Manufacturing

Cambridge Researchers Use Light to Revolutionize Drug Synthesis
Tech & Innovation Cambridge Researchers Use Light to Revolutionize Drug Synthesis

Lukas Hainz sits down with Ivan Kairatov, a distinguished biopharma expert with a deep background in research and development and a keen eye for technological innovation within the pharmaceutical industry. Together, they explore a recent breakthrough from the University of Cambridge that reimagines

Why Is the FDA Shifting Standards for Rare Disease Drugs?
Research & Development Why Is the FDA Shifting Standards for Rare Disease Drugs?

Ivan Kairatov is a distinguished biopharma expert with a career built on navigating the intricate crossroads of biotechnology innovation and regulatory strategy. With extensive experience in research and development, he has spent years analyzing how emerging therapies transition from the laboratory

Review of Rezurock GVHD Treatment
Management & Regulatory Review of Rezurock GVHD Treatment

The journey following a stem cell transplant can be fraught with complications, none more debilitating than chronic graft-versus-host disease, a condition where donor immune cells relentlessly attack the recipient's body. This review assesses Rezurock (belumosudil) as a critical therapeutic option

Biogen Lupus Drug Earns FDA Breakthrough Designation
Management & Regulatory Biogen Lupus Drug Earns FDA Breakthrough Designation

For individuals grappling with the relentless and often disfiguring effects of cutaneous lupus erythematosus, the path to effective treatment has been long and fraught with limited options, but a significant development from Biogen offers a new beacon of hope. The U.S. Food and Drug Administration

Is Samsung's US Move a Game-Changer for Biopharma?
Management & Regulatory Is Samsung's US Move a Game-Changer for Biopharma?

The intricate global network that delivers life-saving medicines has proven remarkably fragile in recent years, prompting a fundamental rethinking of how and where these complex therapies are produced. In this context, Samsung Biologics' recent acquisition of a major US-based manufacturing facility

Enhertu Wins FDA Approval for Breast Cancer Treatment
Management & Regulatory Enhertu Wins FDA Approval for Breast Cancer Treatment

For the first time in more than a decade, the therapeutic landscape for newly diagnosed metastatic HER2-positive breast cancer has been fundamentally altered by a landmark U.S. Food and Drug Administration decision. The agency has officially approved a combination therapy featuring Enhertu and

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