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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Additionally, the immunogenicity of biosimilars, which is the ability of the drug to trigger an immune response, can be highly variable and impact the safety and efficacy of the drug. Robust Clinical Trial Design : Clinical trials for biosimilars should be designed to demonstrate equivalence or non-inferiority to the reference product.

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Innovating in Autoimmune and Bone Health Research: Driving Progress for Better Patient Outcomes

Conversations in Drug Development Trends

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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POLB 001: tackling cytokine storms before they start

Drug Target Review

As the biotech sector races to improve the tolerability of these revolutionary treatments, Poolbeg Pharma has a novel solution: an oral therapy, POLB 001, to block the development of CRS, by limiting inflammation without affecting the anti-cancer immune responses that are vital for effective immunotherapies.

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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

These interactions may disrupt protein function, trigger immune responses, or contribute to other toxicological risks. to ligands or linkers) may elicit immune responses. Immunogenicity: While oligonucleotides are typically non-immunogenic, modifications or conjugations (e.g.,

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Outsmarting immune suppression through GPCR innovation

Drug Target Review

These CCR8+ Tregs are known to suppress immune responses in the tumour microenvironment (TME), allowing cancers to grow unchecked. “DT-7012 The preclinical characterisation of DT-7012 has provided a strong foundation for its clinical development,” says Schann.

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U.S. FDA Grants Orphan Drug Designation to Riliprubart for Treating Antibody-Mediated Rejection in Solid Organ Transplant Recipients

The Pharma Data

It provides a range of incentives to the sponsoring company, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, fee waivers, and eligibility for expedited regulatory pathways. VITALIZE (NCT06290141): Evaluates the drug in CIDP patients currently receiving intravenous immunoglobulin (IVIg).

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Advancements in hit identification for membrane protein drug discovery

Drug Target Review

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions.