Camargo

DECEMBER 13, 2021

Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. On the contrary, due to the complexity involved in comparing the structures of biologics, selecting the correct sampling times to prove bioequivalence for both PK and biomarkers is of primary importance.

Development 161

Development Production Immune Response Licensing 161

Camargo

JULY 8, 2021

The UCLA researchers measured monoamine oxidase A (MAOA) gene expression in tumors from cancer patients and found that high MAOA expression was associated with shorter survival times and turned to a mouse model to investigate these observations with promising results.

Development 130

Development Bioequivalency Gene Expression Drugs 130

The Pharma Data

DECEMBER 27, 2020

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

Trials Antibody Gene Therapy Clinical Trials 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