Breast Cancer Subtypes

Emily BurkeBiotech Basics, Cancer, Genetics, Mechanism of Action

FOUR MOLECULAR VARIANTS EXPLAINED Hearing your doctor utter the words HER2-positive, HR-positive, triple-negative, or BRCA mutation can be devastating — even for the most resilient person. Simply put, breast cancer is a complex disease. A diagnosis can be derived from any combination of the factors listed above — or, none at all. The National Cancer Institute (Bethesda, MD) has outlined four molecular subtypes of the disease. … 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

Pills, Proteins & Peptides

Emily BurkeThe WEEKLY

Promising Peptide Therapies The front runners in the game of drug delivery include small molecule and large molecule drugs, but there is another class that lands right in between: peptides. Several companies, including Rhythm Pharmaceuticals (Boston, MA), Kalos Therapeutics (San Diego, CA), Aileron Therapeutics (Cambridge, MA), and Bicycle Therapeutics (Cambridge, MA) have emerged as prominent players in the peptide arena. Let’s … 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

Swallowing A Biologic Drug?

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

Surviving The Stomach Is Key Over the past two decades, biologic drugs — drugs composed of proteins produced by living cells — have become the safest, most effective top sellers within the pharmaceutical industry. Approved to treat a variety of diseases including rheumatoid arthritis, diabetes, multiple sclerosis, Crohn’s disease, and a whole range of cancers, these drugs include monoclonal antibody … Read More

Cancer Vaccines & Game Changers

Emily BurkeBiologics, Cancer, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Genomics, Mechanism of Action, Term of the Week

The Elusive Cancer Vaccine The promise of cancer vaccines have proven to be elusive. A new crop of biotechs are hoping to change that by taking advantage of the latest advances in genomics. Scientists are working overtime trying to develop cancer vaccines that train the immune system to recognize and fight an established tumor. In this WEEKLY, we’ll break down the science … 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

Catching The First Drop Of Cancer

Emily BurkeCancer, Deoxyribonucleic Acid (DNA), Diagnostics, FDA, Monoclonal Antibodies, Ribonucleic Acid (RNA), Term of the Week, The WEEKLY

The Latest In Cancer Diagnostics Hearing the words “it might be cancer” paired with your doctor’s perplexed look is enough to send shockwaves through your body. Getting to the heart of a diagnosis usually requires a surgical biopsy—removal and examination of the suspected tissue for visible signs of cancer. Less invasive diagnostic tests—called liquid biopsies—might just bring more choices to … 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

Targeting Breast Cancer

Emily BurkeCancer, Drug Approvals, Drug Development, Drug Targets, FDA, Genetics, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

The Subtypes of Breast Cancer Hearing your doctor utter the words HER2-positive, HR-positive, triple-negative, or BRCA mutation can be devastating—even for the most resilient person. Simply put, all are linked to breast cancer. Breast cancer is complex and a diagnosis can be caused by all, some, or even none of the factors listed above. In fact, the National Cancer Institute’s (Bethesda, … Read More

First-in-Class: 2014 Drug Approvals

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

The FDA ushered in six new drugs just before the close of 2014, bringing the final tally to 41– the highest rate since 1996, when the agency approved 53 drugs. 2014 drug approvals were notable not only for their quantity, but also their quality. A number of new drugs utilized first-in-class mechanisms, and new pathways always put a skip in … Read More

Hitting The Mark With Alzheimer’s Drug Development

Emily BurkeBiologics, Clinical Trials, Drug Development, Drug Targets, Genetics, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

The biotech world is still aiming to stop Alzheimer’s disease despite many recent drug attempts missing the mark in late phase clinical trials. While the effects of Alzheimer’s are well known (the degeneration of the brain over time due to nerve cell death), the cause of the disease remains a mystery. As people live longer worldwide, the incidence of Alzheimer’s … Read More

Don’t Be DOA. Learn The MOA.

Emily BurkeThe WEEKLY

MAJOR MECHANISMS OF ACTION The top selling drugs of 2013 were Abilify (Otsuka Pharmaceuticals; $6.9 billion), Nexium (AstraZeneca; $6.3 billion), and Humira (AbbVie; $5.9 billion). Anyone who follows biopharmaceuticals—and plenty of people who do not—are familiar with these drugs. How do they actually work? In this issue, we will take a look at the diverse mechanisms of action (MOA) of … Read More

No Free Lunch For Obesity Drugs

Emily BurkeThe WEEKLY

NO FREE LUNCH FOR OBESITY A major lead in curing obesity came on the scene in the 1990s when researchers noticed that obese mice lacked a critical hormone dubbed leptin. Suddenly, the tantalizing prospect of tackling obesity with leptin treatments sent both drug developers and casual dieters astir. As the saying goes, there’s no free lunch, and excitement waned in recent … Read More