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The rising impact of biomarkers in early clinical development

Drug Target Review

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. 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. Relative to other areas of medicine (e.g.,

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New cell therapy model accelerates cancer treatment development

Drug Target Review

In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.

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Why radiopharmaceuticals are gaining ground in the fight against cancer

Drug Target Review

At the forefront of this transformation is Dr Ebrahim Delpassand, a nuclear medicine physician and the driving force behind RadioMedix (RMX), a radiopharmaceutical company focused on developing targeted diagnostics and therapies. These measures ensure both the efficacy and safety of the final product.

Therapies 100
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J&J’s Dual-Target CAR T-Cell Therapy Shows Promise in Large B-Cell Lymphoma

The Pharma Data

The data were presented during the 2025 European Hematology Association (EHA) Congress (Abstract #S239). Standard single-target CD19-directed CAR T-cell therapies typically enable long-term remissions in roughly 40% of patients, emphasizing a significant unmet need for new and more effective treatment strategies.

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BeOne Medicines Presents Transformative Oncology Portfolio at Research & Development Day

The Pharma Data

With more than 40 clinical and commercial-stage assets in active development, BeOne Medicines is demonstrating a scale of ambition matched by few in the field. BeOne Medicines’ rise has been fueled by a strategic commitment to innovation at every level of the drug development continuum. Global Head of R&D. “We

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Novel Bispecific therapies in oncology

SugarCone Biotech

Where TGF- is present there is no or limited IFN- secretion by T cells and that means no PD-L1 expression within the tumor microenvironment, aka the TME. The recent integrin inhibition program that was being developed by Pliant has not yet demonstrated a positive/risk benefit profile at least in pulmonary fibrosis.