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Cardiva Medical, Inc. Receives FDA Clearance For The Catalyst(TM)III System, First In Class Drug Coated Vessel Closure Device
Cardiva Medical, Inc. announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for its latest technology, the Cardiva Catalyst III, which is considered the first drug coated vessel closure device in the market.
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Cytori's Celution(R) 700 System To Be Regulated As A Medical Device By U.S. FDA
Cytori Therapeutics (NASDAQ:CYTX) was informed by the U.S. Food and Drug Administration (FDA) that the Celution® 700 System will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act. This determination, in response to Cytori"s Request for Designation, clears the way for Cytori to compile and submit a marketing application to the FDA for the Celution® 700 System for use as a medical device in aesthetic body contouring and/or filling of soft tissue voids.
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Patients With Moderate To Severe Periodontitis Need Evaluation For Heart Disease Risk
Additional research is called for and patients with moderate to severe periodontitis should receive evaluation and possible treatment to reduce their risk of atherosclerotic cardiovascular disease (CVD), according to a special consensus paper by editors of The American Journal of Cardiology and Journal of Peridontology in the July 1, 2009 issue of The American Journal of Cardiology, published by Elsevier.
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Biomedical Sciences Companies Expanding In Asia Invested More Than US$500 Million In Singapore

Global biomedical sciences companies invested more than US$500 million in Singapore in the year 2008. This rides on Singapore"s strong scientific fundamentals, with biomedical sciences R&D expenditure exceeding US$760 million in 2007. The continued confidence in Singapore points to the city-state"s attractive investment environment, as companies look to the fast growing Asian market to fuel their growth. As a leading bio-cluster in Asia, Singapore provides access to global talent, world-class scientific and clinical excellence, as well as excellent connectivity to key regional markets. Mr. Yeoh Keat Chuan, Executive Director, Biomedical Sciences, Singapore Economic Development Board (EDB) said: "Singapore is aggressively positioning itself as a home for business, innovation and talent in Asia to be future-ready. Our efforts will enable companies based in Singapore to innovate and create value, thereby capturing the opportunities presented by Asia"s growth." Expanding Base of Research Investments A growing base of more than 50 global pharmaceutical, biotechnology and medical technology companies are carrying out R&D in Singapore, alongside 30 public-sector research and medical institutes. Bayer has committed US$13 million to carry out R&D in Singapore, starting with a US$2.3 million collaboration with the National University of Singapore (NUS) Yong Loo Lin School of Medicine to conduct translational cancer research, which includes profiling oncology drugs in an Asian context. Schering-Plough opened a 30,000 square-foot Translational Medicine Research Centre (TMRC), which will support the company"s global R&D programmes by focusing on biomarker discovery and development. Schering-Plough"s TMRC will also be the company"s focal point for non-invasive imaging for discovery research and early clinical development. In addition, companies are leveraging Singapore"s central location for the oversight and coordination of multi-centre, regional clinical trials. Takeda announced its US$3 million regional clinical coordination centre, while Quintiles doubled the size of its regional headquarters to an 80,000 square-foot facility, which will house its Central Laboratory and Clinical Development Services offices. Commercialising Homegrown Innovation On the home front, Singapore"s biotech and research institutes successfully concluded significant licensing agreements with international partners. S*BIO, for example, is entitled to receive more than US$600 million in payment under two licensing agreements with Onyx and Tragara to develop oncology drugs. S*BIO"s agreement with Onyx will include the development of SB1518, a JAK2 inhibitor that received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2008. The Institute of Materials Research and Engineering (IMRE) has attracted investment from Sumitomo Corporation Asia and will be spun-off as Micropoint Technologies to produce plastic microneedles, for painless injections and extraction of bodily fluids, which can be mass produced. The Institute of Bioengineering and Nanotechnology (IBN) has also announced licensing deals for its products: -- Micro-Kit, an all-in-one device that allows for rapid, easy, affordable tests for cancer, avian flu and other infectious diseases, licensed to Dyamed Biotech -- Virtual Reaction Chamber, affordable micro fluidics real time PCR machine, licensed to MP Biomedicals under agreement with Exploit Technologies Singapore Draws High Value-Added, Complex Manufacturing Asia"s growth is not limited to its market opportunities. In recognition of Asia"s scientific excellence and capabilities, companies are establishing higher value-added manufacturing activities into Singapore. This trend builds on Singapore"s advanced manufacturing capabilities as well as its expertise in process development and automation technologies. Coupled with the island"s close proximity and excellent connectivity to Asian markets, the city-state presents a choice location for complex manufacturing and the production of innovative medicines and medical devices. Lonza announced the decision to set up its first Asian cell-therapy manufacturing plant in Singapore. This facility will initially manufacture products for clinical trials as a start, and will build up Singapore"s capabilities as one of Asia"s leading sites for cell-therapy. In addition, GlaxoSmithKline (GSK) recently embarked on a US$67 million upgrading project to improve the capability and flexibility of its Singapore manufacturing plant, which is one of GSK"s key global sites that manufacture new pharmaceutical active ingredients. Coupled with its new R&D pilot plant opened in 2008, this upgrading project will support the seamless development and implementation of new processes from the R&D bench to full-scale manufacturing. Marking a new milestone in its successful 31-year partnership with Singapore, Baxter Biosciences recently held a ground-breaking ceremony for a biopharmaceutical manufacturing plant for biologics and recombinant therapy. This facility is Singapore"s sixth biologics manufacturing plant and will produce ADVATE, which is one of the world"s most chosen recombinant FVIII therapies for hemophilia. In response to the expanding base of biologics manufacturers in Singapore, which include Baxter, Genentech, GSK, Lonza and Novartis, Millipore opened a US$2 million regional biopharmaceutical manufacturing training facility. In the field of micro-array, Singapore is emerging as a global leader with Illumina"s decision to set up its US$20 million global manufacturing site in the city-state. Singapore accounts for more than half of the global manufacturing capacity for micro-arrays, which is increasingly used in biopharmaceutical research and diagnostics. Yeoh said: "In 2008, Singapore"s biomedical sciences sector contributed US$13 billion in manufacturing output. With the continued investment from global companies such as Baxter, Illumina and GlaxoSmithKline, we are confident of achieving our target of US$17 billion in manufacturing output by 2015." Developing Companies" Talent-Base in Singapore During these challenging times, Singapore has launched programmes specifically targeted at helping global businesses based in Singapore retain and enhance their talent base. In January this year, the Singapore Government announced a US$14 billion resilience package that includes the Jobs Credit scheme and Economic Development Board"s PREP-UP initiative. Under these programmes, the Singapore Government will co-share the cost of wages and training with companies to upgrade the skills of their technical and engineering workforce, thus ensuring that they are fully prepared for the eventual economic upturn. Singapore Economic Development Board


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