University of Bath

转自：企业公告 整理：水晶 10月21日，安徽山河药用辅料股份有限公司公告称，10月19日14时许，公司发生一起安全事故，经初步调查，系交联羧甲纤维素钠车间员工清理酒精母液罐罐底浆料时发生意外事故。 事故造成一名员工窒息，送医院抢救无效死亡。事故仍在调查中。 10月21日，安徽山河药用辅料股份有限公司（简称山河药辅）公告称，10月19日14时许，公司“新型药用辅料系列生产基地一期项目”（简称南区）发生一起一般安全事故，经初步调查，系交联羧甲纤维素钠车间员工清理酒精母液罐罐底浆料时发生意外事故。事故造成一名员工窒息，送医院抢救无效死亡。 发生事故车间是位于南区的交联羧甲纤维素钠生产线。产量占公司总体业务比重较小，公司已经责令该车间自查整改，进行全面安全风险隐患排查。 截止本公告披露日，事故仍在调查中。 目前，公司整体系列生产基地和车间生产经营秩序正常。 公开资料显示，山河药辅是专业从事新型药用辅料生产、研发和销售为一体的民营股份制企业，目前在国内药用辅料（固体制剂）行业处于龙头地位。其产品涵盖填充剂、黏合剂、崩解剂、润滑剂、包衣材料等常用口服固体制剂类药用辅料。 2024年药企发生安全事故的还有： 河南沈丘县一药厂突发大火：8月19日晚河南沈丘县一药厂突发大火，火势凶猛，浓烟数公里外可见。附近居民称被巨响震醒。 辽宁锦州九泰药业，2人死亡3人受伤：2024年5月12日0时25分，锦州鑫泰基精细化工有限公司（隶属于锦州九泰药业有限责任公司）A区车间发生安全事故起火。2时33分，现场明火被扑灭，两名被困人员经抢救无效死亡，另有三名伤者在医院接受救治，伤势轻微，无生命危险。 金达威，3人死亡3人受伤：1月11日上午9时许，厦门金达威集团股份有限公司全资子公司厦门金达威维生素有限公司污水处理池空间发生一起闪爆事件。 经初步调查，系金达威维生素在污水处理池上方施工安装遮阳棚过程中突发池内空间可燃气体闪爆，导致污水处理池及上方遮阳棚坍塌，事故造成现场施工人员3人死亡3人受伤送医救治。 印度一家制药厂发生爆炸17人死亡：8月21日，印度安得拉邦一家制药厂当时约有190名工人正在上班，据报道该制药厂一个化学反应装置发生爆炸，附近村庄居民听到巨大爆炸声。事故发生后，数十辆消防车前往灭火，但现场烟雾弥漫，救援行动一度受阻。 巴斯夫德国工厂发生爆炸：7月29日中午12点左右，巴斯夫路德维希港基地南部的一处工厂发生有机溶剂泄漏，随后发生火灾爆炸，爆炸发生后巴斯夫表示，正在通知客户，可以从公司库存中获得产品，产品数量将根据相关法律以公平合理的方式进行分配，截止8月16日，目前已知的受影响产品包括：维生素 A、维生素 E 和类胡萝卜素、DL-薄荷醇等产品。 日本一药企发生火灾：1月9日，当天上午东京板桥区一家药品工厂发生溶剂泄漏并着火。目前已经确认有3人受伤，其中1人伤势严重。 安全无小事，警钟长鸣！！！

DURHAM, N.C., July 16, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company’s Board of Directors. “We are delighted to welcome two distinguished commercialization and health system leaders to the Humacyte Board as we prepare for our planned commercial launch of the Acellular Tissue Engineered Vessel (ATEV™) in the vascular trauma indication,” said Dr. Laura Niklason, Founder, President, and Chief Executive Officer of Humacyte. “John is widely recognized for his leadership at Lilly and brings deep commercialization and brand-development expertise that will be critical to us as we continue our planned transition to commercial operations. Tony has extensive medical expertise and administrative experience from his leadership roles at University of Alabama-Birmingham Health System, which will be a valuable perspective as we prepare to introduce the ATEV into major health systems. We look forward to their contributions as we work toward our anticipated U.S. market launch.” John P. Bamforth, PhD has served as Executive Director of Eshelman Innovation, a translational innovation institute at the University of North Carolina–Chapel Hill, since 2019. Prior to joining Eshelman Innovation, Dr. Bamforth spent 30 years at Eli Lilly and Company (“Lilly”) until his retirement in 2018, in an array of roles primarily focused on brand development and commercialization. In 2012, he was appointed Chief Marketing Officer for Lilly’s multi-billion-dollar U.S. business and in 2016 he became Chief Marketing Officer for Lilly’s global business. In 2017, Dr. Bamforth co-founded the Ciara Arts and Sciences Foundation dedicated to enabling disadvantaged youth to attend college. Dr. Bamforth holds a BPharm from the University of Bath and a Ph.D. and D.Sc. (Hon.) from Aston University in England. Keith Anthony Jones, M.D., has served as the Chief Physician Executive of the University of Alabama at Birmingham (“UAB”) Health System since 2017. Dr. Jones has served as the Maurice S. Albin Professor of Anesthesiology and Perioperative Medicine at the University of Alabama Heersink School of Medicine (“UABHSOM”) since 2019. Since 2017, Dr. Jones has also served as Senior Associate Dean for Clinical Affairs of UABHSOM. Since 2017, Dr. Jones has served as President of the University of Alabama Health Services Foundation, which is the Faculty Practice Plan for UABHSOM and employs approximately 1,400 academic physicians. From 2006 to 2017, Dr. Jones served as Chair of the Department of Anesthesiology and Perioperative Medicine for UABHSOM and Chief of Anesthesiology Services for UAB Hospital. He is a member of the American Society of Anesthesiologists, where he has served on and led numerous committees. Dr. Jones holds a B.S. in Microbiology from the University of Alabama and an M.D. from the UABHSOM, and completed his anesthesiology residency and postdoctoral fellowship at the Mayo Graduate School of Medicine. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. As announced previously, based on guidance from the FDA, the proper or generic (non-brand) name "Acellular Tissue Engineered Vessel" (ATEV) replaces the term “Human Acellular Vessel” (HAV) previously used for the engineered vessel product candidate. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. A Biologics License Application is currently under review by the FDA and was granted Priority Review with a PDUFA date of August 10, 2024 for use of the ATEV in the vascular trauma indication. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for peripheral artery disease also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the expected PDUFA date for our ATEV in vascular trauma repair; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of the BVP relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

Funded by a nearly £1.2M (~$1.5M USD) award, this research will enable ongoing validation of AccelADx™, a breakthrough screening test for early detection of Alzheimer's dementia. BELFAST, Northern Ireland and CAMBRIDGE, Mass., July 11, 2024 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, today announced receipt of funding from Innovate UK, the UK's innovation agency, which drives productivity and economic growth by supporting businesses to develop and realise the potential of new ideas. Funded by Innovate UK's Small Business Research Initiative (SBRI), this award is focused on enabling organisations with select novel biomarkers to be evaluated as part of the Global Alzheimer's Platform Foundation (GAP) Bio-Hermes 2 Study. Cumulus will deploy AccelADx in the study, a novel, AI-enabled screening test that detects small, subtle changes in brain waves associated with memory recall. Bio-Hermes 2, which aims to generate data to accelerate the adoption and effective use of biomarkers in the study of Alzheimer's disease, will investigate the relationship of novel biomarkers to the current gold standard diagnosis across an ethnically diverse population of 1,000 participants in the United States, Canada, and Europe. The data collected in Bio-Hermes 2 will provide a rich dataset on the extent to which digital and other biomarkers can substitute for more labor-intensive clinical exams and expensive positron emission tomography (PET) scans. Importantly, Cumulus will gain access to the full Bio-Hermes 2 dataset and regulatory-standard data to enable subsequent submissions. "The diagnosis of Alzheimer's dementia requires detection of changes in brain biology and memory function. While blood tests are emerging to assess biology, physicians still lack accurate tools for detecting changes in cognition and memory, which directly drive loss of independence and reduced quality of life for patients and their caregivers," said Brian Murphy, PhD, Founder and Chief Scientific Officer of Cumulus. "Existing written and computerised cognitive tests can yield false results if patients are anxious or do not understand the instructions. Our goal is to help patients and physicians more directly with the AccelADx screening test, which is uniquely scalable, complementary to protein markers, and specific to Alzheimer's disease. This Innovate UK SBRI award will allow us to validate how well AccelADx works in a large and diverse group of patients, providing critical data to support regulatory approval." The Cumulus NeuLogiq™ Platform – which includes a first-in-class FDA-cleared and UKCA-marked dry electrode electroencephalogram (EEG) headset – can track the integrity and connectivity of brain networks. The headset synchronises with tablet-based assessments across multiple domains of brain function for use in-clinic or remotely at-home, allowing for an increased ease-of-use for patients, caregivers, and clinical teams. "Alzheimer's dementia is a devastating disease for patients and their families, directly affecting almost 60 million people today. This is a global problem that requires a global solution," said Dr. George Stothart, senior lecturer, Department of Psychology, University of Bath, inventor of AccelADx, and Research Fellow at Cumulus. "In many cases, symptoms appear very gradually and can be difficult to detect during the early stages of disease. As a result, many patients miss the opportunity to fully benefit from newer treatments focused on slowing disease progression. Quicker, more accurate ways to diagnose dementia are greatly needed so that patients can get treatments earlier and families have an opportunity to plan for the future. We believe AccelADx has the potential to address this substantial unmet need." Alzheimer's is a progressive disease that affects brain function, memory, and other cognitive abilities. It is the most common cause of dementia, affecting millions of people worldwide. Symptoms usually develop slowly and worsen over time, including memory loss, confusion, mood swings, changes in behavior and personality, and difficulty with language and communication. Currently, there is no known cure for Alzheimer's. Today, earlier diagnosis can enable patients to make lifestyle changes, including exercising and decreasing alcohol consumption, both of which have been shown to slow disease progression. In the future, having the ability to diagnose patients earlier may expedite enrollment in clinical studies and the identification of new treatments. Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function. To learn more, visit . About Cumulus Neuroscience With a mission to generate the data and insights required to accelerate diagnosis and management of central nervous system (CNS) disorders for millions of patients and caregivers around the world, Cumulus Neuroscience is advancing NeuLogiq™, an AI-based, multi-domain digital biomarker platform to enable better, faster decision making in neurology and neuropsychiatry clinical trials and patient care. Designed for and with 10 of the world's leading pharma companies, the platform enables decentralized trials, and is already making a difference in the development of therapies for Alzheimer's Disease, depression, and schizophrenia. Designed to provide an industry-wide standard for real-world measurement of disease progression, Cumulus combines patented technology, in-house expertise, and key industry partnerships to capture large amounts of real-world, clinical data repeated over time, across multiple behavioral and physiological domains in the patient's home – all with an EEG headset synced to a novel, tablet-based neuro-assessment platform. Together with machine learning (ML) analytics and the world's largest database of annotated, longitudinal, neurofunctional data, Cumulus simplifies and improves the robustness of neuroscience clinical trials to provide the best and most cost-effective assessment of CNS treatment outcomes. The Company is supported by highly experienced specialized investors, DDF/SV Health Investors, LifeArc and Future Fund, and a world-class Scientific and Technical Advisory Board. FOR MORE INFORMATION Julie Dietel FINN Partners for Cumulus [email protected] Tel: 978.502.7705 SOURCE Cumulus Neuroscience