FDA Approval, Hospitals, Immune Response and Vaccine

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

The Pharma Data

FEBRUARY 23, 2022

* Final analysis of the global VAT02 booster trial confirms universal ability to boost neutralizing antibodies 18- to 30-fold across vaccine platforms (mRNA, adenovirus). * efficacy against any symptomatic COVID-19 disease, in line with expected vaccine effectiveness in today’s environment dominated by variants of concern.

Vaccine

Vaccine Virus Trials Immune Response

Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

The Pharma Data

DECEMBER 16, 2020

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. The vote itself is not slated to take place until after 3 p.m.

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Vaccine Immune Response FDA FDA Approval

PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure. The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.

Vaccine

Vaccine FDA Virus Immune Response

Insights into cellular therapies for cancer treatment

Drug Target Review

FEBRUARY 21, 2024

Stem cell transplants primarily help the immune response through the “graft-versus-leukaemia effect,” and we have to manage the “graft versus host effect.” While research to optimise BiTE molecules and refine their capabilities is ongoing, this is where most FDA approvals are taking place as the field is developing so rapidly.

Therapies

Therapies Treatment FDA Approval Vaccine

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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Vaccine FDA Clinical Trials FDA Approval

Biopharma Update on the Novel Coronavirus: October 27

The Pharma Data

OCTOBER 26, 2020

FDA Actions. FDA Approval: Last week the FDA approved Veklury (remdesivir) for the treatment of COVID-19 requiring hospitalization in adults and pediatric patients (12 years of age and older). Testing Therapies, Antivirals and Vaccines. Please read more here. . Days after the U.S.

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ACTIV Update: Making Major Strides in COVID-19 Therapeutic Development

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.

Clinical Trials

Clinical Trials Hospitals Vaccine Trials

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History. CALAVI US).

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Trials Clinical Trials Immune Response FDA Approval

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

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. It also stated that companies should consider whether an investigational product might interact with an administered vaccine for Covid-19.

FDA

FDA Clinical Trials Vaccine Trials

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2).

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Vaccine Trials FDA Clinical Trials

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia, 1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Following today’s FDA approval, the U.S.

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Vaccine FDA Approval FDA Disease

Where's the Synthetic Blood?

Codon

JULY 14, 2024

This is particularly beneficial for those who need chronic transfusions and are therefore at risk of developing an immune response to transfusion products from other people, or for those with religious beliefs, like Jehovah’s Witnesses, whose faith prohibits blood transfusions from another person.

Production

Production Clinical Trials Trials Therapies

World RNA Day: What impact RNA it had on drug discovery?

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.

RNA

RNA Vaccine Drugs Disease

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

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.

Therapies

Therapies FDA Clinical Trials Hospitals

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

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.

FDA

FDA Clinical Trials Hospitals Government

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

The Pharma Data

APRIL 27, 2021

at CER driven by growth drivers Dupixent ® and Vaccines. Vaccines up 5.3%, driven by PPH franchise and demand for influenza vaccines in southern hemisphere. Vaccines delivered growth in its core segments. Polio/Pertussis/Hib vaccines (incl. Influenza vaccines (incl. Meningitis/Pneumo vaccines (incl.

Vaccine

Vaccine Production FDA FDA Approval

Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

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),

Immune Response

Immune Response Vaccine Clinical Trials FDA

FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

The Pharma Data

MARCH 29, 2022

Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series.

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Vaccine FDA FDA Approval Immune Response

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

The Pharma Data

JANUARY 29, 2021

January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints.

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Vaccine Trials Pharmaceutical Companies Immune Response

Drug Discovery Digest

Sanofi and GSK to seek regulatory authorization for COVID-19 vaccine

Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

Trending Sources

PFIZER AND BIONTECH ANNOUNCE SUBMISSION OF INITIAL DATA TO U.S. FDA TO SUPPORT BOOSTER DOSE OF COVID-19 VACCINE

Insights into cellular therapies for cancer treatment

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Biopharma Update on the Novel Coronavirus: October 27

ACTIV Update: Making Major Strides in COVID-19 Therapeutic Development

Update on CALAVI Phase II Trials for Calquence in Patients Hospitalised with Respiratory Symptoms of COVID-19

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Where's the Synthetic Blood?

World RNA Day: What impact RNA it had on drug discovery?

Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

Demonstrated a Durable Immune Response and Elicited Dual Mechanisms of Protection Against Delta and Other SARS-CoV-2 Variants of Concern in Data Published in New England Journal of Medicine

FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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