Drug Discovery Featured Articles & Applications
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What Do We (Really) Know About DNA Quality For In Vitro Transcription?
2/19/2025
Gene therapies and nucleic acid medicines are dependent upon a starting DNA template that defines the protein or antigen. The sequence of this template DNA being correct is critical.
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FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products
2/14/2025
The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.
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How Can 3D Bioprinting Advance Drug Discovery?
2/5/2025
Biological printing (bioprinting; also called biofabrication) is a form of additive manufacturing that uses living cells, proteins, and nutrients as the basis of raw materials in pharmaceutical development.
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Are Plant-Based APIs The Future Of Pharma And Nutraceuticals?
1/29/2025
As consumer preferences for natural and organic products rise, pharma and nutraceutical companies are increasingly shifting to plant-based APIs. This article shares new market research, including a spotlight on cannabis-based APIs.
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Survey Findings: How Are IDMP Readiness Efforts Progressing?
12/13/2024
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
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FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics
12/11/2024
FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
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How Atsena Got Its Gene Therapy To Spread Subretinally To Treat XLRS
12/6/2024
The company’s novel capsid, part of a Phase 1/2 trial, is delivering therapeutic genes to the fovea without the need for detaching part of the retina.
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2024 Survey Findings: How Is The "Lab Of The Future" Becoming Reality?
12/3/2024
The Pistoia Alliance conducted a survey as a pulse check on which technologies the pharma/biotech industry is investing in and companies' progress integrating new tech into the lab.
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Seeing Firsthand The Transformative Impact Of AI On Pharmacovigilance And Clinical Research
11/27/2024
Consultants Aashna Goyal and Guriqbal Singh share first-persona accounts of how AI is transforming pharmacovigilance and clinical research by improving data processing, enhancing decision-making, and accelerating drug development.
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Should We Explore Suicidality In Animals During Preclinical Drug Development?
11/19/2024
An adverse side effect for some drugs is suicidal ideation and behavior (SIB). Investigating SIB in animal studies represents the closest approximation to human SIB, yet the FDA Modernization Act 3.0 obligates us to reduce unnecessary animal testing. Let's examine this with data-driven research.