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

The Intrigue Of HIF

Emily BurkeCancer, Clinical Trials, Cocktail Fodder, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Small Molecule Drugs, Term of the Week, The WEEKLY

The Versatility Of HIFs Quite a few headlines touting a term called “HIF compound” or “hypoxia-inducible factor compound” have intrigued us here at WEEKLY headquarters. GlaxoSmithKline (London, England), Akebia Therapeutics (Cambridge, MA) and more have HIF-inducing drugs in the pipeline which may prove to be attractive alternatives to Amgen’s (Thousand Oaks, CA) injectable Epogen currently on the market. In earlier stages of research, HIFs are being studied for their connection to tumor … Read More

The Mechanics Of Melanoma

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

Spectrum Of Therapies Melanoma accounts for less than 1% of skin cancer cases yet causes the vast majority of skin cancer deaths. If detected early enough, melanoma is almost always curable. If not, its ability to metastasize makes it difficult to treat. Melanoma is more common in young adults than many other types of cancer, with 25% of new cases occurring in people under age … 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 Molecular Cause Of Obesity

Emily BurkeClinical Trials, Diabetes, Drug Development, Drug Targets, Mechanism of Action, Term of the Week

Targeting Fat Obesity is considered one of the most pressing public health issues of the day. According to the Center for Disease Control, 37% of adults and 17% of children in the U.S. are obese. The latest drug interventions work by attempting to suppress food intake, which has proven beneficial for some. However, there is still a large unmet need … Read More

A Bone To Pick With Osteoporosis

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

The Race To Be The Next Big Bone Drug Amgen’s recent positive Phase III results for an antibody drug is putting it neck and neck with Radius Health’s peptide — the latest in a batch of osteoporosis therapies edging their way to the market. The current widely prescribed generic — bisphosphonate — only works to slow the loss of bone, while these newer drugs add to the therapies that aim to rebuild. … Read More

Biotech In Space!

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

Experimenting In Lower Earth’s Orbit Drug discovery in space? If this sounds like a page from science fiction, think again. Leading pharmaceutical companies are now collaborating with NASA to run experiments on the International Space Station (ISS). The focus on bone density, protein structure, vaccine development, immune function, and aging brings a swath of potential to this fascinating endeavor. In … Read More

Orphan Drugs Lead 2015 Approvals

Emily BurkeBiologics, Cardiovascular Disease, Drug Approvals, FDA, Mechanism of Action, Monoclonal Antibodies, Orphan Disease, Orphan Drugs, Small Molecule Drugs, The WEEKLY

Treatment Options Broaden Driven by 19 new orphan approvals, a whopping 45 novel drugs were cleared for the marketplace in 2015. Additionally, new approvals opened up treatment options for Americans with diseases ranging from breast and lung cancers to irritable bowel syndrome. According to FDA numbers: 19 were for orphan diseases that affect fewer than 200,000 patients per year in the US. … Read More

Cancer Immunotherapy Goes Viral

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

Oncolytic Viruses Make Their Debut Does a virus engineered to harness the immune system to fight cancer sound like a clever idea? Amgen (Thousand Oaks, CA) certainly thinks so, because their talimogene laherparepvec (T-Vec) recently earned an FDA approval to fight inoperable melanoma recurrent after initial surgery. Oncolytic viruses—like T-Vec—have the attention of both industry media and mainstream news programs. This new class of therapy is an elegant “hack” of the immune … 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

Packing A Punch With The Immune System

Emily BurkeBiologics, Biotech Basics, Drug Targets, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

THE INNER WORKINGS OF YOUR IMMUNE SYSTEM What do monoclonal antibodies, CAR-T therapy, and 3D vaccines all have in common? They are immunotherapies, or therapies that activate a patient’s own immune system to fight or prevent a disease. While immune system activation can help save a life, an overactive immune system can potentially attack the body it is charged with … Read More

The Power Of Oncolytic Viruses

Emily BurkeBiologics, Cancer, Clinical Trials, Cocktail Fodder, Drug Development, Drug Targets, HIV, Mechanism of Action, The WEEKLY

HBO shines light on novel immunotherapies HBO’s Vice news program selected a few promising technologies from the immunotherapy pipeline to feature in its Killing Cancer episode. Vice’s heartrending human interest stories illustrated the potential of three different developmental drugs: An oncolytic measles virus battling myeloma.  An oncolytic adenovirus fighting a brain tumor. An engineered human immunodeficiency virus knocking out childhood leukemia.  While this program has generated buzz around … 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

It’s A Great Time To Be In Biotech

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, FDA, Genomics, HIV, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

It’s a great time to be in biotech—new therapeutics are breaking ground faster than we can say “monoclonal antibody” and the technologies behind them are heavy with promise and potential. Our mission is to keep your industry knowledge up to date and the WEEKLY is here to give you a smart primer on the basics. Below we have outlined several … Read More