The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Keitma/Shutterstock.

Immune Response 52

Immune Response Clinical Trials Licensing Licensing 52

Drug Discovery World

APRIL 20, 2023

SARS-CoV-2 particles spread through the respiratory mucosa and other infected cells, causing changes in peripheral immune cells and eliciting a cascade of immune responses, resulting in a detrimental cytokine storm. 2021, doi: 10.1038/ s41598-021-92045-x. 2021, doi: 10.1016/j.eclinm.2021.101019. S Bliddal et al.,

Drug Development 246

Drug Development Clinical Trials Drugs Virus 246

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% However, Europe is facing increasing competition from emerging economies.

Drugs 147

Drugs Science Molecular Biology Clinical Trials 147

The Pharma Data

AUGUST 16, 2021

Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. In the U.S.,

Vaccine 52

Vaccine FDA Virus Immune Response 52

The Pharma Data

JUNE 24, 2021

Secondary objectives are to describe immune responses produced by each of the vaccines. 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

Vaccine 52

Vaccine Immune Response FDA Licensing 52

The Pharma Data

JANUARY 17, 2021

We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.”. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. Here’s a look.

FDA 52

FDA Small Molecule Immune Response Hospitals 52

The Pharma Data

JANUARY 17, 2021

18, 2021 (GLOBE NEWSWIRE) — Taconic Biosciences (Formerly Known As Taconic Farms, Inc.) Immuno-oncology is a leading research priority because it uses the body’s own immune system to effectively treat some types of cancer. Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services.

Immune Response 52

Immune Response Pharmacokinetics Engineering Licensing 52

The Pharma Data

OCTOBER 26, 2020

based company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus. They expect to launch a Phase III trial of the drug in the first quarter of 2021. . Food and Drug Administration greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the U.K.-based

Vaccine 52

Vaccine FDA Approval FDA Clinical Trials 52

The Pharma Data

JULY 23, 2021

These doses are expected to be delivered from October 2021 through April 2022. In a separate announcement on June 10, 2021, Pfizer and BioNTech shared plans to provide the U.S. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. government under its existing supply agreement to 500 million.

Vaccine 52

Vaccine Government Immune Response FDA 52

The Pharma Data

JANUARY 22, 2021

As research developments into RNA vaccines help scientists accelerate drug candidates to arm the immune system against coronavirus, Pharma IQ ’s Keeping tabs on Covid-19 update returns with news from some of the biotechnology innovators leading the fight against the global pandemic.

Vaccine 52

Vaccine Immune Response Government RNA 52

The Pharma Data

DECEMBER 11, 2020

Government to supply doses in 2020 & 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. immediately, with delivery fulfillment expected to be completed in 2021.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

MARCH 25, 2022

Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein(10) and were optimised by AstraZeneca with half-life extension and reduction of Fc effector function.

Vaccine 52

Vaccine Virus Immune Response Government 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.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

JULY 21, 2021

Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer Disclosure Notice.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

DECEMBER 20, 2020

More mature clinical and immunobiological data are expected to be announced by the end of the second quarter of 2021. Additional MPM patients are currently being enrolled; completion of study enrollment (target total n = 10) and more mature clinical and immunobiological data are expected by the end of the second quarter of 2021.

Immune Response 52

Immune Response Clinical Trials Therapies Trials 52

The Pharma Data

JULY 11, 2021

Phase 3 study met primary and secondary endpoints demonstrating MenQuadfi ® induced superior immune responses to serogroup C compared to a standard-of-care vaccine in healthy toddlers MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers.

Immune Response 52

Immune Response Disease Vaccine Licensing 52

The Pharma Data

JUNE 24, 2021

Results from this trial, which were published in The New England Journal of Medicine on May 27, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The Pfizer?BioNTech

Vaccine 52

Vaccine Clinical Trials Trials FDA 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.

Hospitals 52

Hospitals Trials Clinical Trials Production 52

Drug Discovery World

SEPTEMBER 6, 2022

Unsurprisingly, oncology remains the biggest focus for cell and gene therapy developers, accounting for 52% of clinical activity in 2021, according to ARM’s Regenerative Medicine: Disrupting the Status Quo report. Cancer is king . New indications . Workforce .

Therapies 130

Therapies Clinical Trials Vaccine Disease 130

The Pharma Data

AUGUST 20, 2020

billion doses by the end of 2021. 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

Vaccine 52

Vaccine Clinical Trials Trials Immune Response 52

The Pharma Data

SEPTEMBER 9, 2020

billion doses by the end of 2021. During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. billion doses by the end of 2021. and Germany as well as animal immunogenicity studies.

Vaccine 52

Vaccine Clinical Trials Trials Government 52

The Pharma Data

APRIL 27, 2021

Paris, April 28, 2021. Strong increase in Q1 2021 business EPS ( 1) at CER. Q1 2021 sales increase of 2.4% Q1 2021 business EPS ( 1) growth at CER driven by efficiency and sales performance, supported by a one-time payment. Progress on implementation of the Corporate Social Responsibility strategy. Change at CER.

Vaccine 52

Vaccine Production FDA FDA Approval 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. Regeneron has partnered with Roche to increase the global supply of REGN-COV2 beginning in 2021. Yancopoulos , M.D.,

Virus 40

Virus Trials Clinical Trials Production 40

The Pharma Data

DECEMBER 17, 2020

Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. Once both companies are at full manufacturing capacity in 2021, there are expected to be at least 2 million treatment doses available annually.

Hospitals 52

Hospitals Production Clinical Trials Virus 52

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. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S.,

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

JUNE 26, 2021

JUNE 22 , 2021. About the Phase 1 trial The US-based Phase 1 clinical trial will assess the safety and immunogenicity (immune response) of the monovalent (single-strain) mRNA-based flu vaccine candidate in up to 280 participants. We look forward to sharing initial results by year-end. ”. “

Clinical Trials 52

Clinical Trials Vaccine Trials Immune Response 52

Agency IQ

MARCH 7, 2024

DAVID GREENBERG of Sanofi provided perspective based on an industry questionnaire , saying the transition will require industry to “re-activate or re-submit more than 300 TIV licenses, submit nearly 1500 variations, and update quality data in 174 countries.” service members and dependents.

Vaccine 40

Vaccine FDA Virus Licensing 40

Codon

JULY 14, 2024

However, this dropped under 10% in 2021. It is licensed in Russia and South Africa and is included in a few compassionate use programs across the globe, meaning it can be used clinically in cases where patients have few remaining options. A scientist makes Hemopure, a blood substitute for oxyhemoglobin.

Production 133

Production Clinical Trials Trials Therapies 133

The Pharma Data

SEPTEMBER 30, 2021

Our results show that the candidate vaccine formulation is safe, produces rapid immune responses – within seven days – and elicits comprehensive immunity against SARS-CoV-2,” said Varadarajan. A fundamental limitation of intramuscular vaccines is that they’re not designed to elicit mucosal immunity.

Vaccine 52

Vaccine Disease Immune Response Virus 52

Drug Target Review

FEBRUARY 28, 2024

Kate has served as our Chief Operating Officer since December 2021. gammadelta T cells link innate and adaptive immune responses. Normality sensing licenses local T cells for innate-like tissue surveillance. Mr Ho received an MBA from the University of Notre Dame and a B.S. in Biochemistry from McMaster University.

Therapies 105

Therapies Engineering Molecular Biology Immune Response 105

The Pharma Data

FEBRUARY 22, 2021

Nasdaq: RIGL) today announced a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. vice president of immunology at Lilly. About Rigel.

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Immune Response 40

The Pharma Data

JANUARY 31, 2021

1, 2021 11:00 UTC. 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. FOSTER CITY, Calif. & & EMERYVILLE, Calif.–(

Vaccine 52

Vaccine Science Clinical Trials Licensing 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. As part of Operation Warp Speed, in July the U.S.

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. Results from the NAVIGATOR Phase 3 trial were published in the New England Journal of Medicine in May 2021. Available at: [link] [Last accessed: June 2021].

FDA 52

FDA Trials Therapies Treatment 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? billion doses by the end of 2021.

Vaccine 52

Vaccine RNA Clinical Trials Immune Response 52

The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Contributions to Research, Life-Sciences Industry.

Clinical Trials 52

Clinical Trials Vaccine Virus Trials 52

The Pharma Data

JUNE 18, 2021

On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in the vaccine in adults ages 18 years and older.

Vaccine 52

Vaccine FDA Approval FDA Disease 52