Drug Patent Watch

DECEMBER 12, 2024

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Drugs that require extensive clinical trials for generic approval or fall under special regulatory pathways may have a lower risk of generic entry.

Licensing 92

Licensing Licensing Branding Drugs 92

FDA Law Blog

JULY 9, 2024

For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts.

Clinical Trials 59

Clinical Trials Clinical Trials Development Drugs 59

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

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.

Trials 52

Trials Antibody Gene Therapy Gene 52