IOH Diabetes FDA, UK, European Drug Warnings, Approvals & Update Headline News

Dud diabetes test strips could give diabetics wrong info - News-Medical-Net - October 16, 2006

Diamyd's Type 1 diabetes drug shows efficacy - Diamyd Medical has announces that its lead drug candidate, Diamyd, has demonstrated overall statistically significant efficacy in preserving insulin production in a phase II clinical trial in 70 children and adolescents with type 1 diabetes. 08/29/2006

FDA to Review Merck Diabetes Drug Filing - Merck & Co's new drug application for MK-0431A, an investigational oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for standard review by the FDA. 08/02/2006

FDA Approves Duetact(TM) (pioglitazone HCl And Glimepiride) For The Treatment Of Type 2 Diabetes - Takeda PharmaceuticalsNorth America, Inc. (TPNA) announced that the U.S. Food and DrugAdministration (FDA) has approved the New Drug Application (NDA) forduetact(TM) (pioglitazone HCl and glimepiride), pronounced "Duet Act," forthe treatment of type 2 diabetes. 08/01/2006

FDA approves Takeda's diabetes combo - Takedas US subsidiary has received FDA approval for its new drug application for Duetact in type 2 diabetes. 08/01/2006

FDA Approves Takeda's Diabetes Combo - Takeda's US subsidiary has received FDA approval for its new drug application for Duetact in type 2 diabetes. Duetact combines Actos (pioglitazone HCl) and glimepiride, two widely used diabetes medications with complementary actions, in a single tablet. 07/31/2006

FDA Approves duetact(TM) (pioglitazone HCl and glimepiride) for the Treatment of Type 2 Diabetes - Takeda Pharmaceuticals North America, Inc. announced that the U.S. Food and Drug Administration has approved the New Drug Application for duetact , pronounced "Duet Act," for the treatment of type 2 diabetes. 07/31/2006

NicOx moves diabetes drug into phase II - Following promising results in previous trials, NicOx SA has opted to move NCX 4016 forward in clinical development as a novel insulin sensitizing agent for the treatment of type 2 diabetes. 07/28/2006

New Diabetes Drug Approved - A new drug that could change the way millions of people with diabetes manage their disease may hit the market as early as this week. 07/17/2006

New Diabetes Drug Approved - A new drug that could change the way millions of people with diabetes manage their disease may hit the market as early as this week. NewsCenter 5's Liz Brunner reported Monday that Pfizer's Exubera was approved by the FDA in January. It is the first insulin that you can inhale. But already, doctors are getting questions about who should try it and who should not. 07/17/2006

FDA Approves Avandamet(R) (rosiglitazone Maleate And Metformin HCl) As Inital Therapy In The Treatment Of Type 2 Diabetes - GlaxoSmithKline announced today FDA approval of Avandamet (R) (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy - it was indicated for use in patients who were uncontrolled on metformin monotherapy. 07/16/2006

GlaxoSmithKline Diabetes Drug Receives FDA Approval As Initial Therapy - Avandamet, a diabetes drug from GlaxoSmithKline, can now be used as an initial treatment for type 2 diabetes. 07/12/2006

Glaxo resumes sale of diabetes drug - GlaxoSmithKline P.L.C. said yesterday that it would resume sales and promotion of its diabetes drug Avandamet after making government-ordered repairs at a plant and getting expanded approval for its use. 07/12/2006

FDA approves new Glaxo diabetes drug - Drug-maker GlaxoSmithKline announced Tuesday that the federal government has approved one of its diabetes drugs for use as a front-line treatment. 07/12/2006

Glaxo diabetes drug approved as first-line treatment - GlaxoSmithKlines diabetes drug Avandamet has been approved by the FDA for use as a first-line treatment of type 2 diabetes as an adjunct to diet and exercise. 07/12/2006

Merck & Co: planning to reap sweet rewards in diabetes - Merck & Co has revealed plans to file for FDA approval of MK-0431A in 2006, potentially enabling it to overtake Novartis in the race to commercialize the first DPP-4 inhibitor. The news is also of particular significance to Mercks diabetes pipeline following its failure to successfully launch a drug in the dual PPAR class. 06/08/2006

MediaFact Launches Section On Zyprexa and Diabetes - MediaFact (http://www.mediafact.com), an online resource for information on health care issues related to hazardous occupational exposure and drug side effects, has published a new section on Zyprexa and diabetes. Zyprexa (olanzapine), manufactured by Eli Lilly and Company, is a widely prescribed antipsychotic drug used for the treatment of schizophrenia and manic depression. Evidence now suggests that Zyprexa is linked to the development of diabetes in a significant number of patients. 06/08/2006

Warning over faulty diabetes aid - BBC News - Regulators warn diabetes patients a fault in vital equipment could put them at risk of an overdoes of insulin. 06/08/2006

(AFX UK Focus) 2006-06-05 14:58 GMT: Merck to file Januvia diabetes type II drug in 2006; earlier than expected - Merck & Co Inc said it expects to file a new drug application for its type 2 diabetes drug Januvia to the Food and Drug Administration in 2006, earlier than its initially anticipated 2007 date. 06/05/2006

GENFIT Initiates Phase II Clinical Trials With GFT14 To Tackle Cardiometabolic Risk - Phase I results revealed very good tolerance in healthy volunteers as well as an excellent security profile for GFT14, one of the medical candidates that GENFIT is developing to tackle cardiometabolic risk. 05/03/2006

FDA to consider vaccine against shingles (skip the welcome screen) 12/15/05

Spherix has received FDA approval to conduct a Phase III clinical trial of its diabetes treatment. 12/06/05

Phenergan can cause death in children under age 2.

Freestyle or other meter made by Abbott? Glucose Meter Warnings! 10/26/05

DANA Diabecare Warned by FDA for improper reporting when pump users seriously injured... 08/10/05



		Drug & Medical Procedures FDA, UK & European Drug & Medical Updates/Approvals/Recalls/Warnings If you copy our list of links for your own site, we'd really appreciate it if you would add a link to our site as well. Your support and mention of www.IsletsofHope.com will help others with diabetes. We now donate 100% of the profits from our website to nonprofit diabetes organizations that purchase insulin, diabetes medications, and supplies for others in need. \| Business \| Diabetes Events \| Drug Research & Development \| Education \| General Diabetes Studies \| Human Interest \| \| Legislation - Diabetes, Ethics, Research \| Stem Cell Research \| Your Diabetes Health \| Technology (Diabetes) \| \| FDA, UK & European Drug & Medical Updates Approvals/Rejections/Warnings \| RECALLS & WARNINGS for Diabetes Medications, Products & Devices \| November 2006 See "Current Headlines" October 2006 FTC, US FDA plan drive against internet vendors for marketing fraudulent diabetes cures, treatments - PharmaBiz - October 26, 2006 FDA Approves New Oral Drug to Treat Type 2 Diabetes - RedNova - October 21, 2006 - By Los Angeles Times WASHINGTON -- Federal regulators on Tuesday approved a new class of oral drugs for Type 2 diabetes that are as effective as most existing treatments and avoid common side effects, such as dangerously low blood sugar. Widely Prescribed Diabetes Drug Falls Short Of Promise, Says New Review - Medical News Today - October 21, 2006 Widely Used Diabetes Drug May Not Work - HealthDay via Yahoo! News - October 20, 2006 - FRIDAY, Oct. 20 (HealthDay News) -- It's unclear whether the health benefits outweigh the risks of the widely prescribed diabetes drug pioglitazone (brand name Actos), say the authors of a review that examined 22 studies of the drug involving 6,200 type 2 diabetes patients. Officials Warn of False Diabetes Treatments Online - GigaLaw.com - October 20, 2006 - The Federal Trade Commission and the Food and Drug Administration are teaming with Mexico and Canada to stop deceptive advertising and product sales of purported diabetes cures and treatments. FDA approves drug for type 2 diabetes - UPI - October 20, 2006 Fraudulent Diabetes Cures being Chased off Internet in Three Country Campaign - Senior Journal - October 20, 2006 Merck's Januvia gets approval for type 2 diabetes in US - PharmaBiz - October 20, 2006, 04:46 GMT FDA warn about fake diabetes "cures" - Reuters via Yahoo! News - October 19, 2006 Report Questions Benefits of Diabetes Drug - Newsweek - October 19, 2006 FFTC and FDA act against internet vendors of fraudulent diabetes treatments - News-Medical-Net - October 19, 2006 FTC and FDA Act Against Internet Vendors of Fraudulent Diabetes Cures and Treatments - Federal Trade Commission - October 19, 2006 New Diabetes Drug Wins Federal Approval - WTOL News 11 - October 19, 2006 - Diabetics gained a new way of controlling their blood sugar levels Tuesday with federal approval of a novel pill for Type 2 diabetes, which affects about 20 million Americans. Canada, Mexico and the United States Combat Diabetes Fraud - Government of Canada News - October 19, 2006 Diabetes Drug Questioned - KOLD News 13 Tuscon - October 19, 2006 Widely Prescribed Diabetes Drug Falls Short of Promise, Says New Review - Newswise - October 18, 2006 Widely Prescribed Diabetes Drug Falls Short of Promise, Says New Review - Newswise - October 18, 2006 Diabetes drug wins federal approval - The Washington Times - October 17, 2006 - Diabetics gained a new way of controlling their blood sugar levels today with federal approval of a novel pill for type 2 diabetes, which affects about 20 million Americans. FDA approves new type of diabetes drug - Reuters via Yahoo! News - October 17, 2006 - A new diabetes drug that helps the body control blood sugar won U.S. approval on Tuesday, making it the first in a new class of pills that treat the disease without weight gain seen with some other drugs. FDA approves Merck drug for growing diabetes market - The Philadelphia Inquirer - October 17, 2006 - Merck & Co. Inc. got federal approval today to market a new kind of diabetes drug, the latest aimed at a lucrative but troubling increase in the number of diabetes sufferers. FDA approves new type of diabetes drug - Reuters via Yahoo! News - October 17, 2006 Merck Diabetes Drug Wins Federal Approval - KGO-TV Bay Area - October 17, 2006 New Diabetes Drug Helps Lower Blood Sugar - HealthDay via Yahoo! News - October 17, 2006 FDA OKs new Merck drug for diabetes - Reuters via Yahoo! News - October 17, 2006 Two-fold Higher Mortality From Cardiovascular Disease In Older People With Diabetes - Science Daily - October 17, 2006 LifeScan Canada Warns Counterfeit Diabetes Test Strips Discovered in United States May Be Present in Canadian Market - CNW Group via Yahoo! Finance - October 16, 2006 - LifeScan Canada Ltd., distributors of the OneTouch Brand of diabetes testing supplies, warns that counterfeit OneTouch Ultra and OneTouch (Basic/Profile) Test Strips have recently been identified in the United States. Dud diabetes test strips could give diabetics wrong info - News-Medical-Net - October 16, 2006 Back to Top September 2006 Back to Top August 2006 Diamyd's Type 1 diabetes drug shows efficacy - Diamyd Medical has announces that its lead drug candidate, Diamyd, has demonstrated overall statistically significant efficacy in preserving insulin production in a phase II clinical trial in 70 children and adolescents with type 1 diabetes. 08/29/2006 FDA to Review Merck Diabetes Drug Filing - Merck & Co's new drug application for MK-0431A, an investigational oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for standard review by the FDA. 08/02/2006 FDA Approves Duetact(TM) (pioglitazone HCl And Glimepiride) For The Treatment Of Type 2 Diabetes - Takeda PharmaceuticalsNorth America, Inc. (TPNA) announced that the U.S. Food and DrugAdministration (FDA) has approved the New Drug Application (NDA) forduetact(TM) (pioglitazone HCl and glimepiride), pronounced "Duet Act," forthe treatment of type 2 diabetes. 08/01/2006 FDA approves Takeda's diabetes combo - Takedas US subsidiary has received FDA approval for its new drug application for Duetact in type 2 diabetes. 08/01/2006 Back to Top July 2006 FDA Approves Takeda's Diabetes Combo - Takeda's US subsidiary has received FDA approval for its new drug application for Duetact in type 2 diabetes. Duetact combines Actos (pioglitazone HCl) and glimepiride, two widely used diabetes medications with complementary actions, in a single tablet. 07/31/2006 FDA Approves duetact(TM) (pioglitazone HCl and glimepiride) for the Treatment of Type 2 Diabetes - Takeda Pharmaceuticals North America, Inc. announced that the U.S. Food and Drug Administration has approved the New Drug Application for duetact , pronounced "Duet Act," for the treatment of type 2 diabetes. 07/31/2006 NicOx moves diabetes drug into phase II - Following promising results in previous trials, NicOx SA has opted to move NCX 4016 forward in clinical development as a novel insulin sensitizing agent for the treatment of type 2 diabetes. 07/28/2006 NicOx Moves Diabetes Drug into Phase II – 07/27/2006 NicOx To Move NCX 4016 Forward In Phase 2 For Diabetes – 07/27/2006 New Diabetes Drug Approved - A new drug that could change the way millions of people with diabetes manage their disease may hit the market as early as this week. 07/17/2006 New Diabetes Drug Approved - A new drug that could change the way millions of people with diabetes manage their disease may hit the market as early as this week. NewsCenter 5's Liz Brunner reported Monday that Pfizer's Exubera was approved by the FDA in January. It is the first insulin that you can inhale. But already, doctors are getting questions about who should try it and who should not. 07/17/2006 FDA Approves Avandamet(R) (rosiglitazone Maleate And Metformin HCl) As Inital Therapy In The Treatment Of Type 2 Diabetes - GlaxoSmithKline announced today FDA approval of Avandamet (R) (rosiglitazone maleate and metformin HCl) for use as initial treatment of type 2 diabetes as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy - it was indicated for use in patients who were uncontrolled on metformin monotherapy. 07/16/2006 GlaxoSmithKline Diabetes Drug Receives FDA Approval As Initial Therapy - Avandamet, a diabetes drug from GlaxoSmithKline, can now be used as an initial treatment for type 2 diabetes. 07/12/2006 Glaxo resumes sale of diabetes drug - GlaxoSmithKline P.L.C. said yesterday that it would resume sales and promotion of its diabetes drug Avandamet after making government-ordered repairs at a plant and getting expanded approval for its use. 07/12/2006 FDA approves new Glaxo diabetes drug - Drug-maker GlaxoSmithKline announced Tuesday that the federal government has approved one of its diabetes drugs for use as a front-line treatment. 07/12/2006 Glaxo diabetes drug approved as first-line treatment - GlaxoSmithKlines diabetes drug Avandamet has been approved by the FDA for use as a first-line treatment of type 2 diabetes as an adjunct to diet and exercise. 07/12/2006 Back to Top June 2006 Merck & Co: planning to reap sweet rewards in diabetes - Merck & Co has revealed plans to file for FDA approval of MK-0431A in 2006, potentially enabling it to overtake Novartis in the race to commercialize the first DPP-4 inhibitor. The news is also of particular significance to Mercks diabetes pipeline following its failure to successfully launch a drug in the dual PPAR class. 06/08/2006 MediaFact Launches Section On Zyprexa and Diabetes - MediaFact (http://www.mediafact.com), an online resource for information on health care issues related to hazardous occupational exposure and drug side effects, has published a new section on Zyprexa and diabetes. Zyprexa (olanzapine), manufactured by Eli Lilly and Company, is a widely prescribed antipsychotic drug used for the treatment of schizophrenia and manic depression. Evidence now suggests that Zyprexa is linked to the development of diabetes in a significant number of patients. 06/08/2006 Warning over faulty diabetes aid - BBC News - Regulators warn diabetes patients a fault in vital equipment could put them at risk of an overdoes of insulin. 06/08/2006 (AFX UK Focus) 2006-06-05 14:58 GMT: Merck to file Januvia diabetes type II drug in 2006; earlier than expected - Merck & Co Inc said it expects to file a new drug application for its type 2 diabetes drug Januvia to the Food and Drug Administration in 2006, earlier than its initially anticipated 2007 date. 06/05/2006 Back to Top May 2006 GENFIT Initiates Phase II Clinical Trials With GFT14 To Tackle Cardiometabolic Risk - Phase I results revealed very good tolerance in healthy volunteers as well as an excellent security profile for GFT14, one of the medical candidates that GENFIT is developing to tackle cardiometabolic risk. 05/03/2006 Back to Top April 2006 Transition Therapeutics Completes Target Enrolment for Type II Diabetes Clinical Trial of Lead Regenerative Product, - Transition Therapeutics Inc. , announces today the completion of target enrolment for an exploratory Phase IIa clinical trial of its lead regenerative therapy, E1-I.N.T., in type II diabetes patients and provides an update on the enrolment of patients in the type I diabetes clinical trial. 04/25/06 Osiris Completes Enrollment in Stem Cell Trial for Knee Repair - Osiris Therapeutics, Inc. announced today that it has completed enrollment in the first human clinical trial of a stem cell therapy to repair tissue in the knee. A total of 55 patients were treated in the Phase I/II double blinded, placebo-controlled trial designed to evaluate the safety and effectiveness of Chondrogen(TM), a preparation of adult stem cells formulated for direct injection into the knee. 04/25/2006 Emisphere Completes Enrollment For Phase II Oral Insulin Clinical Trial (India) 04/16/06 Medtronic gets OK for diabetes device - Medtronic Inc. has won government approval of a new system that helps diabetics continuously check their blood sugar levels, alerting them when levels edge too high or plunge too low. The company's Paradigm Real-Time system includes a glucose monitor that relays blood sugar information to the patient every five minutes from a sensor inserted under the skin and attached to a pager-size insulin. 04/14/06 Diabetic Neuropathy Treatment Has Passed The First Clinical Trial 04/10/06 Takeda Submits New Drug Application For Extended-release Type 2 Diabetes Medication, ACTOplus MetTM 04/06/06 Back to Top March 2006 Groundbreaking Human Clinical Trial For Type 1 Diabetes To Start This Spring In Pittsburgh At Children's Hospital Of Pittsburgh 03/28/06 Phase II Clinical Program For XL784 For Diabetes Who Have Proteinuria 03/28/06 Infused Spleen Cells Found Not To Impact Islet Recovery And Reversal Of Type 1 DIABETES In Mice 03/26/06 Once-Weekly Exenatide LAR Clinical Study In Type 2 Diabetes Initiated 03/26/06 People with diabetes warned of antibiotic's side-effects - The antibiotic Tequin can have life-threatening side-effects in people with diabetes, a study by Canadian researchers has found. The antibiotic gatifloxacin is sold under the brand name Tequin by its manufacturer, Bristol-Myers Squibb. 03/01/2006 Back to Top February 2006 ConjuChem gets FDA approcal to Initiate Phase I/II Clinical Study of PC-DAC(TM): Exendin-4 for Type 2 Diabetes 02/27/06 Axis-Shield gets diabetes waiver 02/23/06 Type 2 Diabetes - Merck Announces FDA Acceptance Of New Drug Application For JANUVIA™, The Company's Investigational Medicine 02/20/06 TolerRx Diabetes Drug Given Orphan Status in US. 02/17/06 Merck & Co diabetes drug gets standard review in US. 02/17/06 Lilly Launches Humalog® Mix50/50™ Insulin In United States. 02/07/06 Important Safety Information for Humalog and Humalog Mix 75/25 from Eli Lilly DIabetes. 02/07/06 Lilly Launches Humalog® Mix50/50™ Insulin In United States. 02/07/06 Important Safety Information for Humalog and Humalog Mix 75/25 from Eli Lilly DIabetes. 02/07/06 Back to Top January 2006 Exubera-® (inhaled Insulin Human) - EU Marketing Authorisation For Inhaled Insulin Granted. 01/30/06 FDA Approves Exubera, First Inhalable Form Of Insulin For Controlling Type 1 And Type 2 Diabetes In Adults. 01/29/06 Exubera (inhaled Human Insulin) Approved By European Commission. 01/29/06 Roche Diagnostics & FDA announced a voluntary worldwide recall of specific Accu-Chek Aviva meters. 01/20/2006 FDA Warns Consumers about Brazilian Diet Pills Found to Contain Active Drug Ingredients. 01/13/06 FDA Requests Seizure of More Dietary Supplements Containing Ephedrine Alkaloids. 01/12/06 Back to Top December 2005 Antipsychotic Drugs May Raise Blood Glucose 12/31/05 Lipid Files FDA Application for Cholesterol Filter 12/29/05 Avandia & Avandamet found to cause or worsen a serious vision impairment 12/21/05 FDA Notifies Health Care Professionals of Problem with Baxter Healthcare's Meridian Hemodialysis Instrument. 12/16/05 FDA to consider vaccine against shingles (skip the welcome screen) 12/15/05 Spherix has received FDA approval to conduct a Phase III clinical trial of its diabetes treatment. 12/06/05 FDA Acts to Seize Ephedra-Containing Dietary Supplements 12/06/2005 Back to Top November 2005 - November is National Diabetes Month Health Canada warns consumers not to take the Chinese medicine Shortclean due to potential health risk. 11/23/05 Diabetes 2, ACTOplus met™ (pioglitazone HCl and metformin HCl). 11/06/05 Diabetic black men have much lower amounts of atherosclerosis, or hardening of the arteries than diabetic white men. 11/05/05 Phenergan can cause death in children under age 2. Drug Approved for Treatment of Iron Overload due to blood transfusions. November 4, 2005. Back to Top October 2005 Wall Street Journal Examines FDA Approval Process for Diabetes Drug. 10/30/05 Freestyle or other meter made by Abbott? Glucose Meter Warnings! 10/26/05 Back to Top September 2005 DiObex Receives Fast-Track Status from FDA for VLD-Glucagon 09/28/05 FDA Approves Freestyle Connect™ Blood Glucose Monitoring System, Abbott. 09/22/05 Back to Top August 2005 Dana Insulin Pumps Not Recalled 08/24/05 (related, 07/23/04 FDA Warning letter to Dana Diabecare) DANA Diabecare Warned by FDA for improper reporting when pump users seriously injured... 08/10/05 Back to Top Diabetes Headline News Resources News RX Medical News Today MedlinePlus BioPortfolio/BioCorporate Database offers its users a unique, free to use, database on life science organizations (corporate profiles, research projects, products and collaborations). Users can search using key word searches to identify companies (by city, zipcode, country) or research projects, products and collaborations. Diabetes Health Headlines Legislative & Legal News from 2005 Patient Care Law Weekly Back to Top



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