Remove Clinical Development Remove Immune Response Remove Trials
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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinical development, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.

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POLB 001: tackling cytokine storms before they start

Drug Target Review

As the biotech sector races to improve the tolerability of these revolutionary treatments, Poolbeg Pharma has a novel solution: an oral therapy, POLB 001, to block the development of CRS, by limiting inflammation without affecting the anti-cancer immune responses that are vital for effective immunotherapies.

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

Natural killer (NK) cells are another immune cell type that, as the name suggests, also have potent cell-killing activity, and have a well-known role in the anti-tumour immune response. In the context of a tumour microenvironment, Tregs are often present in high numbers, preventing an effective immune response to the tumour.

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U.S. FDA Grants Orphan Drug Designation to Riliprubart for Treating Antibody-Mediated Rejection in Solid Organ Transplant Recipients

The Pharma Data

It provides a range of incentives to the sponsoring company, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, fee waivers, and eligibility for expedited regulatory pathways. VITALIZE (NCT06290141): Evaluates the drug in CIDP patients currently receiving intravenous immunoglobulin (IVIg).

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Sanofi, GSK launch early trial for COVID-19 vaccine

The Pharma Data

. Sanofi and GSK have begun a Phase I/II clinical trial testing their adjuvanted COVID-19 vaccine in healthy adults. The vaccine candidate, developed in partnership by the firms, is based on the recombinant protein-based technology used in Sanofi’s seasonal influenza vaccines and GSK’s pandemic adjuvant technology.

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Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

The Pharma Data

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.