Labeling in Biological Technology

Peregrine Awarded European Patent for Innovative Labeling Technology Featured in New Study in The Journal of Nuclear Medicine

TUSTIN, Calif., July 1 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM ) today announced that it has been awarded a European patent for a novel device and methods for linking biological agents to labels for diagnostic and therapeutic applications. The technology, which i...

Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Facial Filler

First and Only Collagen-Based Filler Proven To Last Through One Year HERZLIYA, Israel and SKILLMAN, N.J., June 8 /PRNewswire/ -- Ortho Dermatologics today announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement which includes efficacy and safety data through ...

FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

ADHD symptom control demonstrated from the first time point measured (1.5 hours) through 13 hours postdose PHILADELPHIA, June 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY ), the global specialty biopharmaceutical company, today announced that the US Food and Drug Adminis...

Glemser Announces New Labeling Solution: SPL for DCM Addresses New SPL Release 4 Requirements

Glemser Technologies, a Bethlehem, PA based pharmaceutical software and services company, today announced SPL for DCM, a new out-of-the-box labeling solution based on Documentum's Documentum Compliance Manager (DCM) application. SPL for DCM provides a complete labeling content management solutio...

SoluLinK Introduces New One-Shot ChromaLink(TM) Biotin Antibody Labeling Kit with Built-in Biotin Quantification.

SAN DIEGO, Oct. 1 /PRNewswire/ -- SoluLinK, Inc., a leader in conjugation products and complete easy to use kits, announces the introduction of its newest product, the One-Shot ChromaLink Antibody Labeling Kit. This innovative kit includes all the components for the rapid traceable biotinylati...

SoluLinK Introduces ChromaLink(TM) Biotin Labeling Kit to Biotinylate and Measure With One Reagent

SAN DIEGO, Jan. 29 /PRNewswire/ --- SoluLinK, Inc., a leader in biomolecular conjugation products and kits, announced the introduction of their newest product, the ChromaLink Biotin Labeling Kit, a biotinylation reagent with a built-in measurement signature that comes as a complete, easy-to-us...

FDA Approves New Mechanism of Action Labeling for Ranexa(R)

PALO ALTO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX ) announced today that the U.S. Food and Drug Administration (FDA) has approved new language for the product labeling for Ranexa(R) (ranolazine extended-release tablets) which describes the ability of ran...

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

- Labeling Now Includes Lower Once-Daily Starting Dose and Data from First Randomized Trial of SPRYCEL and Gleevec(R)*(imatinib mesylate) - PRINCETON, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) today announced that the U.S. Food and Drug Administration ...

FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia

Study Data Demonstrated Improved Progression-free Survival with Campath CAMBRIDGE, Mass. and WAYNE, N.J., Sept. 20 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ ) and Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY ) today announced that the U.S. Food and Drug Administration (FDA) h...

Niceware releases fourth version of labeling software

MILWAUKEE - Niceware International, a supplier of automatic identification and data collection (AIDC) software, announced on Monday they have introduced version 4.0 of their NiceLabel software. The new versions of NL offerings include support for reading and programming radio frequency ident...

GenTel will sell Dutch firm's biomolecule labeling technology

Madison, Wis. -- GenTel BioSurfaces, Inc., of Madison has been licensed to sell a Dutch company's non-enzymatic labeling technology for biomolecules and labeling agents, GenTel announced on Tuesday. GenTel will market and sell the Universal Linkage System labeling reagents of Kreatech Biote...

USB OptiKinase Eliminates Base Bias in Labeling of Oligonucleotide 5'-Ends

Wild-type T4 Polynucleotide Kinase (PNK) (1,2,3) is commonly used for phosphorylation and labeling of 5'-ends of DNA and oligonucleotides. Labeling, in particular, can be accomplished by two approaches, the forward reaction and the exchange reaction (Fig. 1) (3) . Historically, T4 PNK ha...

Efficient Europium Labeling of Lymphokine-Activated Killer Cells Using the Gene Pulser II with RF Module, Rev C

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Fluorescently Labeling Long dsRNA with the Silencer siRNA Labeling Kit

Although the Silencer siRNA Labeling Kits were developed for labeling siRNA, they can be readily adapted for labeling long dsRNA. The following protocol can be used for t...

Amino Allyl Labeling for Array Analysis

RNA is often labeled with fluorescent dyes (i.e. Cy3 or Cy5) for microarray analysis. Label may be directly incorporated during cDNA synthesis, aRNA amplification or a post-aRNA reverse transcription (RT) reaction, or attached via a...

aRNA Synthesis and Labeling for Array Analysis

Amino Allyl MessageAmp II aRNA Amplification Kits-- Now Available with Cy Dyes Extremely sensitive ArrayScript Reverse Transcriptase--high yields of full-length cDNA increases aRNA ...

New Microarray Labeling Kit for Preparing cDNA Probes

A more reliable and reproducible way to create fluorescently or radioactively labeled cDNA David T. Wong Heidi Davis Darryl Garrison Terry Payette Matt Lundy Kim Kuplent Mary A. Buchanan Joseph A. Sorge Rebecca L. Mullinax Stratagene Travis Ward Andrew Firmin ...

Schering-Plough Shareholders Approve Merger With Merck

...lectual property protection; current and future branded, generic or over-the-counter competition; the regulatory process (including product approvals, labeling and post-marketing actions); scientific developments relating to marketed products or pipeline projects; media and societal reaction to such developme...

Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results

...n of the review process for the Acetavance NDA, or result in limitations in the indications for use or the inclusion of unfavorable information in the labeling for this product candidate; intense competition from existing and new products, which could diminish the commercial potential for Acetavance; the poss...

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

...hire has received a Complete Response Letter from the FDA for INTUNIV. Shire and the FDA were not able to reach agreement on final product labeling in time to meet the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV, request new clinical data or additional analys...

Rapid heating prepares energy-saving zeolite for greater role in industrial separations

... of transparent, 3-D structures. Snyder and Tsapatsis were among the first teams to use the technique to characterize zeolite membranes by selectively labeling grain boundary defects with fluorescing molecules. The zeolite they study is silicate-1, one of the more than 170 frameworks of zeolite, which has por...

IIVS Announces Initiation by EPA of a Pilot Program to Evaluate Non-Animal Eye-Irritation Methods

.../PRNewswire-USNewswire/ -- The EPA has initiated a new program to evaluate the use of non-animal methods to replace the Draize test for eye irritation labeling for antimicrobial cleaning products. The is the first program of its kind and demonstrates the Agency's commitment to evaluate non-animal methods when...

Sanofi-aventis Announces Second Quarter 2009 Results

... and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products c...

Amgen to Collaborate With GlaxoSmithKline to Commercialize Denosumab in Europe for Postmenopausal Osteoporosis (PMO)

...e whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to and rely upon the labeling approved by the FDA or other regulatory bodies for the products, and not the information discussed in this news release. Cautionary statement ...

Schering-Plough Reports Financial Results for 2009 Second Quarter

...lectual property protection; current and future branded, generic or over-the-counter competition; the regulatory process (including product approvals, labeling and post-marketing actions); scientific developments relating to marketed products or pipeline projects; media and societal reaction to such developme...

Blackrock Microsystems Obtains Expanded 510(k) to Market NeuroPort System

...ck Microsystems LLC today announced that it has received a new, expanded 510(k) marketing approval from the U.S. Food and Drug Administration. The new labeling allows the NeuroPort Biopotential Neural Signal Processor (NeuroPort System) to be used with electrodes supplied by users, as well as with the impla...

VisEn Launches New Cat-K FAST(TM) Fluorescence Molecular Imaging Agent

... VisEn also offers its specialized in vivo agent labeling platforms, including its proprietary VivoTag (R) fluorescence labeling dyes for custom agent development, and its NanoSpark (R) labeling nanoparticles, all designed and optimized specific...

Zvetco Biometrics Delivers a Cohesive Security System Integrating Fingerprint Biometrics with Sun Identity Management Solutions.

... use proven AuthenTec and UPEK sensor technology, offer a rugged, elegant design, a standard USB interface, enhanced security and convenience, private labeling and other custom options. Information about Zvetco and its products is available at www.zvetcobiometrics.com or by calling (407) 681-0111. Veri...

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

...ding the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product's approval was based on efficacy studies conducted in animal...

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

...ns for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. ...es. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. ...

Virtify, Inc. Delivers Industry's First Enterprise Content Compliance Software Suite for Life Sciences Companies

...mmon Technical Document (eCTD), Structured Product labeling (SPL) and other electronic submissions standards. ... eCompliance Products Virtx SPL - labeling application that complies with US FDA SPL R4 and P...pcoming Standards Support: Virtx PIM - labeling supporting EU EMEA Product Information Management ...

Celsis Outlines the Top Five Advantages of Cryo-plateable Hepatocytes

...lgus Monkey Hepatocyte CYP P450 Levels 1 Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and labeling (draft): Guidance for Industry, FDA, September 2006. About Celsis IVT Celsis IVT is the premier world provider of specialized in vitro pro...

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

...on of Prophylaxis Therapy Label to Include Patient labeling for Self-Administration - EXTON, Pa., June 4...Pharma announced that FDA has approved the patient labeling for Cinryze to include self-administration for rou...l be approved in the acute setting." Patient labeling for Self Administration Self-administration of...

Genedata Launches Expressionist with Expanded Mass Spectrometry Biomarker Discovery Capabilities

... and metabolomics projects," said Dr. Othmar Pfannes, CEO of Genedata. Expressionist features support for labelled workflows using Stable Isotope labeling with Amino Acids in Cell Culture (SILAC) and Multiple Reaction Monitoring (MRM) targeted analysis. Usability improvements include blank chromatogram s...

Amgen Exercises Option for Exclusive License to Cytokinetics' Cardiac Contractility Program That Includes CK-1827452

...or Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. ...es. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. ...

ImmunoVaccine Technologies Collaborates with NRC Institute for Biodiagnostics Atlantic to measure effectiveness of DepoVax(TM) with novel MRI Imaging

...ent R&D at IVT. In pre-clinical studies, IVT has shown that DepoVax(TM) vaccines can eradicate cancerous tumors. This new research involves labeling liposomes, suspended in the DepoVax(TM) formulation, with iron-oxide nanoparticles. The 3-D MRI analysis will shed light on the activity of DepoVax(TM...

ImmunoVaccine Technologies Collaborates with NRC Institute for Biodiagnostics Atlantic to measure effectiveness of DepoVax(TM) with novel MRI Imagin

...resident R&D at IVT. In pre-clinical studies, IVT has shown that DepoVax(TM) vaccines can eradicate cancerous tumors. This new research involves labeling liposomes, suspended in the DepoVax(TM) formulation, with iron-oxide nanoparticles. The 3-D MRI analysis will shed light on the activity of DepoVax(TM...

Photos: Amgen and ONSEdge Partner With Cancer Survivor Jan Ping for New Campaign

...ns for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. T...es. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. ...

VisEn Launches Next-Generation Fast ('Fluorescence Activatible Sensor Technology') Agent Platform for Expanded Performance in Imaging Disease Biomarkers In Vivo

... VisEn also offers its specialized in vivo agent labeling platforms, including its proprietary VivoTag (R) fluorescence labeling dyes for custom in vivo agent development and its NanoSpark (R) in vivo labeling nanoparticles, all designed and optimized specific...

Preclinical Data From Amgen's Oncology Pipeline to be Presented at AACR

...ns for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. ...es. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. ...