2018, Immune Response, Licensing and Trials

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. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About the Sanofi Pasteur and Translate Bio collaboration.

Clinical Trials

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

The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021.

Clinical Trials

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Where's the Synthetic Blood?

Codon

JULY 14, 2024

However, the subsequent death of another patient thrust Denys into a contentious trial. 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. The results of the trial are expected at the end of 2024. Data from Rousseau G.F.

Production

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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. gammadelta T cells link innate and adaptive immune responses. Trends Immunol 39(6):446-459 (2018).

Therapies

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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

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

Trials

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

The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

Trials

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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. 8) There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.(8) About Severe Asthma.

FDA

FDA Trials Therapies Treatment

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

Trials

Trials Pharmacokinetics Virus Vaccine

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

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. On September 20, 2018, Pfizer announced the U.S.

Vaccine

Vaccine FDA Approval FDA Disease

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

The Pharma Data

OCTOBER 28, 2020

We are pursuing an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, and a parallel approval pathway for COVID-19 ARDS if the randomized controlled Phase 3 trial is positive.”. The dosing regimen in the Phase 3 is the same as in the pilot trial.

Treatment

Treatment Trials Production Disease

Sanofi delivered close to double-digit Q4 2020

The Pharma Data

FEBRUARY 8, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. 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. Outside of the EU, Supemtek is also approved in the U.S.

Vaccine

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

The Pharma Data

FEBRUARY 4, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. 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. Outside of the EU, Supemtek is also approved in the U.S.

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

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. Aubagio ® sales decreased 1.1% Portfolio update.

Vaccine

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Drug Discovery Digest

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

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

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Where's the Synthetic Blood?

Gamma delta T cells: a rising star in cancer therapy

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

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

Tezepelumab granted Priority Review by U.S. FDA

AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

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

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 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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