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Bioheart Announces 35 Leading U.S. Heart Failure Centers Engaged In Phase II/III Marvel Trial Of Myogenic Cells For Treating Advanced Heart Failure

2008-10-02T06:30:00.049-07:00

Bioheart, Inc., (Nasdaq: BHRT), announced that 35 of the leading U.S. Heart Failure Centers have engaged in Bioheart's Phase II/III MARVEL(1) Trial of myogenic cells for treating advanced heart failure. "With 35 leading heart failure centers engaged, we are making tremendous progress in patient screening and enrollment," said Dr.

Evalve Announces Enrollment Completion Of The EVEREST Randomized Study

2008-10-02T06:30:00.047-07:00

Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced the completion of randomized enrollment in the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST), which is evaluating the MitraClip(R) system as a non-surgical repair option for patients suffering from mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States, affecting millions of people worldwide.

Indevus Announces Agreement With Teva To Develop Pagoclone For The Treatment Of Stuttering

2008-10-02T06:30:00.045-07:00

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced that it has signed a development, license and commercialization agreement with Teva Pharmaceutical Industries Ltd. for the exclusive, worldwide rights to pagoclone.

New Information On Hormone Replacement Therapy And The Risk Of Heart Attacks Provided By Danish Study

2008-10-02T06:30:00.043-07:00

It's not what you take but the way that you take it that can produce different results in women who take hormone replacement therapy (HRT), according to new research on the association between HRT and heart attacks, published online in Europe's leading cardiology journal, the European Heart Journal [1] today (Wednesday 1 October).

Stratatech Successfully Completes Clinical Trial Of StrataGraft^ Skin Substitute - Trial's Primary Clinical Endpoint Achieved

2008-10-02T06:30:00.041-07:00

Stratatech Corp. , a regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products, today announced that it has successfully completed the multi-center, 15-patient clinical trial of its StrataGraft^

Cervical Dystonia - FDA's First-Cycle Review Of Dysport(R) To Be Completed By Year-End

2008-10-02T06:30:00.039-07:00

Ipsen (Paris:IPN) announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport^ (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008. This regulatory decision will not impact the anticipated company launch plan timing.

A.P. Pharma Announces Positive Phase 3 Results With APF530 In The Prevention Of Chemotherapy Induced Nausea And Vomiting

2008-10-02T06:30:00.037-07:00

A.P. Pharma, Inc. (NASDAQ:APPA), a specialty pharmaceutical company, announced today positive results from its pivotal Phase 3 study comparing te efficacy of APF530 (the Company's proprietary, sustained release formulation of granisetron) with Aloxi^ for the prevention of chemotherapy induced nausea and vomiting (CINV).

Aethlon Medical Initiates First Clinical Study Of A Medical Device To Treat HIV/AIDS Patients

2008-10-02T06:30:00.035-07:00

Aethlon Medical, Inc. (OTCBB:AEMD) announced today that it has initiated patient enrollment in the "first-in-man" clinical study of a medical device to treat the Human Immunodeficiency Virus (HIV), the disease that causes Acquired Immune Deficiency Syndrome (AIDS). The device, known as the Aethlon Hemopurifier^, assists the immune response in combating infectious disease through real-time therapeutic filtration of infectious viruses and immunosuppressive proteins.

More Minority Physicians Would Help Improve Minorities' Participation In Clinical Trials, Opinion Piece Says

2008-10-02T06:30:00.033-07:00

"The first step in addressing the underrepresentation of black Americans in research ... is to recruit more minority physicians into clinical research," Ken Getz -- chair of the Center for Information and Study on Clinical Research Participation and a senior research fellow at Tufts University

Columbia Laboratories Reports Results From Phase II Clinical Trial Of Vaginally-administered Lidocaine For Dysmenorrhea

2008-10-02T06:30:00.031-07:00

Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced results from its Phase II study of vaginally-administered lidocaine, which the Company is investigating for the prevention and treatment of dysmenorrhea. No treatment currently exists to prevent dysmenorrhea. Seventy women with a history of moderate-to-severe dysmenorrhea participated in this first documented attempt to show prevention of uterine cramping and pain.

Additional Positive Findings For APOPTONEв„ў (HE3235) In Preclinical Models Of Castration-Resistant Prostate Cancer

2008-10-02T06:30:00.029-07:00

Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) today presented new findings that suggest APOPTONEв„ў (HE3235) is inhibiting in preclinical models of castration-resistant prostate cancer, the ability of tumors to synthesize the hormones necessary for their survival, as well as significantly down regulating the androgen receptor.

Follow-On Phase I Study For Novel Oral Anti-Inflammatory Drug Targeting Rheumatoid Arthritis And Type 1 Diabetes

2008-10-02T06:30:00.027-07:00

VGX Pharmaceuticals, a biopharmaceutical company that is developing DNA vaccines for cancer and HIV and therapeutics for other diseases, announced today the results of a Phase I single ascending dose (SAD) study that demonstrated that its lead anti-inflammatory compound, VGX-1027, was generally safe and well tolerated in humans. As a result, VGX Pharmaceuticals and VGX International, a Korean affiliate that is jointly developing VGX-1027, have commenced a multiple ascending dose (MAD) study.

Dosing Began In TransMolecular's Phase 1/2 Clinical Trial For Intravenous Administration Of 131Iodine-TM601 In Recurrent Malignant Glioma Patients

2008-10-02T06:30:00.025-07:00

TransMolecular, Inc., a biotechnology company focused on targeted therapies for cancer, announced today that dosing was initiated in a Phase 1/2 trial of 131I-TM601 delivered intravenously (IV) for the treatment of adult patients with recurrent malignant glioma. The trial will focus on investigating the tolerability, safety, and therapeutic efficacy of multiple doses of 131I-TM601 when administered intravenously.

Premature Ejaculation - Plethora Solutions Has Completed European Phase III Trial Of PSD502

2008-10-02T06:30:00.023-07:00

Sciele Pharma, Inc. ("Sciele") (NASDAQ:SCRX), a specialty pharmaceutical company, today announced that Plethora Solutions Holdings PLC ("Plethora") (AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

Tranzyme Pharma Announces Positive Phase IIb Results With Its Ghrelin Agonist, TZP-101, For Postoperative Ileus (POI)

2008-10-02T06:30:00.021-07:00

Tranzyme Pharma today announced positive Phase IIb results for its first-in-class, highly potent and selective ghrelin agonist, TZP-101, for the management of postoperative ileus (POI). Results demonstrated that TZP-101 was both safe and highly effective in reducing the duration of ileus following surgery in patients undergoing open bowel resection.

Beta Blockers Reduce Mortality In Patients With COPD After Vascular Surgery

2008-10-02T06:30:00.019-07:00

In the first study to directly examine the effects of beta-blockers on surgical patients with chronic obstructive pulmonary disease (COPD), researchers have found that, contrary to previous thought, beta-blockers significantly reduce mortality in COPD patients. "Patients with COPD frequently have unrecognized, atherosclerotic disease. This is also a major cause for late morbidity and mortality," said principle investigator Don Poldermans, M.D., Ph.D.

Lilly Announces Initiation Of Second Global Phase III Trial Of Investigational Alzheimer's Disease Compound

2008-10-02T06:30:00.017-07:00

Eli Lilly and Company (NYSE: LLY) announced it will begin enrolling patients in a second Phase III study of LY450139, a gamma-secretase inhibitor being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The study, called IDENTITY 2, is expected to enroll 1,100 patients from 22 countries.

Alimera Reports Results From The Six-Month Interim Readout Of The Human PK Iluvien(TM) Study

2008-10-02T06:30:00.015-07:00

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, reported the interim month six safety and efficacy results from the first human pharmacokinetic (PK) study of Iluvien(TM). Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME).

Transcept Pharmaceuticals Submits New Drug Application For Intermezzo(R) For Treatment Of Middle-of-the-Night Awakenings

2008-10-02T06:30:00.013-07:00

Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge).

ImmunoVaccine Technologies' DepoVax(TM) Shows Positive Results For Cancer And Infectious Diseases

2008-10-02T06:30:00.011-07:00

ImmunoVaccine Technologies' (IVT) patented depot vaccine formulation, DepoVax(TM) is showing positive pre-clinical results, with single-dose efficacy achieved in therapeutic cancer and several infectious disease vaccine models. The results of this research will be presented October 4th at the Ehrlich II conference in Germany. Collaborators from the University of Miami will also be reporting on the capabilities of IVT's depot formulations for delivery of DNA and SiRNA in vivo.

HIV Drug Maraviroc Effective For Drug-Resistant Patients

2008-10-02T06:30:00.009-07:00

As many as one quarter of HIV patients have drug resistance, limiting their treatment options and raising their risk for AIDS and death. Now, maraviroc, the first of a new class of HIV drugs called CCR5 receptor antagonists, has been shown to be effective over 48 weeks for drug-resistant patients with R5 HIV-1, a variation of the virus found in more than half of HIV-infected patients.

Advanced Ovarian Cancer Patient Enrollment Phase 2 Study Of IMC-1121B Commences

2008-10-02T06:30:00.007-07:00

ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the first patient has been treated in its disease-directed Phase 2 clinical trial of IMC-1121B in patients with advanced ovarian cancer. IMC-1121B is ImClone's proprietary fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

Vitamin C Supplements May Reduce Benefit From Wide Range Of Anticancer Drugs

2008-10-02T06:30:00.005-07:00

In pre-clinical studies, vitamin C appears to substantially reduce the effectiveness of anticancer drugs, say researchers at Memorial Sloan-Kettering Cancer Center.

Genes Affect Weight Loss Drug Effectiveness

2008-10-02T06:30:00.003-07:00

A study conducted by researchers at Mayo Clinic shows that obese patients with specific genetic makeup had enhanced response to the weight loss drug sibutramine, while others who lack these genetic factors lost little or no weight. The findings are published in the October issue of Gastroenterology (http://www.gastrojournal.org).

Clinical Trials In India 44% Less Expensive Than US Trials

2008-10-02T06:30:00.001-07:00

Conducting clinical trials in India is an average of 44% less expensive than conducting US-based trials, according survey data. A new study by pharmaceutical business intelligence leader Cutting Edge Information, "Streamlining Clinical Trials," finds that the average clinical trial costs pharmaceutical companies $125 million in the US compared to $70 million in India, on average.

DSMB Supports Continuation Of The Phase Iii Clinical Trial Of IluvienTM For Diabetic Macular EdemaTreatment

2008-09-30T05:32:00.049-07:00

Global drug delivery company, pSivida Corp. (NASDAQ: PSDV)(ASX: PVA)(FF: PV3) today announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAMEв„ў (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change.

Guided Therapeutics, Inc. Announces Completion Of Subject Enrollment Of FDA Pivotal Clinical Trial

2008-09-30T05:32:00.047-07:00

Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) today announced completion of its U.S. Food and Drug Administration (FDA) pivotal clinical trial for its LightTouch TM non-invasive cervical cancer detection device.

Bioheart Reports Promising Results From Preclinical Study Of Adipose Derived Acute Cell Therapy

2008-09-30T05:32:00.045-07:00

A preclinical study involving the injection of adipose-derived stem cells (ADSCs) into the myocardium (heart muscle tissue) of infarcted rats, was recently completed at the Jordan University of Science and Technology in Irbid, Jordan by medical and veterinary doctors from that institution and the University of Jordan in Amman, Jordan.

Established Safety Profile Of Spiriva Confirmed By 30 Rigorously Controlled Clinical Trials And The Landmark Trial UPLIFT

2008-09-30T05:32:00.043-07:00

Boehringer Ingelheim and Pfizer Inc have released a new analysis of 30 rigorously controlled clinical trials, including UPLIFT, confirming the long term safety profile of Spiriva(R) HandiHaler(R) (tiotropium bromide inhalation powder). The new and expanded safety data contradicts the conclusions about tiotropium in an article by Singh et al. published in the September 24th issue of the Journal of the American Medical Association.

Ironwood And Forest To Present Positive Data From Linaclotide Phase 2b IBS - C Study At ACG Annual Scientific Conference

2008-09-30T05:32:00.041-07:00

Ironwood Pharmaceuticals (formerly Microbia) and Forest Laboratories, Inc. (NYSE: FRX) announced they will present results of a Phase 2b study investigating linaclotide's safety and efficacy in 419 patients with irritable bowel syndrome with constipation (IBS-C) in a plenary session at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando, Fla. on October 7, 2008.

Takeda Submits A New Drug Application In The U.S. For Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) For The Treatment Of Type 2 Diabetes

2008-09-30T05:32:00.039-07:00

Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS(R) (pioglitazone HCl) ("alogliptin/ACTOS") in a single tablet for the treatment of type 2 diabetes.

DSMB Again Supports Continuation Of Alimera Sciences' Phase 3 Clinical Trial Of Iluvien(TM) For The Treatment Of DME

2008-09-30T05:32:00.037-07:00

Alimera Sciences, Inc.

CHMP Recommends Approval Of Olanzapine Long-acting Injection For Maintenance Treatment Of Schizophrenia In Europe

2008-09-30T05:32:00.035-07:00

The Committee for Medicinal Products for Human Use (CHMP) has recommended European approval of Olanzapine Long-acting Injection (LAI), known in Europe by the trade name Zypadhera(TM), for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine, Eli Lilly and Company (LLY) announced today.

Is It Ethical To Include Pregnant Women In Research?

2008-09-30T05:32:00.033-07:00

Why aren't pregnant women included in most clinical trials? That's the question posed by leading bioethicists at Duke University Medical Center, Johns Hopkins and Georgetown Universities, who say it's time to confront the challenges that have led to the exclusion of pregnant women from important research that could positively impact maternal and fetal health.

Promising New TB Drug Receives Phase 2 SBIR

2008-09-30T05:32:00.031-07:00

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat infectious diseases of epidemic potential, has announced that it received a $2.

VEGF Trap-Eye Final Phase 2 Results In Age-related Macular Degeneration Presented At 2008 Retina Society Meeting

2008-09-30T05:32:00.029-07:00

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Bayer HealthCare AG announced that VEGF Trap-Eye achieved durable improvements in visual acuity and in biologic measures of neovascular disease, including retinal thickness and active choroidal neovascularization lesion size, for up to one year in a Phase 2 study in the neovascular form of Age-related Macular Degeneration (wet AMD).

Zypadhera(TM) Receives Positive Opinion From The European Committee For Medicinal Products For Human Use (CHMP) For Treatment Of Schizophrenia

2008-09-30T05:32:00.027-07:00

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection, also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine, Eli Lilly and Company (LLY) announced.

VEGF Trap-Eye: New Data Confirm Successes In The Treatment Of Age Related Macular Degeneration

2008-09-30T05:32:00.025-07:00

VEGF Trap-Eye can achieve durable improvements in visual acuity and in biologic measurement parameters in the formation of new blood vessels in the treatment of age-related macular degeneration (AMG). This was shown in the final evaluation of a Phase 2 study presented at the annual meeting of the Retina Society in Scottsdale, Arizona. These parameters include retinal thickness and active choroidal neovascularization lesion size (the damaged part of the retina).

Monthly Replacement Contact Lens Wearers Report A Decrease In Wearing Comfort Over The Course Of A Month, Research Shows

2008-09-30T05:32:00.023-07:00

Monthly replacement contact lens wearers notice a decline in lens performance in weeks three and four of wear, a survey reveals. Findings from the research among monthly lens wearers in France, in which 20 different brands of lenses were represented, show a decrease in wearing comfort over the course of a month, with no significant differences between wearers of hydrogel and silicone hydrogel monthly replacement lenses.

EVAR Offers Better Results Than Open Repair In High Risk Patients

2008-09-30T05:32:00.021-07:00

Endovascular aneurysm repair (EVAR) yields better results than open surgical repair (OSR) in high risk patients with similar costs, according to a one-year trial study which appears in the October issue of the Journal of Vascular Surgery, published by the Society for Vascular Surgery. Data was collected from 342 patients who had an abdominal aortic aneurysm (AAA) of more than 5.

Baxter's Antimicrobial IV Technology Now Shown To Kill Six Common Pathogens, Including MRSA And VRE

2008-09-30T05:32:00.019-07:00

Baxter Healthcare Corporation announced that it received 510(k) clearance for expanded labeling for the first antimicrobial needleless intravenous (IV) connector, V-Link Luer-activated device (LAD) with VitalShield protective coating.

Cepheid Receives FDA Clearance For First Rapid On Demand Molecular Diagnostic Test For MRSA And S. Aureus

2008-09-30T05:32:00.017-07:00

Cepheid (Nasdaq: CPHD) announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert(R) System, for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections.

ThromboGenics Announces Promising Results Of MITI IV Phase II Trial In The Treatment Of Acute Stroke With Microplasmin

2008-09-30T05:32:00.015-07:00

ThromboGenics NV (Euronext Brussels: THR), a biotechnology company focused on novel therapies for eye disease, vascular disease and cancer, announces positive results from its MITI IV Phase II trial to evaluate the safety and preliminary efficacy of microplasmin when administered intravenously to acute stroke patients. The trial showed that microplasmin was generally well tolerated and also provided some interesting preliminary efficacy data.

Watson Announces Positive Data For RAPAFLO(TM)(silodosin), Its Investigational Product For BPH, At Regional AUA Conferences

2008-09-30T05:32:00.013-07:00

Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced that investigators presented efficacy and safety data on silodosin, its investigational treatment for benign prostatic hyperplasia (BPH, or prostate enlargement), at two regional meetings of the American Urological Association (AUA). The trade name for silodosin will be RAPAFLO(TM).

NeoVista Unveils 18 Month Data On Novel Wet AMD Therapy At Retina Society Meeting

2008-09-30T05:32:00.011-07:00

NeoVista, Inc. made public yesterday 18-month data from the company's Phase II feasibility study examining its novel epiretinal brachytherapy for treatment of the wet form of age-related macular degeneration (AMD) at the 41st Scientific Meeting of the Retina Society.

Synvista Therapeutics Receives Approval To Begin Phase 2 Trial Of Topical SYI-2074 In Psoriasis

2008-09-30T05:32:00.009-07:00

Synvista Therapeutics, Inc. (Amex: SYI) announces that it has received approval from the Israeli Ministry of Health to begin a Phase 2 trial of a topical formulation of SYI-2074 in mild-to-moderate plaque psoriasis. The trial is expected to begin enrollment in the fourth quarter of 2008 at three sites in Israel, and is designed to enroll a total of 30 patients in a randomized, placebo-controlled study.

Potentia Pharmaceuticals Announces Positive Safety Data And Study Expansion In Phase I Trial For Lead Drug Candidate POT-4

2008-09-30T05:32:00.007-07:00

Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD) announced that the Company's leading drug candidate, POT-4, has shown early positive safety results in its Phase I study.

Retrospective Analysis Of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene

2008-09-30T05:32:00.005-07:00

A retrospective analysis of Phase 3 two-year data presented at the annual meeting of the North American Menopause Society (NAMS) suggest that postmenopausal women treated with bazedoxifene/conjugated estrogens (BZA/CE) may experience incidence of breast tenderness and abnormal mammograms no greater than those treated with placebo.

It's Your Doctor Calling: Fibromyalgia Sufferers Sought For Motivational Study

2008-09-30T05:32:00.003-07:00

Researchers at the Indiana University School of Medicine seek 200 people with fibromyalgia to determine if motivational reminder telephone calls can prompt patients to exercise more regularly. Fibromyalgia is a disease that causes pain in joints and muscles in about 5 percent of the population. Although not life-threatening, fibromyalgia can have a debilitating effect on a person's quality of life by causing body aches, headaches, stiffness and disrupted sleep.

Supplements No Better Than Placebo In Slowing Cartilage Loss In Knees Of Osteoarthritis Patients

2008-09-30T05:32:00.001-07:00

In a two-year multicenter study led by University of Utah doctors, the dietary supplements glucosamine and chondroitin sulfate performed no better than placebo in slowing the rate of cartilage loss in the knees of osteoarthritis patients. This was an ancillary study concurrently conducted on a subset of the patients who were enrolled in the prospective, randomized GAIT (Glucosamine/chondroitin Arthritis Intervention Trial).