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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

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Actithera draws new investors to radiopharma drug pitch

BioPharma Drive: Drug Pricing

Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy. subsidiary of Merck KGaA, is the founder of radioligand therapy developer Actithera.

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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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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. There are several types of biomarkers to consider.

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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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Navigating Clinical Development Challenges to Advance Idiopathic Pulmonary Fibrosis Treatments

PPD

The road ahead for idiopathic pulmonary fibrosis treatments The landscape of idiopathic pulmonary fibrosis treatment development is poised to evolve significantly. With the expiration of pirfenidone’s patent exclusivity in 2021, sponsors have renewed their focus on developing new therapies.

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AI in drug discovery: faster, smarter, better

Drug Target Review

In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. How AI is solving CGTs biggest challenges Cell and gene therapy is inherently complex. Kosten Digital was established to bridge this gap.

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