Safety in Biological Technology

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... an abstract on the CAPACITY data, focused on the safety profile of pirfenidone, has been accepted for an ... at later times. There were no remarkable safety findings. The potential product and patient ... statements. The top-line efficacy, safety and tolerability data for pirfenidone reported in ...

Angiotech Pharmaceuticals, Inc. announces financial results for the second quarter ended June 30, 2009

... the clinical trial was to evaluate the device's safety and efficacy in preventing pulmonary emboli, and ... involving 792 patients globally, is assessing the safety and efficacy of the ZILVER PTX in treating ... processes; adverse findings related to the safety and/or efficacy of our products or products sold ...

iCardiac Expands Sales and Marketing Team

... Technologies , Inc., a leader in advanced cardiac safety ECG services and automated QT analysis, announced ... avoiding false positives and negatives in cardiac safety studies." About iCardiac Technologies ... most sophisticated FDA-accepted cardiac safety assessment methodologies. iCardiac's analysis ...

GeoVax Labs, Inc. Provides Clinical Studies Update

... 80 Phase 1 trials for the initial evaluation of safety and immunogenicity of candidate HIV/AIDS ... drugs. This initial trial will determine the safety and immunogenicity of the vaccine in patients ... locally in Atlanta. This first step will be a safety trial using intensive monitoring to verify the ...

Shire plc: Core Portfolio of Products Delivers 20% Sales Growth

... clinical trials to assess the efficacy and safety of VYVANSE in non ADHD ("Attention Deficit ... the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV, request new clinical ... clinical trials to assess the efficacy and safety of VYVANSE as adjunctive therapy in depression, ...

Next Safety Releases Advanced Respirator for Infectious Diseases

... to go to work in a pandemic environment. Next safety is releasing for sale to the public respirator ... (H5N1), which never became contagious. The Next safety respirators are now being sold to the public for ... half facemasks and air supply hoods. Next safety designed its respirators with input from the CDC ...

Rib-X Pharmaceuticals Reports Positive Phase 2 Study Results for Radezolid in Community-Acquired Pneumonia

... to be efficacious and appears to have a favorable safety profile compared to other oxazolidinone ... double-blind study designed to evaluate the safety and efficacy of radezolid in the treatment of ... a day for seven to 10 days. It also evaluated the safety and tolerability of the three doses. The study ...

Poniard Pharmaceuticals Reports Second Quarter 2009 Financial Results and Provides a Corporate Update

... Clinical Developments Cardiac safety Study : Announced results from a cardiac safety study of picoplatin in patients with solid ... Administration (FDA), and evaluated the cardiac safety of picoplatin by determining its effect on the ...

SENOMYX ANNOUNCES CORPORATE UPDATE AND SECOND QUARTER 2009 FINANCIAL RESULTS

... the full sweet taste with no off-tastes. Key safety studies have been completed and the data are ... activities, including scale-up manufacturing and safety studies, intended to support regulatory filings ... ingredients may not demonstrate an acceptable safety profile; Senomyx or its collaborators may be ...

Five Questions About Protopic (tacrolimus) Ointment

... support approval of Protopic and demonstrate its safety and effectiveness in treating adults and children ... What is the important safety information for Protopic? Protopic ... h ould Kno w About Protopic Ointment The safety of using Protopic Ointment for a long period of ...

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

... 3 Randomized Study to Assess the Efficacy and safety of Perifosine Added to the Combination of ... study comparing the efficacy and safety of perifosine vs. placebo when combined with ... double-blind trial comparing the efficacy and safety of perifosine to placebo when combined with ...

Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia

... including 2 pivotal Phase 3 studies in CAP and a safety database of over 5,000 patients. (Logo: ... NDA. The AIDAC voted that Restanza demonstrated safety for the outpatient treatment of adults with ... in June relative to their positive view of the safety profile of Restanza, the therapeutic need for ...

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

... esponse, or cEVR). Additional endpoints include safety and tolerability as well as the proportion of ... United States. Anadys expects to receive 28-day safety and response (RVR) data from the 200 mg dose level by year-end and additional on-treatment safety and response data from both cohorts during the ...

Cardium Announces New Orthobiologics Product Initiative Extending Gene Activated Matrix Technology to Deliver Bone Growth Factors

... and the University of Michigan demonstrating the safety and benefits of adenovector-mediated ... Delivered to Alveolar Bone Defects Exhibits safety and Biodistribution Profiles Favorable for ... and its collaborators demonstrates the potential safety and benefits of PDGF gene therapy for periodontal ...

Sangamo BioSciences Reports Second Quarter 2009 Financial Results

... in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic ... also has a Phase 1 clinical trial to evaluate safety and clinical effect of a ZFP Therapeutic for the ... trial results will validate and support the safety and efficacy of ZFP Therapeutics, and the ability ...

Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients With Endometriosis

... (Nasdaq: NBIX ) today announced new six month safety and efficacy results from its fourth Phase II ... month (Lilac Petal Study) results, a favorable safety profile and clinically meaningful efficacy have ... mg doses of elagolix and, given the superior bone safety profile, the 150 mg once daily dose appears to be ...

Sunesis Reports Financial Results for the Second Quarter 2009

... demonstrating that voreloxin shows promising safety and efficacy in AML and in platinum-resistant ... limitation statements related to the potential safety and efficacy and commercial potential of ... clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the ...

iCardiac Processes Volume of Data Equivalent to One Thousand Traditional Thorough QT Studies

... Technologies, Inc., a leader in advanced cardiac safety biomarker development and automated QT analysis, ... most sophisticated FDA-accepted cardiac safety assessment methodologies. iCardiac's analysis ... Beyond QT, a suite of advanced ECG-based cardiac safety markers that have been accepted as secondary ...

Cardium Provides Update on Phase 2b Excellarate Clinical Study and Plans for Additional Tissue Repair Applications

... study and announced plans to provide detailed safety and efficacy data for their Excellarate(TM) ... 12-week evaluation period with respect to key safety and efficacy criteria. While the efficacy data ... evaluation period, there continues to be no safety concerns since our announcement of completion of ...

Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual Meeting

... clinical trial was focused on evaluation of safety in the clinical application of Histogen's Hair ... clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, ... biopsies were utilized to evaluate treatment safety and efficacy. 84.6% of the patients ...

Sangamo BioSciences Announces Second Quarter 2009 Conference Call and Webcast

... in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic ... also has a Phase 1 clinical trial to evaluate safety and clinical effect of a ZFP Therapeutic for the ... trial results will validate and support the safety and efficacy of ZFP Therapeutics. Further, there ...

ERT Appoints New Vice President of Project Management

... report to the Executive Vice President of Cardiac safety Operations. In this new role, Ms. Miller will be ... Management team works closely with the Cardiac safety and Customer Care teams. Amy Furlong, EVP, Cardiac safety Operations at ERT, said, "With Tammy's extensive ...

Neogen Reports 16% Increase in Revenues

... "Neogen's mission to provide food and animal safety solutions to diverse domestic and international ... Revenues from the company's Animal safety segment grew 29% in 2009 compared to the prior ... the fourth quarter, and 4% for the year. Animal safety was able to capitalize on the acquisition of the ...

Specialty Technical Consultants becomes Women-Owned Business Enterprise (WBE)

... can now contract for Environmental, Health and safety (EHS) services with a highly qualified ... can now contract for Environmental, Health and safety (EHS) services with a highly qualified ... by helping clients manage complex worker safety and environmental challenges as business issues, ...

Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System

... DosePro is based on extensive efficacy and safety data from original filings for needle-based ... by Zogenix on bioequivalence, usability and safety specific to the Sumavel DosePro combination ... of a second dose. Important safety Information Sumavel DosePro is ...

Improving Transfusion Safety: Fenwal, Verax Biomedical Sign Agreement for Rapid, Point-of-Care Bacteria Test

... on improving blood collection, separation, safety and availability, announced today it has signed a ... for patient safety." "Transfusion safety is central to the mission of Fenwal and our ... in the development of products that improve blood safety worldwide," said Jim Lousararian, Verax president ...

USC Hospitals Extend Relationship With Quantros to Manage Compliance and Risk

... July 14, 2009 -- Quantros, a leading provider of safety and quality software and professional services ... Cancer Hospital will continue to use the Quantros safety and Risk Management solution (SRM), a ... built to gathers data so you can identify safety issues and track intervention in real-time, ...

ParagonRx Creates New Website Featuring REMS Help Center for Pharma

... ParagonRx CEO Jeffrey Fetterman, "in that patient safety is no longer merely a statistic that is passively measured for regulatory compliance. Now, patient safety is an objective that is actively managed by many ... share an overwhelming desire to improve patient safety while ensuring the benefits of a pharmaceutical ...

Neogen Named to Fortune's List of Fastest Growing Companies

... community, as well as in our food and animal safety industry, trust is earned. We're extremely proud ... to food and animal safety. The company's Food safety Division markets dehydrated culture media, and ... diseases and sanitation concerns. Neogen's Animal safety Division markets a complete line of diagnostics, ...

Monitoring water through a snake's eyes

... Although most Americans take the safety of their drinking water for granted, that ... has developed a new system to monitor the safety of a building or community's water supply in real ... amounts well below the World Health Organization safety threshold. Preliminary field experiments have ...

iCardiac Selected by Top 10 Pharmaceutical Company

... Technologies, Inc., a leader in advanced cardiac safety biomarker development and automated QT analysis, ... both increase precision of early clinical cardiac safety studies as well as minimize the current ... most sophisticated FDA-accepted cardiac safety assessment methodologies. iCardiac's analysis ...

Hospira Announces New Contract With MedAssets for Intravenous Solutions, Renewal of Infusion Devices Agreement

... Symbiq(R) infusion system with Hospira MedNet(R) safety software; and pain management pumps, such as the LifeCare PCA(R) device with Hospira MedNet(R) safety software, and GemStar(R) ambulatory devices. ... play a critical role in improving patient safety as well as enhancing quality of care and ...

EFSA Issues Positive Safety Statement for the Use of Chromium Picolinate in EU Food Supplements

... The European Food safety Authority (EFSA) concludes no safety concerns for the use of chromium picolinate in ... brands, announced today that the European Food safety Authority (EFSA) released ...

YM BIOSCIENCES' SUBSIDIARY RESOLVES PROPOSED ARBITRATION WITH ONCOSCIENCE AG

... important cancer drug globally." "Its unique safety profile and efficacy make nimotuzumab a very ... will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; ... will continue to generate positive efficacy and safety data in future clinical trials; and that YM and ...

Insmed Announces Results of IPLEX(TM) Phase II Trial in Myotonic Muscular Dystrophy

... life, insulin sensitivity, lipid metabolism, and safety and tolerability of IPLEX(TM). The results ... well tolerated in MMD subjects and demonstrated a safety profile consistent with previous studies of ... "IPLEX(TM) continues to demonstrate a strong safety profile and we believe it offers a potential ...

OmniComm Systems Announces Acquisition of EDC Business of eResearchTechnology

... to collect, interpret, and distribute cardiac safety and clinical data, today announced that OmniComm ... We will continue to expand our core cardiac safety and ePRO business lines." Revenues of the ... http://www.ert.com ) is a provider of cardiac safety and ePRO technology and services to the global ...

B. Braun Medical Inc. Recognized by Industry for Manufacturing Influential Medical Devices

... PVC-free, DEHP-free products and passive safety devices, as being among the most influential ... ) B. Braun's Outlook(R) safety Infusion System , PINNACLE(R) TPN Management ... IV solutions. The company's Outlook(R) safety Infusion System incorporates a host of ...

Oncothyreon announces initiation of Phase 3 trial of Stimuvax in breast cancer

... survival, quality of life, tumor response and safety will also be assessed in this study. ... the timing and results of regulatory reviews, the safety and efficacy of Stimuvax, the indications for ... or clinical trials will be predictive of either safety or efficacy in future clinical trials. These and ...

Human Genome Sciences Announces Completion of Enrollment in Phase 2b Monthly-Dosing Trial of Albuferon(R)

... - Trial conducted by Novartis evaluating safety and efficacy of Albuferon administered every four ... in a Phase 2b clinical trial to evaluate the safety and efficacy of Albuferon(R) (albinterferon ... an important treatment option if it demonstrates safety and efficacy comparable to peginterferon alfa-2a ...

Neogen Named to Fortune's List of 40 Stocks 'To Retire On'

... which sells an array of products focused on food safety from farm to factory, including test kits that ... to food and animal safety. The company's Food safety Division markets dehydrated culture media, and ... diseases and sanitation concerns. Neogen's Animal safety Division markets a complete line of diagnostics, ...