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The rising impact of biomarkers in early clinical development

Drug Target Review

Haemoglobin A1c (HbA1c) is a validated surrogate endpoint for the reduction of microvascular complications associated with diabetes mellitus; reduced HIV-RNA levels serve as an endpoint for HIV disease control; and a reduction in low-density lipoprotein (LDL) cholesterol is used as an endpoint indicating lower likelihood of cardiovascular events.

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Novartis Acquires Regulus Therapeutics, Expanding its RNA-Based Drug Pipeline

The Pharma Data

By integrating Regulus’ expertise in microRNA science with its own deep capabilities in clinical development, regulatory affairs, and commercialization, Novartis is well-positioned to accelerate farabursen’s clinical path and potentially bring a first-in-class treatment to ADPKD patients.

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The Access to Advanced Health Institute receives $18 million award to develop a temperature stable, single-dose chikungunya RNA vaccine through a phase 1 clinical trial

SCIENMAG: Medicine & Health

The Access to Advanced Health Institute Receives $18 Million Award to Develop a Temperature Stable, Single-Dose Chikungunya RNA Vaccine Through a Phase 1 Clinical Trial Credit: Delaney Brown Photography The Access to Advanced Health Institute Receives $18 Million Award to Develop a Temperature Stable, Single-Dose Chikungunya RNA Vaccine Through a Phase (..)

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Discovery and development of COVID?19 vaccine from laboratory to clinic

Chemical Biology and Drug Design

The development of vaccines for SARS-CoV-2 becomes more difficult due to the viral mutation in its non-structural proteins (NSPs) especially NSP2 and NSP3, S protein, and RNA-dependent RNA polymerase (RdRp).

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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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Alnylam Promotes Pushkal Garg to Chief R&D Officer

The Pharma Data

Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D.,

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ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine

The Pharma Data

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.