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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...

Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient

ANN ARBOR, Mich., March 9 /PRNewswire/ -- Terumo Heart, Inc. today announced that NewYork-Presbyterian Hospital/ Columbia University Medical Center recently became the second U.S. center, and first in the Northeast, to implant the DuraHeart(TM) Left-Ventricular Assist System as part of the DuraHe...

Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblastic Leukemia

- 31% COMPLETE RESPONSE RATE - MEDIAN SURVIVAL OF 10.5 MONTHS IN COMPLETE RESPONDERS - FINAL DATA TARGETED FOR 2009 ASH ANNUAL MEETING SOUTH SAN FRANCISCO, Calif., March 3 /PRNewswire-FirstCall/ -- Hana Biosciences (Nasdaq: HNAB ) today announced new positive preliminary efficacy ...

Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound

SOUTH SAN FRANCISCO, Calif., March 2 /PRNewswire-FirstCall/ -- Hana Biosciences (Nasdaq: HNAB ) today announced that an Independent Data Monitoring Committee (IDMC) has completed a planned, pre-specified safety review of interim data from the ongoing pivotal rALLy clinical trial of Marqibo(R...

PTC Therapeutics Completes Enrollment of Pivotal Trial in Muscular Dystrophy

- Ataluren designated as generic name for PTC124 - SOUTH PLAINFIELD, N.J., Feb. 3 /PRNewswire/ -- PTC Therapeutics, Inc. (PTC) today announced that it has successfully completed patient enrollment of its pivotal clinical trial of PTC124 in patients with nonsense mutation Duchenne and Becker m...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

GENEVA, Feb. 3 /PRNewswire/ -- -- The Six-Month Primary Efficacy Endpoint of the Study was met: Both Doses of Investigational Agent Safinamide Significantly Increased "ON" Time in Levodopa-Treated Patients With mid- to Late-Stage Parkinson's Disease -- Secondary Efficacy Endpoi...

Circulation Publishes Pivotal Two-Year Results On XIENCE V(TM) Drug Eluting Stent

ABBOTT PARK, Ill., Jan. 26 /PRNewswire-FirstCall/ -- Data published online today in Circulation from the SPIRIT III U.S. pivotal trial evaluating the XIENCE V(TM) Everolimus Eluting Coronary Stent System demonstrated that Abbott's market-leading XIENCE V outperforms the TAXUS(R) Express2(TM)...

Osteotech Initiates Pivotal Clinical Trial for DuraTech(TM) BioRegeneration Matrix

First of Several Products in Development Based On Osteotech's Proprietary Human Collagen Technology to Stimulate Natural BioRegeneration; FDA Filing Anticipated in Third Quarter 2009 EATONTOWN, N.J., Jan. 7 /PRNewswire-FirstCall/ -- Osteotech, Inc. (Nasdaq: OSTE ), a leader in the emergi...

MannKind Corporation to Review Positive Results From Final Two Pivotal Phase 3 Clinical Studies in Type 1 and Type 2 Diabetes

Live Broadcast on December 18, 2008 at 9 a.m. Eastern Time VALENCIA, Calif., Dec. 15 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD ) will host a live broadcast to review clinical results from its final two Phase 3 studies of AFRESA(TM), the company's ultra rapid actin...

Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma

SAN FRANCISCO, Dec. 8 /PRNewswire/ -- Millennium: The Takeda Oncology Company today reported updated results based on extended follow up of patients from the large, international Phase III VISTA(1) trial showing continued survival improvement for patients with previously untreated multiple myeloma...

Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints

SKOKIE, Ill., Dec. 2 /PRNewswire/ -- 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 combinati...

PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.

Study Expanded to 406 Subjects FRANKLIN, Mass., Nov. 26 /PRNewswire-FirstCall/ -- PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced today that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the C...

Third Pivotal Phase 3 Study for NicOx' Naproxcinod Shows Positive Efficacy, Safety and Blood Pressure Results

SOPHIA ANTIPOLIS, France, November 24 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced that the third pivotal phase 3 study for naproxcinod in patients with OA of the hip showed a highly statistically significant result (p<0.001) on all three co-primary effica...

Cell Therapeutics' Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint

Complete Remission / Unconfirmed Complete Remission Rate 3.5 Fold Higher Compared to Standard Chemotherapy SEATTLE, Nov. 11 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it achieved the primary efficacy endpoint of its pha...

Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial

Novartis notified of data set closing, Top-line results expected in November SEATTLE, Nov. 3 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that it has closed the data set for preliminary analysis of the primary e...

Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)

TAMPA, Fla., Oct. 14 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today preliminary results from a pivotal anterior uveitis trial that compared Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% dosed four times daily (Q...

Neurobiological Technologies Announces FDA Agreement to Consolidate Viprinex Phase 3 Trials Accelerating Time to Pivotal Data

- Company Plans to Announce Interim Results in January 2009 and Final Trial Data in mid-2009 - EMERYVILLE, Calif., Oct. 13 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) (Nasdaq: NTII ) today announced that following a meeting with the U.S. Food ...

SCOLR Pharma Announces Completion of Patient Enrollment and Dosing for Pivotal Clinical Trial Evaluating Extended Release Ibuprofen

Top Line Clinical Results Expected in November 2008 BOTHELL, Wash., Oct. 9 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. (Amex: DDD ) announced today the completion of patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulati...

Recruitment Completed in Ofatumumab NHL Pivotal Study

Summary: Genmab has Completed Recruitment of Patients in the Phase III Study of Ofatumumab in Rituximab Refractory Follicular NHL COPENHAGEN, September 23 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today it has completed recruitment of patients in the pivotal Phase III st...

NicOx Announces Second Naproxcinod Pivotal Phase 3 Study (302) Meets Efficacy Primary Endpoints and Supports Non-Detrimental Blood Pressure Effect

PARIS, September 15 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced successful top-line results from the second phase 3 study for naproxcinod in 1020 patients with osteoarthritis of the knee (the 302 study). Both doses of naproxcinod (750 mg and 375 mg bid) met the t...

Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting

BRIDGEWATER, N.J., Sept. 9 /PRNewswire-FirstCall/ -- Alpharma Inc. (NYSE: ALO ), a global specialty pharmaceutical company, today announced results from its Phase III pivotal efficacy trial that showed ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochl...

338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment

SAN MATEO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced that the pivotal clinical study of Polidocanol, conducted in Germany by BioForm Medical's partner, Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler), successfully met the study primary e...

Second Pivotal Phase 3 Trial In Cystic Fibrosis Begins

SYDNEY, Australia, Sept. 4 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that it has enrolled the first subject into its second pivotal Phase 3 clinical trial evaluating Bronchitol in cystic fibrosis sufferers. The Phase 3 trial is...

First DuraHeart(TM) Left Ventricular Assist System Implanted in the U.S. Pivotal Trial

ANN ARBOR, Mich., Aug. 6 /PRNewswire/ -- Terumo Heart, Inc. announced that the first U.S. implant of the DuraHeart(TM) Left Ventricular Assist System (LVAS) took place on July 30 at the University of Michigan Cardiovascular Center in Ann Arbor, Michigan. The surgery was performed by Francis Pa...

Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant

Investor Conference Call to be held on Wednesday, August 6, 2008 at 8:00 a.m. EXTON, Pa., Aug. 5 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today positive top-line efficacy and safety results from two pivotal, Phase III clinical studies ...

Genmab and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab Chronic Lymphocytic Leukemia Pivotal Study

Summary: Phase III Pivotal Study of Ofatumumab in Refractory CLL Meets Primary Endpoint COPENHAGEN, July 31 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) and GlaxoSmithKline (LSE and NYSE: GSK) announced today positive top-line results from an interim analysis of ...

PLC Systems Defers Pivotal Study of RenalGuard(TM) in the U.S.

Clinical study and limited launch in Italy continue FRANKLIN, Mass., July 21 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC ) announced today that it will defer the commencement of the U.S. pivotal trial of its RenalGuard(TM) System in the prevention of Contrast-Induced Nephr...

Medivation Announces Publication in The Lancet of Dimebon Pivotal Trial Results in Alzheimer's Disease

- Dimebon Improved the Clinical Course of Alzheimer's Disease; Patients Experienced Statistically Significant Improvements in Memory and Thinking, Activities of Daily Living, Behavior and Overall Function - SAN FRANCISCO, July 17 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN ...

Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV

- Once-daily TMC278, the third anti-HIV compound to be developed in Tibotec virology portfolio - YARDLEY, Pa., July 17 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. announced today that two major phase III efficacy trials examining TMC278, its investigational non-nucleosi...

Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program

DANBURY, Conn., July 16 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today announced that its two pivotal Phase III VIAject(TM) clinical trials are now complete, with the last study patient visit on July 14, 2008. Results of the full trial will be released either at Biodel's poster pre...

Isolagen Completes Pivotal Efficacy Portion of Phase III Studies of Isolagen Therapy(TM) for Wrinkles

- Top-line Data Expected in August - EXTON, Pa., July 2 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announced today the completion of the pivotal efficacy portion of its Phase III clinical studies (IT-R-005/006) investigating the Isolagen Therapy(TM) for the trea...
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