Biologics
Biosimilars
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,...
New Approvals for Cancer Treatments
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...
Progress Towards Universal Influenza Vaccine
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 Interesting World of mRNA Vaccines
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...
First Human Trial of Monoclonal Antibody for Malaria Shows Promise
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...
Optogenetics: A cool tool may have found medical use
Optogenetics is a biological technique that uses light to control neurons that have been genetically modified to express light-sensitive ion channels. As such, it is a neuromodulation method that controls the activities of individual neurons in living tissue — even...
A New Type of Antibody –
For a long time 5 antibody types have been known in mammals, IgG, IgM, IgA, IgE, and IgD, with IgG being the work horse in biotechnology. So it drew our attention that a group at Duke University has described a new type of anti-glycan antibody that binds to a patch of...
Monoclonal for Alzheimer’s
On Monday FDA approved Biogen’s aducanumab, brand name Aduhelm, through a program called accelerated approval. Aduhelm is the first new medication for Alzheimer’s disease in nearly two decades. FDA’s decision was welcomed by patients and their families as a...
RNA therapeutics
To those developing treatments for oncology, in the gene therapy space and many other fields it seemed for a long time that RNA-based therapies have many attractive properties but somehow just too many obstacles to overcome. Enter recent break-throughs in vaccine...
Blood Clot Risk from COVID-19 Higher than After Vaccines?
It has been well covered in the news media that some COVID-19 vaccines have recently faced headwinds as severe thrombotic complications have been observed in some people that received the vaccine. However, one fact that is not discussed much is that thrombotic...