Unpacking Digital Medicine

Emily BurkeCardiovascular Disease, Diabetes, FDA, Medical Device

CAN APPS PROGRAM BETTER HEALTH? Digital medicine is defined by the field’s pioneer Dr. Eric Tool of the Scripps Translational Science Institute (La Jolla, CA) as “the ability to digitize human beings, by a variety of means (sequencing, sensors, imaging, etc.), fully exploiting our digital infrastructure of ever-increasing bandwidth, connectivity, social networking, the Internet of all things, and health information systems.” This new field is changing the way … Read More

Putting The NA in DNA

Emily BurkeBiologics, Biotech Basics, Cancer, Cardiovascular Disease, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Ribonucleic Acid (RNA), Small Molecule Drugs, The WEEKLY

Nucleic Acid Therapeutics Small molecule, peptide, and biologic drugs aren’t the only players in the game of drug development. A fourth class of therapeutics differs from all three of these: nucleic acid-based drugs. These drugs are rising in prominence due to their potential to specifically target a wide range of diseases, including various types of cancer, autoimmune, and infectious diseases. Companies … Read More

Stem Cell Snapshot

Emily BurkeBiologics, Cardiovascular Disease, Clinical Trials, Drug Development, Drug Targets, Genetics, Genomics, Mechanism of Action

Inducing Stem Cells To Heal Headlines touting stem cells often claim the therapies heal everything from hair loss to hearing loss. While many of these treatments are not FDA approved, there are some promising innovations winding through preclinical and clinical development. Here at WEEKLY headquarters, we like to tease out the science behind the scene, so let’s review regenerative medicine basics and survey … Read More

Detecting A Silent Killer

Emily BurkeCardiovascular Disease, Diagnostics, Easily Confused, Medical Device, The WEEKLY

Getting To The Heart Of Sudden Cardiac Arrest Sudden Cardiac Arrest (SCA) doesn’t discriminate against anyone. From healthy to unhealthy, young to old, the unexpected cessation happens in an instant. Affecting more than 325,000 people per year with a 90% fatality rate, it is one of the leading causes of death among people over 40. Individuals determined to be at … Read More

Orphan Drugs Lead 2015 Approvals

Emily BurkeBiologics, Cardiovascular Disease, Drug Approvals, FDA, Mechanism of Action, Monoclonal Antibodies, Orphan Disease, Orphan Drugs, Small Molecule Drugs, The WEEKLY

Treatment Options Broaden Driven by 19 new orphan approvals, a whopping 45 novel drugs were cleared for the marketplace in 2015. Additionally, new approvals opened up treatment options for Americans with diseases ranging from breast and lung cancers to irritable bowel syndrome. According to FDA numbers: 19 were for orphan diseases that affect fewer than 200,000 patients per year in the US. … Read More

The Uber Of The Human Body?

Emily BurkeBiologics, Business of Biotech, Cancer, Cardiovascular Disease, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Ribonucleic Acid (RNA), Term of the Week, The WEEKLY

A Tiny Vesicle With Big Potential Cambridge-based startup Codiak BioSciences made headlines last month with $40M launch funding and another $40M if their technology shows promise. So, what’s the big deal? A tiny little particle—once described as a cellular trash truck—called the exosome. First observed in the early 1980s, exosomes were originally thought to be a way for cells to get rid of … Read More

Is Genetic Variety The Spice Of Life?

Emily BurkeBiotech Basics, Cancer, Cardiovascular Disease, Cocktail Fodder, Deoxyribonucleic Acid (DNA), Genetics, The WEEKLY

Understanding Basis Of Evolution Take a look at the person closest to you. Compare the color of their eyes, the texture of their hair, even the complexion of their skin to your own. Do you notice a lot of differences? Genetic variation accounts for the dissimilarities we observe between individuals—seemingly trivial ones such as the differences in eye, hair, and … Read More

RNAi Crashes The PCSK9 Party

Emily BurkeBiologics, Business of Biotech, Cardiovascular Disease, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, FDA, Mechanism of Action, Monoclonal Antibodies, Ribonucleic Acid (RNA), The WEEKLY

Newest Hopeful In Cholesterol Lowering Landscape Just weeks after the biotech world celebrated the approvals of two new cholesterol-lowering PCSK9 inhibitors, Regeneron/Sanofi’s Praulent and Amgen’s Repatha, a potential future rival arrived in style. Enter Alnylam (Cambridge, MA), with its RNAi-based experimental drug ALN-PSCsc, which just completed Phase I with positive results. What makes PCSK9 inhibitors so hot, and why are the new cholesterol drugs on the market … Read More

Potential Of PCSK9 Inhibitors

Emily BurkeBiologics, Business of Biotech, Cardiovascular Disease, Clinical Trials, Drug Development, Drug Targets, Easily Confused, FDA, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

$23 Billion Blockbuster? The PCSK9 inhibitor buzz keeps rolling, especially since sitting before the FDA Advisory Committee earlier this month.  Amgen’s (Thousand Oaks, CA) Repatha and Sanofi’s (Paris, France) Praluent are a new class of cholesterol lowing drug looking to win final approvals by late summer. Both companies are pioneers in the realm of biologics (monoclonal antibodies) aimed at the heart. Early use restrictions … Read More

The Science Behind The Blockbuster Drugs Of Tomorrow

Emily BurkeBiologics, Business of Biotech, Cardiovascular Disease, Clinical Trials, Drug Approvals, Drug Targets, Easily Confused, FDA, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

Billion Dollar Mechanisms Of Action The Most Promising Drugs of 2015—a Thomson Reuters Cortellis Competitive Intelligence report—includes several new drugs with predicted sales of $1 billion plus by 2019. Those on the list are well on their way to winning or have recently won FDA approval and the fervor around their potential has caught the biotech world by storm. While stock gurus are passing … Read More

12 Biotech Concepts Everyone Should Know

Emily BurkeBiologics, Biotech Basics, Business of Biotech, Cancer, Cardiovascular Disease, Clinical Trials, Diabetes, Diagnostics, Drug Approvals, Drug Development, Drug Targets, Ebola, FDA, Genetics, Mechanism of Action, Monoclonal Antibodies, Orphan Disease, Orphan Drugs, Small Molecule Drugs, The WEEKLY

Our mission here at WEEKLY is to keep your industry knowledge up to date. We will be off Thursday, roasting our turkeys and reminding ourselves that it is not the amino acid tryptophan that makes us drowsy after a Thanksgiving feast—it is the massive carbohydrate intake! Whether you are awaiting a Thanksgiving holiday or it is business as usual, we … 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

Squeezing The Juice Out Of Drug Metabolism

Emily BurkeCardiovascular Disease, Drug Targets, HIV, Mechanism of Action, Small Molecule Drugs, Term of the Week, The WEEKLY

When popping a pill, we seldom think about what happens next—to the pill, or even to our bodies. We assume the body welcomes any extra help to fix the problem, but the reaction is quite contrary. A swallowed pill (small molecule drug) is instantly labeled by our body as foreign and the reaction of our body is to immediately get … Read More

Matters Of The Heart

Emily BurkeCardiovascular Disease, Clinical Trials, Drug Development, Drug Targets, Easily Confused, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

In a picture perfect game of drug development, Novartis heartily delivered this week with LCZ696. Also propelling the world of cardiovascular disease treatments into high gear is a promising cholesterol therapeutic by Sanofi and Regeneron called alirocumab. Last week, Novartis released a heart failure drug called LCZ696, along with the data behind their highly successful Phase III trial. Novartis is hopeful, … Read More