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FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Inspire Medical Systems, a leading developer of neuro-stimulation therapies for the treatment of obstructive sleep apnea (OSA), announced today that the company has received approval from the U.S. Food and Drug Administration (FDA) to begin its STAR pivotal clinical trial. The STAR trial (Stimulation Therapy for Apnea Reduction), is a multi-center study that will evaluate both the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients with moderate to severe obstructive sleep apnea (OSA).

30 Nov 2010

Zogenix completes enrollment in ZX002 Phase 3 study for moderate to severe pain

Zogenix, Inc. today announced completion of enrollment in its open-label Phase 3 safety study (Study 802) of ZX002. ZX002 is a novel, oral, single-entity, controlled-release formulation of hydrocodone for the treatment of moderate to severe pain in patients requiring around-the-clock opioid therapy for an extended period of time.

30 Nov 2010

Group drumming can improve social, emotional behavior in low-income children: NAMM Foundation

The NAMM Foundation today announced the findings of a recent study that shows how group drumming can improve social and emotional behavior in low-income children.

30 Nov 2010

University Hospitals receives $42 million for cancer care

Jane and Lee Seidman have donated $42 million to University Hospitals (UH) the largest gift in the Cleveland-based health system's history. In recognition of this unprecedented generosity, UH is naming the "Jane and Lee Seidman Cancer Center" in their honor.

30 Nov 2010

Cytheris' combinational therapy demonstrates possible therapeutic strategy for PML

Cytheris SA, a clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the publication of a case study report based on successful treatment of Progressive Multifocal Leukoencephalopathy (PML) with combination therapy consisting of two investigational agents, Cytheris' recombinant human interleukin-7 (CYT107) and CMX001, an investigational, oral broad-spectrum antiviral drug (Chimerix, Research Triangle Park, NC) in the Journal of Antimicrobial Chemotherapy.

30 Nov 2010

FG-2216 drug offers new treatment option for kidney disease-related anemia

A new drug called FG-2216 can stimulate production of the hormone erythropoietin (EPO) in dialysis patients—possibly offering a new approach to treatment of kidney disease-related anemia, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology (JASN).

30 Nov 2010

Sante to break ground on second and third post hospital stay rehabilitation centers

Sante Partners announces that they will officially break ground on their second and third post hospital stay rehabilitation centers: Sante of Surprise and Sante of Chandler on Wednesday, December 1st at 9 a.m. and Wednesday, December 1st at 1 p.m. respectively. The facilities will be dedicated to servicing patients/guests in the prospective communities of Surprise, Sun City and Chandler with state-of-the-art physical, occupational and speech rehabilitation centers designed by Sante Partners.

30 Nov 2010

GeoVax supports Bionor's Phase 2b trial of therapeutic HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), announced it was pleased to learn of the partial success observed in the recently completed Phase 2b trial of a therapeutic HIV/AIDS vaccine produced by Bionor Immuno AS of Oslo, Norway.

30 Nov 2010

Researchers conduct real-time metabolic imaging in human patient with prostate tumor

A UCSF research collaboration with GE Healthcare has produced the first results in humans of a new technology that promises to rapidly assess the presence and aggressiveness of prostate tumors in real time, by imaging the tumor's metabolism.

30 Nov 2010

APP to launch Topotecan for Injection following FDA marketing approval

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

30 Nov 2010

ABI therapy effective for treating microtears in hamstring injury: Study

Researchers in London say they have found an effective two-part treatment for microtears in the hamstring: injections of the patient's own blood and a steroid along with "dry-needling," in which repeated needle punctures cause controlled internal bleeding in the injured area. Results of the study were presented today at the annual meeting of the Radiological Society of North America (RSNA).

30 Nov 2010

To reduce spread of HIV/AIDS, IFRC calls for more focus on IDU programs

Ahead of World AIDS Day, the International Federation of the Red Cross on Friday released a report (.pdf) calling for governments around the world to do more to help stop the spread of HIV/AIDS among populations of injecting drug users (IDUs), the Associated Press reports (Heilprin, 11/25).

30 Nov 2010

Calistoga to feature data on CAL-101 inhibitor for hematologic malignancies at ASH Annual Meeting

Calistoga Pharmaceuticals, Inc., the leader in the development of delta-isoform-selective phosphatidylinositol 3-kinase (PI3K-delta) inhibitors for the treatment of cancer and inflammatory diseases, today announced the upcoming presentation of clinical and preclinical results supporting the clinical benefit of CAL-101, an oral, PI3K-delta inhibitor, in the treatment of patients with hematologic malignancies.

30 Nov 2010

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Acrux , a drug delivery company that develops and commercializes patented pharmaceutical products for global markets, and Eli Lilly Company today announced that the United States Food and Drug Administration (FDA) has approved the Axiron® topical solution CIII for testosterone replacement therapy in men. Axiron is the first testosterone topical solution approved for application via an underarm applicator.

29 Nov 2010

Zalicus to highlight A2A agonist oncology programs at ASH Annual Meeting

Zalicus Inc. announced today that preclinical data on its discovery of novel A2A agonist oncology programs for the treatment of multiple myeloma and other B-cell malignancies will be highlighted at the 52nd Annual Meeting of the American Society of Hematology in Orlando, FL on December 4-7, 2010.

29 Nov 2010

Ageing reversed in mice: Study

A scientific team at Harvard-affiliated medical centers genetically manipulated mice to age faster. Then they used gene therapy to lengthen telomeres. Telomeres are compounds found at the ends of strands of DNA that are related to age. This lengthening of telomeres reversed age-related problems such as decreased brain function and infertility.

29 Nov 2010

Positive results from Oncolytics' combination REOLYSIN-docetaxel Phase I trial in advanced cancer

Oncolytics Biotech Inc. announced today that a paper entitled "REO-10: A Phase I Study of Intravenous Reovirus and Docetaxel in Patients with Advanced Cancer," was recently published by Comins et al in the journal Clinical Cancer Research (Clin Cancer Res 16(22):5564-5572).

29 Nov 2010

Spectrum's FUSILEV sNDA accepted by FDA for review

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the complete response regarding its supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for Injection for treatment of patients with advanced metastatic colorectal cancer.

29 Nov 2010

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101.

29 Nov 2010

QOI and Quantel enter co-promotion agreement for Activis PDT Lasers

QLT Inc. today announced that its wholly-owned U.S. subsidiary, QLT Ophthalmics, Inc. ("QOI"), and Quantel Medical and its distributor, Quantel USA, Inc., have entered into a co-promotion agreement for the sale of Activis PDT Lasers used to activate Visudyne® during photodynamic therapy of primarily classic lesions in wet age-related macular degeneration (AMD). The lasers are manufactured by Quantel Medical and sold by Quantel USA, Inc. and will be promoted by both Quantel USA, Inc. and QOI's sales force to the retina community in the United States.

29 Nov 2010

Therapy News and Research

FDA approves Inspire to begin STAR clinical trial to evaluate UAS therapy for OSA

Zogenix completes enrollment in ZX002 Phase 3 study for moderate to severe pain

Group drumming can improve social, emotional behavior in low-income children: NAMM Foundation

University Hospitals receives $42 million for cancer care

Cytheris' combinational therapy demonstrates possible therapeutic strategy for PML

FG-2216 drug offers new treatment option for kidney disease-related anemia

Sante to break ground on second and third post hospital stay rehabilitation centers

GeoVax supports Bionor's Phase 2b trial of therapeutic HIV/AIDS vaccine

Researchers conduct real-time metabolic imaging in human patient with prostate tumor

APP to launch Topotecan for Injection following FDA marketing approval

ABI therapy effective for treating microtears in hamstring injury: Study

To reduce spread of HIV/AIDS, IFRC calls for more focus on IDU programs

Calistoga to feature data on CAL-101 inhibitor for hematologic malignancies at ASH Annual Meeting

FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Zalicus to highlight A2A agonist oncology programs at ASH Annual Meeting

Ageing reversed in mice: Study

Positive results from Oncolytics' combination REOLYSIN-docetaxel Phase I trial in advanced cancer

Spectrum's FUSILEV sNDA accepted by FDA for review

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

QOI and Quantel enter co-promotion agreement for Activis PDT Lasers

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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