July 30, 2020 |July was full of exciting news in the clinical trial and healthcare community, including partnerships, products, and promotions from John Snow Labs, LabCorp, the FDA, and more.

John Snow Labs announced the immediate availability of the new major version of the Healthcare AI Platform. This release raises the bar on the industry's only cleanroom AI platform that is designed for high-compliance industries where PHI or PII data is analyzed. The platform runs in a complete air-gap manner without Internet access. All computation is done within the platform; no data, models, or code leave the cluster. The Healthcare AI Platform  is automatically deployed in 2-4 hours on a cluster of your choice on any cloud or on-premise cluster, anywhere in the world as one fully managed Kubernetes cluster. “Data science teams in high-compliance industries often have to make hard trade-off between having access to state-of-the-art libraries and tools; the convenience of managed services, elasticity and scale offered by cloud providers, while adhering to the highest bar of security, privacy, and compliance. Our goal with the Healthcare AI Platform is to deliver on all three areas without compromise,” said Ali Naqvi, lead platform product manager at John Snow Labs, in an official statement. Press release 

LabCorp announced results for the second quarter ended June 30, 2020. Revenue for the quarter was $2.77 billion, a decrease of (3.9%) from $2.88 billion in the second quarter of 2019. The decrease in revenue was due to a (5.4%) decline of organic revenue, (0.3%) from the disposition of a business, and (0.1%) from unfavorable foreign currency translation, partially offset by 1.9% from acquisitions. The (5.4%) decline of organic revenue was due to the pandemic, which reduced the Company's organic Base Business by (20.9%), partially offset by COVID-19 Testing of 15.4%. "Base Business" includes the Company's business operations except for molecular and serology COVID-19 testing ("COVID-19 Testing"). The decline in organic Base Business includes the lower Medicare and Medicaid pricing as a result of PAMA of (0.5%). “We continue to bring the full power of our combined diagnostics and drug development capabilities against this virus, applying our scientific expertise and ingenuity across all aspects of testing, treatments, and vaccines," said Adam Schechter, chairman and CEO, LabCorp, in an official statement. "During the second quarter, we delivered solid performance across the company despite the impact of the pandemic. I continue to be impressed with how quickly our teams have rallied to confront each and every challenge put before them, and I want to thank our 65,000 employees, as their efforts have been heroic during this difficult time.” Press release

The U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL. “Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat. This approval is yet another example of customized treatments that use a patient’s own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in an official statement. “We’re seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine.” MCL is a rare form of cancerous B-cell non-Hodgkin’s lymphoma that usually occurs in middle-aged or older adults. In patients with MCL, B-cells, a type of white blood cell which help the body fight infection, change into cancer cells that start to form tumors in the lymph nodes and quickly spread to other areas of the body. Each dose of Tecartus is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T cells, a type of white blood cell, are collected and genetically modified to include a new gene that facilitates the targeting and killing of the lymphoma cells. These modified T cells are then infused back into the patient. Press release

NantHealth announced the acquisition of OpenNMS which will operate as a subsidiary of NantHealth. The transaction closed on July 22, 2020. Based in Morrisville, NC, OpenNMS provides a highly reliable, scalable and comprehensive fault, performance and traffic monitoring solution that easily integrates with business applications and workflows to monitor and visualize everything in a network. The OpenNMS platform monitors some of the largest networks in existence, covering the healthcare, technology, finance, government, education, retail and industrial sectors, many with tens of thousands of networked devices. OpenNMS customers include three of the top 5 companies on the Fortune 100, as well as multiple large and multi-state health providers and one of the largest electronic medical record providers in the United States. “OpenNMS has set the standard for open-source network monitoring since 2000 with its enterprise-grade network management platform,” said Ron Louks, Chief Operating Officer, NantHealth, in an official statement. “We are thrilled to have them join the NantHealth family.” Press release

The International Partnership for Microbicides (IPM) welcomed a positive opinion from the European Medicines Agency (EMA) on the dapivirine vaginal ring for use by cisgender women ages 18 and older in developing countries to reduce their risk of HIV-1 infection. The monthly ring is the first long-acting HIV prevention product and is designed to help address women’s unmet need for new methods given the persistently high rates of HIV they face, especially in sub-Saharan Africa. Today’s news opens the door to next steps needed to seek approvals for the ring in countries where the need is most urgent. “The EMA’s opinion is a significant step forward for women, who urgently need and deserve new, discreet options to manage their HIV risk on their own terms,” said Dr. Zeda F. Rosenberg, founding chief executive officer of IPM, the nonprofit that developed the dapivirine ring and is the product’s regulatory sponsor, in an official statement. “As we celebrate today’s news with the many partners around the world involved in the ring’s development, we also look ahead to the collective effort still needed to obtain country approvals to make the ring available to women in sub-Saharan Africa.” The EMA’s Committee for Medicinal Products for Human Use reviewed the ring under the Article 58 procedure, which it conducts in cooperation with the World Health Organization (WHO) to facilitate access to essential medicines in low- and middle-income countries using the same rigorous standards as for products intended for use in the European Union. IPM submitted its Article 58 application in June 2017. Global partnerships with researchers, trial communities in Africa, Europe and the United States, civil society, governments, industry and donors spanning 16 years of research and development led to the positive opinion. Press release