Medtronic : Announces Sales Milestone of One Million Continuous Glucose Monitoring Sensors Worldwide

March 24, 2008 — Medtronic, Inc. (NYSE: MDT) announced that it has reached the milestone of more than one million sensors for its continuous glucose monitoring (CGM) products manufactured and sold. The recipient of the milestone one millionth sensor was Tim Parker of San Jose, Calif. Parker, diagnosed with type 1 diabetes 11 years ago, has used CGM therapy for two years to help him manage his diabetes.

“Today we salute Tim, thousands of patients like him and all of the Medtronic employees who have contributed to the success of our CGM technology,” said Chris O’Connell, president of the Diabetes business at Medtronic. “Medtronic pioneered CGM 10 years ago, and this important milestone demonstrates our momentum and clear industry leadership in the exciting new field of continuous glucose monitoring.”

Parker relies on his Paradigm™ REAL-Time System, and says it is fundamental to managing his diabetes effectively. Prior to adopting integrated insulin pump and CGM therapy, Parker – like many people with diabetes – experienced unexplained blood glucose excursions that worried him. “I would go to bed with my blood glucose levels at 110 and wake up at 220. What could be happening to my body while I was asleep?” said Parker. Motivated to keep his blood glucose in check, he began researching options and learned about Medtronic’s CGM products on the Internet... Medtronic's Press Release -

AgaMatrix : WaveSense Europe Launches Jazz Glucose Meter for Diabetes in UK

March 5, 2008 – WaveSense Europe announces the launch of the WaveSense Jazz™ Blood Glucose Monitoring System (BGMS) at the 2008 Diabetes UK meeting in Glasgow, Scotland. The WaveSense Jazz™ blood glucose meter (BGM) has market-leading features designed to help people with diabetes gain tighter control over their blood glucose levels.In addition to requiring no code and having some of the world’s largest backlit digits on a BGM, the Jazz is one of the first meters to provide a glycemic variability value. Glycemic variability is a tool used to show how glucose changes over time and may allow the patient or their health care professional to better analyze high and low readings and take preventative action... AgaMatrix 's Press Release - PDF version -

Boston Scientific : TAXUS Express Stent Shows Similarly Low Re-intervention Rates in Diabetic Patients Compared to Non-Diabetics...

March 29, 2008 - Boston Scientific Corporation (NYSE: BSX) announced results from an analysis of 4,772 patients from its TAXUS ARRIVE 1 and 2 registries, designed to assess the performance of the TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System in real-world practice. The one-year pooled ARRIVE data confirmed the known higher mortality rate for diabetics versus non-diabetics with cardiovascular disease(1), but showed that the TAXUS Stent had similarly low rates of stent-related cardiac death, myocardial infarction (MI), stent thrombosis, and major cardiac events (MCE) across those two patient subsets. The study also showed similar rates of target vessel re-intervention (TVR) and TAXUS-related TVR in indicated patients(2) per the European Union (EU) label, whether or not they had diabetes. Analysis of the data was presented by D. Lynn Morris, M.D., at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago. The pooled analysis included one-year data on 1,530 medication-requiring diabetic patients and 3,242 non-diabetic patients from the ARRIVE registry program. Due to significant disparity in baseline characteristics between diabetic and non-diabetic patients, propensity score analysis was used to allow for adjustment of baseline differences (other than the presence of diabetes) between the two groups... Boston Scientific's Press Release -

SemBioSys : toxicology study for safflower-produced insulin

March 26, 2008 - SemBioSys Genetics Inc. (TSX: SBS), a biotechnology company developing a portfolio of therapeutic proteins for metabolic and cardiovascular diseases, announced that it has initiated a toxicology study in animals to demonstrate the safety and comparability of its safflower-produced insulin to pharmaceutical grade human insulin. This study is a final key step in the Company's preparations to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter in order to initiate a Phase I/II human clinical trial this year. The 28-day repeat dose study in monkeys and rats is the only toxicology study required before submission of the IND application to the FDA. The study is also a required component for the abbreviated 505(b)(2) application process that SemBioSys is eligible to follow, based on the well-characterized nature of insulin. The study aims to establish that the toxicology profile of insulin produced from SemBioSys' plant system is appropriate to begin human trials... SemBioSys Genetics' Press Release -

Keryx Biopharmaceuticals : Termination of SUN-MACRO Phase 4 Trial

March 27, 2008 - Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) announced today that following a Drug Safety and Monitoring Committee (DSMC) review of the SUN-MACRO Phase 4 trial of Sulonex(TM) (sulodexide oral gelcap), the Company has decided to terminate the study and cease further development of Sulonex... Keryx's Press Release -

Atherotech 's VAP Test Helps Researchers Uncover Best Cholesterol Lowering Treatment for Type II Diabetes

March 25, 2008 – The VAP cholesterol test from Atherotech is helping physicians pinpoint the most effective cholesterol and heart disease risk lowering treatments in Type II diabetes patients, providing valuable and potentially lifesaving information to diabetics and the doctors who treat them.

Leveraging the expanded cholesterol profiling capabilities of the VAP test, researchers in the Diabetes and Combined Lipid Therapy Regimen (DIACOR) study found that combining statin therapy with a fibrate is the most effective way to correct an adverse cardiovascular risk profile in individuals with diabetes and mixed dyslipidemia (elevated LDL cholesterol and triglyceride levels combined with decreased levels of HDL cholesterol).

The results of the 12-week, single center, double-blind, placebo-controlled study were recently published in American Journal of Cardiology. Researchers were able to use the VAP Test to measure the effects of simvastatin alone, fenofibrate alone and the combination of both on lipid subparticles in 300 patients (randomized) with Type II diabetes without existing heart disease... Atherotech 's Press Release -

Generex Biotechnology : Its Protocol for Metcontrol, the Company's Proprietary Metformin Chewing Gum Product, Will Be Submitted to Regulatory ...

March 12, 2008 - Generex Biotechnology Corporation (GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that it has finalized the protocol for Metcontrol(tm), the Company's proprietary Metformin chewing gum product, and will be proceeding with applications to regulatory agencies for approval of the protocol for a clinical study. The protocol is an Open-Label Crossover Study comparing Generex's Metformin chewing gum and immediate release tablets in healthy volunteers.
The Company anticipates that approximately 75-100 patients will participate in the study.
Metformin is a generic drug used to regulate blood glucose levels by reducing liver glucose production and improving insulin sensitivity by the cells. Through this action, Metformin allows the insulin produced by the body to be used more effectively and ultimately reduces the amount of glucose in the blood. Metformin is the backbone of all treatment for Type 2 Diabetes Mellitus... Generex's Press Release -

Echo Therapeutics : Positive Results from Symphony(TM) Transdermal Continuous Glucose Monitoring System Study at Tufts Medical Center

March 13, 2008 - - Echo Therapeutics (OTC Bulletin Board: ECTE) announced positive results from its clinical study of the Symphony(TM) tCGM System, a novel, non-invasive, transdermal continuous glucose monitoring (tCGM) system, conducted at the Tufts Medical Center in Boston, Massachusetts (Tufts). Echo is developing the Symphony tCGM System to provide patients with diabetes and healthcare professionals with a reliable, needle-free, wireless, continuous monitoring system to better manage diabetes and control blood glucose levels in the home use and hospital critical care settings. Data from the pilot study demonstrate that Symphony safely and reliably monitored blood glucose levels in the challenging operating room and surgical intensive care unit at Tufts. Echo is planning to present these data at a major medical conference later this year... [PDF] Echo Therapeutics' Press Release -

Oramed Pharmaceuticals : Phase 2A Trials of Its Oral Insulin Capsule

March 18, 2008 - Oramed Pharmaceuticals Inc. (OTCBB:ORMP) has been granted approval by the Institutional Review Board (IRB) committee of Hadassah Medical Center in Jerusalem to conduct a Phase 2A study of its oral insulin on diabetic volunteers. This Phase 2A study is designed to evaluate the safety and efficacy of Oramed’s oral insulin capsule on Type II diabetic volunteers. This study is slated to begin in the second quarter of 2008. The trials are expected to last several months... [PDF] Oramed's Press Release -

MacroChem, Pexiganan Phase 3 Study Results for Topical Treatment of Diabetic Foot Infection

March 13, 2008 - MacroChem Corporation (OTC Bulletin Board: MACM) announced the presentation of a poster entitled "Topical versus Systemic Antimicrobial Therapy for Treating Infected Diabetic Foot Ulcers: A Randomized, Controlled, Double-Blinded, Multicenter Trial of Pexiganan Cream." The poster will be presented at the Diabetic Foot Global Conference 2008 in Los Angeles on March 13 to 15 by Benjamin A. Lipsky, MD, FACP, FIDSA, Professor of Medicine, University of Washington and Director, Primary Care Clinic, VA Puget Sound Health Care System.

The poster presents results of two Phase 3 clinical studies, individually and combined, comparing the efficacy of an investigational topical antimicrobial peptide preparation, pexiganan acetate cream, against systemic therapy with an oral fluoroquinolone antibiotic, ofloxacin, for mildly infected diabetic foot ulcers. The authors conclude, in part, that, "The rates of clinical cure or improvement (the primary outcome of the trial) for topical pexiganan and oral ofloxacin were statistically equivalent for the combined studies."... MacroChem 's Press Release -

MannKind : Response to Recent Market Events

March 10, 2008 - MannKind Corporation (Nasdaq: MNKD) issued the following statement in response to recent market events:
MannKind is absolutely committed to the continued development of its lead development product, Technosphere(R) Insulin. We use our small, patient-friendly Medtone(R) inhaler to deliver Technosphere(R) Insulin to patients with diabetes in a way that much more closely matches the pattern of insulin secretion seen in people without disease. MannKind believes that the resulting efficacy and safety profile is unique and clearly differentiated from all existing diabetes treatments. To achieve normal glucose control, it is necessary to independently address both mealtime and fasting glucose. We believe Technosphere(R) Insulin is the only therapy that separately and independently lowers prandial glucose excursions, and that it will thus offer an important benefit to many patients with this devastating disease.
MannKind recognizes that in order to be successful in today's health care market a product must offer improved efficacy and safety, not just improved convenience. The decisions of Eli Lilly and Company as well as Pfizer and Novo Nordisk to discontinue the development of their inhaled insulin products reinforce this view. None of those products offer any advantages over injectable rapid acting insulin analogs... MannKind 's Press Release -

Generex Oral-lyn, another regulatory approval to conduct Phase III clinical trial

February 14, 2008 - Generex Biotechnology Corporation (NasdaqCM:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that on January 10, 2008 the Company received an additional regulatory approval letter for the conduct of its Phase III clinical trial protocol for Generex Oral-lyn at an additional 28 clinical sites located in Europe. The significance of this approval is that it represents initiation of additional clinical sites for the pivotal study and permits commencement of screening for suitable patients. More importantly, these additional sites allow for an enrollment of up to 340 study subjects in addition to the sites which have already received regulatory approval to initiate the Phase III study. The Company will be conducting the Phase III trial of Generex Oral-lyn in a total of seven countries... Generex 's Press Release -

Metabolon and EGIR, Partnership to Accelerate Pre-Diabetes Diagnostic Development

March 18, 2008 - Metabolon, Inc., the leader in metabolomics-driven biomarker discovery and analysis, announced today a collaboration with the European Group for the Study of Insulin Resistance (EGIR). The EGIR has compiled large numbers of biological samples from studies conducted at 19 clinical research centers across Europe as part of their effort to understand insulin resistance and how it affects disease. Metabolon will discover and validate the biomarkers found in these samples that relate to insulin resistance. These markers will be used to help further develop Metabolon’s diagnostic test for pre-diabetic patients... Metabolon 's Press Release -

Mercury Therapeutics : series of indirect AMPK activators licensed to Makoto Life Sciences

March 12, 2008 - Mercury Therapeutics, Inc. (MTI), a company that discovers and develops orally active protein kinase targeted drugs, announces that it has signed an exclusive license agreement with Makoto Life Sciences, Inc., of Cambridge, Massachusetts.Under this agreement, MTI has licensed to Makoto its lead series of high potency activators of AMP-activated protein kinase (AMPK), a well validated drug target for the treatment of Type-2 diabetes. As part of the license, MTI will transfer all assets related to its MT-39 series of indirect AMPK activators, including all materials, research notes, synthetic routes, and the structures of over 40 compounds. MTI will advise Makoto on the continuing development of the MT-39 series...

Sirtris' SIRT1 Activators; Patent Covers First NCE to Enter Human Clinical Trials

March 19, 2008--Sirtris Pharmaceuticals, Inc. (NASDAQ: SIRT), a biopharmaceutical company focused on discovering and developing small molecule drugs to treat diseases of aging such as Type 2 Diabetes, announced that the United States Patent Office issued to Sirtris the first patent covering a broad class of compounds that activate the enzyme SIRT1. Several Sirtris compounds--or new chemical entities (NCEs)--from this class lower glucose and improve insulin sensitivity in preclinical models of Type 2 Diabetes. The patent covers the first NCE that Sirtris plans to take into a human clinical safety trial in the first half of 2008... Sirtris' Press Release -

DiObex and Camurus , Agreement for the Development of DIO-901 in FluidCrystal(R) Extended Release Technology

March 18, 2008 - DiObex and Camurus announced today that they have signed a license agreement to develop DIO-901(very low dose glucagon) in the Camurus drug delivery technology, FluidCrystal(R). The development candidate is an extended release formulation of low dose glucagon for the prevention of insulin-induced hypoglycemia in patients with diabetes."Intensive glycemic control is beneficial for patients with diabetes, but it increases their risk of hypoglycemia, which can lead to a spectrum of problems ranging from reduced quality of life to coma and death," said David Cory, DiObex CEO. "This license agreement and development program reflects our commitment to deliver an extended release form of low dose glucagon to the market for the prevention of insulin-induced hypoglycemia."... DiObex 's Press Release - Camurus ' Press Release -

Lilly and Transition Therapeutics, Licensing and Collaboration Agreement

March 13, 2008 - Eli Lilly and Company (NYSE: LLY) and Transition Therapeutics Inc. (TSX: TTH; Nasdaq: TTHI) today announced that the two companies have entered into a licensing and collaboration agreement granting Lilly exclusive worldwide rights to develop and commercialize Transition's gastrin based therapies, including the lead compound TT-223, which is currently in early Phase II testing. Gastrin based therapies are an emerging class of potential disease-modifying therapies for patients with diabetes, and have been shown to provide sustained improvement in glycemic control in preclinical models and early clinical studies. Sustained improvement in glycemic control is a key goal for patients with diabetes in order to alleviate the symptoms of hyperglycemia and to prevent diabetic complications, thereby improving their overall quality of life... Lilly's Press Release - Transition Therapeutics' Press Release -

Synvista Therapeutics, Newly Published Data Demonstrating the Value of Haptoglobin Genotype Testing In People with Diabetes

March 5, 2008 - Synvista Therapeutics, Inc. (Amex: SYI) announces the publication of a pre-planned sub-analysis from the ICARE study demonstrating that the addition of vitamin E to statin therapy prevented more cardiovascular events (heart attack, stroke and cardiovascular death) than statin therapy alone in patients with Diabetes Mellitus (DM) who tested positive for a genetic marker called Haptoglobin 2-2 (Hp2-2). This sub-analysis was published in the March issue of Arteriosclerosis, Thrombosis and Vascular Biology, a journal of the American Heart Association.

"These data are significant because they demonstrate that Haptoglobin testing may help physicians tailor optimal therapy for patients with diabetes who may be at risk for cardiovascular events. Physicians can better describe to their patients whether they are at high risk for a heart attack and whether they may anticipate a lower risk for heart attack if they take vitamin E... Synvista's Press Release -

PPD, Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration

February 28, 2008 - PPD, Inc. (Nasdaq: PPDI) confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.Under PPD's agreement with Takeda, the FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. This milestone payment was included in PPD's previously issued 2008 financial guidance... PPD's Press Release -

Alizyme's cetilistat Phase III development programme, for type 2 diabetes as well as for obesity

6 March 2008 - Alizyme plc (“Alizyme”) (LSE: AZM) announces that FDA has agreed
the remaining two protocols for its Phase III development programme for cetilistat under the Special Protocol Assessment (“SPA”) procedure and recommended that Alizyme open a separate diabetes IND.
Cetilistat is Alizyme's metabolic product under development for the treatment of obesity and associated comorbidities, including type 2 diabetes. It is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus weight loss.
Following successful end of Phase II discussions, FDA approved Alizyme’s outline plan for the Phase III clinical development programme of cetilistat... [PDF] Alizyme's Press Release -

Axis-Shield, HbA1c Test on Abbott's AXSYM Analyser

19 March, 2008 : Axis-Shield (LSE:ASD, OSE:ASD), the international in-vitro diagnostics (IVD) company, announces that it has received U.S. Food and Drug Administration (FDA) marketing clearance for its novel HbA1c test, formulated to run on the widely placed, high-throughput AxSYM^® laboratory analyser from Abbott . The test, which is used to monitor treatment efficacy in patients with diabetes, will now be launched into the important US marketplace. Assay development involved novel Axis-Shield patented technology from pioneering research at its Dundee plant, which has allowed measurement of this important marker on an automated high throughput immunoassay system... Axis-Shield's Press Release -

Marcadia Biotech and Merck, strategic collaboration

March 6, 2008 – Marcadia Biotech, Inc., a privately held drug development company, announced a strategic collaboration with Merck & Co., Inc. to jointly discover, develop and commercialize novel biopharmaceutical therapies targeting the glucagon and related receptors for the treatment of diabetes and obesity.

“Merck is a world leader in the discovery of breakthrough medicines and has proven expertise in the development and commercialization of drugs that treat metabolic diseases,” said Fritz French, CEO of Marcadia. “We are excited about the opportunity to significantly leverage the research we have accomplished to date through this collaboration with Merck.”... [PDF] Marcadia Biotech's Press Release -

OSI Pharmaceuticals : the Prior Revocation of Its European DP-IV Patent Has Been Upheld

March 18, 2008--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced that the decision of the European Patent Office (EPO) to revoke one of the Company's dipeptidyl peptidase IV (DP-IV) patents, EP0896538, claiming the use of DP-IV inhibitors to treat type II diabetes and related indications, has been upheld in appeal proceedings brought by the Company.

"We are disappointed with the outcome of the appeal proceedings. However, since the revocation applies to only one patent within our licensed DP-IV patent portfolio, any short-term loss in royalty revenue in Europe should be mitigated as additional licensed patents within the portfolio progress through the EPO examination procedure to grant," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. "The Company's DP-IV patent estate includes licensed rights to patents and patent applications claiming combinations of DP-IV inhibitors with other oral anti-diabetes drugs such as metformin."... OSI Pharmaceuticals' Press Release -

Hollis-Eden Pharmaceuticals, Positive Preliminary Data from Ongoing Phase I/II Clinical Trial with TRIOLEX in Obese Insulin Resistant Subjects

March 18, 2008--Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) announced positive preliminary data from its ongoing 28-day Phase I/II clinical trial in obese insulin resistant subjects with its investigational drug candidate TRIOLEX (HE3286). TRIOLEX is a first-in-class adrenal hormone insulin sensitizer focused on the regulation of unproductive inflammation. Preliminary data to date indicate that TRIOLEX is safe and well tolerated at all doses studied. In addition, the preliminary data thus far suggest that TRIOLEX is reducing fasting blood glucose levels and improving insulin sensitivity as evaluated through euglycemic/hyperinsulinemic clamps, an industry standard measurement for assessing whole body glucose metabolism and to test compounds as potential insulin sensitizers for the treatment of type 2 diabetes. The data were presented at IBC's 6TH Annual Conference, Targeting Metabolic Disorders, being held March 17 through 19 in Chapel Hill, North Carolina, by Jaime Flores-Riveros Ph.D., Vice President of Metabolism and Endocrinology at Hollis-Eden... Hollis-Eden Pharmaceuticals' Press Release -

Diamyd Medical, Authorization to Begin Phase III Study in the US

March 14, 2008 - Diamyd Medical announced that the FDA has given the Company permission to start a Phase III clinical study in type 1 diabetes patients in the US.
“We are eager to start this study and to be able to offer this promising drug to our newly diagnosed type 1 diabetes patients”, says Professor Jerry Palmer, University of Washington in Seattle, USA, who will be the Lead Investigator for the US study.
“We are extremely pleased with the regulatory process, that has now enabled us to go ahead with the Phase III trial in the US,” says Elisabeth Lindner, president and CEO of Diamyd Medical. “Over the past months we have received dozens of patient inquiries with requests to participate in our Phase III type 1 diabetes studies in the US and in Europe. It is very satisfying to be able to start the studies now.”... Diamyd Medical's Press Release -

Sernova, First Regulatory Step Towards Clinical Trials-Granted Formal Pre-IND Meeting With FDA

March 18, 2008 - Sernova Corp. (TSX-V: SVA) is pleased to announce that the company will be meeting with the United States Food and Drug Administration (FDA) on April 25, 2008 regarding Sertolin, the company's investigational cellular therapy being developed for diabetes treatment. This formal pre-Investigational New Drug (IND) meeting is Sernova's first step in seeking IND approval to initiate clinical trials in humans. The FDA meeting will provide Sernova with the opportunity to present its experimental data on Sertolin, obtain feedback on its pre-clinical data package, and receive the FDA's perspective on its proposed clinical strategy... Sernova's Press Release -

Cannasat Therapeutics, Update on Patent Application for Drug Development Programs

February 27, 2008 – Cannasat Therapeutics (TSXV: CTH), the developer of novel cannabinoid-based pharmaceutical products, announced that it has received a favorable decision from the United States Patent and Trademark Office (USPTO)...
...This patent application is important for Cannasat as it is expected to form the basis for at least one of its neuropathic pain products. Neuropathic pain is associated with nerve damage and can be an especially difficult condition to treat, often requiring the use of strong narcotics that can cause serious adverse effects. This condition is caused by many common diseases such as diabetes, herpes zoster, HIV/AIDS, multiple sclerosis, and other causes of chronic pain... Cannasat Therapeutics' Press Release -

Living Cell Technologies' DiabeCell Clinical Trial Program

February 26, 2008 - Living Cell Technologies Limited (ASX: LCT) (PINKSHEETS: LVCLY) announced that the Company has signed a term sheet with the Barbara Davis Center for Childhood Diabetes (BDC) to establish a diabetes clinical trial program in Denver, Colorado.
BDC and LCT will collaboratively pursue regulatory approval and then conduct a U.S. clinical trial in Type 1 diabetes with DiabeCell®, LCT's encapsulated porcine insulin producing cells. The proposed U.S. trial is planned to commence in 2009 and will be planned utilizing the clinical protocols and results from LCT's trials in Russia and New Zealand... [PDF] Living Cell Technologies' Press Release -

Nitric BioTherapeutics, Phase II Clinical Trial for the Use of Nitric Oxide in the Healing of Chronic Wounds

March 13, 2008 – Nitric BioTherapeutics (Nitric Bio) today announced the beginning of a Phase II clinical trial for the treatment of chronic wounds using nitric oxide. Affecting between 4.5 and 5 million Americans in the form of diabetic, venous stasis and decubitus ulcers, chronic wounds cost the U.S. healthcare system in excess of $2.5 billion per year and results in significant burden to patients... Nitric BioTherapeutics' Press Release -

Oramed Pharmaceuticalsals, Phase 1B Clinical Trials of Oral Insulin Capsule

March 11, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral delivery systems, has successfully completed Phase 1B clinical trials of its oral insulin capsule. The Phase 1B trial, which utilized healthy volunteers, was focused on finding the optimal dosage for the formulation of Oramed’s oral insulin product... [PDF] Oramed 's Press Release -

Abbott's FreeStyle Navigator Continuous Glucose Monitoring System : FDA approved

March 13, 2008 - The Food and Drug Administration (FDA) has approved the FreeStyle Navigator® Continuous Glucose Monitoring System in the United States for people with diabetes. Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, Abbott's FreeStyle Navigator system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed... Abbott's Press Release -

Elixir Pharmaceuticals, new data on the role of ghrelin antagonism in the regulation of metabolism and as a potential treatment for Type 2 diabetes

02-22-08 - Elixir Pharmaceuticals, Inc., announced new data on the role of ghrelin antagonism in the regulation of metabolism and as a potential treatment for Type 2 diabetes. The data were presented by Dr. Yong Qi in a platform session during Keystone Symposia’s Neuronal Mechanisms Controlling Food Intake, Glucose Metabolism and Body Weight meeting being held this week in Banff, Alberta, Canada. Elixir’s small molecule ghrelin antagonists derive from the Company’s focus on pathways involved in the regulation of aging. Elixir identifies novel targets in these pathways leading to the development of compounds to treat a range of diseases of aging, including metabolic diseases such as diabetes and obesity... [PDF] Elixir Pharmaceuticals' Press Release -

Akesis Pharmaceuticals, First Patient in Phase IIa Trial of AKP-020 for Type 2 Diabetes

February 25, 2008 - Akesis Pharmaceuticals, Inc. (OTC/BB: AKES), an emerging diabetes drug-development company, announced it has initiated dosing of patients in its placebo controlled Phase IIa trial for AKP-020, a novel vanadium compound, to test its safety and efficacy in patients with Type 2 Diabetes.
"We are pleased to have reached this Phase IIa milestone," said Jay Lichter, president and chief executive officer of Akesis. "We are on track to complete enrollment and dosing according to schedule and anticipate announcing results when they become available."
dgd Research of San Antonio, TX, now a member of Cetero Research, is conducting the Phase IIa, controlled U.S. clinical trial. The trial will enroll a total of 21 diabetic patients at a single site measuring efficacy (using the gold-standard euglycemic-hyperinsulinemic clamping procedure), as well as pharmacokinetic parameters, safety and tolerability of AKP-020 in diabetic patients... Akesis Pharmaceuticals' Press Release -

Oculus Innovative Sciences, Phase II Data with Microcyn® Technology in Mildly Infected Diabetic Foot Ulcers

Feb 27, 2008 - Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) announced positive top-line results from its U.S. Phase II clinical trial evaluating Microcyn® Technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers. Microcyn demonstrated a positive clinical response, defined as the clinical cure or improvement of infection, as a monotherapy and in combination with levofloxacin, a systemic antibiotic. The company plans to request an end-of-Phase II meeting with the FDA to discuss Phase II results and define the scope and parameters for advancing the clinical program... Oculus Innovative Sciences' Press Release -

Alkermes, Eli Lilly, Termination of AIR (Inhaled) Insulin Program

March 7, 2008--Alkermes, Inc. (NASDAQ: ALKS) announced that it has received a letter terminating the development and license agreement between Eli Lilly and Company (Lilly) and Alkermes dated April 1, 2001 thereby terminating the AIR(R) Inhaled Insulin (AIR(R) Insulin) program. The termination will become effective in 90 days. The termination of the agreement also results in the termination of the AIR Insulin supply agreement... Alkermes' Press Release - Lilly's Press Rlease -

PLC Systems' RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy

Feb. 15 , 2008 - PLC Systems Inc. (Amex: PLC) announced that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy™ and RenalGuard System™. This supplement seeks approval to move to a pivotal trial to study the effectiveness of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy. According to the current timetable, PLC expects to commence the pivotal trial after receipt of FDA approval. Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal impairment -- all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media... PLC Systems' Press Release -

Novocell, Successful Use of Stem Cells to Generate Insulin in Mice

San Diego, CA / February 20, 2008 – Novocell, Inc., a stem cell engineering company, announced data demonstrating for the first time that human embryonic stem (hES) cells can be turned into pancreatic cells capable of producing insulin in mice. The findings are reported in an article appearing on-line today, in advance of print publication, in the journal Nature Biotechnology. This research provides evidence supporting the potential future use of hES cells to replace insulin-producing pancreatic cells that are destroyed in people with Type 1 diabetes, requiring them to receive regular insulin treatment... Novocell's Press Release -

Novartis Eucreas combination of Galvus® and metformin, set for launch in first EU countries as new treatment for type 2 diabetes

Basel, February 25, 2008 - European health authorities have approved Eucreas®, an oral tablet combining Galvus® (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes. Eucreas is the first single-tablet combination of a member of the new DPP-4 inhibitor class with metformin to be approved in the European Union.

The approval comes after Novartis proposed changes to the EU label recommending that liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus announced earlier this month.

The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks... Novartis' Press Release -

Johnson & Johnson Diabetes Institute, New Center To Provide State-of-The-Art Education, Training to Health Professionals

Milpitas, CA (February 29, 2008) – With mounting evidence that many health professionals lack the training and skills to combat the nation’s growing epidemic of diabetes, the Johnson & Johnson Diabetes Institute, LLC today opened its first training center in the U.S. to improve how practitioners deliver diabetes care in local communities.The new facility, based in Silicon Valley, will provide comprehensive training each year for thousands of community-based nurses, physician assistants, diabetes educators and other health professionals using a curriculum developed with national diabetes organizations and academic centers. It addresses an acute shortage of skills training in diabetes management at the community level, which practitioners cite as one of the major obstacles to improving patient outcomes... Johnson & Johnson Diabetes Institute's Press Release -

Metabasis Therapeutics, Proof-of-Concept Clinical Trial for MB07803, Its Product Candidate for the Treatment of Type 2 Diabetes

Feb. 28, 2008--Metabasis Therapeutics, Inc. (Nasdaq:MBRX) announced the completion of patient enrollment in its Phase 2a clinical trial for MB07803, a product candidate being studied as a treatment for patients with type 2 diabetes. With this trial fully enrolled and the final patients undergoing dosing, the Company expects to be able to announce top line results in the second quarter of 2008, as planned. MB07803 is a member of a new class of drugs discovered by Metabasis that is designed to regulate glucose production in the liver by inhibiting an enzyme known as fructose-1,6-bisphosphatase (FBPase), a key enzyme in the gluconeogenesis pathway which is responsible for the excessive production of glucose in patients with type 2 diabetes... Metabasis Therapeutics' Press Release -