Disease, Long-Term Care Facilities and Vaccine

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

The Pharma Data

DECEMBER 17, 2020

COVID-19 vaccine developers are faced with an ethical quandary — whether to let phase 3 trial participants become “unblinded” and to receive authorized vaccines as they become available, which could hinder the collection of meaningful trial data. Pfizer, which has received emergency approvals in the U.S.

Vaccine

Vaccine Trials Long-Term Care Facilities FDA

Keys to Success in Vaccine Development for Special Populations

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

Vaccine

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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

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the U.S. 11 ACIP members voted in favor of the vaccine and 0 members voted against. We look forward to vaccinations of this important population starting this week.”. .–( BUSINESS WIRE )– Moderna, Inc.,

Vaccine

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Bridging Innovation & Patient Care: The Growing Role of AI

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Health Care Workers, Nursing Home Residents to Get First Vaccines: Panel

The Pharma Data

DECEMBER 1, 2020

1, 2020 — Health care workers and people in nursing homes should be at the front of the line for upcoming COVID-19 vaccines, a U.S. Centers for Disease Control and Prevention advisory panel recommended Tuesday. The logic is that health care workers are crucial to keeping overtaxed U.S. health care systems working.

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Keeping tabs on Covid-19: BioNTech buys GMP-certified facility to boost vaccine…

The Pharma Data

SEPTEMBER 18, 2020

This week Pharma IQ looks at how the pharma industry is expanding its vaccine manufacturing and testing protocols to ensure the deadly Covid-19 outbreak yields in its spread around the globe. . BioNTech acquires Novartis GMP manufacturing site to expand Covid-19 vaccine production.

Vaccine

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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

1, 2021 — As America’s vaccination campaign begins to gain momentum, a promising sign has emerged: Federal data shows that coronavirus cases in nursing homes have declined over the past four weeks. Since the rollout began, nursing home residents and staff have been prioritized as among the first groups to get the vaccine.

Nurses

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FDA Advisory Panel Says Yes to Pfizer’s COVID Vaccine

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration advisory panel recommended on Thursday that the agency authorize the emergency use of Pfizer’s coronavirus vaccine, clearing the way for a national campaign to inoculate enough Americans to stop the spread of COVID-19. The FDA is expected to authorize the vaccine’s use within days, the Post reported.

Vaccine

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Britain Approves Emergency Use of Pfizer’s COVID Vaccine

The Pharma Data

DECEMBER 2, 2020

2, 2020 – Britain became the first Western country to allow emergency use of a coronavirus vaccine on Wednesday, after approving Pfizer’s candidate in the race to inoculate millions of people around the globe. But there are daunting obstacles to the vaccine’s delivery to the masses. WEDNESDAY, Dec.

Vaccine

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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

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Government

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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 scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. .

Government

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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.”. The PROVENT trial will give us more clarity in this patient population.

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

“The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus,” said Daniel Skovronsky, M.D., www.lilly.com?and?www.lilly.com/news.?P-LLY.

Treatment

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

The Pharma Data

APRIL 16, 2021

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Treatment

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Clinical Catch-Up: January 18-22 | BioSpace

The Pharma Data

JANUARY 24, 2021

Gritstone Oncology , based in Emeryville, California, announced that it is advancing development of its own second-generation vaccine against COVID-19. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. It is being administered together with FOLFOX chemotherapy.

Long-Term Care Facilities

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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

Lilly will donate both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together – providing options to treat COVID-19 patients at different stages of the disease. ” The allocation of therapies will be based on the disease burden and hospitalization rates in each country.

Therapies

Therapies Hospitals Treatment FDA Approval

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 company is focused on areas with the highest disease burden and global allocations are made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet need, no matter where they live. while bamlanivimab and etesevimab together is currently authorized for emergency use in the U.S.

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

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. .

Hospitals

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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

Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Hospitals

Hospitals Trials Long-Term Care Facilities Treatment

ECDC and EMA highlight considerations for additional and booster doses.

The Pharma Data

SEPTEMBER 6, 2021

Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued by the European Centre for Disease Prevention and Control (ECDC). EMA will also be assessing data on booster doses.

Long-Term Care Facilities

Long-Term Care Facilities Vaccine Immune Response Virus

Study Suggests Link Between Sleep Supplement and COVID-19

The Pharma Data

DECEMBER 21, 2020

Its role as a moderator may lead to it one day protecting the body from going haywire when exposed to disease. However, there are two vaccines that have been authorized in the U.S. Both vaccines require two doses, according to USA Today. The vaccines work by presenting this spike protein to the immune system.

Long-Term Care Facilities

Long-Term Care Facilities Vaccine Virus Clinical Trials

Biden Will Ask Americans to Wear Masks for 100 Days

The Pharma Data

DECEMBER 4, 2020

As for Fauci, Biden made it clear that the nation’s top infectious diseases expert would be a central player in the U.S. Britain First to Approve Emergency Use of Pfizer’s COVID vaccine. But there are daunting obstacles to the vaccine’s delivery to the masses. Just 100 days to mask — not forever, just 100 days.

Vaccine

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Biden Says He Will Release All Vaccine Doses After Taking Office

The Pharma Data

JANUARY 8, 2021

8, 2021 — President-elect Joe Biden plans to release nearly all available doses of COVID-19 vaccine when he takes office, reversing the Trump administration’s strategy of holding back half the supply to ensure second doses are available. Centers for Disease Control and Prevention. FRIDAY, Jan.

Vaccine

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CDC Director Warns of Dire Winter Ahead for COVID Hospitalizations, Deaths

The Pharma Data

DECEMBER 3, 2020

Centers for Disease Control and Prevention warned Wednesday that the coming winter months might be the darkest period yet in the coronavirus pandemic. ” Britain First to Approve Emergency Use of Pfizer’s COVID vaccine. But there are daunting obstacles to the vaccine’s delivery to the masses. THURSDAY, Dec.

Hospitals

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‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

The Pharma Data

DECEMBER 31, 2020

million doses of the approved Pfizer and Moderna COVID-19 vaccines had been distributed across the United States by Monday morning, just 2.1 That’s far too slow a pace, said one official charged with spearheading the vaccination of Americans. million vaccination tally — compiled by the U.S. . THURSDAY, Dec.

Vaccine

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Drug Discovery Digest

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

Keys to Success in Vaccine Development for Special Populations

Webinars

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

Health Care Workers, Nursing Home Residents to Get First Vaccines: Panel

Keeping tabs on Covid-19: BioNTech buys GMP-certified facility to boost vaccine…

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

FDA Advisory Panel Says Yes to Pfizer’s COVID Vaccine

Britain Approves Emergency Use of Pfizer’s COVID Vaccine

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

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

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.

Clinical Catch-Up: January 18-22 | BioSpace

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

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

ECDC and EMA highlight considerations for additional and booster doses.

Study Suggests Link Between Sleep Supplement and COVID-19

Biden Will Ask Americans to Wear Masks for 100 Days

Biden Says He Will Release All Vaccine Doses After Taking Office

CDC Director Warns of Dire Winter Ahead for COVID Hospitalizations, Deaths

‘Warp Speed’ Officials Say U.S. COVID Vaccine Distribution Too Slow

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