Navigating A Clinical Hold
FDA-ordered clinical holds are on the rise, and biologics IND are driving them. Immunome CEO Purnanand Sarma, Ph.D. shares his take on the role of...
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FDA-ordered clinical holds are on the rise, and biologics IND are driving them. Immunome CEO Purnanand Sarma, Ph.D. shares his take on the role of...
Convergent Therapeutics is bullish on the combination of radioisotopes and antibodies to direct radiation directly to cancer cells. As enabling...
2022 could be a breakout year for oral, intranasal, and inhalable biologics. As innovative biopharma companies clear formulation, stability, and...
When is it time for an emerging biopharma company to truly emerge, and what goes into its competitive positioning? Biopharma industry veteran Allan...
The Placental Stem Cell Advantage As Celularity makes its most significant clinical progress to date, the company is putting theories born of 20 years of postpartum placental stem cell research into practice. Could the production platform it’s building be the key to accessible, affordable allogeneic cell therapy? Last month, Celularity announced that the FDA granted Orphan Drug Designation status to the company’s lead therapeutic candidate, CYNK-001, for the treatment of malignant gliomas. The month prior, the same candidate received Fast Track Designation. These designations mark importa...