The Pharma Data

OCTOBER 28, 2020

REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits and/or physician office/telemedicine visits). In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 There was a 1.08

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The Pharma Data

FEBRUARY 23, 2022

. * In the VAT08 Phase 3 primary series trial, two doses of the Sanofi-GSK vaccine in seronegative populations demonstrated: * 100% efficacy against severe COVID-19 disease and hospitalizations * 75% efficacy against moderate or severe COVID-19 disease * 57.9% Favorable safety profile following both primary series and booster vaccinations.

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The Pharma Data

DECEMBER 23, 2020

While the overall understanding of the condition is as novel as the virus that causes it, a recent survey from the U.K.’s Leronlimab, which is a viral-entry inhibitor against the CCR5 receptor, is originally intended as an HIV drug, though it has yet to receive FDA approval in this disease area. said in a statement.

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The Pharma Data

OCTOBER 29, 2020

We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS.

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Broad Institute

APRIL 25, 2024

Sabeti and her lab had also responded quickly to Ebola in 2014, working with hospitals and government officials in Sierra Leone to sequence viral genomes from patients and make the data available to local communities. Ozonoff is also an associate professor of pediatrics at Harvard Medical School and a scientist at Boston Children’s Hospital.

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Broad Institute

FEBRUARY 8, 2024

By Allessandra DiCorato February 8, 2024 Credit: NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland Scanning electron image of the Lassa virus budding off a cell. Other scientists had discovered that this gene was critical for the Lassa virus to enter cells.

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The Pharma Data

DECEMBER 12, 2020

“More than 100,000 in long-term care have died from this virus in the U.S. and our nursing homes are now experiencing the worst outbreak of new cases since last spring, with more than 2,000 residents succumbing to this virus each week.” Third of Americans live where hospitals are short on ICU beds. and Troy, Mich. —

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The Pharma Data

JANUARY 12, 2021

Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. Regeneron Pharmaceuticals, Inc. NASDAQ: REGN ) today announced that the U.S. Yancopoulos , M.D.,

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The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. PALO ALTO, Calif., Outside the U.S.,

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The Pharma Data

DECEMBER 29, 2020

29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. TARRYTOWN, N.Y. , Regeneron Pharmaceuticals, Inc.

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The Pharma Data

NOVEMBER 20, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . “The Yancopoulos, M.D.,

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The Pharma Data

OCTOBER 30, 2020

Gilead’s Veklury (remdesivir) is First Approved Treatment for COVID-19 . In October, the US Food and Drug Administration (FDA) approved the first treatment for COVID-19, Gilead’s antiviral drug Veklury (remdesivir). hospitals. kg or hospitalized pediatric patients weighing 3.5 It is widely available in U.S.

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The Pharma Data

DECEMBER 16, 2020

To this point, Moderna has only submitted two months of follow-up safety data, and the FDA typically requires six months for a full approval. intends to ship just shy of six million doses of Moderna’s vaccine once the FDA approves EUA. Both vaccines have shown about 95% efficacy in preventing novel coronavirus infections.

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The Pharma Data

JULY 29, 2021

Hepatitis B virus (“HBV”) and hepatitis delta virus (“HDV”) product sales increased 8% to $237 million for the second quarter 2021 compared to the same period in 2020. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations. Total second quarter 2021 revenue of $6.2

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The Pharma Data

MARCH 29, 2022

The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death.

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The Pharma Data

NOVEMBER 21, 2020

Casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. . Yancopoulos , M.D.,

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The Pharma Data

DECEMBER 18, 2020

. “ With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen M. Hahn , M.D.

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The Pharma Data

OCTOBER 24, 2020

The country could soon be facing its worst stretch of the pandemic, with some hospitals in the West and Midwest already overwhelmed and death counts beginning to rise, the Post reported. Already, hospitals are reporting shortfalls of basic drugs needed to treat COVID-19 infections. Remdesivir gets full FDA approval to treat COVID-19.

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The Pharma Data

NOVEMBER 21, 2020

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. Hahn , M.D.

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The Pharma Data

NOVEMBER 5, 2020

FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). REGN-COV2 , a dual antibody therapy to SARS-CoV-2 virus. Regeneron Pharmaceuticals, Inc. Schleifer , M.D.,

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration advisory panel will vote on Thursday whether to recommend emergency approval of Pfizer’s coronavirus vaccine, a decision that will come not a moment too soon as the country reported more than 3,000 new COVID-19 deaths on Wednesday. Third of Americans live where hospitals are short of ICU beds.

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The Pharma Data

OCTOBER 23, 2020

Remdesivir gets full FDA approval to treat COVID. Remdesivir’s full approval Thursday by the FDA comes after the agency granted it emergency use authorization last spring. It is given intravenously to hospitalized patients. The drug works by blocking the ability of the virus to replicate itself.

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The Pharma Data

DECEMBER 11, 2020

Operation Warp Speed, the White House-led initiative to develop and distribute vaccines, has already said it plans to begin shipping the vaccine to all 50 states within 24 hours of an FDA approval. Third of Americans live where hospitals are short on ICU beds. Initially, a shipment of 2.9 The companies have negotiated a $2.1

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The Pharma Data

OCTOBER 14, 2020

based Hoag Hospital this month with adult subjects up to age 55. By targeting the nucleocapsid protein on the interior of the virus particle as well as the spike protein on the virus’s surface, we believe this vaccine can stimulate both T-cell-mediated and antibody-mediated immunity to SARS-CoV-2.”.

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The Pharma Data

JANUARY 29, 2021

Prevention of severe disease; protection against COVID-related hospitalization and death The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, [i] 28 days after vaccination in all adults 18 years and older. COV2-S (SARS-CoV-2 vaccine) FDA Approval History. i] [link] [ii] The B.1.351

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The Pharma Data

NOVEMBER 30, 2020

We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. Source: Moderna, Inc. . Source link.

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The Pharma Data

DECEMBER 8, 2020

During the call, Takeda provided a deep dive into TAK-721, which has the potential to be the first FDA-approved agent for the treatment of eosinophilic esophagitis (EoE), and TAK-003, which is a live attenuated tetravalent vaccine for prevention of dengue disease.

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NIH Director's Blog: Drug Development

FEBRUARY 16, 2021

hospitals are stretched to the limit trying to help people battling serious cases of COVID-19. This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. Credit: NIH Right now, many U.S.

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Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. supplemental oxygen, mechanical ventilation). These topics were covered in the body of the guidance and were addressed in two new appendices.

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The Pharma Data

JANUARY 26, 2021

“The death toll from COVID-19 continues to rise around the world and hospitalizations, particularly in the U.S., These data further support our belief that bamlanivimab and etesevimab together have the potential to be an important treatment that significantly reduces hospitalizations and death in high-risk COVID-19 patients.

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The Pharma Data

MAY 4, 2021

Direct Relief will allocate donations of baricitinib to low- and lower-middle-income countries (based on World Bank classification) for the treatment of hospitalized COVID-19 patients requiring supplemental oxygen, based on requests from these governments to Direct Relief.

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Agency IQ

NOVEMBER 3, 2023

According to the FDA, a recombinant LBP is distinctive from a standard LBP. In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP. AgencyIQ is planning a deeper dive into these recent actions by the FDA. What’s next?

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The Pharma Data

APRIL 27, 2021

At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. Developed as part of a joint-partnership between Sanofi and Merck, Vaxelis ® is the first and only hexavalent combination vaccine approved in the U.S. First-quarter sales in the U.S.

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Eye on FDA

AUGUST 8, 2022

That means there is an increasing amount of virus out there. The virus has mainly spread among men who have sex with men and transmission is being attributed to skin contact. It is also a virus that can move between people and animals. Monkeypox is not COVID, and COVID was not AIDS. There are big differences between the three.

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The Pharma Data

MAY 4, 2021

An initial donation of 400,000 baricitinib tablets is being made immediately available to the Indian government for eligible hospitalized COVID-19 patients in India and Lilly will work urgently to increase the quantity of donated product multifold over the coming weeks. Ricks , Lilly chairman and CEO.

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The Pharma Data

MAY 26, 2023

Pfizer’s PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. 1) “Great advancements have been made in the fight against COVID-19, yet the virus remains a present and unpredictable concern. NYSE: PFE) announced today that the U.S. More than 11.6 More than 11.6

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Codon

AUGUST 26, 2024

After the outbreak ended, it took another three years for the first Ebola vaccine by Merck to be approved. When COVID-19 emerged in 2019, by contrast, mRNA vaccines developed by Pfizer and Moderna took just 326 days from the initial sequencing of the virus to gaining approval for emergency use. Unsubscribe any time.

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