The Multiple Myeloma Landscape

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

BLOOD CANCER: MULTIPLE MYELOMA Plasma cells are the antibody-producing cells of our immune system which happen to play a critical role in our defense against infections. In multiple myeloma, plasma cells begin to grow and divide in an uncontrolled manner, forming a cancerous mass known as a plasmacytoma. Marrow — which produces plasma — no longer functions in our defense, it simply takes … Read More

Decoding Your Genes

Emily BurkeBiotech Basics, Deoxyribonucleic Acid (DNA), Diagnostics, Drug Approvals, Easily Confused, FDA, Genetics, Genomics, Orphan Disease, Term of the Week, The WEEKLY

The Skinny On DNA Testing 23andMe (Mountain View, CA) recently found itself back in the limelight after the disease risk section of its mail-in DNA kit received an OK from the FDA. The Silicon Valley biotech had to halt sales of its direct-to-consumer genetics testing back in 2013 after regulatory officials grew concerned over marketing claims and the possibility of consumers misinterpreting the test results. 23andMe rebooted a limited part of … Read More

The PARP Race Is On

Emily BurkeCancer, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Approvals, Drug Development, Drug Targets, Easily Confused, FDA, Mechanism of Action, The WEEKLY

PARP1 INHIBITOR LINEUP PARP1 inhibitors are making a strong statement! Tesaro’s (Waltham, MA) just-approved Zejula has garnered predictions of blockbuster status. AstraZeneca’s (Cambridge, UK) Lynparza was the first PARP1 inhibitor to make it to market back in 2014, and their recent clinical trial results showed significant survival benefit in ovarian cancer. Clovis Oncology (Boulder, CO) achieved the second FDA approval of a PARP1 inhibitor with Rubraca in … 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

The Next Generation Fight Against CF

Emily BurkeClinical Trials, Drug Approvals, Drug Development, Drug Targets, Easily Confused, Genetics, Mechanism of Action, Orphan Disease, Orphan Drugs, The WEEKLY

TARGETING THE ROOT OF CYSTIC FIBROSIS Innovative therapies targeting the root cause of cystic fibrosis (CF) hit the market several years ago, but those treatments were only for a subset of CF patients.  Now, companies like AbbVie and Vertex may have the potential to treat a large majority of the population—up to 90%—according to clinical trial data. In this issue, we’ll explain … Read More

Hacking The Immune Response

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Easily Confused, Monoclonal Antibodies, The WEEKLY

BIOPHARMA’S DARLING Immunotherapy is the current biopharma darling, garnering massive investment and media attention. Ranging from monoclonal antibodies to engineered T-cells, companies are rapidly learning how to harness the power of the immune system to fight disease. There are two general categories of immunotherapies: Activation immunotherapies “turn on” or “turn up” the patient’s own immune response to help fight disease. Suppression immunotherapies suppress the … Read More

Two Monoclonal Antibodies Walk Into The Market

Emily BurkeBiologics, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, Easily Confused, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, Term of the Week, The WEEKLY

Attacking Asthma & Pushing Out Psoriasis Two new monoclonal antibodies debuted on the market thanks to FDA approvals last month. Both treat chronic inflammatory conditions: Lilly’s (Indianapolis, IN) Taltz for psoriasis and Teva’s (Petah Tikva, Israel) drug Cinqair for severe asthma. Interestingly enough, having psoriasis is associated with an increased risk of developing asthma according to a study in the British Journal of Dermatology. While these two conditions … 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

Et Tu, Immune System?

Emily BurkeBusiness of Biotech, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Easily Confused, The WEEKLY

Autoimmune Disorders: A Story Of Betrayal “Et tu, Brute?” The famous line spoken by Shakespeare’s Julius Caesar is synonymous with unexpected betrayal by a close friend. A once trusted member of the inner circle, Marcus Brutus joined the coup and turned on Caesar. The 23.5 million Americans suffering from autoimmune disorders also have a Brutus in their midst—their own immune … Read More

Presenting The New Class Of Transcriptional Therapeutics

Emily BurkeBiotech Basics, Cancer, Deoxyribonucleic Acid (DNA), Drug Development, Easily Confused, Genetics, Genomics, Mechanism of Action, Ribonucleic Acid (RNA), Small Molecule Drugs, Term of the Week, The WEEKLY

DNA: Coding Vs. NON-Coding The completion of the Human Genome Project in 2003 revealed a big surprise: up to 98% of the DNA making up the human genome does not code for proteins! The notion that parts of the genome were non-coding had been circulating for several decades, but when the actual percentage was confirmed it blew the industry’s mind. This … Read More

What The Heck Is qRT-PCR Diagnostics?

Emily BurkeBiotech Basics, Cancer, Cocktail Fodder, Deoxyribonucleic Acid (DNA), Diagnostics, Easily Confused, Genetics, Genomics, HIV, Ribonucleic Acid (RNA), The WEEKLY

From Impossible to possible The genetics of cancer has progressed from the impossible to a multifaceted mountain of possible. Comprehensive projects in whole genome sequencing and tumor genome sequencing are providing data to unravel the genetic predispositions of cancer. The other half of possible lies in quantitative PCR. This platform technology can identify types of cancer, effective therapeutics, and aggressiveness of the … 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

A Health Crisis In The Making

Emily BurkeBusiness of Biotech, Clinical Trials, Drug Development, Drug Targets, Easily Confused, FDA, Mechanism of Action, Small Molecule Drugs, The WEEKLY

The Race Against Nash A silent epidemic creeping upon the Western world pushed the headline grabbing acquisition of a Phase 1 non-alcoholic steatohepatitis (NASH) drug last week. Boehringer Ingelheim (Ingelheim, Germany) acquired Pharmaxis (Sydney, Autralia) due to the promise of PXS4728A. Several other companies also have NASH drugs in development, such as Intercept, Genfit, Gilead, Galmed, Conatus, Raptor, and Galectin Therapeutics. With no approved treatment on the market and liver transplant … Read More

Ready. Set. CRISPR.

Emily BurkeBiotech Basics, Business of Biotech, Cancer, Deoxyribonucleic Acid (DNA), Easily Confused, Genetics, Genomics, HIV, Ribonucleic Acid (RNA), The WEEKLY

CRISPR/CAS9 TECHNOLOGY BUILDS UP STEAM The world definitely weighed in after Chinese scientists published a paper detailing the use of CRISPR/Cas9 to edit nonviable human embryo genomes. While the embryos used were never intended to become a living human being, this controversial milestone created a firestorm of opinion. Tweets, blogs, and mainstream news stories were abuzz about the opening of Pandora’s box. … 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

The State Of Cystic Fibrosis And Precision Medicine

Emily BurkeCancer, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, Easily Confused, FDA, Genetics, Genomics, Mechanism of Action, Orphan Disease, Orphan Drugs, Small Molecule Drugs, The WEEKLY

During President Obama’s State of the Union address last month, a cystic fibrosis patient named Bill Elder sat beside First Lady Michelle Obama. Diagnosed with the disease at 8 years old, Mr. Elder is “healthier now than ever before” at age 27, thanks to Vertex’s (Boston, MA) Kalydeco. As a third-year medical student, he is not only surviving, but thriving. Receiving an invitation to … Read More