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The rising impact of biomarkers in early clinical development

Drug Target Review

However, standard preclinical safety assessment studies may not accurately predict adverse events in humans, particularly with emerging modalities like precision medicine targeting human antigens or genes not present in preclinical species. For use as endpoints, biomarkers must be correlated to a valid clinical outcome.

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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

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.

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Clinical Development of the GluN2B-selective NMDA Receptor Inhibitor NP10679 for the Treatment of Neurologic Deficit after Subarachnoid Hemorrhage [Neuropharmacology]

ASPET

The delayed nature of cerebral ischemia secondary to SAH-related vasculopathy presents a window of opportunity for the evaluation of well-tolerated neuroprotective agents administered soon after ictus.

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Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Conversations in Drug Development Trends

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography. The post Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies appeared first on Worldwide Clinical Trials.

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The Evolution of Adaptive Protocols: Early Clinical Development

PPD

Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset. Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey.

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MorphoSys To Present At the 39th Annual J.P. Morgan Healthcare Conference

The Pharma Data

Chief Executive Officer of MorphoSys, will present at the 39 th Annual J.P. EST. Live audio of the presentation can be accessed from the Media and Investors section under Conferences on MorphoSys’ website, www.morphosys.com. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.

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Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting

The Pharma Data

Pfizer Presents Scientific Advancements from its Leading Oncology Portfolio at ASCO 2023 Annual Meeting will present data across its Oncology portfolio and growing pipeline, covering multiple tumor types and novel mechanisms of action at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 2 through June 6.