Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Product Type-Specific Analysis.

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

Even with the holidays among us, there were a number of clinical trial announcements. Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. Here’s a look. COVID-19-Related. Non-COVID-19-Related.

Trials 52

Trials Antibody Gene Therapy Clinical Trials 52

The Pharma Data

MAY 3, 2021

Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ). 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 ).

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52