Camargo

DECEMBER 13, 2021

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.

Development 161

Development Production Immune Response Licensing 161

Worldwide Clinical Trials

MAY 30, 2024

Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

The Pharma Data

DECEMBER 27, 2020

Taysha Gene Therapies announced that Queen’s University in Ontario, Canada, received Clinical Trial Application (CTA) approval from Health Canada for its Phase I/II trial of TSHA-101 for infantile GM2 gangliosidosis. RESTORE-1 is a Phase II trial of an intracerebral AAV-based gene therapy for Parkinson’s disease.

Trials 52

Trials Antibody Gene Therapy Gene 52

The Pharma Data

MAY 3, 2021

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 ).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52