BioPharma Drive: Drug Pricing

JANUARY 12, 2025

The biotech plans to use the funding to advance clinical testing of an epigenetic silencing therapy it hopes could treat chronic hepatitis B infections.

Research 202

Research Therapies 202

FDA Law Blog: Drug Discovery

JANUARY 12, 2025

By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J. Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs application and use of accelerated approval has evolved dramatically since it was first developed by the Agency to help address the HIV/AIDS epidemic in the late 1980s.

FDA 64

FDA Clinical Trials Trials Therapies 64

Codon

JANUARY 12, 2025

On a winter’s day in 1884, a group of Augustinian friars gathered around a fire and tossed papers into its hungry flames. Thousands of pages withered and burned, each containing hand-written text, charts, and data from a lifetime of work. By the time the smoke dissipated into an azure sky, it had all vanished. The papers eaten by those flames belonged to Gregor Mendel, a quiet scientist and religious man today revered as the “father” of genetics.

DNA 107

DNA Nurses Research Molecular Biology 107