2018, Immune Response, Licensing and Research

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. Expected to enroll 415 participants; interim results expected in Q3 2021.

Clinical Trials

Clinical Trials Vaccine Trials Immune Response

Gamma delta T cells: a rising star in cancer therapy

Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. from 2003 to 2006, covering the biotechnology and life-science tools sectors.

Therapies

Therapies Engineering Molecular Biology Immune Response

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

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 trial follows successful preclinical research which demonstrated promising safety and immunogenicity.

Clinical Trials

Clinical Trials Vaccine Trials Immune Response

Where's the Synthetic Blood?

Codon

JULY 14, 2024

The creation of synthetic blood is one of the holy grails of biomedical research as it would alleviate such shortages and overcome current barriers to obtaining and storing blood products. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial.

Production

Production Clinical Trials Trials Therapies

Tezepelumab granted Priority Review by U.S. FDA

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. executive vice president of Research and Development at Amgen. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second.

FDA

FDA Trials Therapies Treatment

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

The Pharma Data

JUNE 18, 2021

Senior Vice President and Head of Vaccine Research & Development, Pfizer. With a single injection, PREVNAR 20 provides adults with strong and meaningful protection against serotypes responsible for the majority of circulating pneumococcal disease around the world.”. “We On September 20, 2018, Pfizer announced the U.S.

Vaccine

Vaccine FDA Approval FDA Disease

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

The Pharma Data

NOVEMBER 9, 2020

2018 for patients with severe asthma, without an eosinophilic phenotype. executive vice president of Research and Development at Amgen. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Reese , M.D.,

Trials

Trials Production Clinical Trials Government

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

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. 2018) PLoS One.

Vaccine

Vaccine Pharmaceuticals Small Molecule Virus

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

The Pharma Data

DECEMBER 21, 2020

executive vice president of Research and Development at Amgen. In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Reese , M.D.,

Trials

Trials Production Clinical Trials Government

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

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. 2018; 37(9): 886-892. About AstraZeneca.

Trials

Trials Pharmacokinetics Virus Vaccine

Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report

The Pharma Data

OCTOBER 28, 2020

Mesoblast has formally requested a Type A meeting with the FDA to discuss a potential accelerated approval of the Biologics License Application (BLA) for remestemcel-L for the treatment of SR-aGVHD in children, with an additional randomized controlled study in patients 12 years and older as a post-approval requirement. In addition, $5.2

Treatment

Treatment Trials Production Disease

Sanofi delivered close to double-digit Q4 2020

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).

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

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).

Vaccine

Vaccine Production FDA Pharmaceuticals

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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%

Vaccine

Vaccine Production FDA FDA Approval

Drug Discovery Digest

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

Gamma delta T cells: a rising star in cancer therapy

Trending Sources

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine

Where's the Synthetic Blood?

Tezepelumab granted Priority Review by U.S. FDA

U.S. FDA Approves PREVNAR 20™, Pfizer’s Pneumococcal 20-valent Conjugate Vaccine for Adults Ages 18 Years or Older

Tezepelumab NAVIGATOR Phase 3 Trial Met Primary Endpoint Of A Statistically Significant And Clinically Meaningful Reduction In Exacerbations In A Broad Population Of Patients With Severe Asthma

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Update On SOURCE Phase 3 Trial For Tezepelumab In Patients With Severe, Oral Corticosteroid-Dependent Asthma

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

Update on Remestemcel-L For the Treatment of COVID-19 ARDS and Steroid-Refractory Acute GVHDQuarterly Activity Report

Sanofi delivered close to double-digit Q4 2020

Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER

Sanofi continued its growth trajectory. Strong increase in Q1 2021 business EPS(1) at CER

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