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In vivo preclinical models for immune-mediated inflammatory disease drug development

Crown Bioscience

Interest in IMIDs has grown rapidly in recent years, largely fueled by the view that IMIDs share common inflammatory pathways, and therefore, there is the possibility that novel therapies that work in one IMID may work in other IMIDs.

Disease 52
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eBook: Unlocking Undruggable Targets

DrugBank

The world of drug discovery is in a state of transformation, with advancements in biotechnology opening doors to new possibilities for targeting previously "undruggable" disease mechanisms. You’ll discover real-world examples, such as the transformation of KRAS from an undruggable target to a success story in targeted therapy.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. The two broadest categories of drug development can be separated into the preclinical and clinical research stages.

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Unlocking Undruggable Targets: Shifting Paradigms in Modern Drug Discovery

DrugBank

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding.

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An Evolving Regulatory Environment for Rare and Orphan Diseases

Advarra

The law established the Office of Orphan Products Development , providing financial incentives for pharmaceutical companies to develop orphan drugs and making it more viable to invest in orphan drug research and development. The impact was clear: Between 1983 and 2020, FDA approved 599 orphan drugs.

Disease 52
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ACTIV Update: Making Major Strides in COVID-19 Therapeutic Development

NIH Director's Blog: Drug Development

This improvement stems from several factors, including the FDA’s emergency use authorization (EUA) of a number of therapies found to be safe and effective for COVID-19. ACTIV was founded last April to accelerate drug research that typically requires more than a decade of clinical ups and downs to develop a safe, effective therapy.

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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. High-priced cell and gene therapies are being increasingly developed for rare diseases.