| Company |
Medication |
News Fact |
| Access Pharmaceuticals |
Cobalamin - oral insulin |
Access Pharma launches clinical development program for its oral insulin product 30 March 2010 |
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Access Pharmaceuticals presents results of studies on oral insulin delivery 11 March 2010 |
| American Associates, Ben-Gurion University of the Negev |
Alpha-1 Antitrypsin (AAT) - T1D |
FDA approves clinial trial for Type 1 diabetics with treatment developed by BGU researcher 28 June 2010 |
| Amylin Pharmaceuticals |
SYMLIN - pramlintide acetate |
No increased risk of cardiovascular adverse events associated with SYMLIN treatment June 26 2010 |
| Amylin Pharmaceuticals, Eli Lilly, Alkermes |
Bydureon (Exenatide once weekly) - GLP-1 receptor agonist |
BYDUREON safety and tolerability pooled summary data presented at ADA 2010 26 June 2010 |
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Bydureon better than Januvia but comparable to metformin and Actos in reducing A1C levels 15 June 2010
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FDA to review BYDUREON in October 6 May 2010
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Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON 22 April 2010
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FDA issues response letter regarding the NDA for exenatide once weekly -
Amylin Pharmaceuticals15 March 2010 |
| Amylin Pharmaceuticals, Eli Lilly |
BYETTA (exenatide) - GLP-1 receptor agonist |
Study finds BYETTA use was not associated with increased rate of acute pancreatitis compared to other antidiabetic drugs 26 June 2010 |
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Type 2 diabetes patients with long-standing disease achieved glycemic control when BYETTA was added to Lantus 26 June 2010 |
| Biodel |
BIOD620 |
Biodel reports progress with development of glucose-regulated 'smart' basal insulin 12 July 2010
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VIAject - recombinant human insulin |
JDRF funds studies with Viaject (Biodel) and AFREZZA (MannKind) - JDRF 16 Aug 2010
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FDA accepts Biodel's VIAject NDA for review 1 March 2010 |
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Biodel submits VIAject new drug application to FDA for treatment of diabetes 30 Dec 2009 |
| Boehringer Ingelheim |
11beta-HSD-1 |
Vitae Pharmaceuticals receives $14 million milestone payment as Boehringer Ingelheim advances lead compound into phase I clinical trials - Vitae Pharmaceuticals 28 June 2010 |
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GPR119 - G-protein coupled receptor (GPCR) |
Boehringer Ingelheim and Neurocrine to develop diabetes drug - Neurocrine 17 June 2010
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| Bristol-Myers Squibb, AstraZeneca |
Onglyza (saxagliptin) - DPP4 inhibitor |
FDA accepts NDA for saxagliptin-metformin combination drug 17 March 2010 |
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Onglyza (SAVOR-TIMI 53) study commences - Bristol-Myers Squibb; 9 March 2010 |
| Cellonis Biotechnologies |
T1D |
Novel stem cell therapy from Cellonis Biotechnologies to treat Type 1 diabetes 23 Aug 2010
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| CPEX Pharmaceuticals |
Nasulin - nasal insulin |
CPEX Pharmaceuticals announces study results for its nasal insulin product (Nasulin) 17 March 2010 |
| Diamyd Medical |
Diamyd Vaccine - T1D |
Diamyd receives $45 million upfront payment from Ortho-McNeil-Janssen Pharmaceuticals (a J&J company) 29 July 2010
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Diamyd Medical signs agreement with Ortho-McNeil-Janssen Pharmaceuticals (a J&J company) 22 June 2010 |
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Diamyd granted Orphan Drug Designation in the US 23 March 2010 |
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Diamyd US Phase III study well under way; one hundred study participants have been included in DiaPrevent study 10 March 2010 |
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Diamyd hopes to file for market approval for the Diamyd diabetes vaccine in 2011 - 29 Jan 2010 |
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| Dr. Reddy's |
Balaglitazone (DRF 2593) - partial agonist of PPAR-gamma |
Dr. Reddy's and Rheoscience announce headline results from first phase III clinical trial of Balaglitazone (DRF 2593) 4 Jan 2010 |
| Exsulin Corporation |
Exsulin - T1D |
EVMS receives more than $1 million in federal funds to develop a new approach to reverse Type 1 diabetes - EVMS 25 March 2010
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Study of new Exsulin peptide treatment for type 1 diabetes starts this month 10 Feb 2010 |
| Extended Delivery Pharmaceuticals |
SIA-II Insulin |
Single injection of new insulin maintains tight glucose control for 140 days 13 July 2010 |
| GlaxoSmithKline |
Avandia (rosiglitazone) - thiazolidinedione |
Avandia (rosiglitazone) and Actos (pioglitazone) have same heart disease and death risks -American Heart Association 24 Aug 2010
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FDA halts enrollment of new patients in GlaxoSmithKline's Avandia trial -FDA 21 July 2010 |
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GlaxoSmithKline statement in response to FDA announcement on TIDE trial 21 July 2010 |
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Advisory Committee recommends that U.S. Food and Drug Administration keep rosiglitazone (Avandia) on the market, continue clinical trial of safety and efficacy -American Heart Association 14 July 2010 |
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GlaxoSmithKline statement in response to FDA Advisory Committees' vote on safety of Avandia (rosiglitazone) 14 July 2010 |
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Joint statement on rosiglitazone (Avandia) risks -ADA 12 July 2010 |
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GSK EU regulatory update on Avandia (rosiglitazone) 9 July 2010 |
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Data support Avandia (rosiglitazone maleate) cardiovascular safety profile 9 July 2010 |
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Study finds no link between diabetes drug rosiglitazone and increased rate of heart attack - Washington University School of Medicine 29 June 2010 |
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Rosiglitazone associated with increased risk of stroke, heart failure and death, compared to pioglitazone - JAMA/Archives journals 28 June 2010 |
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Avandia trial is unethical and dangerous, must be stopped - Public Citizen 11 May 2010
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FDA drug safety communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety - FDA 22 Feb 2010 |
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GSK rejects conclusions reported in The New York Times story on Avandia 20 Feb 2010 |
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GSK rejects conclusions of Senate Committee on Finance Staff report on Avandia 20 Feb 2010 |
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US Senate Finance Committee concerned about FDA's role in protecting patients in Avandia study - US Senate Finance Committee; 20 Feb 2010 |
| JDRF |
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JDRF funds studies with Viaject (Biodel) and AFREZZA (MannKind) - JDRF 16 Aug 2010
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REPAIR T1D: JDRF and Sanford Health to test beta-cell regeneration therapy for T1D 11 Aug 2010
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LCT receives grant from JDRF - 27 April 2010 |
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Researchers use novel nanoparticle vaccine to cure type 1 diabetes in mice 8 April 2010
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JDRF, Pfizer, Hadassah Medical and the Hebrew University announce collaboration 22 March 2010 |
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JDRF funded research advances potential for regeneration as a possible cure for Type 1 Diabetes 2 Feb 2010 |
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Osiris completes enrollment in stem cell trial for Type 1 Diabetes 25 Jan 2010 |
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Fast Forward, JDRF and Axxam SpA join forces to accelerate development of treatments for Multiple Sclerosis and Type 1 Diabetes 19 Jan 2010 |
| Joslin Diabetes Center |
Salsalate - anti-inflammatory agent |
Generic drug for type 2 diabetes passes next clinical hurdle 16 March 2010 |
| Kineta |
ShK-186 - T1D |
The Iacocca Family Foundation and Kineta partner on Type 1 diabetes drug 7 June 2010
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| Lexicon |
LX4211 |
Lexicon reports positive results from phase 2 study of LX4211 20 Jan 2010 |
| Living Cell Technologies |
Diabecell |
LCT receives approval to expand DIABECELL NZ Trial 4 Aug 2010
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LCT reports consistent benefit in DIABECELL NZ trial 13 July 2010 |
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LCT receives grant from JDRF - JDRF 27 April 2010
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Report from LCT's Russian phase I/IIa diabetes trial 7 April 2010
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LCT receives approval to progress its DIABECELL study 30 March 2010 |
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Living Cell Technologies' encapsulation device granted registration in Russia 10 March 2010 |
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Living Cell Technologies awarded NZ$4.04 million New Zealand government grant to advance DIABECELL for type 1 diabetes 12 Feb 2010 |
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Living Cell Technologies receives 10% of US based wound healing company 9 Feb 2010 |
| MannKind Corporation |
Afrezza |
MannKind providing AFREZZA to JDRF for Artificial Pancreas Project 23 Aug 2010
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FDA takes new look at MannKind's inhaled insulin 20 July 2010 |
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ADA/The Lancet Symposium will highlight study showing AFREZZA provides comparable glycemic control with less weight gain and hypoglycemia than standard of care 24 June 2010 |
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MannKind announces study results for inhaled insulin AFREZZA 10 June 2010
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Follow-up safety data show AFREZZA comparable to standard antidiabetic therapy in lung function tests 23 April 2010
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AFREZZA controls blood sugar levels in type 1 diabetes, results in weight loss, less hypoglycemia... 23 April 2010
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FDA needs more info on MannKind's inhaled insulin AFREZZA 15 Mar 2010 |
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FDA needs more time to review MannKind's inhaled insulin 8 Jan 2010 |
| Merck / Envoy |
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Envoy and Merck to partner on diabetes and obesity - Envoy Therapeutics 26 Jan 2010 |
| Novo Nordisk |
Degludec |
Phase 2 data for degludec show the potential to effectively lower blood sugar, including when used three times a week 26 June 2010 |
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Mixtard 30 |
Novo Nordisk's decision to pull Mixtard 30 from the UK could add £9 million to the NHS drugs bill -EurekAlert! 3 Aug 2010
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NN9924 (oral GLP-1 analogue) |
Novo Nordisk starts phase 1 trial with long-acting oral GLP-1 analogue 13 Jan 2010 |
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NN9925 (oral GLP-1 analogue) |
Novo Nordisk starts Phase I trial with oral GLP1 analogue using Merrion Pharmaceutical's GIPET technology - Merrion 29 April 2010
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NovoDose (mobile insulin dosing guide) |
Novo Nordisk launches NovoDose - a mobile insulin dosing guide for physicians 24 Aug 2010
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Victoza (liraglutide) |
Data from meta-analysis show Victoza achieved improved blood sugar control in African-Americans with type 2 diabetes 4 Aug 2010
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Novo Nordisk announces results of study comparing Victoza with Januvia 26 June 2010 |
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Victoza to be launched in Japan in June 2 June 2010 |
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Novo Nordisk partners with international scientific community for Victoza cardiovascular outcomes trial 6 May 2010
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Novo Nordisk touts results of study comparing Victoza to Januvia (sitagliptin) 23 April 2010
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Switching to Victoza (liraglutide) from exenatide further improves A1C control 30 March 2010 |
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Novo Nordisk makes Victoza commercially available in the United States 16 Feb 2010 |
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Novo Nordisk receives US approval for Victoza (liraglutide) 26 Jan 2010 |
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Novo Nordisk receives approval for Victoza in Japan 20 Jan 2010 |
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Update on timeline for formal feedback on liraglutide from the FDA 30 Dec 2009 |
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| Oramed Pharmaceuticals |
ORMD-0801 |
Oramed and sanofi-aventis to partner on oral insulin capsules -Oramed 7 July 2010 |
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Oramed Pharmaceuticals announces results for study of its oral insulin capsule 6 May 2010 |
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Oramed completes oral insulin capsule studies 25 March 2010 |
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Oramed completes patient enrollment for pivotal phase 2B clinical trials of ORMD-0801 19 Jan 2010 |
| Osiris Therapeutics |
Prochymal |
Osiris Therapeutics receives FDA orphan drug designation for stem cell treatment for type 1 diabetes 4 May 2010
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| Roche |
GSA3 |
SiDMAP technology used to characterize novel drug for Type 2 Diabetes -SiDMAP 21 July 2010
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Taspoglutide |
Ipsen's partner Roche announces that Taspoglutide meets its primary endpoint in a key phase III clinical trial - Ipsen 29 April 2010
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Roche study drug may offer valuable new treatment option for patients with type 2 diabetes 11 Feb 2010 |
| Sanofi-aventis |
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Sanofi-aventis and JDRF form partnership to improve therapies, work toward cure for Type 1 diabetes 1 July 2010 |
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Metabolex and Sanofi-Aventis enter into an agreement for novel Type 2 diabetes treatment -Metabolex 25 june 2010 |
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Insulin glargine (Lantus) |
Provocative editorial on insulin glargine and cancer published in Diabetes Technology and Therapeutics - liebertonline.com 10 june 2010
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Lixisenatide (AVE 0010) |
Sanofi-aventis announces positive study results for Lixisenatide 15 April 2010
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Pancreate |
Sanofi-aventis and CureDM to partner on novel regenerative compound to treat diabetes 8 April 2010
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| Sernova |
Cell Pouch System |
Sernova announces positive results of its proprietary cell pouch system in preclinical diabetes model 12 July 2010 |
| Spherix |
D-tagatose |
Spherix completes enrollment in NEET; A phase 3 clinical trial evaluating an oral drug for type 2 diabetes 12 Jan 2010 |
| Takeda |
Actos (Pioglitazone) |
Avandia (rosiglitazone) and Actos (pioglitazone) have same heart disease and death risks -American Heart Association 24 Aug 2010
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Takeda responds to FDA Advisory Committee recommendation (rosiglitazone) 14 July 2010 |
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Takeda and Watson settle Actos patent litigation - Watson Pharmaceuticals; 10 March 2010 |
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Alogliptin |
Approval of additional indication of NESINA: combination therapy with Thiazolidinediones in Japan 20 Aug 2010
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Takeda applies for additional indications of alogliptin in Japan 25 March 2010 |
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Competact (metformin and pioglitazone) |
Takeda withdraws application for a prolonged-release formulation of competact in Europe 19 March 2010 |
| Tolera Therapeutics |
TOL101 |
Tolera Therapeutics granted Orphan Drug Designation for treatment of Type 1 diabetes mellitus 22 June 2010
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| Tolerx |
Otelixizumab |
Tolerx initiates confirmatory phase 3 clinical trial, DEFEND-2, with Otelixizumab for Type 1 diabetes - JDRF 28 June 2010 |
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Tolerx completes enrollment in DEFEND-1, a phase 3 Type 1 Diabetes study with otelixizumab 7 January 2010 |
| XOMA |
XOMA 052 |
XOMA 052 phase 2 trial initiated in type 1 diabetes patients 12 March, 2010 |
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XOMA initiates Phase 2b dose-ranging clinical trial of XOMA 052 in type 2 diabetes patients 9 Feb 2010 |
| Zydus Cadila |
ZYOG1 |
Zydus' GLP-1 agonist - 'ZYOG1' enters phase I clinical trial 21 June 2010 |
MISCELLANEOUS |
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Drug Delivery |
New pump created for microneedle drug-delivery patch - Purdue University; 31 Aug 2010
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Metformin |
New use for old drugs in treating hepatitis C - University of Leeds 7 June 2010
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Popular diabetes drug works differently than thought - University of Cincinnati 4 May 2010
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Metformin may prevent lung cancer in smokers - AACR; 19 April 2010
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Metformin XR may help to lower BMI in obese adolescents - JAMA and Archives Journals ; 1 Feb 2010 |
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Metformin safe, effective for those with diabetes and heart failure - University of California - Los Angeles ; 7 Jan 2010 |
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Thiazolidinedione |
Thiazolidinediones linked to fractures in type 2 diabetic patients-The Endocrine Society; 29 July 2010
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TZD's up risk for fractures in women - Henry Ford Health System; 9 Feb 2010 |
