Echo : Prelude SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony Transdermal Continuous Glucose Monitoring System

April 9, 2008 - Echo Therapeutics (OTC Bulletin Board: ECTE) announced positive results from its human feasibility study of the Prelude(TM) SkinPrep System, Echo's next-generation, needle-free, non-invasive skin permeation medium for its Symphony(TM) tCGM System, a novel transdermal continuous glucose monitoring (tCGM) system in development for diabetes home use and hospital critical care markets. Prelude incorporates Echo's patented skin permeation control feedback technology into a comfortable, wireless, hand-held device used to prepare a small area of the skin for the non-invasive, biosensor and monitoring components of its Symphony tCGM system. Results of the feasibility study on healthy subjects demonstrate that Prelude safely and effectively permeated the skin so that the Symphony tCGM System could continuously monitor blood glucose levels reliably over a 24-hour period. Echo plans to use Prelude in the remaining pilot and pivotal clinical studies necessary to commercialize the Symphony tCGM System, including clinical studies scheduled to begin in the second quarter of this year... [PDF] Echo Therapeutics' Press Release -

Rigel's R788 : Preclinical Activity in Type 1 Diabetes Model

April 8, 2008 - Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that its oral Syk kinase inhibitor, R788, may be a useful treatment for type 1 diabetes mellitus, according to research being presented at the American Association of Immunologists meeting in San Diego, California on April 8, 2008. Using Rigel's R788, researchers from the Department of Medicine at Columbia University Medical Center have shown that blocking Syk kinase in a well-established murine model of type 1 diabetes, delayed the onset of diabetes and prolonged survival. A reduction in the production of insulin-specific autoantibodies, an early event in type 1 diabetes pathogenesis, was also observed... Rigel Pharmaceuticals' Press Release -

Pelikan and Lilly : Diabetes Education Alliance

April 16, 2008 - Pelikan Technologies Inc., a leading developer of innovative hand-held diagnostic and monitoring devices, and Eli Lilly and Company announced the signing of a three-year co-promotion agreement.

Under the terms of the co-promotion agreement, the companies will promote awareness and education in the management and treatment of diabetes, including insulin therapy, insulin delivery devices and technological advancements in lancing designed to optimize Finger Health and Glucose Monitoring... [PDF] Pelikan Technologies' Press Release -

Smiths Medical to Promote and Distribute Abbott’s FreeStyle Navigator Continuous Glucose Monitoring

29 Apr, 2008 - Smiths Medical will promote and distribute Abbott’s FreeStyle Navigator® Continuous Glucose Monitoring System.
Smiths Medical is the manufacturer of the CozMore® insulin technology system and the Deltec Cozmo® insulin pump.
To supplement Abbott's own promotional efforts, a non-exclusive distribution agreement will allow Smiths Medical representatives to promote Abbott’s FreeStyle Navigator System to their growing customer base in the United States. Financial terms will not be disclosed.

Approved in March 2008 and available by prescription only, the FreeStyle Navigator System is designed to continually record interstitial fluid glucose levels for the purpose of improving diabetes management... Smiths Medical's Press Release - Abbott's Press Release -

Medtronic : FDA Clearance of New OneTouch Ultralink Blood Glucose Meter

April, 28 2008 – Medtronic and LifeScan to Co-Market Integrated Diabetes Management System with Wireless Blood Glucose Data Transmission - Medtronic, Inc. (NYSE: MDT) announced that the FDA has cleared the OneTouch® UltraLink™ Meter as the new wireless meter exclusively certified by Medtronic to wirelessly communicate with Medtronic diabetes management products in the United States.

This new meter uses Medtronic-certified wireless technology to transmit glucose readings directly to MiniMed Paradigm® insulin pumps and the Guardian® REAL-Time Continuous Glucose Monitoring System. This makes bolus dosing more accurate and easier for patients compared to the manual entry of blood glucose readings... Medtronic's Press Release -

Metabasis Therapeutics : Extension of Its Collaboration with Merck & Co., Inc. to Develop AMPK Activators for Diabetes and Other Metabolic Diseases

April 23, 2008--Metabasis Therapeutics, Inc. (Nasdaq:MBRX) today announced an extension to the sponsored research term under its collaboration with Merck & Co., Inc. for an additional year, through June 2009.
The two companies will continue their joint efforts to identify novel small molecule therapeutics with the potential to treat several diseases, including type 2 diabetes and other metabolic diseases, by activation of an enzyme called AMP-activated Protein Kinase (AMPK). AMPK is thought to play an important role in regulating carbohydrate and fat metabolism and consequently in metabolic diseases such as type 2 diabetes... Metabasis' Press Release -

Hadasit : Successful Phase I Study Results of a New Orally Administered Drug for Autoimmune Diseases

April 16, 2008 --- Hadasit, the technology transfer company of Hadassah Medical Organization in Jerusalem, and Brigham and Women’s Hospital (BWH), a teaching affiliate of Harvard Medical School, announced the successful results of a Phase I study of a new orally administered drug for immune mediated diseases such as diabetes, Crohn's disease, psoriasis, multiple sclerosis, and liver diseases. The trial was announced in January 2008... [PDF] Hadasit' Press Release -

Innocoll : Phase 2 Clinical Trial to Investigate CollaRx® GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers

April 17, 2008 –Innocoll, Inc., a privately-held biopharmaceutical company, announced that the second of three planned phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx® GENTAMICIN TOPICAL for the treatment and prevention of infected diabetic foot ulcers, has commenced dosing. CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold... Innocoll 's Press release -

Pacira Pharmaceuticals and Amylin Pharmaceuticals : collaboration for DepoFoam

April 15, 2008 – Pacira Pharmaceuticals, Inc. announced a collaboration with Amylin Pharmaceuticals, Inc. for the development of sustained release injectable products based on the DepoFoam® technology platform from Pacira. The companies will work together to enhance the dosing profile for compounds within Amylin’s early research and development pipeline. The goal of the collaboration is to develop multiple products based on sustained release, subcutaneous injection...


..."Pacira’s DepoFoam® technology is an attractive delivery system and Amylin is excited to apply this technology to our peptide and protein therapeutics platform," said Christopher Rhodes, Ph.D., Executive Director, Pharmaceutical Sciences of Amylin. “This collaboration fits well with Amylin’s research and development activities, which leverage our expertise in metabolism to develop potential therapies for diabetes and obesity.”... [PDF] Pacira Pharmaceuticals' Press Release -

Tolerx : Advancing Novel Type 1 Diabetes Agent into Phase III Clinical Trial Program Following End of Phase II FDA Meeting

Phase III study will evaluate effects of otelixizumab, an investigational anti-CD3 monoclonal antibody, on preservation of endogenous insulin secretion
April 9, 2008 - Tolerx, Inc., a biopharmaceutical company engaged in the discovery and development of novel therapies for immune-mediated diseases, today announced that it is proceeding toward the initiation of a Phase III study of otelixizumab in new-onset type 1 diabetes. Tolerx is initiating this pivotal trial after reviewing the results of the otelixizumab development program with the US Food and Drug Administration (FDA) at an End of Phase II meeting.

The Phase III study, known as DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes), will be conducted at multiple centers in North America and Europe and will evaluate whether a single course of otelixizumab reduces the amount of administered insulin required for control of blood glucose levels by inhibiting destruction of beta cells. Maintenance of beta cell function has been associated with improved glycemic control (HbA1c levels), fewer hypoglycemic events and reduction of long term disease complications in established diabetics in the Diabetes Control and Complications Trial (DCCT). DEFEND enrollment is expected to begin mid-2008... Tolerx' Press Release -

Biovitrum : unique neuropathic pain compound is very safe and shows positive effect

2008-04-07 - Biovitrum has completed a first phase 2 study in patients with neuropathic pain. The candidate drug, BVT.115959, is a pH-selective A2A-receptor agonist for the treatment of pain. The results of this first patient study is promising as it shows a high level of safety and tolerability, as well as a positive treatment effect that increased over time.
The most important finding in this first phase 2 study is that the unique candidate drug BVT.115959 is very safe and tolerable. Moreover, a positive treatment effect that increased over time was observed although the analysis of the primary variable was not statistically significant. Further analysis of the efficacy data showed statistical significance. The conclusion of these observations is that BVT.115959 has a clear opportunity to show good efficacy and few side-effects in further studies.

192 patients with chronic neuropathic pain secondary to diabetes were included in this exploratory phase 2 study. The study is the first of its kind with a compound which is steered to its target protein (A2A-receptor) depending upon pH in the injury area... Biovitrum's Press Release -

SciGen and Generex : Distribution Agreement for Oral-lyn

2nd April, 2008: SciGen Limited (ASX:SIE) announces that it has entered into a product licensing and distribution agreement pursuant to which SciGen Ltd. will procure governmental approvals for the importation, distribution, marketing, and sale of Generex’s Oral-lyn™,
the Company’s proprietary oral insulin spray product, in the People’s Republic of China, Hong Kong, and the following additional countries : Indonesia, South Korea, Malaysia, the Philippines, Singapore, Thailand, and Vietnam... [PDF] SciGen's Press Release - Generex’s Press release -

MetaCure : NewYork-Presbyterian/Weill Cornell Is First New York Medical Center to Offer Tantalus Clinical Trial to Diabetes Patients

March 27, 2008 — NewYork-Presbyterian Hospital/Weill Cornell Medical Center is recruiting patients for a national clinical research study of an investigational implantable device designed to help those with type-2 diabetes who are overweight and do not respond to current oral anti-diabetic treatments.
The Tantalus® System is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation when a person eats. The device is implanted though a minimally invasive laparoscopic procedure that can be performed in an outpatient setting...
...NewYork-Presbyterian/Weill Cornell is one of thirty sites in the U.S. participating in the study, which is funded by MetaCure, the manufacturer of Tantalus. The device is currently CE-marked in Europe.... Weill Cornell Medical Center's Press Release -

GlaxoSmithKline to acquire Sirtris Pharmaceuticals : a world leader in 'Sirtuin' research and development

22 April 2008 – GlaxoSmithKline (NYSE: GSK) and Sirtris Pharmaceuticals Incorporated (Nasdaq: SIRT) announced today that they have entered into a definitive agreement pursuant to which GlaxoSmithKline will acquire Sirtris Pharmaceuticals for approximately USD720 million (or approx. GBP362 million) through a cash tender offer of USD22.50 (or approx. GBP11.33) per share.

Through the acquisition of Sirtris, GSK will significantly enhance its metabolic, neurology, immunology and inflammation research efforts by establishing a presence in the field of sirtuins, a recently-discovered class of enzymes that are believed to be involved in the ageing process. Sirtris Pharmaceuticals has established a drug discovery capability to exploit sirtuin modulation for the treatment of human disease, an approach that has the potential to generate multiple clinically and commercially important products. Their focus to date has been on the development of SIRT1 activators for the treatment of Type 2 Diabetes Mellitus (T2DM)... GlaxoSmithKline's Press Release - Sirtris' Press Release -

Medicure : Presentation of Phase II Matched Results at Cardiovascular Conference

April 16, 2008 - Medicure Inc. (TSX:MPH)(AMEX:MCU), a cardiovascular-focused biopharmaceutical company, announced that the positive results from the Phase II MATCHED study, which evaluated the combination of MC-1 and lisinopril in patients with coexisting type II diabetes and hypertension, will be presented at the Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) Annual Conference 2008 in Atlanta, GA... Medicure's Press Release -

Daiichi Sankyo : Welchol Added to the ACE/AACE "Road Maps to Achieve Glycemic Control in Patients With Type 2 Diabetes Mellitus"

April 15, 2008 - Daiichi Sankyo announced that Welchol™ (colesevelam HCl) has been added to the American College of Endocrinology (ACE) and American Association of Clinical Endocrinologists (AACE) 2008 "Road Maps to Achieve Glycemic Control in Type 2 Diabetes Mellitus." The Road Maps are updated regularly by ACE/AACE to provide physicians with the latest and most comprehensive treatment options for their patients with type 2 diabetes mellitus. Welchol is the first and only therapy approved to treat both type 2 diabetes and high LDL-cholesterol.

Welchol, which is indicated for use in combination with metformin, sulfonylureas, or insulin, was added to the combination therapy section of the Road Maps for treated patients with type 2 diabetes mellitus. This is the second major diabetes related milestone for Welchol this year. In January, Welchol was approved by the FDA for the treatment of type 2 diabetes. Welchol is also approved for lowering LDL-C in patients with primary hyperlipidemia... [PDF] Daiichi Sankyo's Press Release -

AtheroGenics : Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes

04/14/2008 -- AtheroGenics, Inc. (NASDAQ: AGIX), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, released topline results from a planned interim analysis of its ongoing ANDES Phase 3 clinical trial of AGI-1067 for the treatment of Type 2 diabetes. ANDES is evaluating two dose levels of AGI-1067 given once daily over six months. The primary efficacy endpoint is changed in hemoglobin A1c (A1c) from baseline compared to placebo in patients with Type 2 diabetes.

The interim analysis of 806 patients who completed three months in the study showed dose-related, statistically significant reductions in A1c... AtheroGenics' Press Release -

Pacific Biometrics : Research Contracts as Part of Global Phase I and II Diabetes and Obesity Programs

April 3, 2008 - Pacific Biometrics, Inc. (PBI) (OTCBB: PBME) has been awarded a series of contracts with a top multinational pharmaceutical company (the “Sponsor”) to provide essential laboratory data for a global Phase I and Phase II metabolic disease program. These contracts are part of a series of seven contracts related to clinical trials that form part of a global development program for an innovative approach for the treatment of type 2 diabetes and obesity.
PBI will provide the Sponsor with testing of metabolic markers and gut hormones on samples collected to support the Sponsor’s clinical development program. Testing has already commenced and is anticipated to be completed by the end of the first quarter of calendar 2009, although additional studies may be added to the program. PBI estimates total revenue over the expected life of these contracts at over $800,000... Pacific Biometrics' Press Release -

AGI Therapeutics : key findings of clinical PK study of arbaclofen (AGI-006)

2nd April 2008 - AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, announces the key findings of a clinical study to assess the pharmacokinetic profile of arbaclofen (AGI-006), which is being developed for the treatment of gastroparesis, a significant gastric condition amongst diabetics.

The pharmacokinetic study was conducted in healthy human volunteers and compared the drug exposure profile of arbaclofen, under both fasted and fed conditions, following a single oral administration of a 5mg dose. Arbaclofen contains the purified R-isomer form of the previously approved drug baclofen (which is an equal mixture of the S- and R-isomers). In addition, this study compared the drug exposure of arbaclofen (5mg), in terms of both the S- and R-isomer forms of baclofen, with a single 10mg oral dose of Lioresal® (a marketed form of racemic baclofen)... AGI Therapeutics' Press Release -

Living Cell Technologies : Proprietary Nanobiocapsules at NZBio 2008

April 1, 2008 - Living Cell Technologies Limited (ASX: LCT) (PINKSHEETS: LVCLY) announced that Dr. Paul Tan, LCT CEO and Dr. Anil K. Anal, LCT Material Scientist, presented some data at a session on nanotechnology at the NZBio 2008 Conference in Auckland, New Zealand. Their presentation showcased the company's proprietary nanobiocapsules which allow encapsulated pig insulin producing cells, DiabeCell®, to be implanted without the use of toxic immune suppressive drugs.

On March 31, the Company reported positive early preliminary data from an on-going Phase I/IIa clinical trial which shows that following implant into patients with insulin dependent diabetes, the encapsulated porcine pancreatic islets remain functioning for at least 6 months and beneficial effects were greater than expected... LCT's Press Release -

Karo Bio : Positive Results in First Clinical Study with Anti Diabetes Compound KB3305

April 17, 2008 - Karo Bio’s compound, KB3305, for treatment of type 2 diabetes, shows robust and predictable pharmacokinetics and the subjects are well exposed without serious adverse events in the first phase I clinical study. The incidence of type 2 diabetes is increasing rapidly and there is a need for improved pharmaceuticals with new mechanisms of action. KB3305 is a first in class liver selective glucocorticoid antagonist that has shown excellent efficacy and safety in several preclinical models for type 2 diabetes... Karo Bio's Press Release -

Elixir Pharmaceuticals : National Diabetes Advisory Board

April 09, 2008 - Elixir Pharmaceuticals, Inc., announced the formation of its U.S. Diabetes Advisory Board to provide independent scientific and clinical advice regarding the Company's product candidates in phase III development, Glinsuna™ (mitiglinide) and Metgluna™ (mitiglinide plus metformin), for the treatment of type 2 diabetes, as well as to provide input on other Elixir product candidates in development to treat metabolic diseases... [PDF] Elixir Pharmaceuticals' Press Release -

BioChemics & Beth Israel Deaconess Medical Center : Wound Healing Research Collaboration

April 8, 2008 - BioChemics, Inc., a company “pioneering transdermal drug delivery,” announced it has entered into a research collaboration with Beth Israel Deaconess Medical Center (BIDMC) to evaluate the wound healing effects of some of the Company’s novel, proprietary formulations in preclinical models. BIDMC is one of the largest, most respected research hospitals in the country. BioChemics is a pharmaceutical company that has developed a novel, transdermal drug delivery system that for the first time may allow almost any drug to be efficiently delivered through the skin. The transdermal technology, called VALE® (Vaso-active Lipid Encapsulated), may allow a substantial portion of the pharmacopeia to be re-engineered, turning oral drugs into transdermals that are safer (no gastro-intestinal problems), cheaper and potentially faster acting (applied directly to the treated area) than oral equivalents.
Recent industry reports estimate the global wound care market to approach $12 billion by 2009, with a yearly growth rate in excess of 7%. US markets account for approximately half of the spending in this area. Indications for wound therapy and management include diabetes, age related skin or pressure ulcers, trauma and surgery... BioChemics' Press Release -

DiaKine : Lisofylline Reduces Obesity-Related Inflammation and Insulin Resistance

April 16, 2008 - -DiaKine Therapeutics today announced that its developmental drug Lisofylline (LSF), significantly reduced indicators of inflammation in visceral fat tissue that are predictive of heart disease and diabetes risk, according to results of a pre-clinical study presented at the Arteriosclerosis, Thrombosis and Vascular Biology Annual Conference 2008.

“This study using ‘Western’ type high-fat, diet fed obese mice, suggests that medications with the actions of LSF could reduce inflammation and insulin resistance associated with central obesity – therefore providing a novel opportunity to treat heart disease and prevent type 2 diabetes development... [PDF] DiaKine's Press Release -

PerkinElmer : New Innovations to Strengthen Drug Discovery Product Portfolio

Latest AlphaLISA(TM) Immunoassay Kits Reduce Customers' Time, Labor and Materials; Enhance Research Efforts for Cancer, Alzheimer's, Diabetes, HIV, Inflammation and Cardiovascular Disease
April 4, 2008--PerkinElmer, Inc. (NYSE: PKI), a global leader in Health Sciences and Photonics, announced the release of eight new AlphaLISA(TM) immunoassay kits in conjunction with the Society for Biomolecular Sciences' (SBS) 14th Annual Conference and Exhibition. These latest innovations include research reagents and assays for investigating HIV, cancer, central nervous system disorders, cardiovascular disorders, and diabetes(a).
AlphaLISA is a line of highly sensitive "No-Wash" immunoassay reagents offering a wide dynamic range and easy automation for analysis of biomarkers and other analytes. The technology allows researchers to replace multi-step, cumbersome ELISAs with a high throughput screening (HTS) platform, significantly reducing the time, labor and materials necessary for processing complex samples... PerkinElmer's Press Release -

Exelgen : Two New Major Drug Discovery Collaborations

April 02, 2008 - -Exelgen, Ltd, a wholly owned subsidiary of Commonwealth Biotechnologies, Inc. (CBI) (NASDAQ Capital Market:CBTE) and a leading provider of drug discovery chemistry services and small molecule products, announced that it has entered into two new drug discovery collaborations: one with a leading US pharmaceutical company and one with a major European pharmaceutical company. Given the proprietary nature of the collaborations both partners declined to be named. "With our new European partner, we have entered into a broad-based collaboration to discover and develop novel small-molecule therapeutics for use in the fields of CNS; Alzheimer's disease, neuro-inflammation and type-2 diabetes... [PDF] Commonwealth Biotechnologies' Press Release -

Entelos : U.S. Patent for its Diabetes Model

April 3, 2008 - Entelos, Inc. (LSE:ENTL) a leading life sciences company building predictive computer models of human physiology and "virtual patients" for drug discovery and development, announced today that the U.S. Patent and Trademark Office has granted U.S. Patent No. 7,353,152 entitled "Method and Apparatus for Computer Modeling Diabetes" to the Company. This enabling technology forms the basis for the Entelos^® Metabolism PhysioLab^® platform, an innovative and predictive computer model that can simulate diabetic patients and drug effects and is used to select the most effective compounds, find the best doses, and support clinical trial design... Entelos' Press Release -

Kamada : AAT proved efficient in treating Type-1 Diabetes in mice in a study conducted at Harvard, USA

April 7, 2008 - A recent BBC publication demonstrating the efficacy of Alpha-1 Antitrypsin in treating Type-1 Diabetes, shows a potential additional indication for AAT, Kamada's leading product. Kamada is a biopharmaceutical company developing, manufacturing and marketing specialty life-saving therapeutics.
According to the BBC publication, the scientists demonstrated the ability to stop the on-going destruction of insulin-producing beta cells in mice using a combination of three drugs, although they were unable to regenerate the cells. However, when they added an extra ingredient - an enzyme called Alpha 1 Antitrypsin - a significant rise in the number of beta cells was seen... Kamada's Press Release -

Home Test Kits from BioIQ Help Consumers Detect Diabetes

April 09, 2008 – The number of Americans at risk for diabetes, heart disease, prostate cancer, colorectal cancer and other common illnesses has increased significantly in recent years, potentially shortening the lifespan of millions and putting an unprecedented strain on the health care system. Fortunately, with early detection and appropriate treatment, the complications and costs related to these diseases can often be minimized. Now thanks to a line of test kits from BioIQ, people can order test kits to blood sugarcholesterol, blood sugar and other important biometric information. BioIQ also offers corporate health screening programs to bring the benefits of home testing to employers, employees and their dependents, enabling people throughout the U.S. to screen themselves for many of today’s most common and preventable illnesses in the privacy of their own homes... BioIQ's Press Release -

DiaKine Therapeutics & Kinexum Metabolics : Combination Drug Therapy May Hold the Key to Reversing Type 1 Diabetes

04/08/2008 - -Seventy percent of mice with type 1 diabetes treated with a combination therapy of Lisofylline (LSF) (DiaKine Therapeutics) and INGAP Peptide (Kinexum Metabolics) went into complete remission and no longer needed insulin, LSF or INGAP Peptide in order to maintain normal blood sugar levels. Additionally, mice treated with this novel combination therapy required less insulin during the treatment regimen than the controls, according to results of a preclinical study presented at the prestigious Keystone Symposia on Beta Cell and Islet Biology... [PDF] DiaKine's Press Release -

12-Month Data from Endeavor IV Show Strong Clinical Efficacy of Medtronic’s Drug-Eluting Stent Across All Patient Groups

March 30, 2008 – Data showing strong clinical efficacy for Medtronic’s Endeavor® drug-eluting stent were presented today at the American College of Cardiology meeting. Entitled “One-Year Clinical and Angiographic Results in Diabetics from ENDEAVOR IV: A Randomized Comparison of the Endeavor Drug Eluting Stent System Versus Taxus in de novo Native Coronary Lesions” (2803-8) – the presentation featured an analysis of 477 diabetic patients from the ENDEAVOR IV clinical study. ENDEAVOR IV is an ongoing head-to-head comparison of the Endeavor and Taxus stents in 1,548 patients... Medtronic's Press Release -

ArthroCareSports Medicine : to Tackle Diabetic Foot Ulcers

March 26, 2008--As part of ArthroCare Sports Medicine's recent entry into the Foot and Ankle arena, ArthroCare(R) Corp. (Nasdaq: ARTC) announced that it has launched early stage clinical and pre-clinical research work for treating diabetic foot ulcers and is encouraged by preliminary results reported by physicians.

There are an estimated 18 million Americans living with diabetes today and each year at least 5% of that population develops foot ulcers as an effect of the disease. The Centers for Medicare and Medicaid Services (CMS) report that up to 30% of those suffering from diabetic foot ulcers eventually require amputation and that even for those whose ulcers heal, there is a 66% recurrence rate in that patient population. Indeed, such ulcers are far and away the most common condition leading to lower extremity amputations in the world today... ArthroCare's Press Release -

WellDoc Communications : Diabetes Management Program Assists Patients by Lowering Blood Glucose Levels by Two Points

March 19, 2008 - -WellDoc Communications, Inc., a technology-based healthcare company focused on improving diabetes management, announced that patients in its initial pilot program experienced significant improvements in their diabetes control. Patients using WellDoc’s web- and cell phone-based diabetes management platform achieved, on average, a two-point drop in their hemoglobin A1c -- or HbA1c, a measure of blood sugar control, within 90 days. The pilot results will be published in June in a peer-reviewed diabetes journal... [PDF] WellDoc Communications' Press Release -

Elixir Pharmaceuticals : enrollment in its final pivotal phase III clinical study of mitiglinide for the treatment of patients with type 2 diabetes

March 25, 2008 – Elixir Pharmaceuticals, Inc., announced that it has completed enrollment in its final pivotal phase III clinical study of mitiglinide for the treatment of patients with type 2 diabetes. The study is expected to be completed during the third quarter of 2008, with data available shortly thereafter. The results from this study will supplement the existing clinical database of more than 4,000 patients to form the basis of the Company's anticipated new drug application (NDA) submissions to the FDA in early 2009 for Glinsuna(TM) (mitiglinide) and a fixed combination product, Metgluna(TM), combining metformin and Glinsuna... [PDF] Elixir Pharmaceuticals' Press Release -

Pfizer Statement on Exubera Labeling Update in the US

April 09, 2008 -Pfizer Inc said today that it updated the United States product labeling for EXUBERA® (insulin human [rDNA original]) Inhalation Powder to include a warning with safety information about lung cancer cases observed in patients who used Exubera.

This update is based on an ongoing review of the data from the Exubera clinical trial program and post-marketing experience by Pfizer and the Food and Drug Administration (FDA). Since the inception of the program, Pfizer has continuously monitored respiratory safety. Over the course of the clinical trial program, 6 of the 4,740 Exubera-treated patients versus 1 of the 4,292 patients not treated with Exubera developed lung cancer. In addition there was a post-marketing report of lung cancer in one Exubera-treated patient. The update to the labeling states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera... Pfizer's Press Release -

Diabetech Launches GlucoMON-RT Real-Time Monitoring for Remote Diabetes Caregivers

February 6, 2008 – As the result of over 5 years of development in over a dozen clinical trials conducted throughout the USA, Diabetech is pleased to announce the direct-to-consumer commercial availability of the GlucoMON-RT subscription service for delivering real-time blood glucose alerts to remote caregivers as well as automated reporting. This program has proven to be especially valuable for families with children at school who must cope with the remote aspects of managing their children with type 1 diabetes. Children with 'type 1' require insulin and are always at high risk of severe complications. The blood sugar lowering effects of insulin also lead to seizure, coma and other serious life-threatening events. The GlucoMON-RT 'out-of-the-box' experience is the easiest way to collaborate with others who share in the management of an individual's diabetes... [PDF version] Diabetech's Press Release -

Luminous Medical : Automated Blood Glucose Monitor For Critical Care Use

March 18, 2008 – Luminous Medical, Inc. announced that it has completed a $23.5 million round of Series B financing. Adams Street Partners led the investment, joined by new investors RiverVest Venture Partners, and Finistere Ventures. Existing investors De Novo Ventures and Latterell Venture Partners also participated in the round.
The company is developing an automated blood glucose monitor for in-hospital use with critically ill patients. Establishing tight glucose control in these patients has been shown to improve outcomes including highly significant reductions in complications, length of stay and mortality. The Luminous Medical monitor will simplify the implementation of tight glucose control by providing frequent glucose measurements automatically... [PDF] Luminous Medical's Press Release -

Alimera Sciences and pSivida : DSMB again supports continuation of Phase III Trial of Medidur FA for the treatment of Diabetic Macular Edema [DME]

March 24, 2008 – After completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study can continue under the current protocol, without change. The trial is studying the use of Medidur FA for the treatment of diabetic macular edema (DME).FAME is two, duplicate, double-masked, randomized, multi-center studies that are following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up. Enrollment for the FAME study was completed in October 2007... Alimera's Press Release - [PDF] pSivida's Press Release -

Metabolex : Phase 1 clinical trial of MBX-2982, Potential First-in-Class Treatment for Type 2 Diabetes

March 26, 2008 : Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced that it has dosed the first cohort of healthy subjects in a Phase 1 clinical trial of MBX-2982, a potential first-in-class treatment for type 2 diabetes.

The Phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of MBX-2982. Investigators expect to enroll a total of 60 healthy volunteers in the 6-cohort ascending-dose study.

MBX-2982 is an agonist of GPR119, a G-protein coupled receptor (GPCR) that is expressed in pancreatic islets and the gastrointestinal tract. Pre-clinical studies conducted by Metabolex and others show that GPR119 agonists can stimulate glucose-dependent insulin secretion... Metabolex's Press Release -

Takeda : ACTOS® (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients with Type 2 Diabetes

March 31, 2008 – New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS^® (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline. These data stem from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial.

The PERISCOPE trial was presented today as a late breaker at the 57th Annual Scientific Session of the American College of Cardiology in Chicago. This trial adds to the body of cardiovascular data for ACTOS. ACTOS studies, conducted over the past 10 years in more than 16,000 patients, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death... Takeda's Press Release -