The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. The study showed this broad immune response led to the complete clearance of the virus in a matter of days after infection of previously-vaccinated primates. and its affiliate NantKwest, Inc.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

DECEMBER 18, 2020

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts. ” The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. SILVER SPRING, Md. ,

Vaccination 52

Vaccination Vaccine Production Manufacturing 52

The Pharma Data

DECEMBER 11, 2020

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. Manufacturing and Delivery Capabilities. Germany, Turkey, South Africa, Brazil and Argentina. Pfizer is leveraging three of its U.S.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

XTalks

AUGUST 17, 2020

Immune system modulators (i.e. receptors) of the immune system to enhance, or suppress immune responses. Cell-based immune therapies, including CAR-T cell therapy, have had some marked success, particularly in hematological cancers such as acute lymphocytic leukemia (ALL). Nature by Design.

Protein 98

Protein Engineer Immune Response In-Vivo 98

Drug Discovery World

MAY 29, 2024

Hummersone shares that when it comes to purification, many of the processes that are being used now have been repurposed from monoclonal antibodies, and so they work, but they don’t work efficiently – the same can be said for the upstream processes for the manufacturing parts. This, he says, minimises any sort of target immune responses.

Gene Therapy 109

Gene Therapy Gene Genetics DNA 109

The Pharma Data

DECEMBER 10, 2020

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. The information contained in this release is as of December 10, 2020. Germany, Turkey, South Africa, Brazil and Argentina.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

The Pharma Data

DECEMBER 27, 2020

Our work began modestly, but we hit our stride in 2020 and reached important clinical, manufacturing, and business milestones this year, which created substantial value and advanced us toward our ultimate goal. Our goal of building Lineage into the preeminent cell therapy company is ambitious but attainable.

Manufacturing 52

Manufacturing Production Development 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 company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. and Roche will develop, manufacture and distribute it outside the U.S.

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

Vaccination 52

Vaccination Vaccine FDA Approval Containment 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. INTERCHANGEABILITY. Pfizer Disclosure Notice.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

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. and Roche will develop, manufacture and distribute it outside the U.S. Yancopoulos , M.D., combined dose groups; 6.5%

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

DECEMBER 17, 2020

The development and manufacturing of the antibody cocktail has been funded in part with federal funds from BARDA under OT number: HHSO100201700020C. If the therapy proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will manufacture and distribute it in the U.S. ,

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

OCTOBER 14, 2020

Additionally, immunogenicity, duration of immune response and occurrence of symptomatic COVID-19 will be measured. agreed to share equally the costs of development, manufacturing, marketing and commercialization of the products each is developing related to COVID-19, including the hAd5 vaccine candidate.

Antibody 52

Antibody Vaccination Vaccine Trials 52

Drug Discovery World

MAY 11, 2023

However, the increased complexity and diversity involved in the development and manufacturing of gene therapies and vaccines can cause challenges when it comes to determining the quality of the final product, particularly around the detection of impurities. In the case of therapeutics, the aim is usually to avoid patients’ immune responses.

Production 52

Production Gene Protein Vaccination 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. INTERCHANGEABILITY.

Vaccination 100

Vaccination Vaccine Medicine Clinical Trials 100

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

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

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.

Antibody 52

Antibody Production Clinical 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.

Antibody 40

Antibody Production Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 4, 2021

Tiragolumab is the first anti-TIGIT molecule to be granted BTD from the FDA, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Vaccination 52

Vaccination Vaccine Trials Containment 52

Pfizer

NOVEMBER 2, 2022

The flexibility and manufacturing speed of the mRNA technology has demonstrated that it is well-suited for other respiratory diseases. The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron BA.4/BA.5

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

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.

Sales 52

Sales Vaccination Vaccine Medicine 52

XTalks

OCTOBER 16, 2020

The FDA approval is based on results from the large, multi-center clinical trial called PALM (PAmoja TuLinde Maisha) in which Inmazeb showed superiority over other antiviral investigational agents, namely ZMapp and remdesivir, with respect to mortality. Targeted Antiviral Treatment.

Antibody 98

Antibody Drugs Clinical Trials Clinical Trials 98

The Pharma Data

JANUARY 29, 2021

The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. Please dial (877) 869-3847 in the U.S.

Vaccination 40

Vaccination Vaccine Trials Immune Response 40