Remove 2023 Remove Clinical Development Remove Drug Development
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The rising impact of biomarkers in early clinical development

Drug Target Review

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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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. billion in 2023 to 1.2 billion in 2023 to 1.2 billion in 2035. billion in 2035.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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Good things come in 3s

SugarCone Biotech

Tarlatamab triggered an ORR of ~40% in refractory (second-line or later) SCLC patients in the DeLLphi-301 clinical trial published in 2023. The tarlatamab results have of course triggered a stampede of development of DLL3-targeted therapies. The Next Wave: Targeting B7H3 – a drug development tsunami in the making?

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Targeting HER3 – a little wave of drug development that’s about to get a lot bigger

SugarCone Biotech

It follows that HER3-targeting therapies have emerged as a class of anti-cancer treatments designed to treat various tumors that have developed resistance to EGFR or HER2-directed therapies or have emerged due to a NRG1 gene fusion. This is an active drug development landscape with a lot of recent news.

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

billion buyout of Blueprint Medicines is the sector’s second-largest M&A deal this year and represents the highest value paid for an immune drug developer since April 2023. Sanofi’s $9.1 Sanofi’s $9.1

FDA
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#ScienceSaturday: September 30, 2023

KIF1A

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.