Treatment and management of COVID-19

Biophytis: Biophytis has requested a pre-submission meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the treatment of COVID-19

Retrieved on: 
Thursday, July 20, 2023

Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.

Key Points: 
  • Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.
  • Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients.
  • According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe.
  • We look forward to starting discussions with the FDA, and depending on feedback from this agency, we could consider filing an Emergency Use Application by the end of 2023 or in the first half of 2024."

Ambu Supports FDA’s Recommendations on the Use of Single-use Bronchoscopes

Retrieved on: 
Friday, June 25, 2021

The FDA recommends that healthcare providers consider using single-use bronchoscopes where there is increased risk of spreading infection, or no support for immediate reprocessing available.

Key Points: 
  • The FDA recommends that healthcare providers consider using single-use bronchoscopes where there is increased risk of spreading infection, or no support for immediate reprocessing available.
  • This latest update follows recent recommendations from the American Association for Bronchology and Interventional Pulmonology (AABIP) on treating COVID-19 patients.
  • Ambu believes that any patient that enters the OR or ICU should not be exposed to further risk of infection.
  • In 2020, more than 1 million Ambu single-use endoscopes were used around the world, making Ambu the worlds largest supplier of single-use endoscopes.

NRx Pharmaceuticals Announces Positive Results for ZYESAMI™ (Aviptadil-acetate) and Submits Emergency Use Authorization Application to US Food and Drug Administration to Treat Critical COVID-19 in Patients Suffering from Respiratory Failure

Retrieved on: 
Tuesday, June 1, 2021

Patients enrolled in the study had respiratory failure despite prior treatment with all approved medicines for COVID-19 including remdesivir.

Key Points: 
  • Patients enrolled in the study had respiratory failure despite prior treatment with all approved medicines for COVID-19 including remdesivir.
  • ZYESAMI is the first reported medicine to demonstrate increased recovery and survival in patients who have already progressed to respiratory failure.
  • "The positive results from this trial turned into positive implications for some of our sickest COVID-19 patients and support the clinical benefit of ZYESAMI in critically-ill COVID-19 patients with respiratory failure.
  • Separately, the National Institutes of Health is conducting a confirmatory trial that randomizes patients with COVID-19 respiratory failure to ZYESAMIvs.

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries

Retrieved on: 
Tuesday, May 4, 2021

This donation furthers both Lilly and Direct Relief\'s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries.

Key Points: 
  • This donation furthers both Lilly and Direct Relief\'s charitable goal of providing access to COVID-19 treatments to patients in need by providing these medicines free of charge to low- and lower-middle-income countries.
  • This is a wonderful example of each of us doing whatever we can to get through this pandemic," said Direct Relief president and CEO Thomas Tighe.
  • "\nThe allocation of therapies will be based on the disease burden and hospitalization rates in each country.
  • Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.

Lilly, Vir Biotechnology and GSK Announce Positive Topline Data from the Phase 2 BLAZE-4 Trial Evaluating Bamlanivimab with VIR-7831 in Low-Risk Adults with COVID-19

Retrieved on: 
Monday, March 29, 2021

These virology data support our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment.

Key Points: 
  • These virology data support our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment.
  • VIR-7831 demonstrated positive results in the COMET-ICE trial and recent pre-clinical data suggest that VIR-7831 maintains activity against current circulating variants of concern.
  • We look forward to continuing conversations with the FDA about VIR-7831 as monotherapy and co-administered with bamlanivimab.
  • VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

Incyte Announces Results from the Phase 3 DEVENT Study Evaluating Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) on Mechanical Ventilation

Retrieved on: 
Thursday, March 18, 2021

More than half of study patients (55%) received remdesivir and 90% of study patients received corticosteroids prior to or during the study.

Key Points: 
  • More than half of study patients (55%) received remdesivir and 90% of study patients received corticosteroids prior to or during the study.
  • The safety profile was generally consistent with hospitalized patients with COVID-19 and consistent with treatment with ruxolitinib.
  • We look forward to discussing the results of the DEVENT study with regulatory authorities in the United States.
  • The protocol will allow eligible patients with severe COVID-19 associated ARDS with disease severity requiring mechanical ventilation to receive ruxolitinib.

SignatureCare Emergency Center Approved to Administer Eli Lilly's Monoclonal Antibody Treatment for COVID-19

Retrieved on: 
Tuesday, March 9, 2021

HOUSTON, March 9, 2021 /PRNewswire-PRWeb/ --SignatureCare Emergency Center is pleased to announce that it has been approved to administer Eli Lilly's Bamlanivimab (LY-CoV555) COVID-19 treatment to patients through its network of 24-hour emergency centers located in Texas.

Key Points: 
  • HOUSTON, March 9, 2021 /PRNewswire-PRWeb/ --SignatureCare Emergency Center is pleased to announce that it has been approved to administer Eli Lilly's Bamlanivimab (LY-CoV555) COVID-19 treatment to patients through its network of 24-hour emergency centers located in Texas.
  • Dr. Hashibul Hannan, a board-certified emergency medicine physician and managing partner at SignatureCare Emergency Center, said SignatureCare ER is glad to receive the approval and has already begun administering the life-saving treatment.
  • "This treatment is available now and no preregistration is required to receive the treatment through our emergency centers.
  • To find the SignatureCare Emergency Center in your area, please go to https://ercare24.com .

Global Extracorporeal Membrane Oxygenation (ECMO) Market Report 2020: Emergence of New Participants with Integrated and Advanced Circuit Solutions Set to Drive Inorganic Growth Strategy

Retrieved on: 
Tuesday, February 16, 2021

DUBLIN, Feb. 16, 2021 /PRNewswire/ -- The "COVID-19 Pandemic and Rising Prevalence of Respiratory Disorders Catapult Growth in Global Extracorporeal Membrane Oxygenation (ECMO) Market" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 16, 2021 /PRNewswire/ -- The "COVID-19 Pandemic and Rising Prevalence of Respiratory Disorders Catapult Growth in Global Extracorporeal Membrane Oxygenation (ECMO) Market" report has been added to ResearchAndMarkets.com's offering.
  • Extracorporeal membrane oxygenation (ECMO) therapy has been in the limelight during the recent COVID-19 pandemic.
  • However, ECMO therapy had started gaining wider acceptance among critical care physicians post the 2009 influenza A (H1N1) pandemic.
  • Competitive Environment - Key Competitors: Extracorporeal Membrane Oxygenation Market

Global Extracorporeal Membrane Oxygenation (ECMO) Market Report 2020-2021 - COVID-19 Pandemic and Rising Prevalence of Respiratory Disorders Catapult Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, February 15, 2021

The "COVID-19 Pandemic and Rising Prevalence of Respiratory Disorders Catapult Growth in Global Extracorporeal Membrane Oxygenation (ECMO) Market" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "COVID-19 Pandemic and Rising Prevalence of Respiratory Disorders Catapult Growth in Global Extracorporeal Membrane Oxygenation (ECMO) Market" report has been added to ResearchAndMarkets.com's offering.
  • Extracorporeal membrane oxygenation (ECMO) therapy has been in the limelight during the recent COVID-19 pandemic.
  • However, ECMO therapy had started gaining wider acceptance among critical care physicians post the 2009 influenza A (H1N1) pandemic.
  • Competitive Environment - Key Competitors: Extracorporeal Membrane Oxygenation Market

FDA Adds Kantaro's Semi-Quantitative COVID-19 Antibody Test to Revised Emergency Use Authorization for Convalescent Plasma

Retrieved on: 
Wednesday, February 10, 2021

The revised EUA qualifies the COVID-SeroKlir test for detecting high titer COVID-19 convalescent plasma during manufacturing.

Key Points: 
  • The revised EUA qualifies the COVID-SeroKlir test for detecting high titer COVID-19 convalescent plasma during manufacturing.
  • The EUA limits the use of high titer COVID-19 convalescent plasma only to treat hospitalized patients early in the disease course.
  • COVID-19 convalescent plasma is an investigational product and is not currently approved or licensed for any indication.
  • "We are pleased the FDA has added Kantaro's COVID-SeroKlir antibody test to the EUA for convalescent plasma and authorized the test's use in qualifying convalescent plasma titers," said Erik Lium, PhD, Chairman of the Board of Kantaroand Executive Vice President and Chief Commercial Innovation Officer attheMount SinaiHealth System.