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 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

The Biotech Primer BIO 2017 Preview

Emily BurkeBiotech Basics, Business of Biotech, The WEEKLY

Biotech Primer At BIO 2017 Biotech Primer will be headlining a few events at the BIO 2017 Annual International Convention in San Diego, CA next week. Will you be there? If so, please join us! Learn the fundamentals of biotechnology in our all-day class BioBriefing: Biotech for the Non-Scientist on Monday, June 19th. SOLD OUT What are the most popular topics in the WEEKLY? Attend Readers’ … Read More

The Science Of CRISPR/CAS9

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

 CRISPR/CAS9 UPDATE CRISPR/Cas9 can’t seem to stay out of the news — from first in human to patent disputes, we here at the WEEKLY want to update you on this hot technology. A group of scientists from the State Key Laboratory of Proteomics (Beijing, China) and the National Center for Protein Sciences (Beijing, China) recently reported the first ever edit using CRISPR/Cas9 in healthy human … Read More

Next-Generation CAR-T

Emily BurkeBiologics, Business of Biotech, Cancer, Clinical Trials, Drug Development, Drug Targets, Genomics, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

The Race Is On Our last WEEKLY—Hacking the Immune Response—unveiled the science behind CAR-T and TCR, two immunotherapies under the microscope of the mainstream press. The well-deserved media attention highlights the ability of these “living drugs” to recognize and obliterate cancers. With all of the early phase clinical success, a few challenges have popped up: • Safety: CAR-T and TCR can … Read More

The Emerging Proteomics Market

Emily BurkeBusiness of Biotech, Cancer, Deoxyribonucleic Acid (DNA), Diabetes, Diagnostics, Drug Targets, Genomics, Term of the Week, The WEEKLY

Picking Apart The Protein Genomics continues to be all the rage in biotech circles—with special kudos to Illumina’s (San Diego, CA) recent ability to obtain an entire human genome sequence in 24-hours for a mere thousand dollars. Our overall understanding of human DNA combined with our ability to determine individual genomes leads to better disease insight, more powerful diagnostics, and a … Read More

Drugging The Undruggable

Emily BurkeBiotech Basics, Business of Biotech, Drug Development, Drug Targets, Mechanism of Action, Ribonucleic Acid (RNA), Small Molecule Drugs, Term of the Week, The WEEKLY

Antagonists Fight A Good Fight Small molecule inhibitors, also known as antagonists in the industry, fight a good fight. In fact, many drugs on the market today work by inhibiting overactive, disease-associated proteins. Novartis’ (Basel, Switzerland) top selling leukemia drug Gleevec, for example, is a small molecule inhibitor of a protein called Bcr-Abl, whose overactivity promotes excessive cell division. The downside? It is … Read More

The Uber Of The Human Body?

Emily BurkeBiologics, Business of Biotech, Cancer, Cardiovascular Disease, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Ribonucleic Acid (RNA), Term of the Week, The WEEKLY

A Tiny Vesicle With Big Potential Cambridge-based startup Codiak BioSciences made headlines last month with $40M launch funding and another $40M if their technology shows promise. So, what’s the big deal? A tiny little particle—once described as a cellular trash truck—called the exosome. First observed in the early 1980s, exosomes were originally thought to be a way for cells to get rid of … 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

The Powered Exoskeleton

Emily BurkeBusiness of Biotech, Medical Device, Orphan Disease, Term of the Week, The WEEKLY

THINKING OUTSIDE OF THE BODY Last WEEKLY’s focus on Duchenne muscular dystrophy got us to thinking, what products are available for those with limited mobility? A new type of medical device called a powered exoskeleton certainly caught our eye. Originally conceived as a tool to aid soldiers in lifting heavy objects, medical device companies are turning to exoskeletons as a way to dramatically improve quality of … 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

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

Interchangability Denied To First US Approved Biosimilar

Emily BurkeBiologics, Biomanufacturing, Biosimilars, Business of Biotech, Drug Approvals, FDA, Mechanism of Action, Term of the Week, The WEEKLY

G-CSF: The original Innovator Sandoz’s (Princeton, NJ) Zarzio rode the first wave into the U.S. biosimilars market after it received FDA approval last week. Zarzio is similar to Amgen’s (Thousand Oaks, CA) Neupogen and both of these medications are recombinant versions of the “go to” stimulator for white blood cell production—known as granulocyte-colony stimulating factor (G-CSF). White blood cells (WBC) … Read More