Biologics

This post and a huge thank you to David Sergeant and Justin Foox of Ipratech has been overdue for some time. Early last year, Somatek acquired a CYTOSYS control platform for its process development work. Having experience with bioreactor controllers from several other...

The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, on Wednesday announced the results of an independent, scheduled data review of the Phase 3 Mosaico study of Janssen’s investigational HIV vaccine regimen. The...

Much research has gone in recent years into augmenting checkpoint inhibitor immunotherapies to make them effective in more cancer types and for more cancer patients. In this context, there is now excitement about the combination of checkpoint inhibitors with...

About 8 million Americans with diabetes take insulin, a peptide hormone, to regulate their blood sugar. Those without health insurance, or who have high-deductible plans, often spend hundreds of dollars a month on this life-saving medication, and one 2019 study found...

The circadian rhythm influences bodily functions in health and disease. The study of biological cycles driven by environmental and genetic factors is an emerging field and some circadian aspects of metabolism have received considerable attention by the public (looking...

Biologics, especially antibodies, are important cancer therapeutics that have significantly improved outcomes for a number of solid tumors. However, biologics are considerably more costly than small-molecule drugs; in part because they are more complex to manufacture,...

In 2021, FDA approved more than 60 oncology drugs and biologics including dangling accelerated Approvals, drug dosing, new approvals and more. This recently published article coauthored by FDA’s Steven Lemery and Richard Pazdur provides a nice summary of FDA...

Influenza vaccines typically coax the immune system to generate antibodies that recognize the head of hemagglutinin (HA), a protein that extends outward from the surface of the flu virus. The head is the most accessible regions of HA, making it a good target for the...

The Scientist published under the title "Moderna vs. Pfizer: Is There a “Best” mRNA Vaccine?" an interesting summary of the current data on effectiveness of the Pfizer and Moderna mRNA COVID-19 vaccines. As a somewhat accidental member of #team Moderna this helps to...

A Phase-I trial of a monoclonal antibody for malaria, sponsored by the National Institutes of Health (NIH), has shown that one dose prevented malaria for up to nine months in those exposed to the malaria parasite Plasmodium falciparum. The open-label, dose-escalating...