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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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Unlocking Undruggable Targets: Shifting Paradigms in Modern Drug Discovery

DrugBank

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding.

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UK Pharma Company Scancell Selects COVID-19 Vaccine for Clinical Trials | 2020-12-21

The Pharma Data

UK drug developer Scancell said it has chosen a COVID-19 vaccine candidate, SN14, from more than a dozen potential products to advance to a clinical trial. . SN14 works by targeting the coronavirus’ nucleocapsid and spike proteins to prevent viral replication using the company’s ImmunoBody DNA vaccine technology.

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The power of combinations in blood cancers

Drug Target Review

These options are creating opportunities to develop more sophisticated, novel combination regimens for patients. For example, combining IO agents with ADCs to mount a two-pronged attack against cancer by activating an anti-cancer immune response and directly killing cancer cells may drive stronger and more durable responses in the clinic.

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Exploring the Future of Oncology with ADCs and TILs: Key Insights From ASCO  

Conversations in Drug Development Trends

Although there are a range of efficacies across different tumor types that require a greater understanding, the use of circulating tumor DNA profiles holds promise for personalized treatment strategies that better target the drug for the patient, potentially revolutionizing how ADCs are deployed in clinical practice.

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New insights into the role of viral capsids in gene therapy safety

Drug Target Review

2 Structure and function of AAV capsids in gene therapy Wild-type AAV is composed of a protein shell (capsid) that contains a single-stranded DNA genome encoding proteins involved in viral replication, structure and assembly. Therefore, vectors based on these serotypes may enable targeted gene delivery and optimal transduction efficiency.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.