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Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Femta Pharmaceuticals and Lonza Group Ltd jointly announce the execution of a manufacturing services agreement to facilitate the development and cGMP manufacturing of FM101. FM101 is a high affinity monoclonal antibody in late pre-clinical development for the treatment of Rheumatoid Arthritis.

15 Dec 2009

Pfizer to co-promote Actos with Tianjin Takeda Pharmaceuticals in China

Takeda Pharmaceutical Company Limited (“Takeda”) and Pfizer Inc. (“Pfizer”) announced that they have entered into an agreement under which Pfizer in China will co-promote Takeda’s Actos® (pioglitazone HCl) with Tianjin Takeda Pharmaceuticals in China.

15 Dec 2009

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Spinal Restoration, Inc. announced today it has received a Special Protocol Assessment concurrence letter from the U.S. Food and Drug Administration (FDA) for the design of its Phase 3 study of the Biostat System for the treatment of chronic discogenic low back pain.

15 Dec 2009

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

Almac Discovery today announced the start of Phase I clinical trial of the novel intranasal Granisetron product. This product, which uses Archimedes' proprietary ChiSys® delivery technology, is being developed as a rapidly acting, well tolerated and convenient treatment for chemotherapy-induced nausea and vomiting (CINV).

15 Dec 2009

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

GenSpera, Inc. announced today that the Institutional Review Board (IRB) at the University of Wisconsin, in Madison, WI, has approved a Phase I study of its target activated pro-drug, G-202, for the treatment of cancer. The FDA (US Food and Drug Administration) approved the study in September. GenSpera expects to enroll the first study patient early in the first quarter of 2010.

15 Dec 2009

Encouraging results from DAVANAT in combination with chemotherapies and biologics

Pro-Pharmaceuticals, Inc. today announced that the Brussels Branch of the Ludwig Institute of Cancer Research is testing the ability of DAVANAT® to stop Galectin-3 from blocking the immune system’s action on cancer cells. Peer reviewed studies have demonstrated that Galectin-1 and Galectin-3 induce apoptosis (cell death) in immune system T cells (“Galectins,” Chapter 7, Wiley, 2008).

15 Dec 2009

Celgene announces positive data from its apremilast Phase IIb study for plaque-type psoriasis

Celgene Corporation announced clinical data from an investigational Phase IIb, double-blind, placebo-controlled study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis (PSOR-005). This was a 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of apremilast twice per day (BID), or placebo.

15 Dec 2009

Novartis submits JOULFERON MAA to the EMEA

Human Genome Sciences, Inc. today announced that Novartis has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for approval to market JOULFERON® (albinterferon alfa-2b, known in the United States as ZALBIN™) for the treatment of chronic hepatitis C. In November 2009, HGS submitted a Biologics License Application (BLA) for ZALBIN to the FDA in the United States.

15 Dec 2009

Lytix Biopharma AS receives approval to commence Phase I clinical trials of Oncopore

The Norwegian pharmaceutical company Lytix Biopharma AS today announced approvals from the Norwegian Medicines Agency (”Statens legemiddelverk”) and the Swedish Medical Products Agency (”Läkemedelverket”) to commence Phase I clinical trials of OncoporeTM (LTX-315) for the treatment of cancer.

15 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

New technique may help diagnose treatments for Alzheimer's, diabetes and cancer

Chemists and biologists from the University of Bath have developed a new technique that could be used to diagnose and develop treatments for age-related conditions like Alzheimer's disease, diabetes and cancer.

15 Dec 2009

Cerebrospinal fluid signature and PiB imaging help predict Alzheimer's disease

Early Alzheimer's disease detected by a compound that binds to brain plaques appears likely to progress into symptomatic Alzheimer's disease with dementia, according to a report in the December issue of Archives of Neurology, one of the JAMA/Archives journals.

15 Dec 2009

Risks and benefits of CT scans

Doses of radiation from commonly performed computed tomography (CT) scans vary widely, appear higher than generally believed and may contribute to an estimated tens of thousands of future cancer cases, according to two reports in the December 14/28 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

15 Dec 2009

Mutant ATPase blocks autophagy partway and causes multi-tissue degenerative disease

It's important to finish what you start, say Jeong-Sun Ju and researchers from Washington University School of Medicine, St. Louis. In the December 14, 2009 issue of the Journal of Cell Biology (www.jcb.org), Ju et al. reveal how a mutant ATPase blocks autophagy partway through to cause a multi-tissue degenerative disease.

15 Dec 2009

Nanoprobes deliver drugs directly to the right tumor cellular compartments

Tiny nanoprobes have shown to be effective in delivering cancer drugs more directly to tumor cells - mitigating the damage to nearby healthy cells - and Purdue University research has shown that the nanoprobes are getting the drugs to right cellular compartments.

15 Dec 2009

Cancer patients with dementia have lower survival rate than patients with cancer alone, says study

A new study published by researchers from the University of Georgia and the Moffitt Cancer Center in Tampa, Fla., has found that cancer patients with dementia have a dramatically lower survival rate than patients with cancer alone, even after controlling for factors such as age, tumor type and tumor stage.

15 Dec 2009

Findings suggest variations in accelerated aging disorders

UT Southwestern Medical Center researchers have provided the most extensive account to date of the unique observable characteristics seen in patients with an extremely rare premature aging syndrome.

15 Dec 2009

Study to determine link between insulin glargine and cancer

Type 2 diabetes and obesity are linked to an increased risk of certain cancers. Recently published studies suggested that insulin glargine (a synthetic insulin preparation marketed under the trade name Lantus), may be associated with a higher risk of certain cancers than other insulins or oral glucose lowering medications. However, these studies were unable to control for important factors such as obesity that may have driven the association.

15 Dec 2009

Enrolment for pivotal Phase II/III trial of C-Cure completed ahead of schedule

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in cell-based therapies for the treatment of cardiovascular diseases, announced today that it has completed, two months ahead of schedule, enrolment in the first stage of its pivotal Phase II/III trial of C-Cure, a unique stem cell therapy for heart failure.

15 Dec 2009

Medical Condition News

Positive results from study comparing exenatide once weekly to BYETTA

Femta Pharmaceuticals, Lonza Group collaborate in cGMP production of FM101 antibody

Pfizer to co-promote Actos with Tianjin Takeda Pharmaceuticals in China

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Almac Discovery initiates Phase I clinical trial of intranasal Granisetron for CINV

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

Encouraging results from DAVANAT in combination with chemotherapies and biologics

Celgene announces positive data from its apremilast Phase IIb study for plaque-type psoriasis

Novartis submits JOULFERON MAA to the EMEA

Lytix Biopharma AS receives approval to commence Phase I clinical trials of Oncopore

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

New technique may help diagnose treatments for Alzheimer's, diabetes and cancer

Cerebrospinal fluid signature and PiB imaging help predict Alzheimer's disease

Risks and benefits of CT scans

Mutant ATPase blocks autophagy partway and causes multi-tissue degenerative disease

Nanoprobes deliver drugs directly to the right tumor cellular compartments

Cancer patients with dementia have lower survival rate than patients with cancer alone, says study

Findings suggest variations in accelerated aging disorders

Study to determine link between insulin glargine and cancer

Enrolment for pivotal Phase II/III trial of C-Cure completed ahead of schedule

How can microdialysis benefit drug development

Global and Local Efforts to Take Action Against Hepatitis

Addressing Important Cardiac Biology Questions with Shotgun Top-Down Proteomics

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