PHARMACY MARKET

NRx Pharmaceuticals to Work with Cardinal Health to Ensure Efficient Distribution of Potential Therapies

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.

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Bluepharma, a Portuguese pharmaceutical company, has just opened a state-of-the-art industrial unit specialized in the production of oral solid high potent drugs, namely in the oncology area.

Spotlight

Bluepharma, a Portuguese pharmaceutical company, has just opened a state-of-the-art industrial unit specialized in the production of oral solid high potent drugs, namely in the oncology area.

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Tonix Pharmaceuticals to Obtain an Exclusive License from Columbia University

Tonix Pharmaceuticals | February 14, 2023

On February 13, 2023, Tonix Pharmaceuticals, a leading clinical-stage biopharmaceutical firm, announced that it has exercised an option to acquire an exclusive license from Columbia University to develop a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the prophylaxis or treatment of SARS-CoV-2 infection. COVID-19 is caused by SARS-CoV-2. Tonix Pharmaceuticals and Columbia University announced a research collaboration and option agreement in 2020, which resulted in the development of the licensed mAbs. Although the FDA granted emergency use authorization (EUA) to five mAb products containing seven distinct mAbs for either prophylaxis or treatment of COVID-19, none stayed available or functional since January 26, 2023, when the FDA stated that the last remaining mAb, Evusheld®, is no longer authorized. Previously, either FDA or the National Institutes of Health COVID Treatment Guidelines Panel had revoked recommendations or clearances for the other mAbs. Until recently, the earlier EUA-approved products were obtained from the blood of humanized mice or COVID-convalescent patients. Columbia University's TNX-3600 fully human mAbs were generated utilizing a proprietary system that involved a human hybridoma fusion partner. The firm feels that murine monoclonal antibodies, such as TNX-4100, have the capacity to generate antibodies with a high affinity that detect distinct epitopes on the SARS-CoV-2 spike protein. This is due to the fact that mice have a different antibodies repertoire than humans, and the technology for making antibodies optimizes the selection of relevant B cells via harvesting approach, immunization timing and screening platform. About Tonix Pharmaceuticals Founded in 2007, Tonix Pharmaceuticals is a clinical-stage biopharmaceutical firm committed to finding, acquiring, licensing, and developing therapies for the treatment and prevention of diseases and the alleviation of human suffering. Its pipeline is focused on rare diseases, immunology, infectious diseases, and central nervous system (CNS) product candidates. The company's immunology portfolio consists of biologics for the treatment of organ transplant rejection, cancer and autoimmunity. At the same time, its infectious disease portfolio includes next-generation COVID-19 vaccines and vaccinations against smallpox and monkeypox.

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BUSINESS INSIGHTS, PHARMACY MARKET

VERO Biotech Announces FDA Approval for Its Second-gen GENOSYL DS

VERO Biotech | February 03, 2023

On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution. GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow. The following are the expected advantages of the second generation GENOSYL® DS Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture). Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost. Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds. Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment. It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023. About VERO Biotech Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.

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Horus Pharma and Plastic Bank Collaborate to Recycle Nearly 100 Tons of Plastic

Horus Pharma | January 11, 2023

On January 10, 2023, Horus Pharma, an independent French ophthalmology laboratory known for its preservative-free eye and eyelid health products, announced a partnership with Plastic Bank to recycle approximately 100 tons of plastic annually. The pact is a part of Horus Pharma's environmental program, Eco' Ophtalmo. Since its founding in 2003, corporate social responsibility (CSR) has been a consistent part of Horus Pharma's culture. Over the years, the company's increasing awareness of industrial activities' environmental impact has led to numerous initiatives. Horus Pharma has committed to continuously seeking new solutions via innovation and collaboration to minimize its ecological footprint to the greatest extent possible. Furthermore, through its strategy of cooperative actions and initiatives, it strives to encourage and support the spread of ecologically-responsible practices within its industry. Launched in September 2022, the Eco' Ophtalmo initiative has incorporated ecology into Horus Pharma's culture and strategy planning. Eco' Ophtalmo project encompasses major and ambitious initiatives, including an environmental and social commitment to achieve Plastic Net Zero and create recyclable packaging. In addition, Horus Pharma aims to promote awareness among ophthalmologists and drive action by cooperating to increase awareness and encourage collective efforts to reduce the environmental footprint. About Horus Pharma Founded in 2003, Horus Pharma is a leading eye and eyelid health product developer. It operates in most ophthalmology segments to develop effective and safe practical innovations. Focused on patient safety, its laboratories are renowned for their expertise in developing preservative-free formulations and product delivery systems. The laboratory's product portfolio includes medicinal products, food supplements, and medical devices. In addition, it has been pursuing growth with its new surgery division by providing surgical and peri-surgical diagnostic solutions for eye problems.

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