Aphaia Pharma, a clinical-stage biopharmaceutical company harnessing precision-targeted drug delivery technology for the treatment and prevention of metabolic diseases, announced that it has enrolled the first patient as part of a Phase 2 study evaluating the safety...
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food...
Two rare disease companies – Idera Pharmaceuticals and Aceragen – are merging to pursue the common goal of an FDA approval that could come as early as 2024. For Idera, the merger is something of a lifeline after its top drug candidate flopped last year. On...
CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation...
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. The US FDA is rightfully concerned about patient diversity in industry-sponsored clinical trials (iCTs). (1) In its recent guidance to...
Sanofi announced that Xenpozyme (olipudase alfa-rpcp) won FDA approval for adult and pediatric patients with the rare genetic disease acid sphingomyelinase deficiency (ASMD), often referred to as Niemann-Pick disease. In its announcement, the FDA noted that...
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