Sepsis

Public Advisory - Two lots of cystic fibrosis drug Cayston recalled due to the potential of cracked glass vials

Retrieved on: 
Saturday, March 18, 2023

Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots (032168 and 033357) of the cystic fibrosis drug Cayston (aztreonam) (DIN 02329840) on March 1, 2023 , due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.

Key Points: 
  • Health Canada is advising the public that Gilead Sciences Incorporated recalled two lots (032168 and 033357) of the cystic fibrosis drug Cayston (aztreonam) (DIN 02329840) on March 1, 2023 , due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.
  • A cracked glass vial could cause potential injury or lead to potential contamination or a reduced dose.
  • Cayston is a prescription antibacterial medicine used for the management of chronic infections in cystic fibrosis patients.
  • The manufacturer has not received any customer complaints in relation to cracked glass vials in the recalled lots, or any other Cayston lots distributed in Canada.

STATEMENT OF DANCO LABORATORIES REGARDING MIFEPREX®

Retrieved on: 
Friday, March 17, 2023

The hearing laid bare both the unprecedented nature of the plaintiffs' legal theory and the speculative nature of their factual allegations.

Key Points: 
  • The hearing laid bare both the unprecedented nature of the plaintiffs' legal theory and the speculative nature of their factual allegations.
  • This too would upend the pharmaceutical industry and has no basis in (and in fact contradicts) the statute, FDA's regulations or case law.
  • The plaintiffs ultimately were forced to admit that they could point to no precedent consistent with their view of the federal statutes at issue.
  • Danco joined this lawsuit in order to ensure that the FDA approval of Mifeprex® remains in force and people continue to have access to this safe and effective product.

T2 Biosystems Announces Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Monday, March 13, 2023

LEXINGTON, Mass., March 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • LEXINGTON, Mass., March 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced financial results for the fourth quarter and full year ended December 31, 2022.
  • Achieved fourth quarter total revenue of $5.5 million, including product revenue of $2.2 million and research contribution revenue of $3.3 million.
  • “Throughout 2022, the T2 Biosystems team generated record sepsis and related product revenue and expanded the installed base of T2Dx Instruments through record sepsis-driven instrument contracts.
  • We also advanced our product pipeline, positioning T2 Biosystems to expand our test menu in 2023,” stated John Sperzel, Chairman and CEO of T2 Biosystems.

Revelation Biosciences Inc. Appoints Dr. Julia Bohannon and Dr. Antonio Hernandez to Scientific Advisory Board

Retrieved on: 
Monday, March 13, 2023

Dr. Hernandez and Dr. Bohannon are inventors of the phosphorylated hexaacyl disaccharide (PHAD) based technology licensed from Vanderbilt University, previously announced on October 6, 2022 .

Key Points: 
  • Dr. Hernandez and Dr. Bohannon are inventors of the phosphorylated hexaacyl disaccharide (PHAD) based technology licensed from Vanderbilt University, previously announced on October 6, 2022 .
  • Julia Bohannon, Ph.D. is an Associate Professor in the Department of Anesthesiology and the Department of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center.
  • Dr. Antonio Hernandez is a Professor of Anesthesiology Critical Care Medicine, Cardiothoracic Anesthesiology, Research at Vanderbilt University Medical Center, Co-Medical Director, CV-ICU.
  • Hernandez and Dr. Bohannon bring a wealth of knowledge and experience in treatment of infection by augmenting the innate immune response, a form of trained immunity.

El Camino Health is first in the world to adopt FloPatch advanced ultrasound technology for sepsis management

Retrieved on: 
Tuesday, March 14, 2023

MOUNTAIN VIEW, Calif., March 14, 2023 /PRNewswire/ -- El Camino Health is the first health system in the world to adopt FloPatch , an innovative new technology that monitors blood flow in real time.

Key Points: 
  • MOUNTAIN VIEW, Calif., March 14, 2023 /PRNewswire/ -- El Camino Health is the first health system in the world to adopt FloPatch , an innovative new technology that monitors blood flow in real time.
  • "We are proud to be the first hospital in the world to adopt this advanced technology, and have been working with Fogarty Innovation and Flosonics Medical for the past year piloting FloPatch.
  • "We're thrilled to partner with El Camino Health to launch this pioneering ultrasound technology," said Dr. Jon-Emile Kenny, chief medical officer at Flosonics Medical.
  • Flosonics was first introduced to El Camino Health via Fogarty Innovation (FI), a non-profit, educational, medical technology accelerator located on hospital's Mountain View campus.

Spectral Medical Announces the Opening of Two Additional Tigris Clinical Trial Sites

Retrieved on: 
Thursday, March 9, 2023

We are quite excited about participating in a trial that uses a personalized medicine approach.”

Key Points: 
  • We are quite excited about participating in a trial that uses a personalized medicine approach.”
    Blaithin A. McMahon MD.
  • Ph.D., Associate Professor of Medicine at MUSC, stated, “We’re already hard at work to identify patients for Tigris.
  • We also expect to have two more sites onboarded and actively enrolling around the end of the first quarter of 2023.
  • We continue to advance our Tigris trial and remain encouraged by the outlook with preliminary mortality data that continually exceeds our expectations.

Sepsis - Pipeline Insight, 2022: Innovations from SciClone, Sanofi, BioAegis & More Set to Transform Sepsis Treatment - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 8, 2023

This "Sepsis- Pipeline Insight, 2022" report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Sepsis pipeline landscape.

Key Points: 
  • This "Sepsis- Pipeline Insight, 2022" report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Sepsis pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D.
  • This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • Sepsis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Masimo and Temple Health Form Innovation Collaboration with Focus on Hospital Automation and Telehealth Initiatives

Retrieved on: 
Tuesday, March 7, 2023

Masimo (NASDAQ: MASI), a leading global provider of medical technology and automation solutions, and Temple Health , Philadelphia’s 979-bed academic health system, announced today that they are entering into a strategic innovation collaboration.

Key Points: 
  • Masimo (NASDAQ: MASI), a leading global provider of medical technology and automation solutions, and Temple Health , Philadelphia’s 979-bed academic health system, announced today that they are entering into a strategic innovation collaboration.
  • The collaboration is designed to further the organizations’ mutual goals of improving health, increasing care value, and transforming models of care delivery.
  • View the full release here: https://www.businesswire.com/news/home/20230307005243/en/
    Joseph DiMartino, MSN, RN, Associate Vice President of Nursing at Temple University Hospital, said, “Temple Health is committed to driving medical advances through clinical innovation, pioneering research and world-class education.
  • Participation in the Temple Health “Collaboratory,” where the latest Masimo technologies will be trialed and refined before broader deployment.

CATALIST-listed AOXIN Q&M reports lower revenue of RMB 140m for full year ended 31 December 2022

Retrieved on: 
Thursday, March 2, 2023

This includes days when some clinics could not operate because a substantial number of dentists and nurses were down with Covid themselves.

Key Points: 
  • This includes days when some clinics could not operate because a substantial number of dentists and nurses were down with Covid themselves.
  • The Group's revenue was lower by RMB20.5 million or 12.8% from RMB160.2 million for the financial year ended 31 December 2021 (FY2021) to RMB139.7 million for the financial year ended 31 December 2022 (FY2022).
  • The lower revenue was largely due to the resurgence of Covid-19 in Liaoning Province, PRC in the second and fourth quarters of 2022 which affected all business segments of the Group.
  • Revenue from primary healthcare segment was lower by 7.3% from RMB93.9 million in FY2021 to RMB87.0 million in FY2022.

TGV-Dx Announces Study Results Showing AtbFinder as Novel Paradigm for Rapid Antibiotic Susceptibility Testing for Multidrug-Resistant Infections

Retrieved on: 
Thursday, March 2, 2023

The study on the advanced test system for optimal antibiotic therapy for people with severe pulmonary infections was published in the Journal of Clinical Microbiology .

Key Points: 
  • The study on the advanced test system for optimal antibiotic therapy for people with severe pulmonary infections was published in the Journal of Clinical Microbiology .
  • AtbFinder is fundamentally different from other antimicrobial susceptibility tests as it, for the first time, selects antibiotics that target the entire bacterial community.
  • “AtbFinder is a new era in antimicrobial susceptibility testing that can potentially save thousands of lives and reduce healthcare costs.
  • “We are very excited that AtbFinder based on novel principles for antibiotic selection demonstrated such groundbreaking results,” said Victor Tetz, a scientific founder of the project.