Studies in Biological Technology

Arizona Pain Specialists Contend Recent Vertebroplasty Studies are Misleading

... SCOTTSDALE, Ariz., Aug. 7 /PRNewswire/ -- Two studies released August 6, 2009 in the New England ... in the field, this is incorrect, as both studies actually demonstrate a significant improvement in ... is actually a facet injection." "These studies actually show that both treatments are ...

Novavax Reports Second Quarter 2009 Financial Results

... support Phase III clinical development and other studies necessary to achieve market authorization of the ... the scope, rate and progress of its preclinical studies and clinical trials and other research and ... trial results; even if the data from preclinical studies or clinical trials is positive, the product may ...

NeurogesX Reports Second Quarter 2009 Results

... funding for NGX-1998 and post-marketing studies to support Qutenza EU marketing efforts ... activities, including EU post-marketing studies of Qutenza and the further evaluation of ... In addition to funding post-marketing studies for Qutenza, the agreement with Astellas included ...

Viral Genetics Creates Subsidiary to Develop Cancer Therapy

... acids. That process has been found in animal studies to not only directly cause cancer cells to die ... disease or health condition, the development of studies and strategies leading to commercialization of ... carry out the development plan, the completion of studies and tests on time or at all, and the successful ...

InterMune Reports Second Quarter 2009 Financial Results and Business Highlights

... of six-month and nine-month chronic toxicology studies in rats and monkeys, respectively which clear the ... 2. Treatment effect in the CAPACITY studies was also generally consistent with the Phase 3 ... events were comparable to previous clinical studies of pirfenidone. New, pre-specified ...

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

... continues to be encouraged with its preclinical studies with AT2220 in combination with ERT. As ... effort, Amicus continues to conduct preclinical studies in Parkinson's disease and is investing in new ... timing and reporting of results from preclinical studies and clinical trial evaluating Amicus' candidate ...

Pharmasset to Present at Canaccord Adams Conference

... is also in INFORM studies, the first series of studies designed to assess the potential of combinations ... Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic ... analog which recently began Phase 1 clinical studies and Racivir, for the treatment of HIV, which has ...

Five Questions About Protopic (tacrolimus) Ointment

... under the age of 2.(5) What cli n ical studies w ere conducted to support the approval of ... Three randomized, double-blinded, clinical studies using un-medicated ointment were conducted to ... to severe eczema.(7,8,9) In the adult studies of 632 patients, a significantly greater number ...

Micromet Receives European Orphan Drug Designation for Treatment of Acute Lymphoblastic Leukemia with BiTE Antibody Blinatumomab

... so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD ... appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety ... results from early research, preclinical studies or clinical trials may not be confirmed upon ...

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

... 2008 based on the results of 53 clinical studies including 2 pivotal Phase 3 studies in CAP and a safety database of over 5,000 ... available and reported from our ongoing pivotal studies in plague and tularemia by the end of 2009. We ...

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

... Anadys has completed three Phase I clinical studies of ANA598 that have demonstrated potent antiviral ... dosing in two long-term chronic toxicology studies of ANA598 (26 weeks duration in rats and 39 weeks ... the results of preclinical and early clinical studies may not be predictive of future results, and ...

Anadys Pharmaceuticals Reports Second Quarter 2009 Financial Results and Program Highlights

... the now completed 13-week GLP animal toxicology studies and the Phase I oncology clinical trial. The ... and the ongoing long-term chronic toxicology studies which were initiated in September 2008. ... is completed in two long-term, chronic toxicology studies of ANA598 (26 weeks duration in rats and 39 weeks ...

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

... synthetic graft materials. The Company's studies have shown that proliferative cells migrate into ... or trends observed in pre-clinical or clinical studies or procedures will be reproduced in subsequent studies or procedures, that the MATRIX study or other ...

ImmuneRegen BioSciences Confirms Homspera's Therapeutic Anti-Influenza Effect on Pandemic H1N1 Influenza Virus After Oral Administration

... Preliminary analysis of ongoing bioavailability studies in rats had revealed the oral administration of ... both oral and intra-duodenal administration in studies performed by a major, global contract research ... findings, the Company commissioned H1N1 virus studies to be performed in the laboratories of a ...

Sunesis Reports Financial Results for the Second Quarter 2009

... new data on all three of our Phase 2 voreloxin studies at ASCO," said Daniel Swisher, Chief Executive ... "As we finish enrollment of both of our Phase 2 studies in AML, we are actively planning for an ... or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the ...

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

... are expected to be used to support additional studies and applications of Tissue Repair's Gene ... or procedure will be reproduced in subsequent studies or procedures, that clinical studies even if successful will lead to product ...

SAPHRIS(R) (asenapine) Meets Primary Endpoint in Long-Term Extension Study in Patients With Predominant, Persistent Negative Symptoms of Schizophrenia

... system, Schering-Plough Research Institute. "Few studies with the antipsychotics currently available on ... combined data for these two identically designed studies showed a statistically significant treatment ... year of treatment. These large Phase III studies were conducted following a previous Phase II ...

Biomodels Expands Efforts in Cancer Supportive Care, Pulmonary Fibrosis; Preclinical Research Organization Names Dr. Stephen T. Sonis as Partner

... Dr. Sonis is widely recognized for his studies on the molecular and cellular pathogensis of ... in 1997, has developed and conducted preclinical studies for biotechnology and pharmaceutical companies, ... The company specializes in (non-GLP) predictive studies that evaluate efficacy and define mechanism of ...

Tobira Therapeutics Inc. Announces Phase I Data Demonstrating Pharmacokinetic Properties of TAK-652 for the Treatment of HIV

... data and results from two Phase I pharmacokinetic studies for TAK-652, an investigational compound being ... (2ng/mL) with or without food. In both studies TBR-652 was safe and well tolerated in this ... mg in 2 tablet formulations. "These two Phase I studies provide encouraging support for TAK-652 as a ...

Viral Genetics Retires Nearly $3.5 Million Convertible Debt and Provides Updates on Capital Structure and Stock Issuances

... disease or health condition, the development of studies and strategies leading to commercialization of ... carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance ...

REMERON(R) Now Approved in Japan for the Treatment of Depression in Adult Patients

... adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other ... this risk with the clinical need. Short-term studies did not show an increase in the risk of ... (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of ...

PharmAthene's 2nd Generation rPA Anthrax Vaccine, SparVax(TM), Completes FDA Regulatory Strategy Review

... and induces an immune response in humans. These studies suggest that three doses of SparVax(TM), ... to induce protective immunity. In preclinical studies SparVax(TM) has also demonstrated the capability ... Ames strain. The clinical and non-clinical studies for SparVax(TM) have been carried out under ...

Viral Genetics Information Now Available Through OTCIQ.com and Pink Sheets Website

... disease or health condition, the development of studies and strategies leading to commercialization of ... carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance ...

Spanish Government Selects Novavax's VLP Technology for Comprehensive Flu Vaccine Solution in Spain

... support Phase III clinical development and other studies necessary to achieve marketing authorization of ... Company is currently conducting Phase II clinical studies of a seasonal flu vaccine and recently announced ... the scope, rate and progress of its preclinical studies and clinical trials and other research and ...

Palkion Selects Novel Oral Development Candidate for the Treatment of Anemia

... that it has initiated preclinical development studies for its orally available anemia therapeutic ... the initiation of safety and efficacy clinical studies in 2010. There is a high level of enthusiasm as ... than expected start of preclinical development studies is an affirmation of CrystalGenomics' capability ...

Preclinical Proof-of-Concept Studies Published for Novavax Seasonal Influenza Virus-Like-Particle Vaccine

... be important for protection against flu in human studies of influenza vaccines. In addition, ... drifted strains. We look forward to future studies to evaluate the breadth of the immune response ... the scope, rate and progress of its preclinical studies and clinical trials and other research and ...

Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study

... protect against human infection from anthrax. In studies conducted by the U.S. Army Medical Research ... data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal ...

Amgen to Participate in Reproductive Health Drugs Advisory Committee Meeting in August

... of exposure to denosumab. Two Phase 3 pivotal studies with fracture endpoints, in the osteoporosis and ... to reduce the incidence of fractures, and all six studies showed denosumab's ability to increase bone ... all skeletal sites measured. In the two pivotal studies with fracture endpoints, the incidence and types ...

Berlin Heart Inc. Receives FDA Orphan Product Development Grant

... or conditions. At this time, only clinical studies qualify for consideration. All studies must be conducted under an Investigational New ... depending on the availability of funds. On-going studies are funded first with the remainder of funds ...

Celsis Outlines the Top Five Advantages of Cryo-plateable Hepatocytes

... limitations of freshly isolated hepatocytes for studies like induction severely restrict the researcher's ... at the laboratory, controlling the scheduling of studies and accelerating time to market. Standard ... model for stability, transport and induction studies as evidenced in peer-reviewed literature. As ...

New Phase 3 Data Continue to Indicate that Wyeth's Investigational 13-valent Vaccine Has the Potential to Broaden Coverage Against Pneumococcal Disease

... Infectious Diseases (ESPID) come from seven core studies in the pediatric clinical trial program for ... Phase 3 Data Results Data from the studies presented at ESPID indicate that Prevenar 13 is ... Safety Information for Prevenar In clinical studies (n=18,168), the most frequently reported adverse ...

Anadys Pharmaceuticals, Inc. Announces Strategic Restructuring to Focus Operations on Continuing the Advancement of ANA598

... analysis of data from current cohorts in ongoing studies in hepatitis C and oncology, Anadys intends to ... "We have now completed three Phase I studies of ANA598 and we have seen potent antiviral ... which may not be duplicated in future clinical studies of longer duration, the planned timing for ...

ViroPharma Receives Complete Response Letter for Cinryze(TM) Supplemental Biologics License Application for Acute Treatment of Hereditary Angioedema

... against angioedema attacks. In clinical studies and in commercial use, Cinryze has been generally ... its supplemental BLA or conduct future clinical studies with Cinryze as a treatment for acute attacks of ... studies, there can be no assurance that such studies will demonstrate that Cinryze successfully treats ...

Data on VIVUS' Qnexa To Be Presented During Two Podium Presentations at ADA Annual Meeting

... 5-9, 2009 in New Orleans, Louisiana. Previous studies have shown significant weight loss with Qnexa ... chief executive officer of VIVUS. "In clinical studies to date, Qnexa has demonstrated significant ... There are no guarantees that future clinical studies discussed in this press release will be completed ...

Celsense, Inc Receives NIH Grant to Translate Cell Imaging Technology for Clinical Use

... the National Institutes of Health. The funded studies will be the first effort to evaluate Cell Sense, ... reagent, for clinical use. Additionally, the studies will garner preliminary data critically important ... is possible. Existing data from pre-clinical studies using human cells show that the Cell Sense ...

Cimzia(R) (certolizumab pegol) Provides Long-Term Remission and Response Rates in Infliximab-Refractory Crohn's Patients

... controlled and open-labeled portions of CIMZIA studies of Crohn's disease and other diseases, ... duration of the controlled portions of the studies preclude the ability to draw firm conclusions. In studies of CIMZIA for Crohn's disease and other ...

NIMOTUZUMAB DEMONSTRATES EFFICACY IN RANDOMIZED HEAD & NECK CANCER STUDY WITHOUT THE TOXICITIES ASSOCIATED WITH OTHER EGFR DRUGS

... by the authors compare favorably with previous studies of cetuximab in combination with RT alone or CRT. ... Pfister DG et al study (Table 2). The ORR in both studies were similar: 94% for cetuximab + CRT and 100% ... BK et al study. The major difference between the studies is the benign toxicity profile reported with ...

Centocor Ortho Biotech Data to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

... Orlando, Fla., from May 29 to June 2, 2009. The studies were sponsored by Centocor Ortho Biotech ... fighting cancer." Data from the following studies have been selected for presentation and posters: ... decline and survival prognosis in epoetin alfa studies (Abstract 9625) General Poster ...

Quest Diagnostics to Present Genomic Studies Related to New Testing Techniques for Leukemia and Prostate Cancer at 2009 ASCO Meeting

... scientists will present results of three studies revealing the effect of genomic abnormalities on ... for hematologic cancers, we believe our studies will help investigators better understand the ... patients with CML. We are also hopeful that our studies on CML may provide the basis for one day ...

Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

... of care as the control arm in future clinical studies to further advance the timely clinical ... + MMF medication regimen. The Clinical studies The FDA's approval of Prograf + MMF for use ... was based on the review of two clinical studies involving approximately 2,000 kidney transplant ...