Based in Medical Technology

NewCardio Announces Master Services Agreement With Dedicated Phase I

... future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and ... forward-looking statements contained herein are based are reasonable, any of those assumptions could ...

Debiopharm Group and Mercury Therapeutics, Inc. Sign an Exclusive License Agreement for the Development and Commercialisation of Debio 0930

... Inc. (Mercury), a privately held biotech company based in Woburn, Massachusetts focusing on ... the development of the compound and a royalty based on net sales of commercialised product. First ... Mercury's lead generation platform is based on a proprietary technology that enables the ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... in schizophrenia." The approval is based on four acute symptom control studies and a ... of Ortho-McNeil-Janssen Pharmaceuticals, Inc, is based in Titusville, N.J., and is the only large ... Reform Act of 1995. These statements are based on current expectations of future events. If ...

Cryo-Cell Announces C'elle(SM) Research and Development Collaboration with Cryopraxis Cryobiology Ltd.

... The possible diagnostic test will be based on analyses of the menstrual blood stem cells, ... costly to treat." The C'elle service is based on Cryo-Cell's expansive IP technology portfolio ... similar to umbilical cord blood stem cells. based on the continued success of MenSCs in the ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... reduced SLE disease activity versus placebo based on a number of other measures, including SELENA ... Topline BLISS-52 results include: -- based on an intention-to-treat (ITT) analysis, ... activity). Analysis for the primary endpoint is based on intention-to-treat (ITT) and adjusted for ...

New Research Shows: Neurofeedback is an 'Evidence-Based' Treatment for ADHD

... and whether it can be considered an Evidence based treatment or not. In collaboration with ... included 15 studies and 1194 ADHD patients. based on this study - which will be published in ... that Neurofeedback can be considered evidence based for any disorder. The efficacy of Neurofeedback ...

University of Michigan Study Shows SEQUENOM's MassARRAY Technology Identifies HPV Infections Missed by Standard Hybridization Test

... suggest that a type-specific, quantitative PCR-MS based test may be an important advance in the early ... that a type specific quantitative PCR-MS based test may be an important advance in the early ... Commission. These forward-looking statements are based on current information that may change and you ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... The most frequent adverse events were expected based on TASKi1 and appear to be manageable. The ... clinical trial. * The results presented are based on an intention to treat analysis that ... (ACR non-responder). Disease Activity Scores are based on a 28 joint count and CRP or an ESR at ...

Current Status of the Development Programs of New Indications and Formulations for Aricept(R) for Enhancing Patient Value

... marketed Aricept 10 mg immediate release. based on the preliminary review of the data from this ... FDA is planned for the middle of fiscal year 2009 based on the results of the clinical trials. Eisai is working on this new formulation of donepezil based on agreements with Teikoku Seiyaku Co., Ltd. and ...

Accumetrics, Inc. Announces GRAVITAS Trial 50 Percent Enrolled

... therapy for poor responders, identified based on the results of the company's VerifyNow P2Y12 ... of whether poor response to antiplatelet therapy, based on a laboratory test, leads to poor patient ... determine whether tailored antiplatelet therapy based on the results of the company's VerifyNow System ...

Vantia Therapeutics' Lead Candidate VA106483 Demonstrates Positive Anti-diuretic Effect in Phase IIa Trial in Nocturia

... years or more with a history of nocturia. based on these results, Vantia now plans to advance ... was discovered and has been developed by Vantia based on its small molecule drug development expertise ... as well as preclinical and discovery programmes based on protease inhibition with potential in the ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... in the development of malignancies is not known. based on an exploratory clinical trial in patients with ... Reform Act of 1995. These statements are based on current expectations of future events. If ... its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is ...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

... reduction in pain from baseline to endpoint based on the Pain Visual Analog Scale (VAS). Data from ... to the FDA. These forward-looking statements are based on the company's current expectations and ... press release contains forward-looking statements based on current plans, estimates and beliefs of ...

Acute Lymphoblastic Leukemia, the Most Common Childhood Cancer, Is Curable Without Preventive Cranial Radiation

... residual disease was used to modify therapy based on the level of disease detected. This ... Jude investigators applied personalized therapy based on molecular genetics of ALL, pharmacogenetic ... Founded by late entertainer Danny Thomas and based in Memphis, Tenn., St. Jude freely shares its ...

Cordex Signs European Development Partnership for ATPotent(TM) Sperm Motility Drug

... fertilization (IVF) procedures. ATPotent(TM) is based on Cordex's proprietary technologies related to ... that develops new cardiovascular medicines based upon the emerging pharmacology of adenosine ... statements. The forward-looking statements are based on current expectations, estimates and ...

Osteotech Completes Enrollment for DuraTech(TM) BioRegeneration Matrix Clinical Trial

... of its DuraTech(TM) BioRegeneration Matrix. based upon Osteotech's proprietary HCT(TM) (human ... of several products that Osteotech is developing based upon its first-in-class HCT platform. A total of ... product in Osteotech's HCT platform, which is based on Osteotech's breakthrough and proprietary ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... the GO-REVEAL study, the GO-RAISE findings were based on observed data only, in patients who were ... patients receiving SIMPONI 50 mg to 100 mg based on clinical judgment. The primary endpoint was ... Reform Act of 1995. These statements are based on current expectations of future events. If ...

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

... that mimics meal-related early insulin release. based on an extensive phase 3 clinical program, a New ... Study Design and Key Findings Findings were based on pulmonary function tests (PFTs) over a 2-year ... in all groups, including the nondiabetic group. based on the predefined endpoint, over 2 years, there ...

Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients

... the management of immunosuppression therapy was based on ImmuKnow assay levels. In 32 other patients, changes in immunosuppression therapy were based on immunosuppressive drug levels. Although it did ... and immunosuppressive drug dosing was adjusted based on positive viral studies using ImmuKnow results ...

FDA Advisory Panel Makes Favorable Recommendation for GlaxoSmithKline and Genmab's ARZERRA(TM) (ofatumumab)

... The advisory committee made its decision based on an interim analysis of a pivotal trial that ... estimated new cases being diagnosed in 2009. based on 2007 worldwide estimates, leukemia (all types) ... R&D division has a rich early pipeline based on cutting edge molecular biology and genetic ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... of Hepatitis C virus in one patient(3). based on these data, a global Phase III clinical trial ... cognitive function than those taking tamoxifen, based on validated scales of cognitive function ... diarrhea associated with VIP-secreting tumors. based on these attributes, octreotide has been used to ...

Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults

... switching therapies. Vimpat(R) approval based on clinical trials with approximately 1,300 patients The approval of Vimpat(R) is based on efficacy and safety data from one Phase II and ... press release contains forward-looking statements based on current plans, estimates and beliefs of ...

New Phase 3 Study of Tapentadol Immediate Release Tablets Published in Current Medical Research and Opinion Journal

... hours of treatment, responder rates at 48 hours based on the reduction of pain intensity compared with ... Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is ... a privately owned pharmaceutical company based in Aachen, Germany, discovered and started ...

New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)

... to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey ... the current US market share to nearly 12 percent based on weekly branded prescription volume. ... is indicated for the treatment of ADHD. Efficacy based on two controlled trials in children aged 6 to 12 ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... Pre-specified analyses of change in FVC were based on percent predicted FVC and not volume. Given ... and secondary efficacy outcome measures were based on a combined analysis of the 2403 mg group ... information included in this press release are based on information available to InterMune as of the ...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma

... The designs of these two Phase III trials are based on previous successful randomized, ... These NSCLC Fast Track designations were based upon the clinical activity and tolerability data ... the management of Agennix. Such statements are based on current expectations and are subject to risks ...

Food and Drug Administration Accepts Isolagen's Biologics License Application for Full Review

... All statements in this news release that are not based on historical fact are "forward-looking ... discussed above, if at all. While management has based any forward-looking statements contained herein ... the information on which such expectations were based may change. These forward-looking statements rely ...

BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results

... Inc. (Nasdaq: BCRX ) today announced that, based on discussions with the U.S. Department of Health ... year end. Shionogi initiated its Phase 3 study based on positive clinical results from a Phase 2 study ... views with respect to future events and are based on assumptions and subject to risks and ...

Three Clinical Presentations on Tapentadol Extended Release Tablets for Chronic Pain Featured at 2009 American Pain Society Annual Meeting

... Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is ... a privately owned pharmaceutical company based in Aachen, Germany, discovered and started ... Reform Act of 1995. These statements are based on current expectations of future events. If ...

Jubilant Enters Research Collaboration With AstraZeneca

... India, announced today that its Bangalore, India, based subsidiary,Jubilant Biosys Ltd, has signed a ... development milestones, as well as royalties based on successful global commercialization of any of ... product launch are forward-looking statements based on estimates and the anticipated effects of ...

Potentia Pharmaceuticals' POT-4 Drug Candidate for Age-Related Macular Degeneration Successfully Completes Phase I Clinical Trial - Prepares for Phase II

... tolerated by all subjects at all doses tested, based on clinical signs, ophthalmic examinations, and ... "We believe that POT-4 has significant promise based on these early-stage findings and look forward to ... endothelial growth factor (VEGF) in the eye. based on this mechanism of action, POT-4 holds the ...

Melanoma and Pregnancy: What Every Woman Needs to Know About the Risks, Prognosis

... pregnant after being diagnosed with melanoma is based on three small case-controlled studies. Reviewed ... to consider is a woman's prognosis, which is based upon her stage of the disease. Stage of disease for melanoma is based on three variables -- tumor thickness, presence ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... III clinical program individualizes treatment based on response, utilizing RVR criteria at week 4 of ... to determine overall duration of therapy. based on the RVR rate seen in this Phase II study, we ... once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the ...

Phase 1 Trial of Whole-Parasite Malaria Vaccine to Begin

... this approach into an effective and safe vaccine based on live parasites had been widely viewed as ... dream of a practical malaria vaccine preparation based upon whole parasites," states Michael Good, ... "Development of Sanaria's vaccine candidate is based in part on the findings from parallel studies ...

Micromet Presents Preclinical Data Showing Activity of Erbitux and Vectibix Based BiTE Antibodies against KRAS- and BRAF-mutated Human Colorectal Cancer Cells

... and panitumumab into novel bispecific antibodies based on Micromet's proprietary BiTE technology. Both ... produce novel, very potent EGFR BiTE antibodies. based on these results, we believe that the development ... The Company's novel antibody technology is based on its proprietary BiTE(R) antibody platform, ...

New Weight Loss Hope for People with Diabetes

... severe. The new NutriSystem D program is based on more than three decades of scientific research ... weight loss with exercise. NutriSystem D is based on a low Glycemic Index diet that integrates good ... high-cereal fiber diet. New NutriSystem D is based on a structured 28-Day meal plan that is ...

Pivotal Clinical Data Published for the Only Laser Phototherapy Device Cleared by the FDA for Hair Growth

... a Norwood Hamilton classification of IIa to V based on the Male Classification System of Hair Loss, ... About Lexington International, LLC based in Boca Raton, Fla., Lexington International ... of customers since 2001. The HairMax LaserComb is based on 20 years of international research and studies ...

Cequent tkRNAi Technology to be Presented at the Centennial Meeting of the American Association for Cancer Research

... disorders - from inflammatory disease to cancer - based on the company's proprietary technology, ... and deliver RNAi directly into cells. It is based on ground-breaking scientific research ... Harvard Medical School . A privately held company based in Cambridge, Massachusetts, Cequent was ...

Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA Nephropathy

... of Osprey Pharmaceutical U.S.A.'s drug candidates based on the company's proprietary platform of ... of inflammatory and autoimmune conditions based on the company's proprietary therapeutic platform ... Investment Fund. Osprey Pharmaceuticals U.S.A. is based in San Francisco, CA. www.ospreypharma.com ...

Oasmia: FDA Grants Paclical(R) Orphan Drug Designation for Ovarian Cancer in the USA

... drug development. The designation is based on the hypothesis that Paclitaxel is safer ... About Paclical(R) With the retinoid based unique platform XR-17, Oasmia has managed ... develops second and third generation cancer drugs based on nanotechnology for human and veterinary use. ...