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

The Pharma Data

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.

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

The Pharma Data

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. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. “We

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Tezepelumab granted Priority Review by U.S. FDA

The Pharma Data

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018. 2018; 10 (1): 34-45.

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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

(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.

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AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus.

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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

2018 for patients with severe asthma, without an eosinophilic phenotype. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures.

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

The Pharma Data

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

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