Biologics
Phasing out animal testing for new drugs
In April, FDA announced plans to phase out the requirement for animal testing in preclinical safety studies and replace them with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro...
People are open to testing for Alzheimer’s disease
The Alzheimer’s Association reports that nearly 4 in 5 older Americans would want to know if they had Alzheimer’s disease before having symptoms, or before those symptoms interfered with their activities. They also want treatment, even if it comes with risks, as long...
Trump and biotech, two months in
In an earlier blog post, I collected predictions on what impacts Donald Trump’s second presidential term would have on the biotech and pharmaceutical industries. This is a follow-up to that post, two months into the new administration. (Please note that this post does...
G is for Gene Therapy
Gene therapy aims to fix a faulty gene or replace it with a healthy gene to try to cure disease or make the body better able to fight disease. It holds promise as a treatment for a wide range of diseases, including cancer, heart disease, diabetes, and inherited...
First T-cell Engager Has Been Approved
As widely reported, earlier this week FDA approved the first in a novel class of immuno-oncology drugs called bispecific T-cell engagers for the treatment of small cell carcinoma. Small cell carcinoma, an aggressive type of lung cancer, currently has a few effective...
F is for Filtration
Bioprocess filtration comprises the use of filtration techniques to purify and separate biological substances during the production of all biologics, proteins, nucleic acids, and viruses. Filtration plays a critical role in ensuring the safety, efficacy, and quality...
CG Oncology IPO, first biotech IPO of 2024, a smashing success
We are so happy to learn that the IPO of our former client CG Oncology went exceedingly well. After recent news that GC Oncology’s bladder cancer treatment received both FDA fast track and breakthrough therapy designation, this is more good news for people with...
E is for Eggs
Chicken egg yolk antibodies, immunoglobulin Y, abbreviated IgY, are a type of antibody found in birds and reptiles, but not mammals. Like other immunoglobulins, IgY are a critical part of organisms’ immune response to foreign substances including pathogens. IgY are...
Monoclonals for Severe Asthma
Severe asthma affects between nine and 15 million people worldwide, causing chest tightness and difficulty breathing in addition to frequent asthma attacks that sometimes require hospitalization. It is usually treated with inhaled corticosteroids such as fluticasone...
ADC to Help People with Sickle Cell
Sickle cell disease is a set of genetic conditions where abnormalities in the structure of hemoglobin cause red blood cells to take on a long, curved, sickle-like shape, which can then impede blood flow. Gene therapies may make a huge difference in the lives of...