rather than sifting through multiple knowledge bases and data sources. In addition to saving time, this easy search process reduces users’ cognitive load and frees them up to spend their time on other, more essential duties.

  • Enhanced Productivity and Efficiency 

Employee productivity and efficiency rise when they can locate information quickly thanks to workplace search instruments. Employee presentation and results increase when they devote less time to probing for information and more time to their main tasks.

  • Improving Decision-Making 

Having a source of accurate and relevant data helps better decision-making. Decision-makers may act swiftly and confidently by having the data they require at their fingertips by using enterprise search software.

  • Enhanced Cooperation 

Through the promotion of information sharing and access, enterprise search software improves teamwork. A unification search interface that enables individuals from many groups to find and use the same data fosters improved collaboration within the organization.

Features of Enterprise Search Software 

Even if there are lots of providers selling business search technology, they all need to have certain features.

  • Links and Integrations
  • Access controls
  • Security and Privacy
  • Artificial Intelligence

Conclusion

Companies’ search tools considerably promote effective entry into and use of knowledge bases. It improves data accessibility, expedites workflows, and strengthens search capabilities by integrating with knowledge-base apps. Enterprise search has a bright future in front of it thanks to advancements in AI and machine learning, which will only expand existing remarkable capabilities.

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