Pfizer

FEBRUARY 16, 2023

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

DECEMBER 23, 2020

All 38 subjects who were evaluable for immunogenicity had balanced cellular and humoral immune responses following the second dose of INO-4800. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune responses.

DNA 40

DNA Vaccination Vaccine Immune Response 40

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of May 6, 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. Sanofi, Empowering Life.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Chimeric PD-1 T-cells also release cytokines to further initiate immune responses to eradicate the tumor cells. Barber is an associate professor of biology and director of the Office of Student Research.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

The Pharma Data

AUGUST 20, 2020

T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We The information contained in this release is as of August 20, 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of July 21, 2021.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. Defense Advanced Research Projects Agency.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 9, 2020

During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. The information contained in this release is as of September 7, 2020. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de. BioNTech Forward-looking Statements.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

DECEMBER 20, 2020

Weber, MD, PhD, Deputy Director of the Perlmutter Cancer Center at New York University (NYU)-Langone Health, co-Director of its Melanoma Research Program Center and Chair of SELLAS’ Scientific Advisory Board. SELLAS’ lead product candidate, GPS, is licensed from MSK and targets the WT1 protein, which is present in an array of tumor types.

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

The Pharma Data

DECEMBER 29, 2020

The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The EUA is temporary and does not take the place of a formal biologics license application (BLA) submission review and approval process and the use of the antibody cocktail remains investigational.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. Jansen, Ph.D., Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

OCTOBER 28, 2020

“We continue to see the strongest effects in patients who are most at risk for poor outcomes due to high viral load, ineffective antibody immune response at baseline, or pre-existing risk factors. Yancopoulos , M.D., President and Chief Scientific Officer of Regeneron. Regeneron has shared these results with the U.S.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. “The investigational cocktail is now available to indicated high-risk U.S. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.”

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

AUGUST 3, 2021

– Second-quarter 2021 operating expenses increased 18 percent, driven primarily by higher research and development investments for late-stage assets, as well as higher relative marketing and selling expenses due to pandemic-related spending reductions in 2020. – Second-quarter 2021 earnings per share (EPS) decreased to $1.53

Antibody 52

Antibody Sales Production Development 52

Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 The information contained in this release is as of July 19, 2022.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

The Pharma Data

JUNE 26, 2021

We’ve all witnessed the promise of mRNA technology during this pandemic and are now looking to extend that promise to select annual vaccines ”, said Jean-François Toussaint, Global Head of Research and Development, Sanofi Pasteur. “ The two formulations differ in the lipid nanoparticle (LNP) that contains the mRNA.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) approved the companies’ supplemental Biologics License Application (sBLA) for their COVID-19 vaccine, known as COMIRNATY® (COVID-19 Vaccine, mRNA), to include individuals 12 through 15 years of age. The information contained in this release is as of July 8, 2022. have completed a primary series.

FDA Approval 102

FDA Approval Vaccination Vaccine Clinical Trials 102

Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA).

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

JANUARY 31, 2021

Curing HIV remains the ultimate aspiration for Gilead’s HIV research and development efforts. Gritstone’s vaccine technology has the potential to educate the immune system to specifically recognize and destroy HIV-infected cells by leveraging SAM and adenoviral vectors. This press release features multimedia. About Gilead Sciences.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

OCTOBER 20, 2022

“With more than 26 million adults over the age of 19 who have been previously vaccinated with PREVNAR 13®, today’s ACIP vote recognizes the importance of helping to protect them against the seven additional serotypes contained in PREVNAR 20®,” said Angela Hwang, President, Global Biopharma Business, Pfizer.

Vaccination 40

Vaccination Vaccine Containment Immune Response 40

The Pharma Data

JUNE 18, 2021

The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), 8,9,10,11,12 and have been associated with high case-fatality rates, 13,14,15,16 antibiotic resistance, 4,17,18 and/or meningitis. Jansen, Ph.D.,

Vaccination 52

Vaccination Vaccine FDA Approval Containment 52

The Pharma Data

SEPTEMBER 9, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, The information contained in this release is as of September 9, 2020. Jansen, Ph.D.,

Vaccination 52

Vaccination Vaccine RNA Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

This oncolytic virus has induced long-lasting antitumor immune responses and abscopal effects in several tumor models, and its activity is further enhanced through combination with an anti-PD-1 antibody treatment. The Company’s validated, proprietary F.I.R.S.T

Trials 52

Trials Antibody Clinical Trials Clinical Trials 52

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. Department of Health and Human Services.

Antibody 52

Antibody Production Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 15, 2020

I am proud of the truly transformational science that our research and clinical teams are bringing to the fight against disease, as well as the unprecedented speed with which we are advancing our clinical programs in the battle against COVID-19. Disclosure Notice: The information contained in this release is as of September 15, 2020.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

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. Department of Health and Human Services.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

NOVEMBER 9, 2020

executive vice president of Research and Development at Amgen. Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

DECEMBER 21, 2020

executive vice president of Research and Development at Amgen. Specifically, tezepelumab targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.

Trials 40

Trials Production Sales Manufacturing 40

The Pharma Data

DECEMBER 20, 2020

efficacy, according to the state-run Gamaleya research center and the Russian Direct Investment Fund (RDIF). The data demonstrated the vaccine elicited a combined adaptive humoral and cellular immune response and also provided insights into the composite nature of BNT162b2-induced T-cell immunity.

Trials 52

Trials Gene Therapy Vaccination Vaccine 52

The Pharma Data

MARCH 11, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The information contained in this release is as of March 11, 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).

Sales 52

Sales Vaccination Vaccine Production 52

The Pharma Data

FEBRUARY 4, 2021

In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing. glucosidase deficiency).

Sales 52

Sales Vaccination Vaccine Production 52

Pfizer

NOVEMBER 2, 2022

Pfizer is deeply proud of our continued work to explore its potential to protect against influenza and COVID-19 in one combination vaccine, which we think could simplify immunization practices against these two respiratory pathogens, potentially leading to better vaccine uptake for both diseases,” said Annaliesa Anderson, Ph.D., INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

APRIL 27, 2021

The trial program is supported by the United States’ Biomedical Advanced Research and Development Authority (BARDA). MRT5500 (SP0254), an mRNA vaccine candidate against SARS-CoV-2, entered Phase 1/2 to assess safety, immune response and reactogenicity. Research and Development (R&D) expenses decreased 5.5%

Sales 52

Sales Vaccination Vaccine Medicine 52