Therapy News and Research

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Metabolex, Sanofi-Aventis sign global license deal to develop GPR119 for type 2 diabetes treatment

Metabolex and Sanofi-Aventis announced today that they have entered into a global license and development agreement for the research, development, manufacture and commercialization of small molecules that modulate the G-protein coupled receptor 119 (GPR119), a receptor in the gut and pancreas that interacts with bioactive lipids to stimulate glucose-dependent incretin and insulin secretion.

30 Jun 2010

Experts evlauate impact of Medicare Part D program on independent and chain pharmacies

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Part D) added prescription drug coverage to Medicare beginning in January 2006.

30 Jun 2010

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

30 Jun 2010

Herniated disk can cause low back and leg pain in adults

A literature review, led by Dr. Joseph Lee, published in the June 2010 issue of the Journal of the American Academy of Orthopaedic Surgeons (JAAOS) suggests that a herniated disk is one of the most frequent causes of low back and leg pain in adults, but surgery is not for everyone. Between 60 and 80 percent of people will experience low back pain at some point in their lives.

30 Jun 2010

Preliminary findings show RA drug reduces brain damage in stroke patients

A drug used to treat rheumatoid arthritis also reduces the damage a stroke inflicts on the brain according to lab research and preliminary findings from a clinical trial of stroke patients. The results open the door for a larger clinical study to refine the drug anakinra's use as an effective therapy for victims of stroke.

From The University of Manchester 30 Jun 2010

FDA grants IND regulatory clearance for Phase I/II clinical trial of AAT in type 1 diabetics

The U.S. Food & Drug Administration (FDA) has granted Investigational New Drug (IND) regulatory clearance to initiate a Phase I/II clinical trial evaluating Alpha-1 Antitrypsin (AAT) in type 1 diabetics, based on research by Dr. Eli Lewis of Israel's Ben-Gurion University of the Negev.

30 Jun 2010

Study indicates two treatment strategies can reduce progression of diabetic retinopathy

In high-risk adults with type 2 diabetes, researchers have found that two therapies may slow the progression of diabetic retinopathy, an eye disease that is the leading cause of vision loss in working-age Americans.

30 Jun 2010

Cardio3 BioSciences reports positive data from C-Cure stem cell therapy clinical trial for heart failure

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular diseases, today announces positive safety data and preliminary efficacy results from its clinical trial of C-Cure(R), a breakthrough stem cell therapy for heart failure.

30 Jun 2010

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that its applications for ALN-TTR01 have been given clearance by Portuguese, Swedish, and British regulatory authorities to begin clinical testing. The trial will begin enrolling patients shortly in a blinded, randomized, placebo-controlled, multicenter Phase I study.

29 Jun 2010

Alimera submits Iluvien NDA for DME to FDA

Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Iluvien®, (flucocinolone acetonide intravitreal insert), its investigational, sustained drug delivery system releasing sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

29 Jun 2010

BBD reports analyze effectiveness and safety of statin use

A series of new reports from Consumer Reports Best Buy Drugs (BBD) caution that the benefits of statin use by children and some women may not outweigh the risks. Drugs to lower cholesterol - including statins - are the most commonly prescribed drugs in the U.S. and garnered more than $14 billion in sales last year.

29 Jun 2010

Successful growth of mouse embryonic stem cells in rat lungs raises hopes for engineering human transplants

For someone with a severe, incurable lung disorder such as cystic fibrosis or chronic obstructive pulmonary disease, a lung transplant may be the only chance for survival. Unfortunately, it's often not a very good chance. Matching donor lungs are rare, and many would-be recipients die waiting for the transplants that could save their lives.

29 Jun 2010

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the Phase 3 trial initiated last April for the development of its lead anticancer proprietary compound, perifosine, in refractory advanced colorectal cancer.

29 Jun 2010

Rosiglitazone therapy associated with increased risk for heart attack: Study

Eleven years after the introduction of the diabetes drug rosiglitazone, data from available clinical trials demonstrate an increased risk for heart attack associated with its use and suggest an unfavorable benefit-to-risk ratio, according to a report posted online today that will appear in the July 26 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

29 Jun 2010

Statins does not reduce death risk in high-risk individuals without heart disease

A meta-analysis of previously published studies finds no evidence that statins are associated with a reduced risk of death among individuals at risk for but with no history of cardiovascular disease, according to a report in the June 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals

29 Jun 2010

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Tranzyme Pharma announced positive top-line results today from a Phase 2, double-blind, placebo-controlled study evaluating TZP-102 capsules in diabetic patients with gastroparesis, a serious disorder characterized by the inability of the stomach to empty food efficiently. The study achieved a clinically meaningful and statistically significant improvement in critical gastroparesis-related symptoms. All three TZP-102 doses tested were effective, safe and well tolerated.

29 Jun 2010

Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

Results from a 24-week Phase 3 clinical study demonstrated that the addition of the investigational drug dapagliflozin achieved reductions in the primary endpoint, glycosylated hemoglobin level (HbA1c), in inadequately controlled type 2 diabetes patients who were treated with insulin (with or without oral anti-diabetes medications (OADs)), compared to placebo plus insulin (with or without OADs).

29 Jun 2010

Pluristem advances toward PLX-PAD Phase IIb clinical trials for CLI and Moderate-severe Claudication

Pluristem Therapeutics Inc. today announced that following its meeting with the Paul Ehrlich Institute (PEI), the German regulatory authority for advanced therapy products (ATP), the company is advancing toward designing two Phase IIb clinical trials for its placenta-derived cell therapy product, PLX-PAD, for the treatment of Critical Limb Ischemia (CLI) and Moderate-severe Claudication.

29 Jun 2010

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Daiichi Sankyo, Inc. and Eli Lilly and Company appreciate the availability of a "Clinical Alert" from the American College of Cardiology Foundation (ACCF) and American Heart Association (AHA) in response to the FDA's Boxed Warning about Plavix® (clopidogrel), and commend the leading cardiovascular medical societies for providing perspective on the importance of genetic make-up and the variability in response of certain oral anti-platelet (OAP) therapy for patients with acute coronary syndrome (ACS) who are managed with angioplasty and stenting (known as PCI).

29 Jun 2010

Aggressive pursuit of low blood pressure, cholesterol levels may not benefit patients with diabetes

A mathematical model suggests that aggressively pursuing low blood pressure and cholesterol levels may not benefit, and could even harm, some patients with diabetes, according to a report in the June 28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

29 Jun 2010

Therapy News and Research

Metabolex, Sanofi-Aventis sign global license deal to develop GPR119 for type 2 diabetes treatment

Experts evlauate impact of Medicare Part D program on independent and chain pharmacies

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Herniated disk can cause low back and leg pain in adults

Preliminary findings show RA drug reduces brain damage in stroke patients

FDA grants IND regulatory clearance for Phase I/II clinical trial of AAT in type 1 diabetics

Study indicates two treatment strategies can reduce progression of diabetic retinopathy

Cardio3 BioSciences reports positive data from C-Cure stem cell therapy clinical trial for heart failure

Alnylam receives Portuguese, Swedish, British approvals to initiate ALN-TTR01 Phase I study in ATTR

Alimera submits Iluvien NDA for DME to FDA

BBD reports analyze effectiveness and safety of statin use

Successful growth of mouse embryonic stem cells in rat lungs raises hopes for engineering human transplants

Aeterna Zentaris receives positive Scientific Advice from EMA for perifosine Phase 3 trial in colorectal cancer

Rosiglitazone therapy associated with increased risk for heart attack: Study

Statins does not reduce death risk in high-risk individuals without heart disease

Tranzyme reports positive results from TZP-102 Phase 2 study in diabetic patients with gastroparesis

Dapagliflozin in addition to insulin improves glycemic control in type 2 diabetics

Pluristem advances toward PLX-PAD Phase IIb clinical trials for CLI and Moderate-severe Claudication

Daiichi Sankyo, Eli Lilly respond to ACCF/AHA clinical alert on FDA's clopidogrel boxed warning

Aggressive pursuit of low blood pressure, cholesterol levels may not benefit patients with diabetes

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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