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Pivotal in Medical News

Forest Laboratories Announces Positive Top-line Data from Two Pivotal Phase III Trials of Ceftaroline for the Treatment of Community-acquired Bacterial Pneumonia (CABP) Requiring Hospitalization

Ceftaroline Met Primary Objective and Achieved High Clinical Cure Rates in Adult Patients Hospitalized for Moderate to Severe CABP NEW YORK, June 19, 2009 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) announced today positive results from two global multi-center Phase III...

Medifocus, Inc. receives Authorization Approval from Health Canada to launch its pivotal Phase III clinical study of focused microwave heating for treatment of breast cancer in Canada

VANCOUVER, June 9 /PRNewswire-FirstCall/ - Medifocus, Inc. (TSXV:MFS) is pleased to announce that it has been granted the Investigational Testing Authorization (ITA) from Health Canada's Medical Device Bureau (MDB) for initiating Medifocus' pivotal trial with the Microfocus APA 1000 Breast Thermot...

Arena Pharmaceuticals Announces Positive Lorcaserin Pivotal Phase 3 Obesity Trial Results: Meets All Primary Efficacy and Safety Endpoints

- Lorcaserin Very Well Tolerated Throughout Two-Year Study - Conference Call Scheduled for Today at 8:30 a.m. EDT SAN DIEGO, March 30, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) announced today positive top-line results from BLOOM (Behavioral ...

Neuromed Announces Exalgo(TM) (hydromorphone HCl) Extended-Release Tablets (CII) Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial

CONSHOHOCKEN, PA and VANCOUVER, BC, March 23 /PRNewswire/ - Neuromed Pharmaceuticals, Inc. today announced positive results of a pivotal phase 3 clinical trial of its lead investigational drug, Exalgo (hydromorphone HCl) Extended-Release Tablets (CII) (previously NMED-1077 and OROS(R) Hydromorphon...

WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD

OAKLAND, Calif., Jan. 8 /PRNewswire-FirstCall/ -- (Nasdaq: WHRT ) World Heart Corporation ("WorldHeart") announced today that it has submitted an Investigational Device Exemption ("IDE") application to the US Food and Drug Administration ("FDA" or the "Agency") for a pivotal Bridge-to-Transpla...

MannKind Reports Positive Results from Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes

Pivotal efficacy and safety studies meet primary endpoints VALENCIA, Calif., Dec. 4 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD ) today announced that it has met the primary endpoints of its final two pivotal Phase 3 studies of AFRESATM, the company's ultra rapid act...

Horizon Therapeutics announces 2 pivotal HZT-501 Phase 3 trials meet primary endpoints

Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT 501, met all primary endpoints. HZT 501, a novel, proprietary fixed-dose combination product containing ibuprofen and ...

MonoSol Rx Successfully Completes Pivotal Bioequivalence Studies for Ondansetron Thin Film NDA

Expects to File NDA with FDA in Early to Mid-2009 WARREN, N.J.,Dec. 2 /PRNewswire/ -- MonoSol Rx, the developers of PharmFilm(R) technology and a drug delivery company specializing in dissolving thin film pharmaceutical products, and Strativa Pharmaceuticals, the proprietary products divi...

Intellect Neurosciences, Inc. Validates Pivotal European Patent for Alzheimer's Monoclonal Antibody Platform

Follows Option and Royalty-Bearing License Agreements with Top Tier Global Pharmaceutical Companies NEW YORK, Nov. 11 /PRNewswire-FirstCall/ -- Intellect Neurosciences, Inc. (OTC Bulletin Board: ILNS), a biopharmaceutical company focused on development of disease-modifying therapeutic agents...

SCOLR Pharma, Inc. Announces Positive Top-Line Results From Pivotal Clinical Trial Evaluating Efficacy of Extended-Release Ibuprofen

Pivotal Phase III Trial Primary Endpoints Achieved for SCOLR's 12 Hour Ibuprofen BOTHELL, Wash., Nov. 6 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD ) today reported favorable top-line results from its pivotal Phase III trial to evaluate the safety and efficacy of its 12 hour CDT...
Pivotal in Medical Technology

Cardica Announces Publication of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results

REDWOOD CITY, Calif., July 22 /PRNewswire-FirstCall/ -- Cardica, Inc. (Nasdaq: CRDC ) today announced that the full results of the PAS-Port system multi-center pivotal trial, known as the EPIC trial, were published in the July issue of the peer-reviewed publication The J ournal ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

THOUSAND OAKS, Calif., July 7 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN ) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and ...

Enrollment in Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Achieves Seventy-Five Percent Accrual

NEW YORK, June 8 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH ), a medical technology company testing its proprietary percutaneous hepatic perfusion (PHP(TM)) system for the treatment of cancers of the liver, announced today that it has achieved the seventy-five percent enroll...

Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

- Extended Median Survival by 4.1 Months and Increased 3-Year Survival by 38 Percent Compared to Placebo - - First Active Cellular Immunotherapy for Cancer to Prolong Survival - - Company to Host Webcast at 5:30 pm ET - CHICAGO and SEATTLE, April 28 /PRNewswire-FirstCall/ -- Dendreo...

Facet Solutions, Inc. Expands U.S. Pivotal Study With Next Generation Implant System

HOPKINTON, Mass., April 27 /PRNewswire/ -- Facet Solutions, Inc. today announced that it has expanded its Pivotal Study to 12 sites in the United States. The ACADIA(TM) Facet Replacement Pivotal Study for the treatment of lumbar spinal stenosis utilizes the second generation design technology from...

Torax Medical Launches Pivotal Clinical Study of New Acid Reflux Treatment

ST. PAUL, Minn., April 3 /PRNewswire/ -- Torax Medical Inc., a medical device company focused on the minimally invasive treatment of gastroesophageal reflux disease (GERD) has commenced a pivotal clinical trial of its LINX(TM) Reflux Management System. The trial, which is being conducted at 15 le...

QuatRx Completes Enrollment of Ophena(TM)(Ospemifene Tablets) Final Pivotal Phase 3 Study in Women with Postmenopausal Vaginal Atrophy

ANN ARBOR, Mich., March 31 /PRNewswire/ -- QuatRx Pharmaceuticals, a privately-held biopharmaceutical company, today announced that it has completed enrollment in the Company's second pivotal Phase 3 clinical trial of Ophena(TM) (ospemifene tablets). Together with the previously completed firs...

Arena Pharmaceuticals to Host Conference Call and Webcast on Monday, March 30, 2009 to Discuss Lorcaserin Pivotal Phase 3 Obesity Trial Results

SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA ) today announced it will hold a conference call and webcast on Monday, March 30, 2009 at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss top-line results from BLOOM (Behavioral modification and Lo...

Impulse Dynamics Announces Pivotal Results at the American College of Cardiology Annual Meeting Late-Breaking Session

Long-Term Data Demonstrate The OPTIMIZER(R) System to be Safe and Effective ORLANDO, Fla., March 29 /PRNewswire/ -- Impulse Dynamics (U.S.A.) Inc. announced today findings from the FIX-HF-5 study of its OPTIMIZER System at the 58th Annual Scientific Session of the American College of Cardiol...

VirtualScopics' Quantitative Imaging Provides Primary Endpoint in Cartilage Repair Pivotal Clinical Trial

Pioneering study uses quantitative imaging endpoints from MRI analyses ROCHESTER, N.Y., March 12 /PRNewswire-FirstCall/ -- VirtualScopics, Inc. (Nasdaq: VSCP ), a leading provider of quantitative imaging for clinical trials, today announced that BioSyntech Inc., a Canadian medical device co...

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Pivotal in Medical Products

NeutroSpec™

Description:...pec attaches to the white blood cells (and myeloid precursors) at the site of the infected appendix, "lighting up" the infection at its source. In the pivotal trial, NeutroSpec was found to be 96 percent accurate in ruling out appendicitis within 90 minutes....
Company:Tyco Healthcare Group LP

Hip Stabilizer

Description:...ncrements. The unisex male or female pelvic component and vertical adjustability at hip and thigh has a circumferential hip adjustment with padded pivotal back tilt that fits full hip to straight body types, offers medial condylar containment for the right or left. The HAOs trimmable polyethylene comp...
Company:Restorative Care of America

Medtronic Hall™ Mechanical Heart Valve

Features:...emo-compatible. Titanium is a proven heart valve material. A central disc aperture allows free rotation of the disc along the central guide strut. The pivotal axis and downstream disc translation are designed to improve flow around the disc as well as through the minor orifice behind the disc, to enhance thr...
Company:Medtronic Inc.

Prolieve™ Thermodilatation System

Features:...en for whom drug therapy is typically indicated. Eighty-two percent (82%) of patients do not require post-treatment catheterization. (Results based on pivotal clinical trial, 140 patients treated.) ...
Company:Boston Scientific Corporation
Pivotal in Medical Dictionary

Emergency Medicine

...r Level I trauma center. Residents ... Johns Hopkins Department of Emergency Medicine and Residency Program ... Emergency medicine plays pivotal roles in the health care system, medical ... Emory University School of Medicine , Department of Emergency Medicine ... Residency Training Pr...
Pivotal in Biological News

Single molecular 'mark' seen as pivotal for genome compaction in spores and sperm

In higher order animals, genetic information is passed from parents to offspring via sperm or eggs, also known as gametes. In some single-celled organisms, such as yeast, the genes can be passed to the next generation in spores. In both reproductive strategies, major physical changes occur in the g...

Experimental treatment halts hypoxic-ischemic brain injury in newborns

... divisions of Developmental Biology and Neurology at Cincinnati Children's. Besides demonstrating the brain's plasminogen activator system plays a pivotal role in neonatal cerebral hypoxic-ischemic brain injury, Dr. Kuan said the study also shows this system may be a promising therapeutic target in infan...

The right messenger for a healthy immune response

...is research assistant, the scientist Natalia Zietara, investigated what Beta-Interferon is doing in immune cells. She found a molecular factor that is pivotal in producing the pathogen's profile and which is regulated by Beta-Interferon. The factor belongs to a group of proteins that is usually produced in c...

Data published in the New England Journal of Medicine support use of raxibacumab (ABthrax) for the treatment of inhalation anthrax

...d July 9, 2009 Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced publication by the New England Journal of Medicine of the results of two pivotal animal efficacy studies, which showed the life-saving potential of the Company's human monoclonal antibody drug raxibacumab (ABthrax), as well as the ...

Explosive growth of life on Earth fueled by early greening of planet

...losion of life, roughly 540 million years ago, when complex, multi-cellular life burst out all over the planet. While scientists can pinpoint this pivotal period as leading to life as we know it today, it is not completely understood what caused the Cambrian explosion of life. Now, researchers led by Ari...

The sound of light: Innovative technology shatters the barriers of modern light microscopy

...s of a millimeter). And best of all, the sedated fish wakes up and recovers without harm following the procedure. Dr. Daniel Razansky, who played a pivotal role in developing the method, says, "This opens the door to a whole new universe of research. For the first time, biologists will be able to opticall...

Oscar Pistorius: Previously confidential study results released on amputee sprinter

...erests of Oscar Pistorius, other track athletes and the sport of Track and Field. The controversy raised by Oscar's inspiring performances presents a pivotal case for the future regulation of prosthetic and other technology in organized athletics. Accordingly, disseminating all the available facts is essen...

Toxic molecule may help birds 'see' north and south

... CHAMPAIGN, Ill. Researchers at the University of Illinois report that a toxic molecule known to damage cells and cause disease may also play a pivotal role in bird migration. The molecule, superoxide, is proposed as a key player in the mysterious process that allows birds to "see" Earth's magnetic fi...

Slicing chromosomes leads to new insights into cell division

...laser pulses to slice off pieces of chromosomes and observe how the chromosomes behave, biomedical engineers at the University of Michigan have gained pivotal insights into mitosis, the process of cell division. Their findings could help scientists better understand genetic diseases, aging and cancer. ...

Conservationists seek to identify prime stopover sites for migrating birds

...ntal science at RIT, provided GIS expertise, and David Mathiason, director of the RIT honors program and a statistician, designed the model. Both were pivotal to the study, says Waud. "This is one of the most important projects in terms of conservation that any of us will ever have the opportunity to work...
Pivotal in Biological Technology

Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide for Treatment of Cutaneous T-cell Lymphoma

Largest clinical study ever involving patients with cutaneous T-cell lymphoma on schedule for completion in June 2010 RADNOR, Pa., June 29 /PRNewswire/ -- Yaupon Therapeutics, a privately held specialty pharmaceutical company, has announced it has completed enrollment for a pivotal Phase 2 c...

BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel(R) Cartilage Repair Device

LAVAL, QC, June 17 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced statistically significant results from an analysis of patients who completed their 12 month follow-up in the BST-CarGel(R...

Medivation Completes Enrollment in Confirmatory, Pivotal Phase 3 'CONNECTION' Trial of Dimebon in Patients With Alzheimer's Disease

SAN FRANCISCO, June 11 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN ) today announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer's d...

Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial

Updated Safety data presented at BIO International Convention in Atlanta ATLANTA, May 19 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) released updated safety data today from its pixantrone phase III 301 EXTEND trial demonstrating the effectiveness of pixantr...

BioMS Medical's pivotal international multiple sclerosis trial receives positive review from Data Safety Monitoring Board

Toronto Stock Exchange Symbol: MS EDMONTON, April 21 /PRNewswire-FirstCall/ - BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's pivotal phase III MAESTRO-01...

PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study

- Study Meets Primary Endpoint Showing Statistically Significant Improvement in Overall Survival - - First Active Immunotherapy for Cancer to Prolong Survival - - Full Data to be Presented at Plenary Session at Upcoming AUA Annual Meeting - - Company to Host a Conference Call Today ...

ExonHit Therapeutics Invested Strongly in 2008 for Pivotal 2009 Results

PARIS, March 4 /PRNewswire-FirstCall/ -- 2008 Key milestones - Strong R&D investments, especially in EHT Dx21 and EHT 0202 clinical programs: - Recruitment of 311 samples achieved for EHT Dx21 - Start of Phase IIa for EHT 0202 in Alzheimer's disease - Expansi...

BioSyntech Achieves Enrolment Goal for Pivotal Trial of BST-CarGel(R), its Cartilage Repair Device

LAVAL, QC, Feb. 2 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced that it has completed enrolment for the Canadian-European pivotal trial of its cartilage repair device, BST-CarGel(R). The...

BioSyntech to conclude enrolment for pivotal BST-CarGel(R) trial in February 2009

LAVAL, QC, Jan. 14 /PRNewswire-FirstCall/ - BioSyntech, Inc. (TSX: BSY), a biotechnology company developing biotherapeutic thermogels for regenerative medicine, today announced that it will conclude enrolment next month for the Canadian-European pivotal trial of its cartilage repair device, BST-Ca...

Enrollment in Delcath's Pivotal Phase III Metastatic Melanoma Clinical Trial Reaches Halfway Point

NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH ), a medical technology company testing its proprietary Percutaneous Hepatic Perfusion ("PHP") System for the treatment of cancers of the liver, announced today that the first fifty percent (46 of 92) of patients h...
Pivotal in Biological Definition

Diabetes mellitus

... statins might be needed in primary and secondary prevention of cardiovascular complications and mortality. Ideal control of hypertension plays a pivotal role in preventing both diabetic nephropathy and cardiovascular disease. There is emerging solid evidence that full-blown diabetes mellitus type 2 ...

Glycome

...is: "...probably thousands of times as complicated as the genome, in magnitude of complexity and level of diversity". (Perkel 2002) There is a pivotal body in this field, called the Consortium for Functional Glycomics (CFG) funded by the (US) National Institute of General Medical Sciences . This b...

Major histocompatibility complex

...and III. The A, B, and C genes belong to MHC class I while the six D genes belong to class II. Besides being scrutinized by immunologists for its pivotal role in the immune system, the MHC has also attracted the attention of many evolutionary biologists, due to the high levels of allelic diversity f...

Stem cell

...issue, including neurons , smooth muscle cells and fat-cells. These were found in the dermis , the inner layer of the skin. These stem cells play a pivotal role in healing small cuts. Blood vessels , the dental pulp, the digestive epithelium , the retina , liver and even the brain are all said to c...
Pivotal in Biological Dictionary

Stigma

... Stigma (album), an album recorded by the band EMF in 1992 ... Stigma (Italian band), death-core band signed to pivotal Rockordings ... Social stigma is severe social disapproval of personal characteristics or beliefs that are perceived to be against cultural norms...

Estrogen

...k that you will develop endometrial cancer (cancer of ... Before you begin taking estrogen , tell your doctor if you have ... Estrogen plays a pivotal role in the early ... At menopause the ovaries stop producing estrogen . However, the other sources continue to produce estrogen . ... ... that h...

CDNA library

...lines. ... offers a wide range of cDNA libraries produced from a normal and diseased ... cDNA LIBRARIES ... cDNA libraries that are the pivotal component of OriGene's ... For each library , oligo(dT)-primered cDNA was synthesized from high quality ... Full Length cDNA Library Constri...
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