The Pharma Data

JULY 23, 2021

Vaccines have been and will remain critical to protecting lives against this devastating disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. “As a long-term partner to the U.S. These additional doses will help the U.S.

Vaccine 52

Vaccine Government Immune Response FDA 52

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 primary endpoint of the Phase 3 segment will be virologically confirmed COVID-19 disease. . PLYMOUTH MEETING, Pa. ,

DNA 40

DNA Vaccine Immune Response Clinical Trials 40

The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines ( [link] ). AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S.

Vaccine 52

Vaccine Clinical Trials Trials FDA 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

JULY 21, 2021

We believe that our mRNA technology can be used to develop vaccine candidates addressing other diseases as well. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. CEO and Co-founder of BioNTech. “We AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 29, 2020

Early interim data show Cytomegalovirus (CMV)-negative kidney transplant recipients vaccinated with three doses of HB-101 had reduced incidence of CMV viremia, reduced antiviral use and no CMV disease. Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results.

Vaccine 52

Vaccine Clinical Trials Disease Trials 52

Drug Discovery World

FEBRUARY 3, 2023

A research group from the National Institutes of Health has successfully developed a vaccine against Sudan virus (SUDV) based on the licensed Ebola virus (EBOV) vaccine. SUDV, identified in 1976, is one of the four viruses known to cause human Ebolavirus disease.

Virus 130

Virus Vaccine Immune Response Licensing 130

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.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

The Pharma Data

SEPTEMBER 8, 2020

(LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Cambridge, UK.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 52

The Pharma Data

SEPTEMBER 8, 2020

About AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

Science 52

Science Vaccine Clinical Trials Pharmaceutical Companies 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.

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 17, 2020

Have chronic kidney disease. Have immunosuppressive disease. cardiovascular disease, OR. chronic obstructive pulmonary disease/other chronic respiratory disease. sickle cell disease, OR. congenital or acquired heart disease, OR. Have diabetes. Are currently receiving immunosuppressive treatment.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

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. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”. “It View the full release here: [link].

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 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. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

DECEMBER 10, 2020

These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. 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.

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

FEBRUARY 8, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

FEBRUARY 4, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% Fabrazyme ® was launched in China in May and is the first treatment for Fabry disease approved in China. Net sales (€ million). Fabrazyme ®.

Vaccine 52

Vaccine Production FDA Pharmaceuticals 52

Drug Target Review

FEBRUARY 28, 2024

Crain’s New York Business recognised Kate as one of the top women in tech in 2019. Human γδ TCR repertoires in health and disease. gammadelta T cells link innate and adaptive immune responses. Normality sensing licenses local T cells for innate-like tissue surveillance. References Fichtner A, Ravens S, Prinz I.

Therapies 105

Therapies Engineering Molecular Biology Immune Response 105

New Drug Approvals

DECEMBER 16, 2023

2 This is of particular importance to PNH, where one of the disease hallmarks is the mutation of the PIGA gene. 5] [6] Iptacopan is also investigated as a drug in other complement-mediated diseases, like age-related macular degeneration and some types of glomerulopathies. [7] April 2019). 1] It is taken by mouth. [1]

FDA 62

FDA Small Molecule FDA Approval Treatment 62

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. Have chronic kidney disease.

Therapies 52

Therapies FDA Clinical Trials Hospitals 52

The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. “Severe asthma is a challenging, complex disease for physicians and millions of patients and has a high unmet medical need,” said David M. Reese, M.D.,

FDA 52

FDA Trials Therapies Treatment 52

The Pharma Data

SEPTEMBER 9, 2020

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease. producing CD8+ T cell responses, which is thought to promote an anti-viral effect.

Vaccine 52

Vaccine RNA Clinical Trials Immune Response 52

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation. Rare Disease.

Vaccine 52

Vaccine Therapies Trials Clinical 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. Have chronic kidney disease. cardiovascular disease, OR.

FDA 40

FDA Clinical Trials Hospitals Government 40

The Pharma Data

OCTOBER 28, 2020

29, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the potential pathway to marketing approval for its lead product candidate remestemcel-L. NEW YORK, Oct.

Treatment 40

Treatment Trials Production Disease 40

The Pharma Data

OCTOBER 14, 2020

(Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the observational PRECISION study (TNX-C002), to examine the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic.

Vaccine 40

Vaccine Pharmaceuticals Small Molecule Virus 40

The Pharma Data

NOVEMBER 9, 2020

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. 6,7 Approximately 10% of asthma patients have severe asthma.

Trials 52

Trials Production Clinical Trials Government 52

The Pharma Data

AUGUST 22, 2021

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. Under the terms of the licensing agreement with Vanderbilt, AstraZeneca will pay single-digit royalties on future net sales. Approximately 15% of participants were Hispanic.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. Their cone cells, which are responsible for color vision, don’t work like normal. They’re talking about a patient who has a rare genetic disease. In 2019, about 4,000 Americans were waiting for a heart at any given time.)

Therapies 52

Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

CNGA3-achromatopsia is a hereditary disease that causes people to see in shades of gray. Their cone cells, which are responsible for color vision, don’t work like normal. They’re talking about a patient who has a rare genetic disease. In 2019, about 4,000 Americans were waiting for a heart at any given time.)

Therapies 52

Therapies RNA DNA Engineering 52

The Pharma Data

DECEMBER 21, 2020

Severe asthma is a complex, heterogenous disease and many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

Trials 40

Trials Production Clinical Trials Government 40

The Pharma Data

APRIL 27, 2021

Rare Disease. Others Rare Disease. Total Rare Disease. In the first quarter, Rare Disease sales increased 4.4% up 60%) driven by increase disease and product awareness as well as adoption of new ISTH (International Society on Thrombosis and Haemostasis) TTP guidelines. Net sales (€ million). Change at CER.

Vaccine 52

Vaccine Production FDA FDA Approval 52

The Pharma Data

MARCH 11, 2021

NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced real-world evidence demonstrating dramatically lower incidence rates of COVID-19 disease in individuals fully vaccinated with the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2), underscoring the observed substantial public health impact of Israel’s nationwide immunization program.

Vaccine 52

Vaccine Clinical Trials Hospitals Licensing 52

The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines ( [link] ). AUTHORIZED USE IN THE U.S.: IMPORTANT SAFETY INFORMATION FROM U.S.

Government 52

Government Vaccine Clinical Trials Licensing 52

The Pharma Data

FEBRUARY 24, 2022

The Committee considered that the available evidence was sufficient to conclude that the immune response to a booster dose in adolescents would be at least equal to that in adults. No new safety concerns were identified from the data available. For more than 170 years, we have worked to make a difference for all who rely on us.

Vaccine 52

Vaccine FDA Small Molecule Immune Response 52