CSA Medical Announces First Procedure in the SPRAY-CB Pivotal Trial for the Treatment of Chronic Bronchitis

CSA Medical Inc | October 22, 2020

CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced the first patient treated in the SPRAY-CB, U.S. pivotal trial utilizing the RejuvenAir® System for COPD with Chronic Bronchitis at Temple University. Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and principal investigator completed the procedure on October 14th.  "We are pleased to have performed the first procedure in this landmark pivotal trial, building on the European data in which patients achieved meaningful improvements in their cough and overall quality of life," said Dr. Criner. "RejuvenAir Metered Cryospray is a promising new interventional tool that has the potential to reduce emergency hospital visits due to chronic bronchitis symptoms. This definitive intervention may provide a long-term benefit to millions of adults suffering with Chronic Bronchitis."

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RESEARCH

DarwinHealth Announces Scientific Collaboration with Prelude Therapeutics in Oncology

Prelude Therapeutics | October 13, 2021

DarwinHealth, Inc. today announced a scientific research collaboration that uses its Biomarker Enrichment Strategies for Assays (BEST platform ) to elucidate novel biomarkers that guide translational trajectories of multiple cancer molecules being developed by Prelude Therapeutics. Under the collaboration, DarwinHealth will use its proprietary, quantitative, systems biology-based algorithms, CLIA-approved technologies, and validated approaches focused on Protein Master Regulator (MR) and tumor checkpoints to identify novel protein-based biomarkers that will add a significant precision a Selection of patient cohorts for clinical trials to be conducted at Prelude's discretion in hematological and solid tumors. The goal of this biomarker-focused collaboration, is to assess and characterize the general and tumor-specific mechanisms of action of molecules in the Prelude pipeline in an attempt to identify new biomarkers that can align these agents with responding patient cohorts. In addition, the The collaboration will mechanically characterize potential therapeutic opportunities for Prelude pipeline molecules that target various oncogenic pathways through multiple hematologic malignancies and solid tumor subtypes, as selected by Prelude Therapeutics.The study will leverage the VIPER algorithm to characterize the activity of these various compounds against key Master Regulator (MR) protein modules (tumor checkpoints) required for subtype-specific tumor viability. - Professor Andrea Califano , Professor and Director of Clyde and Helen Wu , Department of Systems Biology, Columbia Universityand co-founder of DarwinHealth "The BEST initiative will provide accurate and actionable tumor- and compound-specific information to assess the potential of Prelude's pipeline molecules to reverse the activity of subtype-specific tumor checkpoints," explained Dr. Mariano Alvarez , Chief Scientific Officer of DarwinHealth. "The purpose of such studies is to generate a range of validated compound / tumor subtype / biomarker alignments that represent evidence-based roadmaps and mechanisms for biomarker development and patient selection to potentially accelerate clinical studies." As part of the BEST initiative, DarwinHealth will provide a comprehensive reading of the potential clinical value of selected Prelude molecules in a spectrum of tumor types. Using quantitative modeling and biomarker-focused translation pathways, DarwinHealth will also assist in the design of in vivo validation studies to exploit key opportunities that may not be apparent with conventional technologies. "The BEST collaboration addresses one of the critical unmet needs of the biotech and biopharmaceutical spaces focused on cancer drug discovery, that is, the development of highly predictive biomarkers of clinical response to compounds whose ultimate efficacy may be the result of an incompletely decipherable range of both in - and multi-target off-target drug effects of regulatory programs underlying cancer dependencies, These uncertainties lend themselves to extending the concept of biomarkers beyond the primary target (ie, high affinity) of a drug, to multiple protein classifiers identified by our experimental and computational integrative methodologies." - Dr. Gideon Bosker, CEO and Co-Founder of DarwinHealth. These technologies are ideal for identifying mechanical alignments between drug candidates and cancer patients based on the ability of drugs to inactivate patient-specific MR proteins that are necessary for maintenance of tumor status. Importantly, these discoveries can rapidly mature into precision biomarker-driven human clinical trials and commercial development. About DarwinHealth, Inc. DarwinHealth: Precision Therapeutics for Cancer Medicine is a cancer frontier biotechnology-focused company, co-founded by CEO Gideon Bosker, MD, and Professor Andrea Califano, Clyde and Helen Wu Professor of Chemical Systems Biology and Chair of the Department of Systems Biology from Columbia University. The company's technology was developed by Califano's laboratory over the past 14 years and is exclusively licensed by Columbia University. DarwinHealth technology has been developed to identify mechanistic and biomarker-driven, processable and often unforeseen alignments at the proteomic level between small molecules and specific tumor subtypes / patient cohorts and is therefore positioned to accelerate the development of oncology pipelines. About Prelude Therapeutics Prelude Therapeutics is a precision clinical-stage oncology company developing innovative drug candidates that target critical pathways in cancer cells. The company's main candidate products are designed to be potent and selective oral inhibitors of PRMT5. Prelude's first clinical candidate, PRT543, is in phase 1 development for advanced solid tumors and selected myeloid cancers. Prelude also advances PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a phase 1 clinical trial that includes glioblastoma multiforme (GBM). The company's portfolio also includes its third clinical candidate, PRT1419,

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RESEARCH

GenScript Receives FDA Emergency Use Authorization for World's First SARS-CoV-2 Neutralizing Antibody Detection Kit

GenScript | November 09, 2020

GenScript USA Inc., the world's leading research reagent provider, announced today that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test to specifically detect neutralizing antibodies without the use of live virus. Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in any sample, from those from patients recovering from COVID-19 or those vaccinated against SARS-CoV-2.

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BUSINESS INSIGHTS

Enclara Pharmacia Earns Five Year Contract Extension with VITAS Healthcare

Enclara Pharmacia | February 18, 2022

Enclara Pharmacia the market leader in comprehensive pharmacy benefits management (PBM) services to the hospice community, has announced a five-year contract extension to continue providing comprehensive patient medication management services to VITAS Healthcare, the nation’s leading provider of hospice and palliative care. The contract extension affirms the longstanding collaboration between the two companies based on excellence, innovation and quality care for hospice patients and their families. “The goal of hospice is to provide care and comfort that helps patients maintain the best possible quality of life. Pain and symptom management are central to that work. Our team relies on proper medication management so we value Enclara’s combination of powerful technology and personal service that supports and empowers our team to deliver the best quality care.” Nick Westfall, president and CEO, VITAS Mark Morse, CEO, Enclara, said, “VITAS is an industry leader, and with their scale and commitment to continuous improvement in hospice and palliative care, we are able to better identify and respond to the changing needs of the hospice community. This ultimately positions Enclara to better serve hospices of all shapes and sizes.” Scott Quilty, Chief Commercial Officer, Enclara, noted the VITAS renewal comes as Enclara is completing development of the next generation of its E3 mobile and desktop nurse-facing medication management tools. He said, “I’m grateful to continue this relationship as we prepare to roll out the next generation of our E3 application, E3 ProTM. VITAS’ feedback was essential as we worked to prioritize new features that will empower nurses to efficiently administer clinically appropriate symptom management.” About Enclara Pharmacia Enclara Pharmacia is a national full-service PBM and mail order supplier of medications and clinical services developed specifically for the hospice and palliative care industry. Enclara serves over 400 hospice providers and 97,000 patients nationally, helping to reduce pharmacy costs through a clinically driven model that enables home delivery of pharmaceuticals as well as access to a network of over 65,000 local pharmacies, including an actively managed network subset of over 7,000 retail pharmacies, institutional pharmacies, and Enclara’s own automated fulfillment solutions. About VITAS® Healthcare Established in 1978, VITAS Healthcare is a pioneer and leader in the American hospice movement. Headquartered in Miami, Florida, VITAS operates 49 hospice programs in 14 states and the District of Columbia. VITAS employs 10,618 professionals who care for patients with advanced illness, primarily in the patients’ homes, and also in the company’s 28 inpatient hospice units as well as in hospitals, nursing homes and assisted living communities/residential care facilities for the elderly. At the conclusion of the third quarter of 2021, VITAS reported an average daily census of 18,026.

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