100 Drug Development Acronyms

Emily BurkeBiotech Basics

ADME: Absorption, Distribution, Metabolism, Excretion AE: Adverse Event ANDA: Abbreviated New Drug Application API: Active Pharmaceutical Ingredient ATMPs: Advanced Therapy Medicinal Products BLA: Biologic License Application BsUFA: Biosimilar User Fee Act CAT: Committee for Advanced Therapies CBER: Center for Biologics Evaluation and Research CDER: Center for Drug Evaluation and Research CFR: Code of Federal Regulations CHMP: Committee for Medicinal Products … Read More

100 Biotech and Drug Development Terms

Emily BurkeBiotech Basics

Antibody: A protein produced by the immune system that binds to a specific antigen. Antibody-Drug Conjugate: An antibody that has a toxic drug, typically a chemotherapeutic agent, attached to it for target delivery to a specific tumor cell. Antigen: A foreign substance which, when introduced into the body, stimulates an immune response. Antisense: A short piece of nucleic acid whose … Read More

On The Hunt

Emily BurkeBiotech Basics, Drug Development, Drug Targets, Genetics, Genomics, Mechanism of Action, Orphan Disease, Orphan Drugs, Term of the Week, The WEEKLY

The Hurdles Of Huntington’s The nervous system is an incredibly complex piece of human machinery, stretching to the far reaches of the body while controlling and receiving the nuances of life from a central command station. Just like any part of the human body, the central nervous system (CNS) is affected by various diseases that are sometimes not entirely understood. After … Read More

Attacking All Angles Of Alzheimer’s

Emily BurkeBiologics, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

Alzheimer’s Pipeline Roundup Alzheimer’s disease ranks as one of the toughest nuts to crack within drug discovery and development. Current treatments merely manage symptoms, so finding a better solution becomes more and more urgent as the aging population grows. The pathology most commonly associated with Alzheimer’s disease (AD) is the buildup of amyloid-beta (Aβ) plaques in the brain. Recent research from … Read More

The Emerging Proteomics Market

Emily BurkeBusiness of Biotech, Cancer, Deoxyribonucleic Acid (DNA), Diabetes, Diagnostics, Drug Targets, Genomics, Term of the Week, The WEEKLY

Picking Apart The Protein Genomics continues to be all the rage in biotech circles—with special kudos to Illumina’s (San Diego, CA) recent ability to obtain an entire human genome sequence in 24-hours for a mere thousand dollars. Our overall understanding of human DNA combined with our ability to determine individual genomes leads to better disease insight, more powerful diagnostics, and a … Read More

Biotech Battles Zika

Emily BurkeDeoxyribonucleic Acid (DNA), Genetics, GMO, Term of the Week, The WEEKLY

Latest Mosquito-Borne Disease Outbreak The buzz around the Zika virus isn’t going to die down anytime soon. The global health threat is dominating the news while the Brazilian outbreak threatens to spread to the rest of the Americas. As the ramifications of the virus emerge every passing day, we here at Biotech Primer WEEKLY wonder: what is biotech doing to fight Zika? In this issue, … Read More