Seven biologics walking the approval tightrope in 2023

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As we venture into the second half of 2023, the global biologics market continues to hover between robust growth and unpredictability. Valued at $461.74 billion in 2022, it’s projected to grow at a compound annual rate of 10.3% from 2023 to 2030, according to Grand View Research. In 2022, biologics edged past small molecules for the first time, as Nature reported, but sponsors face mounting scrutiny from regulators.

In the spotlight is the FDA’s Accelerated Approval program, which has faced criticism following a string of high-profile cases of post-approval confirmatory trial failures. For example, the Alzheimer’s drug aducanumab won accelerated approval despite conflicting evidence from clinical trials. Oncology is another area where negative confirmatory trials of accelerated approval drugs has been a concern.

Such developments have led the FDA to increase …

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Finding the right formula for nitrosamine risk mitigation 

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The pharmaceutical industry is facing many challenges to ensure drug products are free from nitrosamine contaminants and safe for human use. Since the discovery of potentially carcinogenic nitrosamines in some commonly prescribed drug products in 2018, mitigating nitrosamine risk has been a top priority for the pharmaceutical industry and its governing bodies. As such, strict regulations have been implemented by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) to assess and minimize the risk of nitrosamine impurities in existing and new drug formulations. However, navigating the new legislation and choosing a suitable mitigation strategy is a complex process.  

Navigating nitrosamine risk mitigation with confidence

Many research groups are investigating possible root causes of nitrosamine contamination in human drug products and potential mitigation strategies…

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