NRx Pharmaceuticals | August 26, 2021
NRx Pharmaceuticals announced today it has signed an agreement with Cardinal Health to provide third party logistics and distribution of ZYESAMI™ upon the potential Emergency Use Authorization (EUA) approval by the US Food and Drug Administration (FDA). In May, NRx submitted an application for EUA to the FDA for ZYESAMI™ (aviptadil) for patients suffering from Critical COVID-19 with respiratory failure.
"This partnership creates an efficient and highly flexible logistics and distribution model for NRx. Cardinal Health's expertise will enable ZYESAMI to quickly reach patients in the intensive care units, as limiting the time to treatment is crucial," said Robert Besthof, Head of Operations and Chief Commercial Officer of NRx. "This also allows NRx to continue focusing on answering requests from the FDA in support of our application for Emergency Use Authorization for ZYESAMI."
Cardinal Health Specialty Pharmaceutical Distribution will serve as the exclusive distributor for ZYESAMI, providing broad access to hospitals for this needed medicine upon FDA authorization. With one of the largest healthcare supply chains, Cardinal Health services more than 90% of hospitals in the U.S., and has more than 20 years of experience supporting rapid delivery of lifesaving medicines.
Additionally, Cardinal Health's Third-Party Logistics Services (3PL) will support the warehousing and distribution, full order to cash, and necessary title model services.
"As the COVID-19 pandemic continues, so does the need for more innovative, effective and FDA-approved therapies for critically-ill patients with respiratory failure," said Marc DeLorenzo, Senior Vice President of Strategic Sourcing at Cardinal Health. "Cardinal Health is pleased to ensure that COVID-19 patients get access to treatment in a timely and efficient manner."
About NRx Pharmaceuticals
NRx Pharmaceuticals draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, NRx was awarded an exclusive worldwide license to develop and commercialize the BriLife (VSV-ΔG) COVID-19 vaccine developed by the Israel Institute of Biological Research.
About Cardinal Health
Cardinal Health is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities. With 50 years in business, operations in more than 35 countries and approximately 44,000 employees globally, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.
Hologic | December 24, 2021
Hologicannounced that it has completed regulatory filings needed to make Panther Trax® available in a number of countries and regions. Launch of Panther Trax represents the latest addition to the Panther® Scalable Solutions portfolio of products, offering the ultimate in lab automation by physically linking multiple Panther instruments together into a single, powerful workcell that allows labs to increase testing volumes without increasing staff.
Panther Trax is now listed as a Class I medical device with the United States Food and Drug Administration, CE-marked for diagnostic use in Europe, and will also be commercially available in Canada, Australia and New Zealand.
“Clinical laboratories have performed heroically, meeting unprecedented demand for close to two years now due to the COVID-19 pandemic. It is the job of manufacturers like Hologic to continue to innovate and enable our lab partners to accomplish more with less, ensuring they manage their workloads while responding to further potential surges in COVID testing.”
Kevin Thornal, president, Diagnostic Solutions Division at Hologic
The Panther system, initially launched in Europe in 2010, offers random access and full automation for molecular testing. It provides a broad assay menu that includes tests for women’s health, sexually transmitted infections, respiratory health, viral load and COVID-19 testing, as well as Open Access™ functionality for laboratory developed tests. This broad menu enables labs to consolidate molecular testing onto a single platform. The Panther system serves as the foundation for optional add-ons including: Panther® Fusion, which launched in 2017 and provides additional IVD menu and the Open Access functionality to run LDTs; Panther® Plus, which gives labs greater flexibility, walk-away time and throughput; and Panther® Link, which virtually connects multiple instruments to share data and reagents while providing a centralized dashboard to monitor all instruments.
These scalable solutions address the needs of today’s laboratories, allowing them to increase operational capacity and testing volumes at their own pace, while building on the flexibility, and streamlined user experience they require. With Panther Trax, labs can customize configuration to meet space constraints and minimize facility costs. Taken together, the suite of Panther Scalable Solutions offered by Hologic significantly expands upon the proven performance and reliability of the foundational Panther system.
About the Panther System
The Panther system for molecular diagnostics is a best-in-class fully automated, sample-to-result platform with adaptable workflow options and consolidated testing menu. The Panther Fusion system provides an expanded in-vitro diagnostics menu, as well as Open Access functionality to run LDTs. Hologic’s Panther and Panther Fusion systems now offer 19 FDA-cleared assays and up to 22 assays outside the U.S. depending on the region. This high-throughput molecular diagnostic platform combines comprehensive sexual health, cervical health, viral load, respiratory testing and open channel functionality on a fully automated system.
Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment.
Aizon | February 02, 2021
Aizon launches its Bioreactor Application, the pharma industry's first predictive analysis and profound knowledge management application. The Aizon Bioreactor Application adds the bioreactor process to the "Smart Manufacturing" transformation that is accelerating across the Pharma and Biotech industry. Aizon is extraordinarily able to achieve GxP compliance and give an audit trail from the start of the process. The turnkey application allows pharmaceutical and biotech companies to leverage rich datasets generated during upstream manufacturing to identify and accurately anticipate deviations and results potentially leading to countless dollars in expense savings, diminished danger, and additional income potential gain.
Intended to work with both persistent and took care of batch bioreactors, the Aizon Bioreactor Application gives a profound understanding of the client's bioprocess manufacturing lifecycle. The application leverages specialized Edge AI and contextualization, which is a prerequisite to make the data actionable. Contextualized data is harnessed, analyzed, and visualized through a persona-based lens for faster root cause analysis (RCA), real-time monitoring, and predictive insight across any number of bioreactor units and manufacturing sites.
AI models for bioreactor analytics are ready for use within the application or can be configured by customers within the GxP cloud-based application. “It is clear that biotech and pharmaceutical companies need an accessible, industry-specific tool that accelerates their path to value. Customers seek a seamless way to analyze complex data sets in real-time and to predict with accuracy the yield from bioreactor units that span multiple sites and global regions,” said Pep Gubau, CTO, Aizon. “Biotech and pharmaceutical companies can now more easily leverage the power of AI/ML in a GxP environment with an end-to-end lifecycle governance of data, models, and applications in order to understand and optimize bioreactor processes in commercial manufacturing.”
Aizon’s CEO, John Vitalie adds, ”Our focus is to empower customers to innovate and rapidly achieve their targeted outcomes without the overhead burden of tracking changes, revalidation, and on-going development to maintain compliance. By building the process knowledge framework, compliance, and scalability into the application, customers benefit significantly from the streamlined industrialization of their digital solutions. We see that this is key for pharma and biotech to realize the vision of smart manufacturing and accelerate their progress toward realizing the promise of the adaptive plant.”
Aizon is an enterprise software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within Pharma and other highly regulated industries. The Aizon AI platform and native GxP based applications seamlessly integrate unlimited sources of structured and unstructured data to deliver actionable, real-time insights across all manufacturing sites. Aizon brings deep domain expertise and works closely with Global System Integrators and technology partners to provide enterprise solutions to customers.