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The rising impact of biomarkers in early clinical development

Drug Target Review

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

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Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

In a Wednesday statement, the biotechnology company said it would use the new funds to advance into clinical development an experimental treatment targeting what are known as fibroblast activation proteins. The company is “preparing for clinical development in 2026” across multiple indications, Goutopoulos said.

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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

The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinical development.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Because biotech companies need to remain flexible and agile while remaining on time and on budget they are harnessing innovations to navigate unexpected drug development challenges and leveraging strategies to fill gaps in resources and expertise. FSP outsourcing is growing faster than FSO.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies.

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Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers

Covalent Modifiers

The preclinical efficacy of zongertinib translates in objective responses in patients with HER2-dependent tumors, including cholangiocarcinoma (SDC4NRG1 fusion) and breast cancer (V777L HER2 mutation), thus supporting the ongoing clinical development of zongertinib. Pan-ERBB blockers are limited by wild-type EGFRmediated toxicity.

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How Japan and South Korea are Shaping the Next Era of Clinical Development

Fierce BioTech

How Japan and South Korea are Shaping the Next Era of Clinical Development Discover why Japan and South Korea are emerging as clinical trial powerhouses, offering cutting-edge infrastructure, streamlined regulations, and unique commercial advantages.