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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. Regulatory bodies require strict adherence to Good Manufacturing Practices (GMPs) to ensure that drugs are consistently produced at high quality.

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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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A Visual Guide to Genome Editors

Codon

If the same virus invades the cell a second time, the gRNA’s spacer sequence will bind to the matching viral DNA sequence, then be cut by the Cas protein. 3 The duo later shared the 2020 Nobel Prize in Chemistry for their discovery. Taken together, these components form what is known as a ribonucleoprotein (RNP) complex.

DNA
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Syringe services for people who inject drugs are enormously effective, but remain underused

National Institute on Drug Abuse: Nora's Blog

3 Evidence on transmission of hepatitis C virus (HCV) is less clear, but in Europe, where SSPs are more widely used, high SSP use is associated with a 76% reduction in HCV transmission. Interventions to prevent HIV and Hepatitis C among people who inject drugs: Latest evidence of effectiveness from a systematic review (2011 to 2020).

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Levers for Biological Progress

Codon

A 200x drop in price over twenty-five years is impressive, but these costs have now flatlined — or have even risen — since 2020. Today, the same feat can be done for about $0.10. The cost to synthesize full-length genes (blue) or small DNA snippets, called oligonucleotides (red), over time.

DNA
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FDA to ask Sarepta to stop shipping Duchenne gene therapy

BioPharma Drive: Drug Pricing

While the two treatments are constructed differently, they both use the same kind of engineered virus to deliver a replacement gene to the body’s muscles. Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. Food and Drug Administration headquarters in Silver Spring, Md.,

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WHO Scientific Group Publishes Findings on COVID-19’s Origins

The Pharma Data

The group, made up of virologists, epidemiologists, public health professionals, and biosafety specialists, has been working for over three years to shed light on one of the most pressing questions in modern global health: how did SARS-CoV-2, the virus responsible for COVID-19, first infect humans?