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Regulatory in Medical Technology

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... alfa program from both a clinical and regulatory perspective," said Sylvie Gregoire, President of ... to work diligently with the FDA and other regulatory agencies to make velaglucerase alfa available as ... by both the physicians and patients." regulatory Updates With regard to ongoing ...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

... to differing interpretations, and the views of regulatory agencies, medical and scientific experts and ... of data and other information that may affect regulatory review and commercialization of BZA/CE. There can be no assurance that BZA/CE will ever receive regulatory approval or be successfully developed and ...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that ... of clinical trial data by the FDA in support of regulatory approval; and the tolerability profile and/or ... prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to ...

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

... uncertainties in the process of development and regulatory review. There is no guarantee that the products will receive regulatory approval, or that the regulatory approval will be for the indications anticipated ...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

... by these patients. The EMEA is a regulatory agency in the European Union (EU) primarily ... the EU include 10 years of marketing exclusivity, regulatory assistance, reduced regulatory fees associated with applying for marketing ...

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

... once weekly is not currently approved by any regulatory agencies. Amylin Pharmaceuticals is a ... filings, not being submitted in a timely manner; regulatory approval, including approval for exenatide once ... the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... Phase 3 studies intended to support U.S. regulatory approval, while continuing to support the ... which have the potential to lead to the first regulatory approval for peramivir." Shionogi has ... other product candidates may not receive required regulatory clearances from the FDA or ...

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

... bladder cancer at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple ... registration trial, will be used to support regulatory submissions under the FDA's Accelerated Approval ... product development, uncertainties related to the regulatory approval process, and other risks detailed from ...

Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237

... which was filed for approval with the regulatory authorities as a monotherapy treatment for COPD ... $172.5 million for achieving pre-agreed clinical, regulatory and commercialisation targets for both ... and services; difficulties or delays in obtaining regulatory approvals to market products and services ...

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

... to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive ... in new product development, including obtaining regulatory approvals; domestic and foreign health care ... generic or over-the-counter competition, the regulatory process, and any developments ...

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

... outcome measure, viewed by both U.S. and E.U. regulatory authorities as a clinically meaningful endpoint, ... are encouraging and suggest that subject to regulatory approval, this may offer a new treatment option ... and default on its senior debt, and risks that regulatory filings may not be made, or may be delayed, and ...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

... leveraging Shire's significant ex-U.S. regulatory and clinical experience as well as its commercial ... timing and outcomes of ongoing discussions with regulatory authorities and the potential goals, progress, ... design for Amigal is insufficient to support regulatory approval; the potential that results of clinical ...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

... uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approval, or that the regulatory approval will be for the indication(s) ...

New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

... to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive ... in new product development, including obtaining regulatory approvals; domestic and foreign health care ... generic or over-the-counter competition, the regulatory process, and any developments ...

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

... to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive ... in new product development, including obtaining regulatory approvals; domestic and foreign health care ... generic or over-the-counter competition, the regulatory process, and any developments ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... statistical analyses) is acceptable to support a regulatory submission seeking new drug approval. ... path that has the potential to lead to regulatory approval of orBec(R) in both the US and the ... and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not ...

Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial

... and cell metabolism. Novartis has also filed regulatory submissions with other regulatory agencies globally for the treatment of advanced ... be affected by, among other things, unexpected regulatory actions or delays or government regulation ...

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

... once weekly is not currently approved by any regulatory agencies. Amylin Pharmaceuticals is a ... submitted and/or accepted in a timely manner; regulatory approval being delayed or not received; or ... the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the ...

Lilly Announces Positive Phase II Data on Investigational Medicine for Patients with Type 2 Diabetes

... uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approval, or that the regulatory approval will be for the indication(s) ...

Cardiogenesis Announces Presentation of its PHOENIX(R) Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) Annual Meeting

... Heart Disease", reinforce the company's regulatory strategy of submitting an IDE for its PHOENIX ... and when needed; any failure to obtain required regulatory approvals; failure of the medical community to ... ability to comply with international and domestic regulatory requirements; possible adverse Medicare or other ...

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

... adversely impact the company's ability to obtain regulatory approval for its product candidates include, but ... and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in ...

NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia

... designation allows for reduction in certain regulatory fees, and additional regulatory support for R&D initiatives. Anthony ... by the FDA; and the timing and outcome of regulatory decisions and label approval being sought or that ...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... payments upon the achievement of certain regulatory approvals and NTI is also entitled to receive ... these programs through their development to regulatory approval. Celtic Pharma's aim is to bridge the ... and the ability of Celtic Pharma to obtain regulatory approval for XERECEPT(R). Actual results may ...

New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer

... to differing interpretations, and the views of regulatory agencies, medical and scientific experts and ... be no assurance that neratinib will ever receive regulatory approval or be successfully developed and ... expense associated with, research, development, regulatory approval and commercialization of our products ...

Perceptive Informatics Enhances Investigator Application of New RECIST Version in Imaging-Based Oncology Trials

... experts will address medical, scientific, and regulatory solutions to improve the use of medical imaging ... criteria into Independent Review Charters for regulatory approval of oncology treatments. Perceptive ... continuum, from drug development and regulatory consulting to clinical pharmacology, clinical ...

Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-CXCR4 Antibody, MDX-1338

... approved for commercial sale, the subject of regulatory applications for marketing authorization or in ... or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ...

PAREXEL Reaches Milestone in Management of Oncology Trials Over Last Five Years Involving 175,000 Patients Worldwide

... access diverse patient populations, navigate regulatory issues, and identify effective investigators," ... medical imaging, technology integration, regulatory affairs, and product lifecycle management. ... continuum, from drug development and regulatory consulting to clinical pharmacology, clinical ...

PharmAthene Submits SparVax(TM) Regulatory Strategy to FDA

... that the Company has submitted its comprehensive regulatory strategy to the U.S. Food and Drug Administration ... to have met our stated goal of submitting our regulatory plan to FDA by May 21st, well ahead of the June ... be shown to be safe and effective and approved by regulatory authorities for use in humans. Copies of ...

Lilly Advances Second Alzheimer's Disease Treatment Candidate Into Late-Stage Testing by Launching Two Global Trials

... uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) ...

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

... with respect to such data and the likelihood of regulatory success. All forward-looking statements and other ... trials and there can be no assurance that the regulatory authorities in either the United States or Europe will grant regulatory approval based upon these data, in combination ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... in Phase 3 clinical trials, the subject of regulatory applications for marketing authorization or ... or that developed products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ...

Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

... forward to working with the FDA throughout the regulatory review process." The company's 505(b)(2) NDA ... as to whether this product candidate will receive regulatory approval or be successfully commercialized; the ... which could prevent or significantly delay its regulatory approval; the potential that changes made in ...

ADVENTRX Announces Results From ANX-514 Bioequivalence Study

... study, was not demonstrated based on benchmark regulatory standards. "Following discussions with ... a strategic transaction; the potential for regulatory authorities to require additional preclinical and/or clinical activities to support regulatory filings, including prior to the submission or the ...

New Analysis Evaluated Impact of Genetic Variation on Response to Prasugrel

... uncertainties in the process of development and regulatory review. There is no guarantee that the compound will receive regulatory approval, that the regulatory approval will be for the indication(s) ...

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

... and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental ...

Perceptive Informatics Survey Results Reveal Top Barriers to Implementing Adaptive Trial Designs

... a broad range of clinical, statistical, and regulatory functions. The survey results identified regulatory acceptance concerns, lack of understanding about ... were able to choose more than one category. regulatory acceptance concerns were cited by more than 35% ...

Perceptive Informatics Introduces Medical Imaging Methodology to Accelerate Development Decisions About Alzheimer's Treatments

... providing higher quality, reproducible, and regulatory compliant assessments with the potential to help ... using Perceptive's medical imaging system and regulatory compliant processes. "It is more critical ... continuum, from drug development and regulatory consulting to clinical pharmacology, clinical ...

Investigational Genetic Test May Help Address Common Problems in Prostate Cancer Diagnosis

... Pivotal Clinical Study in Effort to Gain U.S. regulatory Approval - SAN DIEGO, April 29 ... its investigational PCA3 assay that could lead to regulatory approval by the U.S. Food and Drug Administration ... statements concerning new products, potential regulatory approvals, customer adoption, and results of ...

Gen-Probe and DiagnoCure Amend Collaboration Agreement Surrounding PCA3-Based Prostate Cancer Tests

... subject to DiagnoCure securing the required regulatory approvals from the Toronto Stock Exchange. These ... its investigational PCA3 assay that could lead to regulatory approval by the U.S. Food and Drug Administration ... statements concerning new products, potential regulatory approvals and customer adoption are all ...

University of California Los Angeles Selects Velos eResearch

... patients and the stage they have reached in the regulatory process. "Managing that was always a very ... Those users are responsible for ensuring that all regulatory activities are carried out appropriately. They ... data in formulating NCI reports and for other regulatory functions such as the Internal Scientific Review ...
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(Date:7/11/2014)... 11, 2014 The increased risk of kidney injury ... resuscitation fluids reflects the mass of HES molecules, according ... official journal of the International Anesthesia Research Society (IARS). ... harmful effect of HES on cultured human renal proximal ... Christian Wunder and colleagues of University Hospital Wrzburg, Austria. ...
(Date:7/11/2014)... that under the normal circumstances, astrocytes participate ... neuronal environment, and exhibit therapeutic and repairing ... Previous studies have found that nerve cells ... induction have reduced viability, which produces influences ... Yuan, Kailuan General Hospital, Hebei United University, ...
(Date:7/11/2014)... that let nerve cells send out electrical signals, Johns ... tactic that may offer a new way to protect ... responsible way. , Their findingthat naturally occurring insect ... for a closely related onesuggests that insecticides can be ... like bees. A summary of the research, led by ...
Breaking Biology News(10 mins):In lab studies, hydroxyethyl starch has direct harmful effects on kidney cells 2Potent spider toxin 'electrocutes' German, not American, cockroaches 2Potent spider toxin 'electrocutes' German, not American, cockroaches 3
(Date:7/14/2014)... July 14, 2014 TherapySites, ... for mental health professionals, announced today its affiliation ... North Carolina (LPCANC). This new relationship allows ... solutions to LPCANC members, adding exclusive benefits and ... we have been dedicated to providing online marketing ...
(Date:7/14/2014)... EnergyFirst, manufacturer of all-natural ... Permalean for its great products, thriving customer base, ... markets its products as Jim’s Permalean Protein Powders and ... EnergyFirst’s lineup of nutritional products. The Permalean brand ... year. , Founded in 1999, Permalean’s products were designed ...
(Date:7/14/2014)... CT (PRWEB) July 14, 2014 Summer is ... vacations, camping, days at the beach, swimming and other outdoor ... everyone to be safe, happy and healthy all summer long. ... a list of the three must-have custom imprinted products everyone ... summer essential is of course sunblock. Sunscreen helps ...
(Date:7/14/2014)... 14, 2014 New research and analysis ... for the Earth examines toxic ingredients in tampons, ... nationwide, including specific chemicals that may be found in ... fragrances that may put women’s health at risk. ... Alexandra Scranton , the potential impact of toxic ...
(Date:7/14/2014)... Calgary, Alberta, Canada (PRWEB) July 14, 2014 ... the “Trusted Authority in Turning Information into Money,” ... Spotfire® Partner Network, a global program that helps ... or embed the TIBCO Spotfire® analytics platform. TIBCO ... and business intelligence software, including TIBCO Spotfire analytics, ...
Breaking Medicine News(10 mins):Health News:TherapySites Partners With the Licensed Professional Counselors Association of North Carolina to Make Online Marketing Available to All Therapists 2Health News:EnergyFirst Acquires Permalean - Manufacturer of All Natural Protein Bars and Powders 2Health News:EnergyFirst Acquires Permalean - Manufacturer of All Natural Protein Bars and Powders 3Health News:Why These Three Summer Essentials from 4AllPromos Can Improve Summer 2Health News:New Patent Analysis Shows Toxic Risk From Tampons 2Health News:New Patent Analysis Shows Toxic Risk From Tampons 3Health News:New Patent Analysis Shows Toxic Risk From Tampons 4Health News:New Patent Analysis Shows Toxic Risk From Tampons 5Health News:Cadeon Associates Inc. Joins TIBCO Spotfire Partner Network 2Health News:Cadeon Associates Inc. Joins TIBCO Spotfire Partner Network 3
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