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.

Development 161

Development Production Immune Response Licensing 161

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. MYTH: Clinical pharmacology studies of biosimilars aim to establish safety and effectiveness. What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. 10% of patients 1.

Trials 52

Trials Medicine Production Containment 52

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