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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. One notable success story is Moderna’s mRNA vaccine development for COVID-19, which benefited from early regulatory engagement and streamlined approval pathways.

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A Visual Guide to Gene Delivery

Codon

Some diseases are caused by mutations in large genes that exceed the packaging limits of existing vectors like adeno-associated virus (AAV). AAV is a small virus that lacks a lipid membrane and carries a single-stranded piece of DNA stretching 4.7 Vectors also differ in the duration of their expression.

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mRNA Tech Transfer Phase 2.0 Discussed at G20 Summit

The Pharma Data

This meant putting the fundamentals of mRNA production directly into the hands of local innovators — a dramatic departure from previous models that kept much of vaccine production within a small number of firms in high-income settings. mRNA Technology Transfer Programme Moves Into Phase 2.0, 2026–2030).

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Merck’s ENFLONSIA Receives ACIP Recommendation for Protecting Infants from Severe RSV

The Pharma Data

CDC panel backs long-acting monoclonal antibody to protect infants during their first RSV season; drug also included in federal Vaccines for Children program Merck , operating as MSD outside the United States and Canada, has announced a key regulatory milestone for its respiratory syncytial virus (RSV) prevention program.

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Sanofi Speeds Up Beyfortus Shipments Ahead of 2025-2026 RSV Season

The Pharma Data

Sanofi Ramps Up Early Global Distribution of Beyfortus to Meet Growing RSV Season Demand, Enhancing Protection for Infants Worldwide In a proactive move to ensure readiness for the 2025-2026 respiratory syncytial virus (RSV) season, Sanofi has announced that shipments of Beyfortus® (nirsevimab) will begin in early Q3 2025.

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Olgotrelvir 

New Drug Approvals

By binding to the active site of the protease, the drug prevents this cleavage process, effectively halting viral assembly and impeding the virus’s ability to produce future virions. [1] “Second Generation Oral Mpro Inhibitor for COVID-19 Treatment Proceeds in Phase 3 Study” Precision Vaccinations.

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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.