Drug Discovery Featured Articles & Applications
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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FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics.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.
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How To Overcome Immune Rejection In iPSC-based Gene Therapy
11/6/2024
Even when induced pluripotent stem cells (iPSCs) are derived from the patient's cells, immune rejection can still occur. This article explores the causes as well as strategies to overcome immune rejection.
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Emerging Partnership Trends In Oligo-Based Medicines
11/6/2024
The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.
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Exploring Sanofi R&D's Batch Monitoring Initiative
10/23/2024
The project established predictability during testing and release for the production of medicine to support clinical trials.
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Panavance Details IND Prep Ahead Of FDA Submission For Ovarian Cancer Trial
10/23/2024
Panavance CEO Greg Bosch discusses the company’s pursuit of a second trial for misetionamide, walking us through IND preparations, CRO selection, and securing funding.