Picturing Disease

Emily BurkeBiotech Basics, Cancer, Clinical Trials, Diagnostics, Term of the Week, The WEEKLY

USING MEDICAL IMAGING TO INVESTIGATE DISEASE Medical imaging — using various modalities to take a snapshot of the body’s interior structure — has been around since 1895, with the discovery of X-rays by Wilhelm Roentgen. X-rays are a type of electromagnetic radiation (more on that later!) that are able to pass through soft tissues such as skin, fat, and muscle … Read More

Therapeutic Antibody Primer

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Easily Confused, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs

Basics & Innovations Monoclonal antibody (mAb) therapeutics burst onto the healthcare scene 20 years ago, and today they remain one of the most versatile and effective therapeutics available. The tried and true mAbs are still in high demand, and we suspect this first wave of derivative products clamoring their way through the pipeline will be equally as successful. In this WEEKLY, we’ll … Read More

New Hope For Spinal Muscular Atrophy

Emily BurkeAntisense, Biologics, Clinical Trials, Drug Development, Drug Targets, FDA, Genomics, Mechanism of Action, Orphan Disease, Orphan Drugs, Ribonucleic Acid (RNA), The WEEKLY

FIRST THERAPY APPROVED FOR SMA Squeaking by on December 23rd as the last new drug approval of 2016, Biogen’s (Cambridge, MA) Spinraza now provides hope for the thousands of families affected by a debilitating neuromuscular disorder known as spinal muscular atrophy (SMA). SMA robs people of their ability to walk, eat, and ultimately, breathe. In addition to Spinraza, there are 13 … Read More

Unwiring The Biology Of Fibrosis

Emily BurkeAntisense, Biologics, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, Term of the Week, The WEEKLY

Fibrotic Disease Innovations Fibrotic diseases — organ and tissue disorders that occur as a result of the buildup of excessive scar tissue — are sounding the alarm in the biotech sector. A silent epidemic creeping up on the Western world involves non-alcoholic steatohepatitis (NASH), or liver fibrosis associated with obesity and type 2 diabetes. Left untreated, NASH can lead to liver failure. Currently, … Read More

The Race To Beat SMA

Emily BurkeAntisense, Biologics, Clinical Trials, Drug Development, Drug Targets, FDA, Genomics, Mechanism of Action, Orphan Disease, Orphan Drugs, Ribonucleic Acid (RNA), The WEEKLY

Zeroing In On The SMA Pipeline A decade ago, there was only one drug in development for a debilitating neuromuscular disorder known as spinal muscular atrophy (SMA) — robbing people of their ability to walk, eat, and ultimately, breathe. Today, there are 14 therapies making their way through the clinic according to the patient advocacy group Cure SMA. The increase is … Read More

Post-translational Modifications In Biotech

Emily BurkeBiologics, Biomanufacturing, Biotech Basics, Cancer, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies

Basic Science Meets Application “Post-translational modification” may not be a term you hear every day, but it is critically important to the biotech industry—from understanding how cancer develops to producing biologics. Breaking the term down, we know that: “post” means “after.” “translation” is “the cellular process of making proteins.” “modification” means “change.” So, a post-translational modification (PTM) simply means that … Read More

The Long And Short Of AMD

Emily BurkeBiologics, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Genetics, Mechanism of Action, Monoclonal Antibodies, Term of the Week, The WEEKLY

A Spotlight On One Of The Most Prevalent Eye Diseases It’s easy to take our ability to see for granted. On a day-to-day basis, we rely on vision to process information and to navigate the world without giving it a second thought. For the millions of people affected by eye disease, vision loss, and blindness, impaired vision is a daily reality … Read More

Pushing The Self-Destruct Button

Emily BurkeCancer, Drug Approvals, FDA, Genetics, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

 Pushing the Self-Destruct Button Breakthrough drug Venclexta charged onto the marketplace three months early to battle chronic lymphocytic leukemia. AbbVie’s (North Chicago, IL) and Roche’s (Basel, Switzerland) new therapy gained a quick approval after 80% of patients in the 106-person clinical trial responded to the small molecule inhibitor. Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults, with approximately … Read More

Unmasking Multiple Sclerosis

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

 Many Channels Available To Impede MS Progression Continuing our series on central nervous system (CNS) disorders—previously covering Alzheimer’s and Huntington’s—we pivot to unmask Multiple Sclerosis this week. Famous faces suffering from Multiple Sclerosis (MS) include former talk show host Montel Williams and Sopranos star Jamie-Lynn Sigler. MS typically occurs in susceptible individuals between the ages of 20 and 50, and there are … Read More

Interrupting HIV

Emily BurkeBiologics, Clinical Trials, Drug Development, Drug Targets, Genomics, HIV, Mechanism of Action, Monoclonal Antibodies, Ribonucleic Acid (RNA), Small Molecule Drugs, The WEEKLY

Therapies In HIV Pipeline Medicine has made gigantic strides in understanding and treating the human immunodeficiency virus (HIV) since its emergence in the early 1980s. Thanks to robust drug discovery efforts, today HIV is managed as a chronic disease instead of the death sentence of years past. The secret to HIV’s infectious success lies in its high mutation rate. Developing drug resistance over … Read More

The Medicine Machine

Emily BurkeCocktail Fodder, Drug Development, Drug Targets, Small Molecule Drugs, The WEEKLY

Modern Technology & Mother Nature For thousands of years, nature has been the best medicine cabinet around. Natural products are drugs derived from nature, typically plants or microbes, and have been especially useful in fighting cancer and infectious disease. Drugs from nature can be highly effective. Think Bristol-Myers Squibb’s (New York, NY) Taxol, the breast cancer drug derived from the sap … Read More

Cancer Immunotherapy Goes Viral

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

Oncolytic Viruses Make Their Debut Does a virus engineered to harness the immune system to fight cancer sound like a clever idea? Amgen (Thousand Oaks, CA) certainly thinks so, because their talimogene laherparepvec (T-Vec) recently earned an FDA approval to fight inoperable melanoma recurrent after initial surgery. Oncolytic viruses—like T-Vec—have the attention of both industry media and mainstream news programs. This new class of therapy is an elegant “hack” of the immune … Read More

It’s A Great Time To Be In Biotech

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, FDA, Genomics, HIV, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

It’s a great time to be in biotech—new therapeutics are breaking ground faster than we can say “monoclonal antibody” and the technologies behind them are heavy with promise and potential. Our mission is to keep your industry knowledge up to date and the WEEKLY is here to give you a smart primer on the basics. Below we have outlined several … Read More

Driving Down The Epigenetic Highway

Emily BurkeBusiness of Biotech, Cancer, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, FDA, Genetics, Genomics, The WEEKLY

Biotechnology is enjoying another banner year on Wall Street. Currently, there are at least 39 companies queued for an IPO. This led us at the WEEKLY to wonder: what is the actual science behind each company’s promise that leads public markets to invest billions of dollars? This week and next, we are popping open the hood and checking out what … Read More

Biotech’s Battlefront: Monoclonal Antibodies

Emily BurkeBiologics, Biotech Basics, Cancer, Drug Targets, FDA, Mechanism of Action, Monoclonal Antibodies, Orphan Drugs, The WEEKLY

Since their premier on the scene, monoclonal antibodies (mAb) have demanded top billing on the biotech marquee, creating a cast of therapeutics used to treat diseases like autoimmune disorders and cancer. The first player debuted in 1986 when Janssen-Cilag’s OKT3 gained FDA approval to treat transplant rejection patients. Fast forward to 2013, where half of the top ten best selling … Read More

Mutations And Disease: The Spice Of Life

Emily BurkeBiologics, Biotech Basics, Cancer, Cardiovascular Disease, Cocktail Fodder, Drug Targets, FDA, Genetics, Mechanism of Action, The WEEKLY

This week’s issue features excerpts from the “Genetic Variation” chapter of The Biotech Primer, our 200-page book that provides an in-depth look at the biotech industry and the science that drives it. In this chapter, we explain the different types and causes of genetic mutations and then explore their relationship to disease and therapeutics. Today, we begin with a discussion … Read More