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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Product Type-Specific Analysis. The exact type of the biologic under consideration has a tremendous impact on the analysis.

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Clinical Catch-Up: December 21-25 | BioSpace

The Pharma Data

STP705 is a small interfering RNA (siRNA) therapy that leverages a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to knock down both TGF-beta1 and COX-2 gene expression. RESTORE-1 is a Phase II trial of an intracerebral AAV-based gene therapy for Parkinson’s disease.

Trials 52
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Recon: W. VA opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

The Pharma Data

Six patients with dementia went to Mexico for an unproven gene therapy, a biotech CEO claims ( STAT ). Avrobio changes course after FDA closes path for speedy gene therapy approval ( BioPharmaDive ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ).