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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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

OCTOBER 14, 2020

These dual constructs (bivalent sequences) of SARS-CoV-2 offer the potential for the hAd5 vaccine to provide recipients with durable, long-term cell-mediated immunity with potent antibody stimulation against both the S and N proteins. based Hoag Hospital this month with adult subjects up to age 55.

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The Pharma Data

NOVEMBER 20, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos, M.D.,

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The Pharma Data

NOVEMBER 21, 2020

The clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as REGEN-COV2 have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load. Yancopoulos , M.D.,

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Drug Discovery World

AUGUST 1, 2023

As such, the company has entered into a sponsored research agreement with the Children’s Hospital of Philadelphia (CHOP) in the US to develop a TUBB4A-related leukodystrophy treatment from ASOs. This Phase I trial will test the experimental vaccine, known as H1ssF-3928 mRNA-LNP, for safety and its ability to induce an immune response.

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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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The Pharma Data

JULY 15, 2021

Antibody and T-cell immune responses strong and stable at eight months after immunization Demonstrated neutralizing antibody activity against the Delta variant (B.1.617.2) of Beth Israel Deaconess Medical Center suggest maturation of B-cell response without further boosting. 1.1.7), Beta (B.1.351), 1.351), Gamma (P.1),

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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

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. Global Head, Janssen Research & Development.

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