Taking a Swing at Peanut Allergies

Emily BurkeThe WEEKLY

HOW DO ALLERGIES DEVELOP? Every summer, watching a game at the ballpark and digging into a bag of peanuts is a source of entertainment for many Americans. For the 15 million who suffer from peanut allergies, the idea of being taken out to the ballgame elicits concern — or even anxiety. Food allergies — think tree nuts, milk, eggs, wheat, … Read More

Alzheimer’s Disease: A Tough Nut To Crack

Emily BurkeAlzheimer's Disease, The WEEKLY

AFFECTING 5.1 MILLION Alzheimer’s disease (AD) ranks as one of the toughest nuts to crack within drug discovery and development. Current treatments merely manage symptoms, so finding a better solution becomes more and more urgent as the aging population grows. Approximately 70 percent of dementia cases are caused by AD. It is a neurodegenerative disorder— neurons progressively lose structure and … Read More

Market Access

Linda LanderDrug Approvals, Market Access, The WEEKLY

Market Access Primer  For the last few weeks we here at Biotech Primer have tracked the progression of a drug candidate from the lab to the marketplace, where only the fittest survive. Winning at clinical trials means earning an official regulatory approval. Congratulations! But as any seasoned drug developer will tell you, the game has only just begun. Ensuring newly-approved … Read More

From Drug Development To Approval: Phase III

Emily BurkeAuthor Emily Burke PhD, Drug Approvals, Drug Development, FDA, The WEEKLY

Phase III Is No Guarantee Our last Biotech Primer WEEKLY explored the riskiest part of the human clinical trials pathway: Phase II. About 70% of drugs that enter Phase II never make it out. Most often, it’s because they fail to demonstrate effectiveness. Even making it to Phase III is no guarantee of success – about 40% of drugs fizzle … Read More

From Drug Development to Approval: Phase I/II

Emily BurkeClinical Trials, Cocktail Fodder, FDA, The WEEKLY

Phase I and II Clinical Trials Every drug in clinical use today, from the latest CAR-T treatment to older cholesterol-lowering statins, share one thing in common: they have all successfully navigated the rigorous clinical trials process. This is no small feat, as only ~10% of the drugs that enter Phase I testing successfully emerge as marketed products. Those few drugs … Read More

Plants That Heal

Kevin Curran, PhDThe WEEKLY

Nature’s Medicine Cabinet Where does medicine come from? Before it gets to your medicine chest? Before you purchase it from your neighborhood drugstore? Next time you’re hiking through a forest or gazing at your pretty screensaver of the Olympic Peninsula, think of this: the magic that relieves a throbbing headache or lowers your dad’s blood pressure may well have started … Read More

Bye-Bye Opioids? Introducing Electroceuticals

Emily BurkeThe WEEKLY

MEDICINE-FREE PAIN MANAGEMENT Migraine relief without drugs? No “digestive issues” due to pain meds after surgery? Better still, no worry about addiction after that appendectomy or hip replacement? Sounds a bit science-fictiony, does it not? The news reminds us nearly every day of the profound need for pain management without opioids. As you read last week, alternatives to analgesics such … 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

Off-Color: The Science Behind Color Vision Deficiency

Emily BurkeGenetics, Medical Device, Pharmacogenomics, The WEEKLY

You’re at the supermarket, puzzling over whether those peaches for the pie are ripe. Maybe you’re watching your child’s soccer team, and struggling to separate the Green Hornets from the Scarlet Knights. As if determining offsides isn’t hard enough! Or more seriously, you’re approaching a stoplight on a busy street and can’t tell if the signal is red or green. … Read More

Natural Born Cancer Killers

Emily BurkeCancer, CAR-T, FDA, Immunotherapy, The WEEKLY

Further Down the Cancer Treatment Road with CARs This past August, to much fanfare, the FDA approved the first chimeric antigen receptor (CAR) T-cell therapy for blood cancer. Called Kymriah (Novartis), it promises to revolutionize treatment by genetically altering a patient’s own cells to fight cancer. Less than eight weeks later, Kite Pharma, now a part of Gilead Sciences (Foster … Read More

DNA Vaccines Explained

Emily BurkeBiotech Basics, Clinical Trials, Cocktail Fodder, The WEEKLY, Vaccine

MORE ON THE POWERFUL, ELEGANT SIMPLICITY OF VACCINES Last week, we overviewed vaccine development and manufacture, focusing on those that use whole pathogens to protect us from a disease. This week, we examine subunit and polysaccharide vaccines, which use different strategies to fight infection. We also take a brief look at the US Food and Drug Administration (FDA)’s vaccine approval … Read More

Vaccines: Powerful Simplicity

Emily BurkeBiologics, Biomanufacturing, Cocktail Fodder, The WEEKLY, Vaccine

Vaccines: Elegant, Powerful Simplicity Anyone who’s suffered the aches and fever of influenza has good reason to value the simple flu shot. In fact, millions roll up their sleeves and literally take their medicine. The US Centers for Disease Control (CDC) (Atlanta, GA) estimates that about 146 million doses of influenza vaccine went to doctors’ offices, health departments, and the … Read More

Circadian Rhythm & Disease

Emily BurkeBiologics, Cancer, Diabetes, Mechanism of Action, The WEEKLY

AND THE BEAT GOES ON Earlier this week, the 2017 Nobel Prize in Physiology or Medicine was awarded to three American scientists (Jeffrey Hall and Michael Rosbash, of Brandeis University, and Michael Young, of Rockefeller University) for their work in deciphering the molecular basis of circadian rhythm – the 24-hour cycle that governs the inner workings of all life on … Read More