Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.

Development 161

Development Production Immune Response Licensing 161

Pharmaceutical Technology

AUGUST 24, 2022

A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples. With an increased focus on personalized medicine, including immunotherapy, there’s high demand for FCM.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

The Pharma Data

DECEMBER 11, 2020

Thermo Fisher joined forces with the University of Oxford to harness its academic research capabilities in quantifying IgG antibodies and understanding each patient’s immune response to SARS-CoV-2. Sensitech technology helps to ensure the container refrigeration units can deliver a temperature control within +/- 0.25-degrees

Antibody 52

Antibody Vaccine Vaccination 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. has a fever. Pfizer Disclosure Notice.

Vaccine 111

Vaccine Vaccination Protein Immune Response 111

The Pharma Data

SEPTEMBER 14, 2020

. AstraZeneca has confirmed that clinical trials assessing its Oxford University partnered coronavirus vaccine AZD1222 have resumed in the UK, following a green light by the Medicines Health Regulatory Authority (MHRA). AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. Source link.

Vaccine 52

Vaccine Vaccination Trials Immune Response 52

The Pharma Data

DECEMBER 16, 2020

Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M to enhance the immune response. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. About Novavax.

Protein 52

Protein Vaccine Vaccination Immune Response 52

The Pharma Data

DECEMBER 13, 2020

Nasdaq: SYBX ), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced SYNB1891 has advanced into the combination therapy stage of the ongoing Phase 1 trial. CAMBRIDGE, Mass. , 14, 2020 /PRNewswire/ — Synlogic, Inc. Synlogic’s President and Chief Executive Officer.

Immune Response 40

Immune Response Engineer Medicine Containment 40

The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , 17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc.

Antibody 52

Antibody Medicine Production Trials 52

The Pharma Data

SEPTEMBER 3, 2020

The data, published today in Nature Medicine , demonstrated that the Company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge.

Vaccine 52

Vaccine Vaccination Immune Response Antibody 52

The Pharma Data

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. About Pneumococcal Disease.

Vaccine 52

Vaccine Vaccination Immune Response Containment 52

The Pharma Data

OCTOBER 25, 2020

The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. About Moderna. Forward-Looking Statements.

Vaccine 52

Vaccine Vaccination Manufacturing Clinical Development 52

Pfizer

FEBRUARY 16, 2023

Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies and subject to the agreement of these regulatory agencies to proposed modifications of the clinical trial plan.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccine Vaccination 76

The Pharma Data

JUNE 26, 2021

We believe that mRNA technology could have several advantages for a seasonal flu application including the potential ability to demonstrate robust immune responses based on preclinical data to date, enable antigen specificity within a short timeframe from seasonal virus strain selection, and deploy agile manufacturing capacity.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccine Vaccination 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 lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas , Professor of Medicine at the Hospital of the University of Pennsylvania. .

DNA 40

DNA Vaccination Vaccine Immune Response 40

pharmaphorum

OCTOBER 31, 2022

These mice contain the “full repertoire” of human heavy chain immunoglobulin genes and kappa light chain genes, each linked to the endogenous mouse constant regions. The “normal and robust” immune response exhibited has become what is considered to be the “gold standard” for developing human antibody therapeutics.

Production 52

Production FDA Approval Antibody Gene 52

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. Forward-Looking Statements.

Vaccine 52

Vaccine Vaccination Immune Response Protein 52

Pfizer

JULY 8, 2022

Pfizer and BioNTech also filed these data with the European Medicines Agency (EMA) and other regulatory authorities around the world. are immunocompromised or are on a medicine that affects the immune system. The information contained in this release is as of July 8, 2022. have a fever. Pfizer Disclosure Notice.

FDA Approval 102

FDA Approval Vaccine Vaccination 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. is immunocompromised or is on a medicine that affects the immune system. The information contained in this release is as of July 8, 2022. has a fever.

Vaccine 81

Vaccine Vaccination Clinical Trials Clinical Trials 81

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech Procedures should be in place to avoid injury from fainting. BioNTech COVID-19 Vaccine.

Vaccine 52

Vaccine Vaccination Immune Response Licensing 52

The Pharma Data

FEBRUARY 23, 2022

The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favorable safety profile in multiple settings. Figure 1a – Pre- vs post-booster neutralizing antibody titers in 18-55-yr old participants.

Vaccine 52

Vaccine Vaccination Antibody Protein 52

The Pharma Data

SEPTEMBER 9, 2020

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, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? Pfizer Disclosure Notice. BioNTech Forward-looking statements.

Vaccine 52

Vaccine Vaccination RNA Clinical Trials 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 Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 17, 2020

This new study will complement Mymetics’ other preclinical Covid-19 studies that are ongoing at Baylor College of Medicine in Texas USA and the Helmholtz Center of Infection Research in Germany. For further information, please visit www.mymetics.com.

Vaccine 40

Vaccine Vaccination Containment Development 40

The Pharma Data

DECEMBER 11, 2020

We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” said Ugur Sahin, M.D., Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need.

Vaccine 52

Vaccine Vaccination Clinical Trials 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. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., The information contained in this release is as of May 7, 2021. “Following the successful delivery of more than 170 million doses to the U.S.

Licensing 52

Licensing Licensing Vaccine Vaccination 52

The Pharma Data

JANUARY 31, 2021

Delivery of viral antigens in potent vaccine vectors to elicit a strong immune response is a cornerstone of successful infectious disease vaccines,” said Karin Jooss, PhD, Executive Vice President of Research and Chief Scientific Officer of Gritstone. For more information, please visit gritstoneoncology.com. About Gilead Sciences.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

9, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. THOUSAND OAKS, Calif. ,

Trials 52

Trials Production Sales Manufacturing 52

The Pharma Data

JULY 21, 2021

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. Procedures should be in place to avoid injury from fainting. Pfizer Disclosure Notice.

Vaccine 52

Vaccine Vaccination Manufacturing Clinical Trials 52

The Pharma Data

MAY 6, 2021

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. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Vaccine 52

Vaccine Vaccination Clinical Trials Clinical Trials 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 21, 2020

The 48-week trial assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC). THOUSAND OAKS, Calif. , For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Trials 40

Trials Production Sales Manufacturing 40

Pharmaceutical Technology

MAY 25, 2023

The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The response was more powerful than that generated by MenACWY-D – a licensed quadrivalent meningococcal vaccine marketed by GSK.

Vaccine 195

Vaccine Vaccination Immune Response Bacteria 195

The Pharma Data

DECEMBER 27, 2020

Our basic approach is akin to transplant medicine, in which specific cell types are used to replace the ones which have been lost to disease, not unlike a bone marrow transplant. Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.

Manufacturing 40

Manufacturing Production Development Clinical Trials 40

XTalks

DECEMBER 20, 2021

“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products in the statement from the global health agency. Gavi secured 1.1

Vaccine 96

Vaccine Vaccination Protein Manufacturing 96

pharmaphorum

MAY 11, 2021

Called eRNA for short, this class of medicines is programmable and can continuously express therapeutic proteins inside the body. This makes the body into a “drug factory”, allowing for long-lasting medicines that allow for repeat redosing and can be administered easily by several routes.

RNA 98

RNA Drugs Protein Immune Response 98

The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

Vaccine 52

Vaccine Vaccination Trials Medicine 52