PHARMA TECH

Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor

Zynex | January 04, 2022

Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system.  

"I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM-1600. We have worked diligently at adding key enhancements to our FDA-cleared CM-1500 Fluid Monitoring System, including wireless connectivity to the non-invasive wrist wearable. This 510(k) submission is an important step in the evolution of our fluid monitoring system, which we believe will become a vital tool to ensure optimal fluid management and quality care for patients at risk for hemorrhagic events."

 said Thomas Sandgaard, CEO

"We are pleased to bring a meaningful treatment improvement to market through the submission of the CM-1600 to the FDA for 510(k) clearance," said Donald Gregg, Vice President, Zynex Monitoring Solutions. "The improved fluid and blood volume monitor will provide more accurate patient observance before, during, and after surgical procedures. We look forward to working closely with the FDA throughout the submission and clearance process to bring this next generation, first of its kind technology to the market."

The Zynex Fluid Monitoring System is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative IndexTM (RI) value, allowing for fast interpretation of changes in fluid volume.

About Zynex, Inc.
Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation as well as developing noninvasive patient fluid, pulse oximetry and sepsis monitoring systems. 

Spotlight

In the search for more relevant and translational test systems, researchers are increasingly moving towards more advanced cellular models. These models display complex long-term dynamic biology, which places greater demands on the readouts and detection methods used to study them. Traditional end-point assays fall short and do not illuminate these parameter changes over time. Download this Infographic to identify the critical challenges faced in cell-based analyses, and how these are overcome by means of exciting developments in the real-time live-cell analysis.


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PHARMACY MARKET

Entos Pharmaceuticals Announces Senior Leadership Appointments to Expand Executive Team and Accelerate Growth

Entos Pharmaceuticals | March 07, 2022

EDMONTON, Alberta Entos Pharmaceuticals a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, today announced two executive-level appointments, Dr. Steve Chen as Chief Medical Officer (CMO) and Jason Ding as Chief Business Officer (CBO). Dr. Steve Chen brings over 20 years of academic research and pharmaceutical biotechnology experience across multiple therapeutic areas to Entos. He will be responsible for the strategy, direction, and execution of Entos’ clinical development programs and medical affairs activities. Before this position, Dr. Chen served as the CMO of Cellics Therapeutics and has held leadership positions at La Jolla Pharmaceutical Company, Takeda, Eli Lilly and Company, and Amylin Pharmaceuticals. Dr. Chen also led the clinical research unit at the Center for Human Nutrition at UCLA and was a staff physician for emergency medicine at West Los Angeles Veteran Affairs Hospital. He obtained his medical degree from the Albert Einstein College of Medicine and his B.Sc. and B.A. degrees in Bioengineering and Chinese Studies from UC San Diego. “Steve Chen has a track record of working with companies developing revolutionary therapeutic approaches for complex diseases. We are thrilled to welcome him to our team at such a pivotal time as we continue to expand our footprint and grow our pipeline of Fusogenix PLV nucleic acid therapies.” John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Mr. Jason Ding has almost 20 years of financial and transactional expertise in the life science and healthcare industry. He will oversee Entos’ overall business strategy, building upon the company’s foundation for sustainable, scalable growth and developing partnerships with pharmaceutical companies. Before joining Entos, Mr. Ding served as a Partner and Senior Managing Director in Deloitte’s investment banking practice and as a National Life Sciences & Healthcare Transactions Leader spearheading transactions with a cumulative value of over $1.5 billion in the last two years. He has worked with start-ups, large public companies, and global consulting companies and has been an investor and a Board member for numerous life science and industry organizations. Mr. Ding is a Fellow of the Chartered Professional Accountants of Alberta (FCPA, FCA), a Chartered Business Valuator (CBV), and ICD.D designation with the Institute of Corporate Directors. He received his BSc. and BCom. from the University of Alberta. “We’re excited to have Jason Ding join our team, bringing extensive financial and transactional expertise within the biotechnology and health tech sectors,” said John Lewis, Ph.D., Founder and Chief Executive Officer of Entos. “His insight and perspectives are invaluable as we execute on current partnerships and seek to expand our network to bring next-generation Fusogenix PLV nucleic acid therapies to patients in need.” The appointments come on the heels of exciting momentum for Entos, having entered into a collaboration with Eli Lilly in January, where Lilly acquired rights to Entos’ Fusogenix PLV nucleic acid delivery technology to research, develop and commercialize Fusogenix PLV products for central and peripheral nervous system disease indications. As part of the Alberta provincial government’s effort to grow Canada’s biomanufacturing capacity, Entos also received a commitment of $15.5 million in funding from the province in December 2021 to establish a commercial manufacturing facility in Edmonton, Alberta. About Entos Pharmaceuticals A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and redosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of mRNA or DNA into target cells through direct fusion.

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PHARMACY MARKET

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

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PHARMA TECH

AmerisourceBergen Partners with Chronicled to Optimize Pharmaceutical Chargeback Accuracy Using Blockchain-Powered Technology

AmerisourceBergen | April 22, 2022

Global healthcare company AmerisourceBergen announced its partnership with Chronicled, the administrator of the MediLedger Network, to leverage a new blockchain-powered solution designed to enhance pharmaceutical chargeback accuracy and significantly reduce chargeback rejections. The blockchain solution will allow AB to streamline and optimize the complex process of pharmaceutical chargebacks while creating greater connectivity for its suppliers and customers. Over the past three years, AB has collaborated closely with Chronicled to design and pilot the technology for commercial use. Chronicled provides AB and industry partners with a shared, decentralized infrastructure that offers real-time visibility and contract updates to significantly reduce chargeback disputes and improve pricing accuracy. The blockchain-powered solution effectively enforces the accuracy and integrity of chargebacks submitted across AB’s pharmaceutical supply chain. “At AmerisourceBergen, it’s our responsibility to develop and leverage innovative solutions that create seamless and efficient experiences for our customers and the patients they serve every day. This wouldn’t be possible without trusted partnerships across the supply chain. Being a part of the MediLedger Network and deploying this type of blockchain technology is a crucial step forward in AmerisourceBergen’s ongoing digital transformation journey.” Dina Barton, Vice President, Contracts & Chargebacks at AmerisourceBergen Chargeback errors can occur for many reasons, but always result in manual processing, duplicate effort, and back-and-forth communication between trading partners to resolve them. Suppliers, wholesalers, and GPOs are constantly looking for ways to reduce errors, minimize chargeback disputes, and streamline this process. The Contracts & Chargebacks solution on the MediLedger Network will help AB provide its partner suppliers and GPOs a single source of truth for GPO membership, customer identifier data, and contract pricing data that stays aligned between trading partners on the network. The network itself uses this aligned reference data to enforce chargeback accuracy. Blockchain technology and increased collaboration across the industry are essential in driving efficiencies, reducing costly errors, and significantly improving the chargeback process. "We are excited and thrilled to have AmerisourceBergen join the MediLedger Network," said Susanne Somerville CEO of Chronicled. "We share AmerisourceBergen’s commitment to innovation and driving efficiencies across the industry and look forward to supporting their partners joining the network.” By creating greater connectivity with supplier partners and customers, AB expects this new solution will deliver higher quality results across its supply chain network. About AmerisourceBergen AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies, and providers, we create unparalleled access, efficiency, and reliability for human and animal health. Our 42,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #8 on the Fortune 500 with more than $200 billion in annual revenue. About Chronicled Chronicled, a San Francisco-based technology company, enables automation, trust, and automatic settlement for intra-company transactions in the Life Sciences and Healthcare industry. Through the industry leading blockchain-powered MediLedger Network, Chronicled offers trading partners a new way to manage revenue, automate manual processes, and eliminate revenue leakage, while ensuring pricing accuracy and efficiency for health care providers and dispensers.

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RESEARCH

DEBIOPHARM INVESTS IN VERISIM LIFE'S $15M SERIES A ROUND TO ADVANCE AI-ENABLED DRUG RESEARCH

Debiopharm International SA | January 11, 2022

Debiopharm a Swiss biopharmaceutical company, announced their co-investment in California-based start-up VeriSIM Life's $15 Million Series A Round to advance their mission to accelerate drug development via technology powered by artificial intelligence. VeriSIM Life's computational platform reduces time and cost of drug development as well as reduces the need for animal testing that, in the vast majority of cases, does not translate well to humans. Debiopharm's co-investment in VeriSIM contributes to the growth plan of the start-up and will help to expand and establish transformational partnerships with industry and academia using their first-in-class 'virtual drug development engine' BIOiSIM™. The investment aligns with Debiopharm's focus to invest in digital health solutions that improve the cancer patient journey, transform pharmaceutical R&D, and shift healthcare towards a more patient-centric approach. With the financing round led by Morpheus Ventures, Debiopharm Innovation Fund joins new investors including Colorcon Ventures along with existing investors OCA Ventures, Intel Capital, Serra Ventures and Susa Ventures. Founded in 2017 by Jo Varshney, DVM and PhD alongside a cross-functional team of pharmaceutical scientists, software engineers and AI/ML and simulation experts, the start-up offers a range of translational-based solutions, customized for pre-clinical and clinical programs. "We're moving into a time where AI-based technology will play a critical role in drug development. We absolutely need to reduce the time, costs & risks of drug development in order to be more efficient – that's exactly what the BIOiSIM™ is proven to do. The value of using this AI-based platform is the potential decrease in the need for animal testing and the acceleration of the pre-clinical, translational stage, helping drug research companies to more quickly select which early-stage medicines will most likely benefit patients and cure their disease." Tanja Dowe, CEO of the Debiopharm Innovation Fund More than 90% of drugs tested in animals fail to pass human clinical trials, resulting in delayed development and high costs. VeriSIM's BIOiSIM platform, driven by AI and machine learning (ML), de-risks R&D decisions by providing meaningful insights much earlier in the drug development process with unprecedented accuracy and scalability. VeriSIM's platform solves this decade-old translatability problem within the drug development phase and ensures clinical success of drugs intended for highly unmet needs. With its first-in-class platform, VeriSIM is transforming the way pharmaceutical and biotech companies address the most challenging diseases impacting humankind. About VeriSIM Life VeriSIM Life has developed a sophisticated computational platform that leverages advanced AI and ML techniques to significantly improve drug discovery and development by greatly reducing the time and money it takes to bring a drug to market. BIOiSIM is a first-in-class 'virtual drug development engine' that offers unprecedented value for the drug development industry by narrowing down the number of drug compounds that offer anticipated value for the treatment or cure of specific illnesses or diseases. The program not only reduces the time and cost of drug discovery and development, it also greatly reduces the need for animal testing that, in the vast majority of cases, does not translate to humans. Debiopharm's commitment to patients Debiopharm develops, manufactures and invests in innovative therapies and technologies that respond to high unmet medical needs in oncology and bacterial infections. We aim to provide strategic funding and guidance for companies with Smart Data & Digital Health solutions with the ambition to change the way drugs are developed and the way patients are treated. Our growing portfolio company achievements includes 18 FDA clearances or CE marks and 2 IPOs. Since 2018 Debiopharm has invested over USD 120 million, typically leading the investment rounds of its 16 portfolio companies.

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Spotlight

In the search for more relevant and translational test systems, researchers are increasingly moving towards more advanced cellular models. These models display complex long-term dynamic biology, which places greater demands on the readouts and detection methods used to study them. Traditional end-point assays fall short and do not illuminate these parameter changes over time. Download this Infographic to identify the critical challenges faced in cell-based analyses, and how these are overcome by means of exciting developments in the real-time live-cell analysis.

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