Zika On The Brain

Emily BurkeClinical Trials, Diagnostics, Drug Development, Drug Targets, Mechanism of Action, Ribonucleic Acid (RNA), The WEEKLY

The Latest On The Rise Of Zika The spread of the Zika virus is raising alarm bells in the United States, and Congress has yet to pass any legislation to combat the fight. Zika infections reported in Miami confirm the virus’ stateside arrival, pushing residents to take measures to protect their pregnancies from potentially devastating effects. In our previous issue, we explored the underpinnings … 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

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

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

Capturing The Running Backs Of Cancer

Emily BurkeBiologics, Cancer, Drug Development, Drug Targets, Easily Confused, Medical Device, The WEEKLY

After using diagnostic technology to establish the existence of cancer, determining the severity is the next step toward developing a game plan. If metastasis is in the picture, strengthening your defensive line-up is a must. The dissemination of circulating tumor cells (CTCs) from the primary tumor to unaffected tissue is a key step of early stage metastasis. CTCs break away … 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

Breaking The Ice With ALS

Emily BurkeAntisense, Clinical Trials, Cocktail Fodder, Drug Development, Genetics, Monoclonal Antibodies, Orphan Disease, Orphan Drugs, The WEEKLY

ALS awareness is on the rise, thanks to the ubiquitous ice bucket challenges making worldwide headlines. This social media phenomena prompts us here at WEEKLY to wonder: what is this disease and where does the biotech industry stand? ALS stands for Amyotrophic Lateral Scelerosis. Let’s break it down to its roots: ‘A’ means no ‘Myo’ means muscle ‘Trophic’ means nourishment … Read More

Cerdelga: 25 years In The Making

Emily BurkeDiabetes, Drug Approvals, FDA, Genetics, Mechanism of Action, Orphan Disease, Orphan Drugs, Small Molecule Drugs, The WEEKLY

We have a new orphan drug on the market thanks to last week’s FDA approval of Cerdelga, a small-molecule therapeutic developed by Sanofi for treatment of Gaucher’s disease. This rare genetic disorder is thought to affect around 6,000 in the United States. Regular WEEKLY readers know we like to highlight new drug approvals. After all, there are only 25 to … Read More