Research & Development

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 set to

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

What Are the Essential Skills in Drug Product Formulation?
Research & Development What Are the Essential Skills in Drug Product Formulation?

Understanding the critical skills required in drug product formulation is pivotal for professionals in the pharmaceutical industry. This comprehensive domain encompasses various stages in the drug development process, demanding a multidisciplinary skill set that includes a robust foundation in

FDA Clears Pfizer & Moderna's Updated COVID-19 Vaccines for New Strains
Research & Development FDA Clears Pfizer & Moderna's Updated COVID-19 Vaccines for New Strains

The U.S. Food and Drug Administration (FDA) has recently given its stamp of approval to updated COVID-19 vaccines from Pfizer and Moderna, marking a significant advancement in the ongoing efforts to combat the virus. These newly formulated vaccines are specifically designed to target the currently

FDA Probes Immunotherapies; Biotech Faces Financial and Market Shifts
Research & Development FDA Probes Immunotherapies; Biotech Faces Financial and Market Shifts

The biopharmaceutical industry is in a state of flux, marked by the FDA's scrutiny of immunotherapy drugs, financial challenges faced by biotech startups, and promising advancements in vaccine development and obesity treatments. As regulatory, operational, and market dynamics evolve, companies must

Is Luvelta the Next Breakthrough Drug for Treating NSCLC?
Research & Development Is Luvelta the Next Breakthrough Drug for Treating NSCLC?

Sutro Biopharma has announced a significant step forward in the fight against lung cancer by initiating a global Phase 2 clinical trial, aptly named REFRαME-L1, for their innovative drug luveltamab tazevibulin (luvelta). This trial aims to evaluate the safety and efficacy of luvelta in adults with

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