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Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

XTalks

Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food.

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Biologic CAR T cell engager approved for UK clinical trial

Drug Discovery World

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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The ABCs of Transitioning PK Assays from Preclinical to Clinical

Worldwide Clinical Trials

For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), In contrast, clinical trials focus on both safety and efficacy — the relationship between drug concentrations and pharmacological effects. anti-human IgG).

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Latest Data from Novavax COVID-19 Vaccine Trial Involving B.1.351 Variant Shared by Protein Vaccine Maker

XTalks

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 There is also a Phase I/II continuation trial being conducted in the US and Australia.

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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra. A study involving 765 adults indicate that Bimervax, in addition to reducing antibodies against original SARS-CoV-2 strain, led to higher levels of antibodies against Beta and Omicron variants.

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A protein-based COVID-19 vaccine that mimics the shape of the virus

The Pharma Data

Now, researchers reporting in ACS Central Science have immunized mice with nanoparticles that mimic SARS-CoV-2 by displaying multiple copies of the receptor binding domain (RBD) antigen, showing that the vaccine triggers robust antibody and T cell responses. Although the first vaccines to receive Emergency Use Authorization by the U.S.

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