April Hall

Members of the GRI Bio, Inc. management team discuss the encouraging preclinical data that was recently presented and #whatthismeans for its #IPF program and #SLE development programs. https://lnkd.in/eDa8WtjJ #NKT # IdiopathicPulmonaryFibrosis #SystemicLupusErythematosus

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This is for our research integrity/security clients: This is a valid concern if Congress has not appropriately received an objective balance of information and data from SMEs in foreign research collaboration. Our executives have over the years been engaged and active with various working groups and have provided congressional testimony in foreign research threats to ensure equitable and unbiased information was at lawmakers' disposal for responsible and informed decision-making. #Texasoversight #researchsecurity# #researchintegrity #researchcompliance

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CytoAgents is an innovative, clinical-stage biotech company focused on bringing to market novel treatments for Cytokine Release Syndrome (CRS), an overreaction of the immune system. CytoAgents' solution targets cytokines specifically active in CRS, allowing treatment without disrupting normal immune system mechanisms. Learn more about CytoAgents and CRS here: https://cytoagents.com/ #cytoinereleasesyndrome #crs #cytokines Teresa Whalen, RPh

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InnaRx to Present Positive Phase 2 Data on MY008211A in Poster Presentation at the 66th ASH Annual Meeting & Exposition Gaithersburg, M.D., Oct 25, 2024— InnaRx, a clinical-stage biotechnology company specializing in oral modulators targeting innate immunity pathways, today announced an upcoming poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7–10, 2024, in San Diego, CA. This poster presentation will feature findings from a Phase 2 dose-finding study of MY008211A, an investigational oral complement factor B inhibitor, in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) experiencing active hemolysis. A Phase 2 Dose-Finding Trial of MY008211A in Complement Inhibitor–Naive Patients with Paroxysmal Nocturnal Hemoglobinuria and Signs of Active Hemolysis (Abstract #2701) Session Name: 508. Bone Marrow Failure: Acquired: Poster II Session Date: Sunday, December 8, 2024 Presentation Time: 6:00 PM - 8:00 PM PT Location: San Diego Convention Center, Halls G-H This Phase 2, multicenter, open-label study evaluated three dosing regimens of MY008211A in complement inhibitor–naive patients with PNH, a life-threatening blood disorder characterized by red blood cell destruction, blood clots, and bone marrow failure. Over the 12-week study period, all 34 patients achieved the primary endpoint—an increase in hemoglobin (Hb) concentration of ≥20 g/L from baseline—while also demonstrating significant control over hemolysis and improvements in patient-reported fatigue levels. MY008211A was well tolerated across all dosing regimens, with no treatment-related serious adverse events and only mild to moderate side effects, supporting its potential as a new treatment option for PNH. "We are excited to share these promising results with the hematology community at ASH," said Wilson Wang, VP of corporate development. "The success in our proof-of-concept study in PNH demonstrated MY008’s broad potential as a proven innate immunity modulator for complement-mediated autoimmune diseases.” InnaRx invites attendees at the ASH Annual Meeting to visit the poster session to discuss these findings and learn more about MY008’s development. About InnaRx InnaRx is a clinical-stage biotechnology company developing best-in-class oral modulators targeting innate immunity pathways for immunological and inflammatory (I&I) diseases. InnaRx’s innovative approach to immune modulation offers new options for managing complex and rare immunological conditions, with proof-of-concept demonstrated in clinical studies.

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"Q. How has the use of alternatives assessment in industry changed, how is it being used now, and what would help increase its uptake? A. It has grown, but it varies with different product sectors. Earlier on there was a lot more adoption within textiles and electronics. But now we’re talking to a much broader range of companies, and we’ve started to engage more with large retailers. For example, we’ve been working with Nike for a long time. We work with their innovation team so that they can screen all of their new materials, and that’s been a really great partnership. We’ve been able to go to the Nike offices a few times and provide trainings. They use our tools to look at their supply chain as well..." Ahead of next week's 28th Annual Green Chemistry & Engineering Conference, ACS Green Chemistry Institute interviews our Enhesa Sustainable Chemistry Director of Toxicology, Colleen McLoughlin, Ph.D.,DABT, E.R.T. on Advancing Alternatives Assessment Read the full Q&A >> https://lnkd.in/djBnuAcf

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On April 25, 1953, James Watson, Francis Crick, Maurice Wilkins, and Rosalind Franklin published papers describing the double helix structure of DNA. This discovery was groundbreaking because it provided crucial insights into how genetic information is stored and transmitted, laying the foundation for modern molecular biology. DNA Day serves as an opportunity to recognize and celebrate landmark achievements in Molecular Biology and to promote awareness and education about the importance of DNA in science, medicine, and society. #WorldDNADay #DNA #biotechnology #molecularbiology #lifesciences

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CRS3123 is a small molecule protein synthesis inhibitor that acts on the novel target methionyl-tRNA synthetase (MetRS). CRS3123 has numerous potential advantages over current CDI therapies. Learn more about C. difficile Infection (CDI) and the Phase 2 study of CRS3123 here: https://bit.ly/3zhg5Kb

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CRS3123 is a small molecule protein synthesis inhibitor that acts on the novel target methionyl-tRNA synthetase (MetRS). CRS3123 has numerous potential advantages over current CDI therapies. Learn more about C. difficile Infection (CDI) and the Phase 2 study of CRS3123 here: https://bit.ly/3zhg5Kb

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We at the American Pharmacogenomics Association have recently come across a post, authored by Josiah Allen, who seems to be representing CPIC and PGRN, raising concerns about our organization and its mission. We take these matters seriously and want to provide clarity on the points mentioned. Transparency and Expertise The APGxA was founded by a group of passionate individuals with personal experience in pharmacogenomics and a strong belief in its potential to improve patient care. I, myself, have Multiple Sclerosis, and it helped me enough in my battle to want to help others. We acknowledge that building trust within the established PGx community takes time. We are actively seeking collaborations with experts in the field to enhance our content and educational offerings. Content Development We utilize various methods to create informative content, including a team of writers who leverage AI for efficiency and comprehensiveness. However, the accuracy and evidence-based nature of our content remains paramount. We have subject matter experts review all AI-generated content to ensure it aligns with current scientific understanding. Membership and Marketing APGxA offers a membership program with valuable benefits for individuals interested in PGx. The "membership representative" position was designed to expand our reach and connect with potential members. We believe a commission-based structure can incentivize effective outreach while ensuring fiscal responsibility. When and why did that become a negative thing? APGxA is currently undergoing the process of obtaining 501(c)3 non-profit designation from the IRS, and that has been told to Mr. Allen when he inquired. We are transparent about our status and will provide updates as we progress. With that said, starting this has been very expensive and we have funded it ALL ourselves, simply with the mission to increase awareness of PGx. There is absolutely no profit gained to date. Shared Goals We understand the concern about misinformation in the PGx field. APGxA is committed to providing accurate and up-to-date information to empower patients and healthcare providers. We believe collaboration is key to achieving this goal. We welcome open communication with established organizations like CPIC, PharmGKB, and PGRN to explore potential partnerships. We have reached out to them all, on numerous occasions, asking for collaboration to further the industry as a whole. To date, we still have not had the courtesy of a reply. We believe a strong PGx community requires diverse voices. APGxA is committed to ethical practices, evidence-based content, and collaboration for the advancement of this important field. We have said over and over that our goal is to fill the gaps. We have not harmed you nor been unkind to you, it’s unclear why you and the organizations you represent feel the need to bully. We encourage anyone with further questions or suggestions to reach out to us directly.

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On January 8, 2025, Avidity Biosciences, Inc. announced its progress and planning for a transformational year in 2025. #DuchenneNews Major anticipated milestones include executing on three potentially registrational programs, filing a Biologics License Application for delpacibart zotadirsen (del-zota) for people living with Duchenne mutations amenable to exon 44 skipping (DMD44), preparing for multiple product launches in DMD44, myotonic dystrophy type 1 (DM1) and facioscapulohumeral muscular dystrophy (FSHD) and building a global, fully integrated company to support a growing AOC pipeline in neuromuscular diseases and precision cardiology. Full press release: https://bit.ly/40hG1RF

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The PP2A regulatory subunit PPP2R2A controls NAD+ biosynthesis to regulate T cell subset differentiation in systemic autoimmunity #CellReports https://hubs.li/Q02JFXwm0

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For anyone building diagnostics: Very cool approach to gain valuable insights into FDA decision summaries. Brendan O'Leary scraped the FDA’s decision summaries and provided some simple R code for anyone to get up and running in no time to prod and probe those summaries. Very nice work!

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Kevin King, BioIVT’s Senior Director of #Donor Center Strategy and Growth will be providing his industry insight and expertise by moderating a roundtable session at the 2nd Annual Donor Selection & Source Summit today entitled “Mitigating Risks in #CellandGeneTherapy: Re-evaluating Donor Selection and Characterizing Cellular Starting Material". The discussion will include topics like: • Establishing industry standard criteria for donor eligibility and implementation of advanced screening technologies. • Characterization of cellular properties and standardized assays to assess donor derived cell quality and function. As experts in providing RUO & GMP cellular starting and ancillary materials for the manufacture of #AdvancedTherapies, our aim is to foster collaboration between stakeholders to share needs as well as provide input on implementing risk mitigation strategies and foresight for sourcing donor-derived cellular starting material. Make sure to connect with Kevin and Lisa Kretzschmar, MBA if you will be at the event. If you are not attending the event, you can contact our experts here: https://hubs.ly/Q02Ywbkk0 Or view a recording of one of our previous expert roundtables here: https://hubs.ly/Q02Yw96w0 And access other insightful reference materials here: https://hubs.ly/Q02Ywf510) #CellTherapy #GeneTherapy #ATMPs

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This article appeared today in Feedstuffs. It reviews the results of a collaborative study between MBFT and Dr. Maricarmen Garcia at the University of Georgia using our T-Max vaccine platform. Funding for the study of this prototype vaccine for prevention of ILTV infection in hatchling chickens was provided by a grant from the US Egg and Poultry Foundation. Based on positive initial results, we are continuing this work with Dr. Garcia to make further improvements prior to commercial development. As you are aware, our goal is to set a new standard for animal health vaccines that are both safe and broadly protective. This is a challenging goal but one we believe that we can achieve. 

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ISBER 2024 Best Paper Award Webinar: Quality Measures of Stored Breast Cancer TMAs ISBER is pleased to feature the winner of the 2024 Best Paper Award in Biopreservation and Biobanking through this webinar. This award recognizes a most impactful paper that was published in Biopreservation and Biobanking each year. Selection of the Best Paper Award is based on qualities including both originality/novelty of the research and its potential applications in biopreservation and biobanking fields, ranging from biobanking governance, operation, management, cryobiology, cryopreservation, cold chain, ethical/legal/social issues, to biospecimen science and quality control. At the end of this presentation, the learner will be able to: 1. Understand the impact of poor storage of TMAs 2. Understand that water is a primary driver of TMA degradation 3. Failure to appreciate the risk of degradation can result in errors in evaluation of biomarkers 4. Some biomarkers are more subject to degradation than others When: Wednesday, August 7th       9:00 AM - 10:00 AM Pacific Discover the paper being featured in this webinar! Quality Assessment of Proteins and RNA Following Storage in Archival Formalin-Fixed Paraffin-Embedded Human Breast Cancer Tissue Microarray Sections Kyungeun Kim, Kris Ylaya, Candice Perry, Mi-Yeon Lee, Jeong Won Kim, Joon-Yong Chung, and Stephen M. Hewitt https://lnkd.in/ea279MeZ

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Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference   • Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) • Results consistent with those shown in earlier human volunteer studies and Phase 2a studies • Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated  • Actinobacteria and Bacteroides preservation also confirmed using quantitative analysis   https://lnkd.in/eseFt8GZ   #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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