Veeva Systems | October 07, 2021
Veeva Systems (NYSE: VEEV ) announced that Celerion has launched Veeva eConsent , a MyVeeva for Patients solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects.
Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent,
- Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion .
An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. "
Celerion, a leading global provider of early clinical research services, uses Veeva SiteVault to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring.
Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors.
- Tim Davis , vice president, MyVeeva for Patients at Veeva Systems.
About Veeva Systems
Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.
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.
Moberg Pharma | November 06, 2020
The Board of Directors of Moberg Pharma AB (publ) (OMX: MOB) ("Moberg Pharma" or "the Company") has today resolved to carry out a fully guaranteed issue of new ordinary shares and warrants ("Units") with preferential rights for existing shareholders (the "Rights Issue") of approximately SEK 150 million before transaction costs. The Rights Issue requires the approval of an extraordinary general meeting (the "Extraordinary General Meeting"). The proceeds will be used for registration activities and clinical work for MOB-015. When the Rights Issue is completed, the Company intends to terminate the current convertible note agreement. By a separate press release, the Company has today announced its intention to distribute the BUPI project to the shareholders of Moberg Pharma through a Lex Asea distribution with a subsequent listing on Nasdaq First North Growth Market during the Q1 of 2021.