Longevity In Biotech

Emily BurkeBiologics, Business of Biotech, Cancer, Clinical Trials, Drug Development, Drug Targets, Genomics, The WEEKLY

Longevity has fascinated mankind for centuries, from ancient myths about fountains of youth to current speculation around caloric restriction. With our increased scientific understanding of aging, clinical validation and commercialization of treatments are near. The goal is to extend lifespan as well as health span, and we may be looking at a future where the norm is to remain mentally and physically active at age 90, or even … Read More

Designer Genes: An Introduction To Genome-Editing

Emily BurkeBiologics, Biotech Basics, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Targets, Genetics, Genomics, HIV, Mechanism of Action, Ribonucleic Acid (RNA), The WEEKLY

Five years ago, altering an individual’s genome would have been labeled unimaginable. Fast forward to today and one of the hottest new developments in biotech is genome-editing—the ability to selectively disable or edit the sequence of specific genes. In this WEEKLY we will compare and contrast the different genome-editing platforms in development and discover how close we are to a clinical reality. Got Gaps in Your … Read More

Biosimilars: Ready or Not, Here They Come

Emily BurkeBiologics, Biomanufacturing, Biosimilars, Biotech Basics, Drug Development, Easily Confused, FDA, Small Molecule Drugs, The WEEKLY

Last week, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended Novartis’  biosimilar version of Amgen’s megahit Neupogen (filgrastim), effectively paving the way for the first US biosimilar approval in the near future. Filgrastim is a recombinant version of a naturally-occurring protein which stimulates the bone marrow to increase production of white blood cells. Patients undergoing chemotherapy, as well as those receiving bone marrow … Read More

First-in-Class: 2014 Drug Approvals

Emily BurkeBiologics, Cancer, Drug Approvals, Drug Targets, FDA, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

The FDA ushered in six new drugs just before the close of 2014, bringing the final tally to 41– the highest rate since 1996, when the agency approved 53 drugs. 2014 drug approvals were notable not only for their quantity, but also their quality. A number of new drugs utilized first-in-class mechanisms, and new pathways always put a skip in … Read More