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Navigating Regulatory Hurdles in Drug Development

DrugBank

Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. For example, the FDA’s Breakthrough Therapy Designation grants priority review to medicines demonstrating substantial improvement over existing treatments.

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A Visual Guide to Gene Delivery

Codon

The gene therapy is designed to protect this infant from the neurological disorders that otherwise would have resulted from this rare, and often fatal, condition. And while matching a gene therapy to its targeted mutation is an intricate and nuanced process, much boils down to two core elements: a vector and its cargo.

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PRITELIVIR MESYLATE

New Drug Approvals

1428321-10-1 Pritelivir mesylate is an antiviral drug currently under development, specifically targeting herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV).

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Tackling complex manufacturing challenges in modern drug development

Drug Target Review

With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. We are driving rapid analytics to support the release of cell and gene therapies and other biologics.

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Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. You can unsubscribe at anytime.

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AZVUDINE

New Drug Approvals

SYN [link] According to the inventor’s research and understanding, at present, the synthesis of azvudine mainly includes the following methods according to different raw materials: 1. It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV). 2024, 67, 4376−4418 Azvudine (1).

RNA
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Cell therapy limitations with iPS-based multi-cell therapeutics

Drug Target Review

Induced pluripotent stem cell (iPSC) therapies have the potential to treat a wide variety of devastating diseases. While iPSC therapies hold great promise, several challenges remain, including poor infiltration of cytotoxic lymphocytes into solid tumours and insufficient cytotoxicity of myeloid cells.