GMP Manufacturing Pitfalls That Delay Biologics Production (and How to Avoid Them)

by 53Biologics

GMP manufacturing pitfalls that delay biologics production can increase costs, disrupt clinical timelines, and compromise regulatory readiness if not addressed early.

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IR Sant Pau Advances the Development of Fanconinib, a Pioneering Inhibitor Targeting a Key Cancer Pathway

by Hospital de la Santa Creu i Sant Pau

The IR Sant Pau has received funding from the national call to advance the development of Fanconinib, the first specific inhibitor designed to block the FA/BRCA DNA repair pathway.

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ORYZON reports financial results and corporate update for quarter ended December 31st, 2025

by Oryzon Genomics

Investment in R&D reached €12.6 million, representing an increase of 50% (€4.2 million) compared to the €8.4 million invested in the previous financial year.

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AI in drug development. A CRO’s strategic roadmap

by Pivotal

The AI revolution in Pharmaceutical R&D is transitioning from experimental curiosity to operational necessity. This transformation is supported by quantifiable operational improvements: AI-enabled dis...

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The key to attacking 'undruggable' proteins: IRB Barcelona reveals a breakthrough drug mechanism

by IRB Barcelona - Instituto de Investigación Biomédica

Published in Science Advances, the study shows that the drug does not act on the protein in isolation, but instead takes advantage of the moment when they briefly group together into small complexes (...

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Vall d’Hebron takes part in a study showing the long-term benefits of ruxolitinib in paediatric graft-versus-host disease

by Vall d’Hebron

The REACH5 study confirms that the efficacy and safety results observed in previous studies are maintained after three years of follow-up.

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Understanding the Manufacturing Responsibilities for Drug Substances and Drug Products

by 53Biologics

Understanding the responsibilities involved in Drug Substance and Drug Product manufacturing is essential for making the right strategic decisions. Many biotech companies approaching clinical phases d...

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Promising results for GAT Therapeutics drug in development for pulmonary fibrosis

by Parc Científic de Barcelona

The biotech company GAT Therapeutics is making progress in the development of GTX-11, a new oral drug candidate for the treatment of idiopathic pulmonary fibrosis. Preclinical results show that GTX-11...

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Chemistry, Manufacturing, and Controls (CMC) in the drug development process: analytical strategies to support Investigational New Drug (IND) readiness and regulatory progression

by AMSbiopharma

Manufacturing and Controls (CMC) framework ensures that every dose of an investigational product is safe, effective, and consistent in quality. As a candidate moves through the drug development stages...

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ORYZON expands patent protection for iadademstat with grant decision in Mexico covering combinations with PD-1/PD-L1 inhibitors

by Oryzon Genomics

Oryzon Genomics today announced that the Mexican Patent Office has issued a decision to grant for its patent application MX/a/2021/011610, entitled “Combinations of iadademstat for cancer therapy”...

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Researchers design a pioneering drug capable of reversing cognitive decline in Alzheimer’s disease in animal models

by Universitat de Barcelona

Unlike current drugs, which mainly remove beta-amyloid plaques that accumulate in the brain, this new experimental drug reprogrammes the neuronal epigenome by correcting alterations in gene expression...

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