Biosensor Technology Growing in Leaps and Bounds

Improvements to biosensor technology are taking off in labs around the world.  Biosensors which are unique electronic sensors, some able to detect the presence or changes in as small as molecular models or biomolecules to major physical changes and are set to play a major role in the advancement of biomedical science over the next few years and decades.  A number or critical breakthroughs have been noted over the past few days, months and years that will revolutionize the field biomedical technology and medicine.

In a study presented at the Orthopaedic Research Society Annual Meeting, a smart sensor was developed that could be implanted during spinal, knee, or hip repair to detect temperature, motion, strain, stress, and pressure at the location of surgery.  This information can then be used to determine the progress of the patient more accurately to determine the amount or type of recovery needed.

One research group at the University of Leeds is developing biosensor technology that is able to test for the presence of the Adenovirus, i.e. the common cold.  The technology could be developed to rapidly, efficiently, and cost effectively detect the common cold.  Such technology is still a long way from clinical use, however the promise of such technology is endless.  The rapid and early detection of such viruses could prevent an unnecessary prescription for antibiotics or tailor treatment for specific strains of a virus.

Viral infection discovered via traditional pathology

Endless uses for biosensor technology are being explored in labs around the world including intelligent blood pressure detection, disease detection, and glucose detection.  This technology could improve and simplify detection of countless disease and ailments, reducing the costs to treat and improving outcomes.

Sources:
A Step Closer To Diagnostics For Viruses (University of Leeds)
2012 Annual Meeting (Orthopaedic Research Society)
Biosensors Inspired by Nature (Medical News Today)
Viral Infection Photo (Pulmonary Pathology)

Have some great information or research about biosensors that you would like to share?  Let us know!

FDA Pharma Quarterly Review

Our staff has reviewed some of the most significant pharmaceutical review decisions by the FDA over the past quarter.  A number of interesting drugs are in the development pipeline for many companies, awaiting their fate from the FDA.

Approvals

• Genzyme receives FDA approval for a manufacturing plant for the production of Farazyme, a drug for the treatment Fabry disease.  Fabry disease is an enzyme-related lipid storage disease.
  Genzyme Gets Nod From FDA For Plant (FDA / Wall St. Journal)
  NINDS Fabry Disease (National Institute of Health)
• The kidney cancer drug axitinib by Pfizer was approved for used in treatment of advanced kidney cancer as a second-line treatment
  Pfizer Kidney Drug Gains FDA Approval (FDA / Wall St. Journal)
• Amlin Pharmaceutical's diabetes drug Bydureon was approved for once-weekly treatment for type-2 diabetes
  FDA Approves Amylin's Bydureon Diabetes Drug (FDA / Wall. St. Journal)
• A new drug approval for basal-cell carcinoma,  Erivedge (vismodegib), developed by Roche and marketed by Genentech Inc. paves the way for a new class of cancer drugs.  The new class of drugs known as "hedgehog drugs" targets cell communication pathways.  The entire course of treatment for the drug would average around t $75,000 per patients
  New Type of Cancer Drug Gets Approval (FDA / Wall St. Journal)
• Cystic Fibrosis drug Kalydeco by Vertex Pharmaceuticals was approved for first-line treatment of cystic fibrosis with a genetic mutation in the CFTR gene, affecting approximately 1200 people in the US.  Treatment with the drug is priced at $294,000 per year due to the small amount of patients and the high cost of development.
  FDA Approves Cystic Fibrosis Drug (FDA / Wall St. Journal)
• Two new suppliers of cancer drugs were approved by the FDA addressing an issue with shortages in the market due to a plant shutdown.
  Cancer-Drug Suppliers Approved (FDA / Wall St. Journal)

Denials and Warnings

• Dapagliflozin, an experimental diabetes drug as a part of a joint venture between AstraZeneca and Bristol-Myers Squibb was denied approval by the FDA
  Drug Setback for Bristol, Astra (FDA / Wall St Journal)
• Infinity Pharmaceuticals stopped development of hedgehog drug for pancreatic cancer after disappointing results.
  New Type of Cancer Drug Gets Approval (FDA / Wall St. Journal)
• The FDA issued a general warning on statins, requiring manufactures to add risks such as an increased risk of diabetes, high sugar levels, and memory loss.  The warning affects over a dozen different drugs in one of the most widely prescribed drug segments
  FDA Warns on Statin Drugs (FDA / Wall St. Journal)
• Merck was issued an FDA warning letter for failure to submit safety information for a rodent study in its diabetes drug Januvia and is required to resubmit a final study design within 30 days.
  Merck Gets FDA Warning Letter on Drug Study (FDA / Wall St. Journal)

Did we miss something or do you have any suggestions?  Let us know in the comments!

Photo Source: Food and Drug Administration

It's been a while: An Update, with more frequent ones to come!

It has been quite a while since our last post.  Members of our team have been busy with a number of other career and business opportunities so we decide to take a hiatus.  Our team now has more experience and is now gaining more members and a renewed focus in order to provide better content.  Below are some of the big stories that you may have missed over the past quarter.

Health and Business

While political quibbling still is occurring, major portions of the recent Health Care Reform Bill are beginning to take effect:
The Future of US Health Care (Wall St. Journal Health)
2.6M Young Adults Gain Health Insurance (Wall St. Journal Health)

The daVinci Surgical Robot may be used to repair NASA satellites
Da Vinci surgical robots may help repair NASA satellites (MassDevice)

WSJ Shows Examples of How Promising Scientific Discoveries Don't Always Pan Out

Scientist's Elusive Goal: Reproducing Study Results  (Wall St. Journal Health)

The former official in charge for Medicare and Medicaid states that 20-30% of spending is waste, mostly due to administrative and bureaucratic red-tape.

Health Official Takes Parting Shot at 'Waste' (New York Times)

Are There Advantages or Health Risks to Being Left-Handed?  Being left-handed, I found this article very interesting

The Health Risks of Being Left-Handed (Wall St. Journal Health)

Some controversial comments on rationing health care for seniors by the Chicago Tribune and the MassDevice blog staff 

Rationing Health Care for Seniors (MassDevice)

Medical Device and Diagnostics

New innovation in integrated imaging technology by Phillips, incorporating MR and PET scanning in one

FDA Approves Phillips Whole Body PET/MR Imaging System (Medical News Today)

There is now increased approval of Cardiac Resynchronization Therapies (CRT) for the treatment of Heart Failure by journals in Europe and the US as a result of a new survey on CRT effectiveness.

Cardiac Resynchronization Therapy in Heart Failure (Medical News Today)

An iPhone-syncing glucose meter by Sanofi gains 510(k) clearance from the FDA and the FDA released guidelines for the development of artificial pancreas's for the treatment of type I diabetes.
Sanofi's iBGStar Becomes First iPhone Glucose Meter to Land FDA Clearance (MassDevice)
Diabetes: FDA Releases Artificial Pancreas Guidance (MassDevice)

Researchers at Brigham and Women's Hospital have developed a method to use the magnetic field from an MRI to potentially control a capsule endoscope within the digestive tract.
Capsule Endoscope Controlled By MRI to Investigate Digestive System - A "Fantastic Voyage" (Medical News Today)

A number of suggestions for utilizing gaming paradigms to improve compliance with making appointments and achieving health goals
Using Dynamics from Gaming to Improve People's Health (MassDevice)

The FDA cracking down on surgical centers improperly advertising lap band surgery for weight loss
Stop Misbranding Lap=Band in Your Advertising, FDA Warns Companies (Medical News Today)

GE Healthcare and Financial Invest in Two Upstart Device Technologies
GE Invests in Non-invasive Continuous Glucose Monitors (MassDevice)
InfraReDx Lands $10M from GE Capital (MassDevice)

A promising new HIV Test in trials is cheaper with similar efficacy to the current standard test.
Blood Cell Test for HIV Treatment Monitoring is Cheaper But Just As Effective  (Medical News Today)

A Traumatic Brain Injury handheld brain hemorrhage detector by Infrascan is expected to recieve FDA approval in 2012.  The company has been hoping for approval as early as 2009 and development has been in process since 2004.
Infrascan CEO Expects FDA Approval in 2012 for Handheld Brain Bleed Detector (Medcity)

Bionic digital vision takes one step closer to reality; researchers successfully demonstrated that the could display one-pixel on a contact lens worn by a live subject.
One Step Closer to Terminator-Style Info Vision (Medical News Today)

ArtiCure's surgical cardiac ablation device receives FDA approval, the first cardiac ablation device approved for surgery
FDA approves AtriCure's Synergy cardiac ablation device (MassDevice)



Pharmaceutical
J&J Supply Issues for Doxil Cancer Drug (Wall St. Journal Health)

Pharmaceutical and Medical Device regulation in India is changing, as a government entity will being taking applications for Medical Device and Pharmaceutical products.
DCGI to Begin Prescreening Device Registration Applications in India (MassDevice)

An article about a Plavix and FDA intervention highlights the ongoing debate between over-regulation and under-regulation

Study Challenges FDA on Plavix (Wall St. Journal Health)

J&J's Zyrtec brand of allergy medication utlizes social mediat to try to promote its product.  This will pose some major questions to the FDA on compliance with marketing guidelines in the future.

J&J Goes Viral (MassDevice)

Biologics

The first Drug-eluting Bioresobable Vascular Scaffold / Stent developed by Abbot Laboratories is implanted in a patient.  The stent resorbs into the body after two years, providing the benefits of stents during artery repair without leaving a permanent metal artifact in place.
World's First Drug Eluting Bioresorbable Vascular Scaffold Treats Coronary Artery Disease (Medical News Today)

biomedPULSE Beat - Today's Top News: 9/7/2010

Check out some of the major stories in biotechnology:

New Clue in Heart Disease (Wall St. Journal) - The accumulation of aging-linked protein Progerin has ben linked to heart disease in adults in a study by the NIH and Progeria Research Foundation.

New TB diagnostic proves effective, expedient, study finds (EurekAlert) - A new molecular test appears to be effective in developing specific, effective and fast diagnosis of TB

U.K. Medical Journal Questions Avandia License - (Wall St. Journal) - The British Medical journal questions wether diabetes drug Avandia should be withdrawn from the market arguing the drug risks outweigh benefits.  This follows multiple US FDA investigations into the drug.

biomedPULSE Beat - Top News: Labor Day Weekend 9/3/10-9/6/10

We hope all of our US readers had a great Labor Day weekend.  Here is a quick snapshot of all the top stories from the past few days:

Novel Nanotechnology Collaboration Leads To Breakthrough In Cancer Research (Medical News Today) - A multidisciplinary team at UCLA is working on modifying viruses for use in gene therapy

Snake Fangs Inspire Airway Device Start-up (MassDevice) - Medical and university students develop a startup company developing innovative intubation techniques for emergency situations to be used by EMTs and ER staff.

Reports of Narcolepsy in Europe Following Vaccination with Pandemrix™[H1N1 Vaccine] (PharmaNews.edu) - The European Medicines Agency had been informed of possible cases of narcolepsy (a sudden sleep disorder) associated with the H1N1 vaccine.

Magic Mushroom Ingredient Psilocybin Improves Late Stage Cancer Anxiety (Medical News Today) - A new study finds that the hallucinogen psilocybin found in some mushrooms has been found to have positive effects on mood for patients with advanced-stage cancer and anxiety.

Coming Soon: Theaters, Airplanes to Post Calories (Wall Street Journal) - The FDA released preliminay guidelines requiring establishments such as food courts, movie theateres, and airline food to adhere to new nutrition reporting requirements

Low Grades in Adolescence Linked to Dopamine Genes (EurekAlert) - New research at Florida State finds a link between three dopamine genes and academic performance