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Navigating Regulatory Hurdles in Drug Development

DrugBank

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

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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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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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Tackling complex manufacturing challenges in modern drug development

Drug Target Review

“A big part of my role involves interacting with customers, learning from them on their challenges and providing solutions to expedite their path to clinical trials or commercialisation of their drug,” Galbraith explains. We are driving rapid analytics to support the release of cell and gene therapies and other biologics.

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Levers for Biological Progress

Codon

Although Amodei does acknowledge some real-world issues limiting scientific progress — such as the slow growth of organisms and tedious clinical trials — he mostly passes over the more general tools that will be required to accelerate research in the near term. This essay focuses on how we might do both, specifically for the cell.

DNA