Saama Technologies, Inc. | October 27, 2020
Saama Technologies, Inc. (“Saama”), the AI clinical analytics platform company, announced today the launch of the new Active Safety Analytics for Pharma (ASAP) product. ASAP is the first validated pharmacovigilance solution to leverage the U.S. Food and Drug Administration’s (FDA) Sentinel Common Data Model and the TreeScan methodology for detecting safety signals. ASAP was co-built with Gilead Sciences, a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Saama and Gilead partnered to develop ASAP, with scientific advice from the Reagan-Udall Foundation for the FDA, and accelerate the life sciences industry’s paradigm shift to adopt active safety analytics.
LEO Pharma | September 30, 2021
LEO Pharma , a global leader in medical dermatology, and Veeva Systems announced a strategic technology partnership to enable scalable digital trials, paperless and patient-centered.
Building on its success with the Veeva Clinical Operations suite, LEO Pharma will complete its standardization on existing Veeva clinical technology, be an early adopter of future Veeva solutions, and help shape the Veeva digital trials roadmap. By adopting technology and optimized business processes, LEO Pharma plans to achieve the following goals while maintaining the highest standards in data accuracy, regulatory compliance and patient safety:
Significant improvement in the patient experience
Increased patient diversity through decentralized trials
Greater precision of clinical data
25% reduction in the cost of clinical trials
25% reduction in clinical trial time
LEO Pharma will use the integrated suite of Veeva clinical products, including eTMF, CTMS, CDMS, Site Connect, eConsent, ePRO, Virtual Visits and eSource.
We were exploring ways to transform clinical trials, but COVID-19 has accelerated this process. By responding quickly to changing market dynamics, we allowed our testing to continue without delay. The partnership with Veeva supports our 2030 strategy because it will help us deliver innovative treatments to patients faster while supporting a more sustainable business. Veeva's results in terms of product excellence make it the ideal long-term partner to help us achieve this goal, which allows us to help patients better and faster.
- Jörg Möller, Executive Vice President and Head of R&D at LEO Pharma.
We are excited and honored to extend our long-standing partnership with LEO Pharma to be an early adopter of our comprehensive digital testing platform, We intend to help the industry move forward with a scalable digital trials platform that dramatically improves the clinical trial process for patients, sites and sponsors.
- Peter Gassner , Founder and CEO of Veeva
About Veeva Systems
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence and customer success, Veeva has more than 1,000 customers, from the world's largest pharmaceutical companies to emerging biotechnology companies. As a public benefit company, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.
About LEO Pharma
LEO Pharma helps people achieve healthy skin. The company is a leader in the field of medical dermatology, with a strong R&D portfolio, a wide range of therapies and a pioneering spirit. Founded in 1908 and majority-owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advancing the science of dermatology, setting new standards of care for people with skin diseases. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company achieved net sales of 1,359 million euros.
NRx Pharmaceuticals | August 30, 2021
NRx Pharmaceuticals announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm."
NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef.
"With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID," This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA."
Prior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital one year ago. Dr. Youssef and colleagues reported the results in 21 patients treated with ZYESAMI, compared to 24 patients who received best-available standard of care.
This latest analysis also supports NRx's application for Breakthrough Therapy Designation (BTD) to the FDA for ZYESAMI. BTD is a process designed to expedite the development and review of medicines intended to treat a serious condition and is supported by preliminary clinical evidence showing the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s). https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
About ZYESAMI™/VIP in COVID-19
ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19.
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, a 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. NRx currently has the BriLife for COVID-19 in phase 3 trials, and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.