Clinical Trials

Regeneron’s Ordspono Wins EU Approval, Faces FDA Hurdle for Lymphoma
Research & Development Regeneron’s Ordspono Wins EU Approval, Faces FDA Hurdle for Lymphoma

The European Commission's recent authorization of Regeneron's bispecific antibody drug Ordspono (odronextamab) for the treatment of two types of lymphoma marks a significant milestone in the European market. Garnering approval for use across 27 European Union countries, Ordspono is now

Optimizing Drug Product Formulation and Process Development Strategies
Research & Development Optimizing Drug Product Formulation and Process Development Strategies

The journey from a new chemical entity (NCE) to a marketable drug product is a complex, multifaceted process that demands an intricate blend of scientific expertise and practical knowledge. The transformation involves a deep understanding of organic chemistry, analytical development, pharmaceutical

How Can UshurX Revolutionize Clinical Trials with AI and HIPAA Security?
Research & Development How Can UshurX Revolutionize Clinical Trials with AI and HIPAA Security?

Clinical trials are the bedrock upon which medical advancements are discovered and validated. However, the traditional processes involved in clinical trials are fraught with inefficiencies, high costs, and prolonged durations that hinder timely medical innovations. Ushur, a leader in AI-powered

How Will eXmoor's New License Transform Cell and Gene Therapy?
Research & Development How Will eXmoor's New License Transform Cell and Gene Therapy?

The transformative journey of eXmoor Pharma has reached a pivotal moment with the recent acquisition of a Manufacturing and Import Authorization for Investigational Medicinal Products (MIA(IMP)) license from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This milestone

Lawmakers Urge FDA to Probe U.S.-China Military-Linked Clinical Trials
Research & Development Lawmakers Urge FDA to Probe U.S.-China Military-Linked Clinical Trials

Recent tensions between the United States and China have extended into the biotech and pharmaceutical sectors, sparking bipartisan calls for increased regulatory scrutiny. At the heart of the matter: clinical trials conducted by U.S. pharmaceutical companies in collaboration with Chinese

AN2 Therapeutics Shifts Focus, Cuts Workforce After Trial Setback
Research & Development AN2 Therapeutics Shifts Focus, Cuts Workforce After Trial Setback

AN2 Therapeutics, a prominent biopharmaceutical company, has announced a major restructuring of its operations following an unexpected clinical trial outcome. This decision marks a significant strategic pivot from their previous research initiatives and has substantial implications for the

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