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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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The science of ageing and restoring healthspan

Drug Target Review

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. About the author Jerry McLaughlin CEO, Life Biosciences, Inc.

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Pharmacy Considerations for Early Phase Trials

Fierce BioTech

First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.

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Five Predictions for the Biopharma and Biotech Industries in 2024

PPD

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Sanofi continues on path to industry leadership in Immunology with Dupixent® (dupilumab) as key driver

The Pharma Data

By 2025, Dupixent is expected to generate an additional 11 new regulatory submissions across indications and age groups. These drug development programs include our acceleration of priority asset amlitelimab, an anti-OX40L antibody that aims to restore immune homeostasis between pro-inflammatory and anti-inflammatory T cells.

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Sentiment & Themes Emerging From JPM 2024

LifeSciVC

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.

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Drug candidates with blockbuster potential for CNS diseases

Drug Target Review

Could you give us an overview of IRLAB’s current drug development pipeline? Top-line data from the Phase IIb study is expected at the beginning of 2025. The third project in clinical phase, IRL757, is in Phase I and is being developed for the treatment of apathy.

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