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COVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines | 2020-12-17

The Pharma Data

DECEMBER 17, 2020

Regardless of their decisions or which treatment they receive, all participants will be monitored for two years. Currently, healthcare personnel and long-term care facility residents participating in their trial are the only ones who can opt to receive the vaccine.

Vaccine

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Therma Bright Acquires 100% Control of its COVID-19 Rapid Saliva Antigen Test and Announces Proposed Name Change for the Test

The Pharma Data

JANUARY 24, 2021

The test can help identify infected individuals in 15 minutes and is designed for at-home or point-of-need settings such as long-term care facilities, schools, or sporting events. To identify if patients require further testing or treatment in a clinical setting. About Therma Bright Inc.

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U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older

The Pharma Data

DECEMBER 19, 2020

Today’s ACIP recommendation follows the December 1, 2020 ACIP recommendation for a Phase 1a rollout in which the first priority for COVID-19 vaccines is given to healthcare personnel treating patients and residents in long-term care facilities. Department of Health and Human Services (HHS) for review and adoption.

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Analysis Chemical Thank You EPA issues guidance for disinfectant product claims used on soft surface textiles in non-residential settings

Agency IQ

SEPTEMBER 6, 2023

OPP recommends that applicants utilize these methods to support the registration of disinfectant products with claims for efficacy against viruses and bacteria when used on soft-porous surfaces Surfaces in clinical and/or institutional environments (non-residential) are within the scope of this guidance and include non-clothing fabrics and textiles/upholstery (..)

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FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients.

FDA Approval

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Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly subsequently developed bamlanivimab and etesevimab for administration together, in order to meet the potential challenge of SARS-CoV-2 variants likely to resist treatment with either monoclonal antibody used alone.

Government

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Drop in COVID Cases Seen in Nursing Homes as U.S. Vaccine Effort Makes Headway

The Pharma Data

FEBRUARY 1, 2021

million shots have now been administered in long-term care facilities, according to the U.S. The variant is perhaps the most worrisome to public health experts, because it seems to have some ability to evade COVID-19 antibody treatments or vaccines. “I’m optimistic, this is good.”

Nurses

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Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19

The Pharma Data

OCTOBER 28, 2020

Lilly submitted a request for an EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Food and Drug Administration (FDA).

Government

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FDA Advisory Panel Says Yes to Pfizer’s COVID Vaccine

The Pharma Data

DECEMBER 10, 2020

First in line are health care personnel and residents and staff of long-term care facilities, according to earlier recommendations released by the CDC panel. Centers for Disease Control and Prevention will also vote on whether to recommend the vaccine and for whom, the Post reported.

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Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19

The Pharma Data

JUNE 25, 2021

While COVID-19 vaccination efforts have been successful, there is still a significant need for prevention and treatment options for certain populations, including those unable to be vaccinated or those who may have an inadequate response to vaccination.”. Preliminary analyses show similar adverse events in the placebo and treatment arms.

Trials

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Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

The Pharma Data

NOVEMBER 9, 2020

Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Sites of care will then confirm their need and AmerisourceBergen will distribute bamlanivimab overnight.

Treatment

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bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

The Pharma Data

APRIL 16, 2021

for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. Lilly developed bamlanivimab and etesevimab for administration together to meet the potential challenge of treatment-resistant variants likely to resist treatment with either monoclonal antibody used alone.

Treatment

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EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

The Pharma Data

MARCH 5, 2021

The opinion advises bamlanivimab alone and bamlanivimab administered together with etesevimab can be used for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19. The CHMP scientific opinion under Article 5.3

Treatment

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New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence,” said Daniel Skovronsky, M.D., It is not known if bamlanivimab is safe and effective for the treatment of COVID-19. .

Hospitals

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

The Pharma Data

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. Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA.

Therapies

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Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

National Institute of Allergy and Infectious Diseases (NIAID), of bamlanivimab (LY-CoV555) decreased the risk of COVID-19 among residents and staff of long-term care facilities, i.e., nursing homes. Eli Lilly announced that its BLAZE-2 clinical trial conducted with the U.S. Non-COVID-19-Related.

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Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

The Pharma Data

MARCH 11, 2021

In this new Phase 3 cohort, there were four deaths total, all of which were deemed related to COVID-19 and all of which occurred in patients taking placebo; no deaths occurred in patients receiving treatment with bamlanivimab and etesevimab together. Lilly’s chief scientific officer and president of Lilly Research Laboratories.

Hospitals

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Drug Discovery Digest

COVID-19 Vaccine Developers Adjust Phase 3 Trial Protocols to Allow Authorized Vaccines | 2020-12-17

Therma Bright Acquires 100% Control of its COVID-19 Rapid Saliva Antigen Test and Announces Proposed Name Change for the Test

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Trending Sources

U.S. CDC Advisory Committee on Immunization Practices Recommends Vaccination with Moderna’s COVID-19 Vaccine for Persons 18 Years and Older

Webinars

Analysis Chemical Thank You EPA issues guidance for disinfectant product claims used on soft surface textiles in non-residential settings

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

Bamlanivimab alone with the U.S. government and is focusing on supply of bamlanivimab and etesevimab together

Drop in COVID Cases Seen in Nursing Homes as U.S. Vaccine Effort Makes Headway

Lilly Announces Agreement with U.S. government to Supply 300,000 vials of Investigational Neutralizing Antibody Bamlanivimab (LY-CoV555) in an Effort to Fight COVID-19

FDA Advisory Panel Says Yes to Pfizer’s COVID Vaccine

Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19

Lilly’s Neutralizing Antibody Bamlanivimab (LY-CoV555) Receives FDA Emergency Use Authorization for the Treatment of Recently Diagnosed COVID-19

bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.

EMA issues advice on Lilly’s bamlanivimab (LY-CoV555) alone and administered together with etesevimab (LY-CoV016) for the treatment of confirmed COVID-19 in the European Union

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

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

Clinical Catch-Up: January 18-22 | BioSpace

Lilly’s bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

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