Breaking Bad With SCLC & NSCLC

Emily BurkeALK, Cancer, Drug Development, Drug Targets, The WEEKLY

Breaking Down Lung Cancer  The hit TV series Breaking Bad features anti-hero Walter White, who starts out as a sympathetic character: a mild-mannered high school chemistry teacher with a nagging cough that turns out to be lung cancer. Money problems precipitated by costly treatments, poor insurance, and a modest salary push him to start cooking up meth to ensure the financial security of … Read More

Groundbreaking Migraine Drug Explained

Emily BurkeAuthor Emily Burke PhD, Drug Approvals, Drug Development, Drug Discovery, Drug Targets, Edited by Sarah Van Tiem, Migraine

FIRST IN CLASS MIGRAINE APPROVAL Last month the FDA approved Amgen’s (Thousand Oaks, CA) new migraine drug Aimovig, the first drug shown to prevent the onset of migraines. The drug significantly reduces the number of migraine days in difficult-to-treat (those that have failed 2 to 4 prior treatments) patient populations. In some patients dubbed “super responders”, migraines occurrence went from several times/month to no occurrence for 6 … Read More

Turning On Cellular Garbage Disposals

Emily BurkeDrug Discovery, Drug Targets, Proteasomes

Proteasomes to the Rescue Many drugs work by stopping overactive proteins that cause disease. The leukemia drug Gleevec, for example, is a small-molecule inhibitor (antagonist) of the protein Bcr-Abl, whose over-activity promotes excessive cell division. Humira treats a range of autoimmune diseases by stopping TNF-alpha, a protein that activates inflammation. Such antagonists can be powerful. However, it’s not always possible … Read More

Exploring Different Strategies to Fight Alzheimer’s

Emily BurkeAlzheimer's Disease, Drug Development, Drug Discovery, Drug Targets

TAKE THAT, ALZHEIMER’S Alzheimer’s pernicious amyloid-beta plaques and tau tangles, discussed last week, remain important targets for the biotech industry. In the past few years, however, companies have begun to search more broadly for new treatments. This Weekly looks at products in development that use different strategies to fight this heartbreaking illness. REVIVING THE BRAIN? Loss of neurons is Alzheimer’s … Read More

From Drug Development to Approval: A Recap

Emily BurkeClinical Trials, Drug Approvals, Drug Development, Drug Discovery, Drug Targets, FDA

From The Lab To The Patient In this issue of the Biotech Primer WEEKLY we will recap the past seven issues that highlight the journey a molecule takes from the lab to the patient. Beginning in the 1980’s, scientists took a new tack in developing drugs. They adopted an approach known as rational drug discovery. Using this methodology, researchers first … Read More

Drug Discovery 201

Emily BurkeDrug Development, Drug Discovery, Drug Targets

WE WANNA NEW DRUG “One that won’t make me sick/ One that won’t make me crash my car/ and make me feel three feet thick…” Huey Lewis is singing about love, but he voices very human concerns when it comes to the medicines that heal bodies and minds. Last time, the Weekly explored how researchers identify drug targets—the molecules in … Read More

Drug Discovery 101

Emily BurkeDrug Development, Drug Discovery, Drug Targets

On the Road to New Medicines For most of the 20th century, we discovered new drugs by trial and error. Scientists investigated countless unrelated compounds in animals to see which improved disease symptoms. For instance, in the 1950s and 60s, British scientists at Boots Laboratories tested hundreds of unrelated chemicals on guinea pigs searching for an alternative to aspirin for … Read More

The Science Behind Opioid Addiction

Emily BurkeBusiness of Biotech, Cocktail Fodder, Drug Development, Drug Targets, Mechanism of Action, The WEEKLY

THE SCIENCE BEHIND OPIOIDS Concerns over the opioid epidemic continue to grow, with deaths from narcotic overdoses the leading cause of death in people under 50 last year. Nearly half of those deaths were attributable to prescription opioids. The directors of both the Center for Disease Control (Atlanta, GA) and the Food and Drug Administration (Silver Spring, MD) have called … Read More

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

Eye Of The Cytokine Storm

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

THE FLASH OF THE FIRST CAR-T Last week’s much anticipated FDA approval of the first chimeric antigen receptor T-cell (CAR-T) therapy for acute lymphocytic leukemia hails as the first gene therapy on the US  market. Classified as a “cell-based gene therapy,” Novartis’ (Basel, Switzerland) Kymriah works by removing patients’ T-cells, using a viral vector to introduce a gene that will allow the … Read More

The Microbiome Magnified

Emily BurkeBiologics, Biotech Basics, Drug Development, Drug Targets

DECODING THE GUT-BRAIN AXIS There is no shortage of microbiome-focused startups in biotech right now. The link between the gut microbiome — the entire collection of microbes living in the gut — and diseases such as inflammatory bowel disease are well-established. New research has made it clear, however, that the gut microbiome also impacts neurological health, leading to the phrase “the gut-brain … Read More

The Science Of CRISPR/Cas9

Emily BurkeBiologics, Business of Biotech, Cancer, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Genetics, Genomics, Mechanism of Action, Ribonucleic Acid (RNA)

CRISPR/CAS9 UPDATE As CRISPR/Cas9 adds new indications to its resume, legal battles over its IP continue to be waged in the US and Europe. On the clinical front, CRISPR/Cas9 entered its first human trial at Sichuan University (Chengdu, China) last fall for metastatic lung cancer, and is widely expected to do so in the U.S. by the end of the year. This … Read More

Stopping A Big Problem: Blood Clots

Emily BurkeCocktail Fodder, Drug Approvals, Drug Targets, Mechanism of Action, Small Molecule Drugs

MEDS FOR THINNER BLOOD CAN EQUAL FEWER CLOTS, BUT HOW? The FDA’s recent approval of Portola Pharmaceuticals’ (South San Francisco, CA) new blood thinner drug Bevyxxa paved the way for the prevention of blood clots in patients hospitalized for conditions such as heart failure, stroke, and pulmonary disease. The medical term for blood clot is venous thromboembolism (VTE), but if we take it apart: “venous” means relating … Read More

A Skin Cell With Stem Cell Diversity?

Emily BurkeBiologics, Clinical Trials, Drug Development, Drug Targets, Term of the Week, The WEEKLY

INDUCED PLURIPOTENT STEM CELLS SHOW PROMISE Imagine being able to reprogram one of your own skin cells to produce a functioning nerve cell or section of cardiac tissue. This may sound like science fiction — but the groundwork for this to become a reality is already in the works as researchers expand their ability to create and manipulate induced pluripotent stem … Read More

Epigenome: Writing, Reading & Erasing

Emily BurkeCancer, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Genomics, Mechanism of Action, Small Molecule Drugs

FOUNDATIONS OF EPIGENETICS Genetic mutations — changes in the order of the A, C, G, and T nucleotide bases that make up a gene — have been the primary focus of cancer researchers over the last several decades. By sussing out mutations involved in regulating cell growth and division, scientists better understand the molecular range of different cancers and consequently develop … Read More

Nanobodies: These Are Not Your Mother’s mAbs

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Orphan Disease, Orphan Drugs

The Drug Kingpins Monoclonal antibodies (mAbs) are the undisputed drug kingpins. In 2013, the mAb market raked in $75 billion in combined sales, covering a whole range of indications from cancer and infectious disease, to autoimmune disorders, and even high cholesterol. Despite the success, mAbs have one chink in their armor: they cannot enter cells due to their large size, hampering their range … Read More