Remove 2024 Remove Drug Development Remove Trials
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Redefining Acceleration of the Drug Development Journey

PPD

It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drug development. According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8 billion in 2023 to 1.2 billion in 2035.

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study.

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Key Trends Drug Developers Need to Know to Succeed

PPD

As the pharmaceutical industry continues to evolve, drug developers encounter new challenges and opportunities in their pursuit of innovation. From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape.

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The Real Cost of Complexity: What Every Drug Developer Needs to Know

PPD

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.

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How Clinical Trial Trends are Redefining Drug Development

Quanticate

With the implementation of technology rapidly increasing, stricter regulatory standards, and growing demand for innovative treatments, the trends within the industry continue to evolve, impacting the future of clinical trials both positively and negatively.

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Sentiment & Themes Emerging From JPM 2024

LifeSciVC

Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g., The incretins as a class also look interesting across a number of follow-on indications, as evidenced by clinical trials in these areas (below).

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.