Your source for news from the medical device industry!

Sylvester Comprehensive Cancer Center At UM First In Miami To Offer "GPS For The Body(R)"

Sylvester Comprehensive Cancer Center, part of UHealth-University of Miami Health System, announced it is the first cancer-care program in the region enabling clinicians to accurately manage delivery of radiation to prostate cancer tumors through a new technology called the Calypso® 4D Localization SystemT. The System enables precision-guided radiation therapy delivery to the prostate with continuous, objective, organ-motion detection and monitoring.

Monitoring Pollution And Detecting Disease Using Portable And Precise Gas Sensor

In the air, it is a serious pollutant. In the body, it plays a role in heart rate, blood flow, nerve signals and immune function. Nitric oxide, a gas well known to scientists for its myriad functions, has proven challenging to measure accurately outside the laboratory. A team of Princeton and Rice University researchers has demonstrated a new method of identifying the gas using lasers and sensors that are inexpensive, compact and highly sensitive.

Accurate Prostate Cancer Diagnosis With Randox PSA Tumour Array

Randox Laboratories have developed a biochip array for simultaneous quantitative detection of three tumour markers in a single patient sample, providing a quick and reliable method to screen for prostate cancer. This revolutionary technology reduces the need for expensive invasive tests. Prostate cancer is the second most common cancer found in men but if caught and treated early has a 90% cure rate.

Kriger Graduates Have Come To Realize Their Potential Within The Industry And Have Gone On To Successful Careers.

Kriger www.krigerinternational.com has maintained it's status within the industry because these training courses lead to the creation of highly trained individuals, due to the rigorous tasks that each student must perform in the projects. It results in individuals who are motivated to make the ...
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Methods For The Diagnosis Of Heart Failure Reviewed

A blood test (BNP) should be recommended over an electrocardiogram (ECG) for the diagnosis of heart failure suggests research published by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme. Heart failure is associated with significant morbidity, mortality, and healthcare expenditure. There is however, a good evidence base for interventions to improve prognosis although the diagnosis of heart failure in primary care is often inaccurate.

Proteon Receives FDA Fast Track Designation For First Drug Candidate PRT-201

Proteon Therapeutics, Inc., announced it has received Food and Drug Administration (FDA) fast track designation for the development program for PRT-201. PRT-201 is being investigated for its ability to improve vascular access in patients currently on or being prepared for hemodialysis. The fast track designation is intended to facilitate development and expedite review for drugs that treat serious diseases and fill unmet medical needs.

Concurrent Imaging Of Metabolic And Electric Signals In The Heart

Cardiac rhythm disorders can result from disturbances in cardiac metabolism. These metabolic changes are tightly linked with specific cardiac electrophysiology (CEP) abnormalities, such as depressed excitability, impaired intra- and extracellular conductivities, wave propagation block, and alteration of conduction velocity, action potential amplitude, and duration.

It is recommended that sponsor companies should first check what budget they can allocate, and then seek Clinqua Inc. expertise in achieving their goal.

It is an undesirable reality, but the development of pharmaceutical drugs is a costly undertaking. Yet, these costs are necessitated by the substantial investment of both time and resources of the companies in question. It stands to reason that if a company is willing to invest millions of ...
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Product Recall - Insulin Pen Injection Devices, UK

The following faulty insulin pen injection devices are being recalled: Owen Mumford Autopen® Classic (1 unit 3ml), 1-21 units. Product code: AN3810. Affected lots: CJF, DBR, DEX, DMP, DND BRG and CCW. The manufacturers warn that the affected devices may fail to correctly dispense insulin. Autopen Classic (1 unit 3ml) devices are the only devices affected and are specifically for use with Eli Lilly and Wockhardt UK insulin cartridges.

Tiny Gold Clusters As Top-Notch Catalysts Identified By NIST And Partners

For most of us, gold is only valuable if we possess it in large-sized pieces. However, the "bigger is better" rule isn't the case for those interested in exploiting gold's exceptional ability to catalyze a wide variety of chemical reactions, including the oxidation of poisonous carbon monoxide (CO) into harmless carbon dioxide at room temperatures.

Big Changes In Public Attitudes Toward Different Industries Since Last Year

Every year at this time, The Harris Poll® measures public attitudes about 20 different industries. Specifically, we ask whether each industry is generally doing a good or a bad job of serving consumers. This year's survey finds many big changes, up and down, since last year. These are some of the results of a nationwide telephone survey conducted by Harris Interactive® among 1,010 U.S.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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Most Patients Not Receiving Stress Tests To Confirm Need For Cardiac Stent, New Study Finds

UCSF researchers investigating the appropriate use of procedures to open narrowed coronary arteries -- such as angioplasty and stenting -- found that less than half of Medicare patients had documented noninvasive stress testing prior to elective percutaneous coronary intervention, or PCI, the clinical name for such procedures. The team analyzed a 20 percent random sample of 2004 Medicare claims data, amounting to 23,887 patients who were 65 years or older.

FDA Updates Earlier Guidance On Respiratory Treatment Spiriva HandiHaler

The U.S. Food and Drug Administration announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine...

Treatment Of Patients With Heart Blockage Guided By New Appropriate Use Criteria

If you're committed to fitness, the decision to climb a couple of flights of stairs rather than take the elevator is clear. But if you develop chest pain on the way up, deciding how to treat the symptoms of clogged arteries in your heart is much more complicated.

Pharmalef Developments plays a vital role in proper documenting the drug development process.

New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By ...
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Baxa Launches Sterile, Pre-filled Saline Syringes For Safe And Efficient Flushing Of IV Lines

Baxa Ltd announces its launch of a new line of pre-filled saline IV syringes in the UK. Baxa Ltd, an organisation committed to increasing patient safety through specialty devices for the preparation and administration of liquid medication, is adding a range of pre-filled saline intravenous flush syringes for catheter care in UK health systems. Baxa ZR sterile, pre-filled saline IV syringes provide a safe and effective alternative to flushes drawn from multi-dose vials or manual filled.

J & J: Hospital Deal Will Hurt Medical Device Sales

The CFO for Johnson & Johnson's said President Obama's deal with hospitals to cut Medicare costs will reduce the sales of medical devices, Bloomberg reports: "Hospitals buy medical devices, including J&J's artificial hips and stents to prop open clogged arteries, directly from the manufacturer, (Johnson and Johnson CFO Dominic) Caruso said today in an interview with Bloomberg News.

Grassley, Kohl Seek Information About Money Going From Medical Device Makers To Doctors, USA

Senators Chuck Grassley and Herb Kohl are continuing their campaign to shed light on financial relationships between the pharmaceutical and medical device industries and medical doctors. Today the senators sent letters asking for detailed information about industry dollars going to research physicians affiliated with Columbia University and to the Cardiovascular Research Foundation.

US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril Derivatives

Cereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. This company is also developing a family of other promising novel chemical compounds. Proof of efficacy of these compounds has been obtained in ...
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Discovery Of Disparity In Use Of Implantable Devices To Prevent Sudden Death In Heart Failure Patients

A study of heart failure patients who meet national guidelines for devices that stabilize and strengthen the heart's electrical system found that only half of eligible patients received the devices...

NICE Guidelines Recommend Use Of Stent Grafts For Treatment Of AAA

Lombard Medical Technologies PLC (AIM: LMT), the specialist medical device company, welcomes guidance from the National Institute for Health and Clinical Excellence (NICE) which recommends the use of endovascular stent grafts to treat abdominal aortic aneurysms (AAAs), a dangerous ballooning of arteries that can lead to massive internal bleeding and death.

Growing Demand On Health Care Resources And Increased Incidence Of Kidney Disease Draw Attention To Peritoneal Dialysis On Its 30th Anniversary

While peritoneal dialysis home therapy (PD) was originally introduced 30 years ago to offer patients with kidney failure a better way to filter toxins and fluids from the body overnight or several times a day in the convenience of their home, the economic advantages of PD have taken on increasing importance and visibility due to recent Centers for Medicare and Medicaid Services (CMS) rule changes and legislation affecting reimbursement and patient education.

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007. Analysts predict that by the year 2010 the industry could see numbers well into and over ...
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Potential Fix For Damaged Knees Identified By Study

Investigators from Hospital for Special Surgery have shown that a biodegradable scaffold or plug can be used to treat patients with damaged knee cartilage. The study is unique in that it used serial magnetic resonance imaging (MRI) and newer quantitative T2 mapping to examine how the plug incorporated itself into the knee. The research, abstract 8372, was presented during the annual meeting of the American Orthopedic Society for Sports Medicine, June 9-12, in Keystone, Colo.

New Data On Cancer Diagnostic Presented By Arbor Vita

Arbor Vita Corporation (AVC), a privately held biopharmaceutical company, presented new data on its rapid, point-of-care prototype HPV test with a high positive predictive value for cervical cancer and pre-cancer. Targeted for use throughout the developing world, this diagnostic test is being developed in partnership with PATH.

Imaging Systems From GE Healthcare Spotlight The Possibilities Of Connected Oncology Care At ASTRO 2009

According to the American Cancer Society, more than one million people are diagnosed with cancer each year. In the United States, about 1 out of every 2 men and 1 out of every 3 women will have some type of cancer at some point during their lifetime. The sooner a cancer is detected and treatment begins, the better the patient's chances for survival.

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval. Since the ...
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Venture Capital 'Boot Camp' Open To Entrepreneurs

Next week (13th-14th October) UCL will become the first British university to host the successful 'Entrepreneurship Boot Camp' successfully pioneered by leading venture capitalist Dr. Jack M. Gill.

Gore Announces First Patient Treated With Recently-Cleared GORE Flow Reversal System

W. L. Gore & Associates (Gore) announced the first clinical use of the GORE Flow Reversal System for neuroprotection during carotid artery stenting (CAS). Gore obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the system in February. The procedure was performed by Daniel McCormick, MD and Sheldon Goldberg, MD, Interventional Cardiologists at Hahnemann University Hospital, Philadelphia, Pennsylvania.

Focussing On Manufacturing Breakthroughs

Flexible plastic solar cells that can be printed like money, carbon fibres so thin they can be spun into yarns and a raft of new biomedical products to combating illness and injury are just some of the research breakthroughs being developed by the new CSIRO National Research Flagship for Future Manufacturing just launched. The Flagship - a $A36.

Legal Issues in Clinical Research

Bruce Kriger, CEO of Kriger Research Group International www.kriger.com, leading training institution and clinical research organization told in the interview to our edition that one hundred years ago, any doctor could prepare a new medication without any external approval. Since the ...
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New Instrument Can Quickly Examine Multiple Proteins In A Single Cancer Sample

Researchers have demonstrated a new instrument that makes it possible to detect and quantify multiple different clinically important proteins in a single tumor sample using conventional staining. Currently, pathologists usually need a separate tissue slice for each protein they want to examine, making it impossible to see how molecules interact within individual cells.

Edwards Lifesciences Launches New Mitral Valve Repair Ring At STS

Edwards Lifesciences Corporation (NYSE: EW), the world leader in the science of heart valves, announced that the company is launching the Carpentier-Edwards Physio II mitral valve repair ring at the 45th annual meeting of the Society of Thoracic Surgeons (STS) in San Francisco. The new therapy represents the next generation of the Carpentier-Edwards Physio ring, the global market-leading heart valve repair device.

DNA Deletion Makes Swedish Chlamydia 'Invisible'

New sequencing and analysis of six strains of Chlamydia will result in improved diagnosis of the sexually transmitted infection. This study provides remarkable insights into a new strain of Chlamydia that was identified in Sweden in 2006 after spreading rapidly across the country by evading most established diagnostic tests.

Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

As a drug makes its way through the different phases of pre-clinical and clinical trials in human testing, the public and the company can rest assured that their product has been thoroughly tested and that each progression through its development has been predicated upon safe, sound, efficient ...
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Hepatitis C Therapeutic DNA Vaccine Delivered By Inovio Biomedical's Electroporation Technology Reduces Viral Load By Up To 99.7%

Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB, reported positive additional interim results from its ongoing phase I/II clinical study of its therapeutic DNA vaccine against hepatitis C virus (HCV). This vaccine is being delivered using Inovio's electroporation-based DNA delivery system.

Cardium's InnerCool Announces Positive Benefits Of Cooling During Robotic-Assisted Prostate Surgery Published In Urology

Cardium Therapeutics (NYSE Alternext US: CXM) and its operating unit InnerCool Therapies, Inc., today reported that positive clinical findings demonstrating faster recovery of urinary continence using localized manual cooling techniques during robotic-assisted radical prostatectomy surgery will be published in the April 2009 issue of Urology and is now available online at http://www.

Research Will Allow Identification Of Numerous Potential Cancer And Other Treatments

Understanding the tens of thousands of proteins that compose the human proteome has emerged as a key challenge of this century, and research efforts to date have already enabled major advances in drug discovery and understanding basic biology. But many potential avenues have been blocked by lack of information about how the majority of these proteins function.

CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published

September 18, 2008A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: ...
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Compliance For LifeT Medication Dosing Reminders Go Global

Compliance for LifeT is going global. iReminder, LLC, announces that Compliance for Life now delivers dosing reminders anywhere in the world by phone and SMS text message, as well as email.

FDA Advisory Panel Recommends Approval Of VisionCare's Implantable Telescope For End Stage Macular Degeneration

VisionCare Ophthalmic Technologies, Inc., a developer of advanced visual prosthetic devices for individuals with age-related macular degeneration (AMD), announced the FDA Ophthalmic Devices Advisory Panel unanimously recommended that the FDA approve, with conditions, the premarket application (PMA) for its implantable telescope for End-Stage AMD.

"Smart Hip" Monitors Real-time Performance Of Bone Implants

To monitor the real-time performance of bone implants is the challenge of "Smart Hip", an innovative medical device that aims to reduce the number of surgical interventions in the hip area and regenerate bone tissue by using non-evasive methods...

Skyrocketing growth of the CRO market

The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid, cost-effective manner, has lead to skyrocketing growth of the CRO market. The CRO market grew from $1 ...
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Spectranetics Quick-Cross Extreme Product Line Receives FDA Clearance

Spectranetics Corporation (NASDAQ:SPNC) today announced clearance from the Food and Drug Administration for the Quick-Cross ExtremeT product line, which represents an extension of its Quick-Cross support catheters. The FDA clearance follows the recent receipt of the CE Mark in Europe and approval to market these products in Canada.

Advancing Cystic Fibrosis Testing

Three reports describing advances in cystic fibrosis genetic testing appear in the May 2009 issue of The Journal of Molecular Diagnostics. Cystic fibrosis is a hereditary disease that affects mucus secretions in the lungs, liver, pancreas, and intestines. Approximately 1 in 4000 children born in the United States is affected with cystic fibrosis.

Injectable Drugs Benefiting From Advances In Evolving Device Designs

As life expectancy increases in developed economies, the healthcare industry is preparing for a number of new challenges as well as opportunities. A longer life span is expected to translate to a growing number of patients diagnosed with chronic conditions.

Esploron is one of the innovative companies within the CRO industry.

Esploron www.esploron.com is one of the innovative companies within the CRO industry. This industry has evolved from providing limited clinical trial services in the 1970s to a full-service industry that today encompasses the entire drug development process, including preclinical evaluations, ...
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ASP Announces Availability Of EVOTECHT Endoscope Cleaner And Reprocessor

Advanced Sterilization Products (ASP) is pleased to announce the availability of the EVOTECHT Endoscope Cleaner and Reprocessor, the first commercially available system to eliminate labor-intensive manual cleaning of endoscopes. The results of the EVOTECHT System establish a consistently high standard of automated endoscope cleaning and high-level disinfection that is comparable to professional society guidelines for manual cleaning.

Nebraska DHHS Offers Low-Cost Radon Test Kits - January Is Radon Action Month

To make it easier for Nebraskans to test their homes for radon, the Radon Program of the Nebraska Department of Health and Human Services is offering low-cost radon test kits. Governor Dave Heineman has proclaimed January to be Radon Action Month. January is an opportune time for Nebraskans to test for radon in their homes, according to Dr. Joann Schaefer, the state's Chief Medical Officer.

Wearable Blood Pressure Sensor Offers 24/7 Continuous Monitoring - Device Could Help Diagnose Hypertension, Heart Disease

High blood pressure is a common risk factor for heart attacks, strokes and aneurysms, so diagnosing and monitoring it are critically important. However, getting reliable blood pressure readings is not always easy. Visits to the doctor's office can provoke anxiety that distorts blood pressure readings, and even when accurate, such visits provide only one-time snapshots of the patient's condition.

In the United States, CROs receive an estimated 60% of the clinical research outsourced from pharmaceutical companies.

Typically, large CROs compete on the basis of medical and scientific expertise in specific therapeutic areas; the ability to manage large-scale trials on a global basis with strategically located facilities, by providing medical database management capabilities, providing statistical and ...
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Flamingo Hoist Causes Elderly And Disabled To "Drop To The Floor"

A hoist used in healthcare facilities as well as private homes across the country could cause an elderly or disabled person to "drop to the floor" risking death or serious injury according to a Field Safety Notice (FSN) issued by the manufacturer. The old design of the spreader bar on the Flamingo mobile hoist could be incorrectly attached via an open hook and therefore come off the hoist jib as it lifts the occupant.

Siemens Healthcare Diagnostics Celebrates Success In Urinalysis

The 50,000th Siemens Clinitek Status® Urine Chemistry Analyser recently rolled off the production line in Sudbury, Suffolk, England. Mr Donal Quinn, Chief Executive Officer, Siemens Healthcare Diagnostics handed over the instrument, that was specially marked with a commemorative plaque, to one of the company's customers, Lynda Petley, Point of Care Manager, Partnership Pathology Services, Surrey at a ceremony held to mark the occasion.

DexCom™ Receives CE Mark Approval For The SEVEN(R) PLUS Continuous Glucose Monitoring System

DexCom, Inc. (NASDAQ: DXCM) announced that it has received CE Mark (Conformité Européene) approval for the SEVEN® PLUS continuous glucose monitoring system, enabling commercialization of the system in the European Union and the countries in Asia and Latin America that recognize the CE Mark. The SEVEN PLUS is DexCom's third generation device designed to help people with diabetes better manage their diabetes and control their glucose levels.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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Yorkshire Hosts Global 'healthcare Technology' Workshop

A team of 20 UK Trade & Investment (UKT&I) commercial staff from across the world - including China, USA, Brazil, India, Malaysia and Thailand - have visited Yorkshire to gain a deeper understanding of the British healthcare sector. Helping to further support UK businesses internationally, the week-long visit offered a valuable insight into the UK healthcare technology sector, highlighting the expertise that is taking place across Yorkshire and throughout the rest of the country.

New Way To Clinically Assess Condition Of Tooth Enamel Using Lasers Described By Optics Express Paper

A group of researchers in Australia and Taiwan has developed a new way to analyze the health of human teeth using lasers. As described in the latest issue of Optics Express, the Optical Society's (OSA) open-access journal, by measuring how the surface of a tooth responds to laser-generated ultrasound, they can evaluate the mineral content of tooth enamel -- the semi-translucent outer layer of a tooth that protects the underlying dentin.

House Staffers Discuss Revisions To Draft Legislation That Aims To Improve Drug Safety

Aides to Democratic members of the House Energy and Commerce Committee met on Monday to discuss revisions to draft legislation that aims to improve the safety of prescription drugs and medical devices, CongressDaily reports. According to CongressDaily, the proposed revisions are limited to the pharmaceutical portions of the bill and reflect provisions negotiated by

CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published

September 18, 2008A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: ...
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Mortara Receives Frost & Sullivan Award For DICOM ECG - Diagnostic Cardiovascular Monitoring Equipment Product Line Strategy

Today Mortara Instrument announced receipt of a Frost & Sullivan Award for its incorporation of DICOM ECG into the company's diagnostic ECG modalities.

Endarterectomy Alternative Found In Angioplasty With Stenting

To prevent ipsilateral stroke in patients with symptomatic stenosis of the cartoid artery, cartoid angioplasty with stenting shows a similar level of effectiveness as enarterectomy, according to two articles released on September 6, 2008 in The Lancet Neurology. Stenosis of the lumen of the cartoid artery occurs when the space in the artery is abnormally narrow.

New Research Field Promises Radical Advances In Optical Technologies

A new research field called transformation optics may usher in a host of radical advances including a cloak of invisibility and ultra-powerful microscopes and computers by harnessing nanotechnology and "metamaterials." The field, which applies mathematical principles similar to those in Einstein's theory of general relativity, will be described in an article to be published Friday (Oct. 17) in the journal Science.

Limdato: Patient recruitment is essential to the accelerated success of a clinical trial.

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. Limdato www.limdato.com along with its team of ...
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A London Effort To Develop Point-of-care Nanosensors For HIV Diagnosis And Monitoring

The London Centre for Nanotechnology will develop a new device to enable people living with HIV to monitor their own health and the effectiveness of their treatments, thanks to a £2 million EPSRC (Engineering and Physical Sciences Research Council) grant announced today. The device will give people a way to monitor the virus for themselves, reducing the need to visit a doctor as often.

COMVAC5(R), Single Shot Pentavalent Combination Vaccine Containing Diphtheria, Pertussis, Tetanus And Hepatitis B, And Haemophilus Influenza Type

Bharat Biotech International (BBIL) a leading producer of vaccines and biotherapeutics in India with a strong focus on product-oriented research and development announced today the launch of COMVAC5®, a single shot Pentavalent Combination vaccine containing Diphtheria, Pertussis, Tetanus and Hepatitis B, and Haemophilus Influenza type b (Hib).


Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.


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