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ImClone Systems And Bristol-Myers Squibb Announce Revisions To ERBITUX(R) (cetuximab) U.S. Product Labeling For Metastatic Colorectal Cancer
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for ERBITUX® (cetuximab) concerning the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The labeling revisions include a modification to the indication, which now includes a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Revisions concerning the use of ERBITUX in colorectal cancer tumors with K-ras mutations were also made to the clinical studies and clinical pharmacology sections of the product"s prescribing information.
Polygraphy
Increase Global Productivity By Giving Eyeglasses To All In Need
Huge economic gains could be made if eyeglasses were provided to approximately 150 million people in need, according to research published today in the international public health journal, the Bulletin of the World Health Organization.
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House Rejects Amendment To HHS Bill To Limit Funding To Planned Parenthood Clinics
The House on Friday voted 264-153 to approve its fiscal year 2010 Labor-HHS-Education spending bill (HB 3293) after voting on five amendments addressing price and policy issues, CQ Today reports. The bill would appropriate $730.5 billion. The Senate Appropriations Committee is scheduled to begin markup of its version of the bill on July 28.The House voted 183-247 to reject an amendment offered by Rep. Mike Pence (R-Ind.) that would have prohibited family planning funding through the Title X program to Planned Parenthood clinics. The House also voted 211-218 to reject an amendment by Rep. Mark Souder (R-Ind.) that would have stripped language to lift the ban on federal funding for needle-exchange programs. Lawmakers did approve an amendment offered by Rep. Darrell Issa (R-Calif.) to strip $5 million in funding for three NIH grants to study the HIV/AIDS risks associated with alcohol and substance use among sex workers in Asia and alcoholics in Russia (Wolfe, CQ Today, 7/24).
Endocrinology

FUJIFILM Dimatix Inkjet Printer Aids Researchers In Developing Paper-Based Biosensors To Detect Toxins

FUJIFILM Dimatix announced that a research team at McMaster University in Hamilton, Ontario, working with Canada"s SENTINEL Bioactive Paper Network, has used its DMP-2800 Dimatix Materials Printer to develop a new inkjet method for printing bioactive inks (bioinks) on paper strips used to detect harmful substances that can make animals or humans sick or be used as bioterrorism agents. The researchers successfully used the novel inkjet-printed biosensors to quickly and easily detect two test neurotoxins both visually with the naked eye and by using a digital camera and image analysis software. The paper-based sensors provided reproducible results after storage at 4° C for two months, showing the system is suitable for storage and use in the field. By showing that inkjet deposition is a simple, portable and cost-effective method of adhering biochemical reagents to paper, the McMaster University researchers have brought the concept of "bioactive paper" a significant step closer to commercialization. Their research is described in the July 1 issue of Analytical Chemistry, in a paper entitled, "Development of a Bioactive Paper Sensor for Detection of Neurotoxins Using Piezoelectric Inkjet Printing of Sol - Gel-Derived Bioinks". Bioactive paper is any low-cost and easy-to-use paper product laced with biologically active chemicals that provides a rapid, portable, disposable and inexpensive way to detect - and in some cases deactivate - toxins like E. coli bacteria and salmonella, or pathogens such as SARS or influenza. Applications for bioactive paper range from food packaging and hospital masks to paper strips for detecting and purifying unsafe drinking water or checking for banned pesticides in crop produce. The ability to rapidly detect toxic substances with tools that are simple, portable, disposable and inexpensive is also extremely useful in monitoring environmental and food-based toxins in remote settings such as less industrialized countries where simple bioassays are essential for the first stages of detecting disease settings and where the time and expense of using sophisticated instrumentation would be prohibitive. The new inkjet method relied on a FUJIFILM DMP-2800 to print a toxin-detecting enzyme-doped bioink sandwiched between two layers of biocompatible silica nanoparticles onto readily available filter paper substrates to create colorimetric sensor strips. The sensor strips can be used like a home pregnancy test to identify the presence and concentration of certain toxins by changing color when the enzyme is exposed to a specific toxin. "This research represents the first report published on the utilization of piezoelectric inkjet printing in the development of sol-gel-based paper biosensors," said John Brennan, Ph.D., the lead researcher and a faculty member in the Department of Chemistry at McMaster University. "Our research shows that inkjet printing provides a new platform for fabricating bioactive paper strips that can detect a range of biohazards that affect animals and humans. Inkjet printing is ideal for this application because the system is simple, rapid, scalable, compatible with paper substrates and amenable to pattern formation," said Dr. Brennan. The FUJIFILM Dimatix DMP-2800 system incorporates microelectromechanical system (MEMS)-based Dimatix Materials Cartridge (DMC) printheads that were filled with the desired volumes of bioinks. The precision jetting and cartridge design of the DMP-2800 allowed the researchers to jet droplets in sizes of 1 to 10 picoliters using a separate DMC printhead for each of the three different bioinks. The DMP-2800 was equipped with a drop visualization system that allowed observation and capture of drop formation on the printhead nozzles and the trajectory of the drops after ejection. The cartridge design of the DMP-2800 prevented interaction of the sol-gel-derived bioinks to avoid gelation in the inkjet nozzle prior to deposition on the paper surface, while its precision jetting and droplet imaging capabilities enabled the researchers to adjust and analyze varying applications of the materials deposited in layers as thin as 4 í¼m - or about 20 times thinner than a human hair. "FUJIFILM Dimatix is glad to participate as an industry partner of the SENTINEL Network and to provide technical support to its researchers in using the Dimatix Materials Printer for a purpose that has both practical and pressing application," said Martin Schoeppler, President and CEO of FUJIFILM Dimatix. The SENTINEL Bioactive Paper Network (http://www.sentinelbioactivepaper.com) is a consortium formed in 2005 of 11 Canadian universities plus industry and government partners working toward development of bioactive paper that will detect, capture and deactivate water and airborne toxins. The Faculty of Engineering at McMaster University hosts SENTINEL"s administrative center. The Dimatix Materials Printer is a turnkey, bench-top materials deposition system that leverages FUJIFILM Dimatix" industry-leading inkjet technology silicon MEMS fabrication processes in depositing picoliter-sized droplets of functional fluids on all types of surfaces. By employing single-use cartridges that researchers can fill with their own fluid materials, the DMP system minimizes waste of expensive fluid materials, thereby eliminating the cost and complexity associated with traditional product development and prototyping. The DMP is suitable for prototyping and low-volume manufacturing, and the technology is scalable from R&D to production. FUJIFILM Dimatix


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