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

Drug Target Review

Delivery of therapy is being evaluated through injections of DNA and RNA encoding IL-12, viral vectors, and other exploratory platforms designed to bring IL-12 in close proximity to the tumour and avoid excessive IL-12 in systemic circulation. Ultimately, our goal is for this approach to yield an enhanced cancer fighting response.

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Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

Several viral vectors are being used currently, in addition to non-viral vectors, such as oligonucleotides, naked DNA, and lipoplexes and polyplexes. Several small molecule GLP-1R agonists, such as oral orforglipron, are in late-stage clinical development. Asia, and Europe.

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Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting

The Pharma Data

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer.

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling. Any CMC changes (e.g.,

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BioSpace Global Roundup, Oct. 15

The Pharma Data

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.