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Promising Malaria and Dengue Vaccines Will Not Defeat Diseases

May 20, 2015 | by Christopher J. Pace, Ph.D., GlobalData Managing Analyst, Infectious Diseases | Comments

Some industry pundits rightfully question the modest protective efficacies of CYD-TDV and RTS,S/AS01. Read more...

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Early Metastatic Breast Cancer Cells May Not Be Stem Cell-Like, After All

November 20, 2015 9:18 am | by Cynthia Fox, Science Editor | Comments

Metastatic breast cancer cells that spread to the lung do not tend to be stem cells, a.k.a. cells undergoing the epithelial-mesenchymal (EMT) transition, says a new study in Nature. The finding contradicts the commonly held belief that stem-like EMT cancer cells are the main cells that metastasize. Read more...


The Lure of Rare Disease Drugs

November 19, 2015 11:39 am | by Stephanie Guzowski, Editor | Comments

While rare diseases were historically passed over by pharmaceutical companies in favor of those with larger patient populations, such as cardiac disease and diabetes, today the story reads differently. Sales of orphan drugs are expected to grow at an annual rate of nearly 11 percent per year to about $176 billion in 2020, compared with 4 percent for drugs treating larger populations. Read more...


Working with Reference Laboratories to Support CDx Commercialization

November 18, 2015 8:59 am | by Brian Baranick and Alex Vadas, L.E.K. Managing Directors in Life Sciences and Biopharmaceutical practice | Comments

Companion diagnostic (CDx) tests are vital to personalized medicine, but the commercialization of these tests increases challenges for biopharmaceutical companies, whose main objective is to ensure patients’ unconstrained access to the tests. Read more...


6 Steps Towards Clinical Evaluation Report (CER) Compliance

November 12, 2015 8:53 am | by Chris Rule, Manager, Solutions Delivery at Maetrics | Comments

Following scandals such as Poly Implant Prostheses’ (PIP) use of cheaper, industrial-grade silicone in breast implants and toxic debris from metal-on-metal (MoM) hip implants, Clinical Evaluation Reports (CERs) have become an increasingly hot topic in the Medical Device regulatory world. Now thrust into the public eye, Notified Bodies (NBs) are increasingly scrutinising CERs in order to protect Patient Safety. Read more...


Nobelist Calls Macular Degeneration Trials “One of Most Successful” in Stem Cell Field

November 11, 2015 10:04 am | by Cynthia Fox, Science Editor | Comments

Clinical trials for what Nobel Prize-winner Sir John Gurdon, D.Phil., recently called “one of the most successful stem cell treatments so far” are cranking into second gear. Read more...


Two Drugs—FDA Approved for Arthritis and Blood Disorders—May Help Fight Baldness

November 9, 2015 9:14 am | by Cynthia Fox, Science Editor | Comments

Two oral drugs—approved by the FDA for inflammation in blood diseases (ruxolitinib) and rheumatoid arthritis (tofacitinib)—grow hair when slathered on skin, report surprised Columbia University researchers in Science Advances. Read more...


SfN 2015 Recap: Harnessing the Power of Microglia in Neurodegenerative Diseases

November 6, 2015 8:49 am | by Stephanie Guzowski, Editor | Comments

Microglia, which comprise 10 to 15 percent of all cells found within the brain, act as the primary defenders in the central nervous system (CNS). But scientists are finding out that these immune cells play a significant role in shaping neural circuits, and may be implicated in developmental and neurodegenerative disorders. Read more...


SfN 2015 Recap: The Role of Synapses, Neural Networks in Alzheimer’s

November 5, 2015 10:15 am | by Stephanie Guzowski, Editor | Comments

Cognition and behavior rely on communication between individual neurons and extensive interactions between neural networks. But when synaptic dysfunction occurs, the results can be dire, leading to neurodegenerative symptoms in Alzheimer’s disease. “Our ability to treat these diseases is limited at the moment. We need new insight into what goes wrong,” said Valina Dawson, Ph.D., of Johns Hopkins University. Read more...


Study Startup: New Battleground in CRO Differentiation Strategy

November 2, 2015 9:55 am | by Craig Morgan, director at goBalto Inc. | Comments

The drug development process is long, arduous, and costly, driving many sponsors to consider greater use of contract research organizations (CROs). This move reflects sponsors’ sharper focus on core competencies and the shifting of management and conducting of clinical trials to CROs. Read more...


Physiologic Progesterone Not Associated with Breast Cancer in WHI Trial

October 29, 2015 8:30 am | by Cynthia Fox, Science Editor | Comments

A prominent editorial, finding breast cancers arose in the massive 16,000-patient Women’s Health Initiative (WHI) study due to “progesterone,” is outright wrong, wrote a top gynecologist and a top oncologist in a recent JAMA Oncology. Read more....


PTH Testing Inaccuracy Demonstrates the Need for Mass Spec in the Clinical Lab

October 28, 2015 8:30 am | by Mary F. Lopez, Bryan Krastins, Gregory Byram, Maryann Vogelsang, Gouri Vadali; at Nuclea Biotechnologies | Comments

Mass spectrometry (MS) is revolutionizing the way that biomarkers are detected and quantified, with proven application in clinical laboratories in toxicology, endocrinology, and biochemical genetics. The detection of parathyroid hormone, (PTH) in human blood is a new case in point. Read more...


Pipeline Update: The Emergence of Biosimilars

October 27, 2015 8:30 am | by Meg Snyder, Editor, Pharmaceutical Processing | Comments

Today’s pharmaceutical market is growing exponentially in potential. Not only has there been new brand-name and generic drugs produced for a myriad of medical conditions, but also the arrival of biosimilars in the United States. All of these changes only serve to engender a competitive environment, thriving on quantitative and qualitative productivity and rapidity, among manufacturers. Read more...


Biomarkers in Systemic Autoimmune Diseases

October 26, 2015 9:06 am | by Holly Hilton, Ph.D., Director, Biomarkers and Translational Sciences, PPD Laboratories; Gregory J. Dennis, M.D., Therapeutic Area Head, Immunoinflammation, PPD | Comments

In an ideal scenario, a biomarker would both reveal the driver of disease and identify an effective treatment. However, biomarkers are necessarily based on the pathobiology of the underlying disease and therefore for most diseases must be used to advance drug development and patient care in a more sequential fashion. Read more...


Moving Toward Clinically Actionable Liquid Biopsies

October 21, 2015 8:26 am | by ​ George Karlin-Neumann, Digital Biology Center, Bio-Rad Laboratories, Inc. | Comments

Liquid biopsy represents an attractive non-invasive way to monitor cancer progression and response (e.g. resistance) to treatments. The ultimate goal of physicians and clinicians is to use this approach to screen asymptomatic patients for the disease. As companies enter the estimated multibillion-dollar liquid biopsy market, one important question has yet to be addressed: Are such tests clinically useful? Read more...


Is 2016 the Year for Immunotherapy? Predictions on a Buzz-Worthy Field

October 20, 2015 8:23 am | by Ralf Huss, MD, Chief Medical Officer, Definiens | Comments

Immunotherapy is touted more and more as the future of cancer treatment. Big pharma is determinedly looking for alternative therapeutics beyond chemotherapy, which has not shown to provide convincing benefit with solid tumors, and immunotherapies provide a good option as we learn more about the mechanisms of action and how they impact the immune system. Read more...



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