Expansion in Medical Technology

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

... 2009 reflect higher expenses associated with the expansion of the Company's programs as discussed in more ... higher expenses in 2009 were primarily due to the expansion of the Company's clinical development programs, ... core team and expenses related to the Company's expansion of its drug discovery activities into new ...

Peregrine Pharmaceuticals Highlights Promising Early Data From Its Three Phase II Bavituximab Cancer Trials

... Studies Surpassed Pre-Established Criteria for expansion of Patient Enrollment - - Positive Initial ... enrollment and dosing are continuing in the expansion stage of the trial, which will enroll an ... and dosing are now underway in the expansion stage of the trial, which will enroll an ...

Peregrine Pharmaceuticals Reports Positive Preliminary Data From Phase II Bavituximab Lung Cancer Trial

... Response - - Patient Dosing Initiated in expansion Stage of Trial with Target of Enrolling 49 ... reported that patient dosing is underway in the expansion stage of the trial, which will enroll an ... that the rate of objective tumor response for the expansion stage of this trial will not be consistent with ...

Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System

... today announced reaching a critical milestone in the worldwide expansion of its DuraHeart(TM) Left-Ventricular Assist System (LVAS) as the 100th ... hundredth patient. In a fitting example of the successful ongoing global expansion of the DuraHeart LVAS program, the distinction for the 100th implant came ...

Lions Eye Institute for Transplant & Research, Inc. Launches Multi-Million Dollar, State-of-the-Art Research Institute that Will Advance the Study of Blinding Eye Diseases

... residence, sleeping quarters, and meetings/events. This marks an expansion of the current 35,000 square-foot Tampa Eye Bank facility, already the ... growth and incidence of macular degeneration and glaucoma. "The LEITR expansion means that, for the first time, diseased as well as healthy human eye ...

Late-Breaking Data Highlighting Research Advances in Several Blood Disorders to Be Presented At the American Society of Hematology Annual Meeting

... cell. In contrast, a second subset of patients (15 percent) had an early expansion of very immature malignant progenitor cells, close to the stem cell. ... of patients had a pre-existent molecular defect able to promote the early expansion of the malignant cells. With high-resolution arrays, researchers were able ...

Evalve Expands Executive Leadership Team

... sales and marketing, Sean Cleary will take responsibility for Evalve's expansion into the European markets and adoption of the MitraClip system by the ... the Evalve team and eager to take on the responsibility of leading the expansion and growth of Evalve as we begin sales in Europe and gear up for U.S. ...

CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)

... are pleased to have scheduled a meeting with the FDA to discuss a label expansion for Zevalin which could broaden its availability to patients," said James ... producing and selling Zevalin. There is also a risk that even if label expansion of Zevalin is approved, it may not result in a significant market increase ...

Sangamo BioSciences Provides Update on Diabetic Neuropathy Clinical Programs

... Sangamo Announces Completion of Accrual and expansion Plans for SB-509-701 Phase 2 Clinical Trial for Treatment of Moderate to ... that targets the major peripheral nerves in the legs and feet. The expansion protocol will enroll approximately 45 additional subjects in the trial. ...

FDA Grants NeoVista's Request to Expand CABERNET Trial to 30 Sites in the U.S.

... Agency Approves expansion of Company's Phase 3 Study for Wet AMD after 90-day ... 90-day safety data, typical of new-to-market medical devices. "With this expansion to 30 sites, we will not only be able to recruit more patients at a higher ...

PAREXEL Expands Global Clinical Pharmacology Capabilities

... services provider, today announced that the Company had completed the expansion of three Clinical Pharmacology Research Units located in Baltimore, ... studies in the early phases of clinical development. "Continued expansion of local capabilities combined with an integrated global clinical ...

FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial

... Jan. 16 /PRNewswire/ -- Ablation Frontiers, Inc. today announced the expansion of enrollment in the first ever U.S. Investigational Device Exemption ... led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, the company is ...

HealthMedia's Strongest Single Quarter Results: Growth Driven by Product Enhancements, New Partnerships

... continues to be driven by product enhancements, new partnerships, and expansion of existing relationships," explained Ted Dacko, HealthMedia President and ... to make HealthMedia's wellness programs available to its employees, an expansion of the organization's employee benefits program. HealthMedia also ...

CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary Syndromes

... Positive Opinion Coincides with expansion of The Medicines Company into Europe ... in ACS patients during the first quarter of 2008, which coincides with the expansion of our commercial operations into major European markets." The Medicines ...

New Minimally Invasive Breast Reconstructive Procedure for Breast Cancer Patients - Actively Recruiting Participants for Clinical Study

... invasive breast reconstruction technique utilizing the Brava external expansion system and liposuctioned micro-fat grafts primarily on women who have had ... survival rate, is the preparation of the recipient breast site with the expansion device (Brava) enabling greater volumes of fat to be transferred, and its ...

NewCardio Announces Master Services Agreement With Dedicated Phase I

... assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to ...

Online H1N1 Management: FairChoice Helps Schools Respond to Infectious Disease on Campus

... NEW YORK, July 29 /PRNewswire/ -- FairChoice Systems has announced an expansion of FairChoice Health, its campus health management service, in response to rising concern about H1N1 (Swine Flu). FairChoice Health empowers campus ...

Lilly and New York City Mayor Michael R. Bloomberg Announce Lilly Agrees to be First Tenant of East River Science Park; Issue Urgent Call for Healthcare Reform that Protects Innovation and Jobs

... -- will house ImClone's Research Division including approximately 125 ImClone scientists with plans to add scientists in those areas that support expansion of the ImClone pipeline. The new location enables unprecedented access to academic research organizations in the New York area. This move is ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

... being predictive of real world use including results relative to other diabetes medications; pre-clinical trials not predicting future results; label expansion requests or New Drug Application (NDA) filings, not being submitted in a timely manner; regulatory approval, including approval for exenatide once ...

Bioniche Life Sciences Inc. and Endo Pharmaceuticals Sign Licensing Agreement for Urocidin(TM)

... the treatment of bladder cancer. If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise." Graeme McRae, Chairman, President & CEO of Bioniche, added, "Endo Pharmaceuticals represents the ...

Mayo Clinic Proceedings: A Comprehensive Review of Addiction to Prescription Painkillers Among Patients and Physicians

... leads to abuse. According to Dr. Lanier, the recent growing interest in opioids stems from five sources: advances in the design of these drugs; expansion and innovation in methods of drug delivery; increased public awareness of pain management options and the appropriateness of aggressively treating ...

UPCI Joins ExCell Research Study Using Stem Cells for Leukemia and Lymphoma Patients

... in research grants and is ranked 10th in funding from the NCI. About Gamida Cell Gamida Cell Ltd. is a world leader in stem cell expansion technologies and therapeutic products. The company is developing a pipeline of products in stem cell transplantation and in tissue regeneration to ...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

... new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests not being submitted in a timely manner or receiving regulatory approval; the clinical data analyses mentioned in this press release not ...

Micromet's Blinatumomab Achieves Primary Endpoint in Phase 2 Study with Acute Lymphoblastic Leukemia Patients

... utilization of blinatumomab and other product candidates, the conduct, timing and results of future clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words "ongoing," "may," "will," "believes," ...

Micromet Presents Update on Blinatumomab's Response Rate and Duration in a Phase 1 Study in Non-Hodgkin's Lymphoma Patients

... utilization of blinatumomab and other product candidates, the conduct, timing and results of future clinical trials, and expectations of the future expansion of our product pipeline and collaborations. You are urged to consider statements that include the words "ongoing," "may," "will," "believes," ...

Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009

... not achieving the intended clinical endpoints; the DURATION-1 study extension results potentially not being accepted to support comparability; label expansion requests or NDA filings, including the NDA filing mentioned in this press release, not being submitted and/or accepted in a timely manner; regulatory ...

IBM and EU Partners Create a Better Way to Fight AIDS Virus

... that not only take into account the patient's own history, but tap into the wealth of information that EuResist researchers have amassed. The recent expansion of the EuResist database to include information from more than 33,000 patients and 98,000 therapies, and 370,000 viral load measurements, makes it ...

CuraGen Updates CR011-vcMMAE Data at ASCO

... "This study has confirmed that CR011 is active and that more total drug can be safely given with more frequent dosing," stated Dr. Simantov. "The expansion phase of the study will be used to generate a better estimate of the response rate with these schedules to compare to the once every three week ...

Trubion Announces Positive Data From a Phase 1 / 2 Study of TRU-016 for the Treatment of Chronic Lymphocytic Leukemia (CLL)

... has two components: a Phase 1 dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TRU-016, and a Phase 2 expansion cohort designed to further evaluate safety and estimate clinical activity of TRU-016 in patients with previously treated CLL or SLL. About ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... inflammation/allergy, is based on the merger in 2005 between Sumitomo Pharmaceuticals Co., Ltd., and Dainippon Pharmaceutical Co., Ltd. With global expansion plans on the horizon, this multi-billion dollar company has about 5,000 employees worldwide. Through its research and development efforts, DSP aims ...

Study Confirms Effectiveness of Innovative Prism Glasses For Hemianopia Patients

... research team found that 67 percent of patients chose to continue to wear the glasses at the end of the study. They also found that all patients had expansion of their visual field of about 22 degrees and expressed reduced difficulty in noticing and avoiding obstacles. On the other hand, only two patients ...

TriLink BioTechnologies, Inc. Announces Supply Agreement With Osmetech Molecular Diagnostics

... The eSensor(R) XT-8 system is designed to support a broad test menu. A cytochrome P450 2C9 genotyping test (RUO) is now available while planned menu expansion includes an extended warfarin panel with the proprietary 4F2 marker, a venous thrombosis panel (Factor II, Factor V Leiden and MTHFR) and a ...

Spherix Reports First Quarter 2009 Earnings

... expenses were $1.6 million in the quarter, up from $1.0 million in the previous year's quarter. The increase in R&D expenses is related to the expansion of the Phase 3 trial to India. The Company's R&D expenses for both years consisted of costs for both the Phase 3 clinical trial and a related ...

Peregrine Pharmaceuticals Completes Patient Enrollment in its Phase II Trial of Bavituximab Plus Docetaxel in Breast Cancer Patients

... forward-looking statements involve risks and uncertainties including, but not limited to, the risk that the rate of objective tumor response for the expansion stage of this trial will not be consistent with the objective tumor response experienced in the first stage of the trial and the risk that the ...

Isis and Collaborators Present New Research at the ATVB Annual Conference

... research presented at this year's ATVB in Washington D.C. showcases Isis' prolific antisense drug discovery capabilities and supports the continued expansion of Isis' cardiovascular franchise. At ATVB, Isis collaborator, Dr. Frank Sacks, Professor of Cardiovascular Disease Prevention at the Harvard ...

Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly

... technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; New Drug Applications and label expansion requests not being submitted in a timely manner or receiving regulatory approval; or manufacturing and supply issues. The potential for BYETTA and ...

Dendreon Initiates Phase 1 Clinical Trial of Small Molecule Targeting TRPM8 in Cancer

... to standard therapies. The Phase 1 trial will enroll three to six patients per cohort during the dose escalation phase of the study. An expansion cohort may be enrolled following determination of the maximum tolerated dose. The primary endpoint of the study will be safety, but patients also ...

Watson Announces United States Availability of RAPAFLO(TM) (silodosin), a Novel New Treatment in Benign Prostatic Hyperplasia (BPH)

... "The launch of RAPAFLO(TM) is an important milestone and, coupled with the forthcoming launch of GELNIQUE, marks the continued strength and expansion of Watson's Brand Division and urology franchise," said Paul Bisaro, President and Chief Executive Officer of Watson . "We are confident that the ...

NewCardio Leadership to Present Two Abstracts at ISCE Conference

... assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to ...

Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study

... being predictive of real world use including results relative to other diabetes medications; pre-clinical trials not predicting future results; label expansion requests or New Drug Application (NDA) filings, including the NDA filing for exenatide once weekly, not being submitted in a timely manner; ...