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	<title>Comunicati Stampa Immediapress</title>
	<link>http://www.immediapress.it</link>
	<description>I comunicati stampa di Immediapress</description>
	<language>en</language>
	<managingEditor>info@immediapress.it (Informazioni)</managingEditor>
	<webMaster>info@immediapress.it (Info tecniche)</webMaster>
	
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		<title>New Study of Primary Liver Cancer Seeks to Enroll 400 French Patients</title>
		<category>Salute e Benessere/Healthcare, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61866</link>
		<author>global@prnewswire.co.uk (Sirtex Medical Limited)</author>

		<description><![CDATA[PARIS, February 3, 2012 /PRNewswire/ -- 'SARAH' - a French national collaborative randomized controlled trial of radioembolization with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma is now open for recruitment<br /><br />The start of SARAH, a new randomized controlled trial to directly compare the effectiveness of radioembolization with yttrium-90 resin microspheres (SIR-Spheres® microspheres; Sirtex Medical Limited, Australia) versus sorafenib (Nexavar®, Bayer HealthCare Pharmaceuticals, Germany), a systemic therapy that is the current standard of care for patients with non-surgical advanced hepatocellular carcinoma (HCC), was announced today by the principal investigator, Professor Valérie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique - Hôpitaux de Paris, Clichy and Université Paris Diderot, Sorbonne Paris Cité, France.<br /><br />SARAH (SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma)is a Phase III multi-centre prospective randomized open-labelled trial, which aims to recruit 400 patients in France with advanced HCC (Barcelona Clinic Liver Cancer stage C) with or without portal vein thrombosis and no extrahepatic spread, who are ineligible for surgical resection, liver transplantation or radiofrequency ablation; or whose disease has progressed or recurred after previous therapies.[1]<br /><br />The primary goal of the study will be to assess if radioembolization with yttrium-90 resin microspheres provides an increased survival benefit compared to sorafenib in patients with advanced HCC.<br /><br />Professor Vilgrain said: "Around 20 specialist cancer centres throughout France will be involved in this trial. SIR-Spheres microspheres were selected for the test arm of this collaborative trial, which is being promoted by the 'Assistance Publique - Hôpitaux de Paris'."<br /><br />In patients with advanced HCC, sorafenib is now the standard treatment.  Its use is associated with an increased median overall survival (from 8 to 11 months in the SHARP trial) but 80% of patients also experience treatment-related adverse events.  <br /><br />Selective Internal Radiation Therapy (SIRT), also known as radioembolization, is a novel treatment for inoperable liver cancer that delivers high doses of radiation directly to the site of tumours.  It is a minimally-invasive treatment, in which millions of radioactive SIR-Spheres microspheres (diameter between 20-60 microns) are infused via a catheter into the liver, where they selectively target liver tumours with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue. There is a growing interest in radioembolization using yttrium-90 resin microspheres in this patient population, based on a substantial number of open-label single-group studies as well as a large multi-centre European analysis[2] of the long-term outcomes related to survival and safety of radioembolization using SIR-Spheres microspheres in patients with inoperable HCC.  In 13 open-label single-group studies totalizing 400 patients with advanced HCC, the combined estimation of the median overall survival after radioembolization with yttrium-90 microspheres was of 15 months (min-max: 7 to 27 months).<br /><br />SIR-Spheres microspheres are approved for use in Australia, the European Union (CE Mark), New Zealand, Switzerland, Turkey and several other countries including in Asia (e.g. India, Korean, Singapore and Hong Kong) for the treatment of unresectable liver tumours.  SIR-Spheres microspheres are also indicated in the U.S. for the treatment of non-resectable metastatic liver tumours from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine.  <br /><br />Professor Vilgrain said that: "The SARAH trial is testing the hypothesis that radioembolization using yttrium-90 resin microspheres can increase the median overall survival with fewer side effects and/or a better quality of life in comparison with sorafenib.  We hope that the results of this study will help improve the prognosis for these difficult to treat patients".<br /><br />About Hepatocellular Carcinoma<br /><br />Hepatocellular carcinoma (HCC) occurs in people whose livers have become severely damaged or cirrhotic, due to conditions such as hepatitis and alcoholism.  It is one of the ten most-common cancers in the world, with nearly 750,000 cases diagnosed annually, and the third-leading cause of cancer deaths.[3]  It occurs with greatest frequency in regions where viral hepatitis B or C aremost often diagnosed, such as in Asia Pacific and Southern Europe.  <br /><br />Hepatocellular cancer can be cured by surgery, either by resecting the diseased parts of the liver, or by transplantation with a liver from a healthy donor.  These interventions, however, are inappropriate for the great majority of patients, whose survival may range from a few months to two or more years depending largely on the state of their liver at the time of their diagnosis and the extent of tumour invasion.<br /><br />References:<br /><br />- SorAfenib versus Radioembolization in Advanced Hepatocellular carcinoma (SARAH): http://clinicaltrials.gov/ct2/show/NCT01482442.<br />    <br />- Sangro B, Carpanese L, Cianni R et al on behalf of European Network on Radioembolization with yttrium-90 resin microspheres (ENRY). Survival after [90]Y resin microsphere radioembolization of hepatocellular carcinoma across BCLC stages: A European evaluation. Hepatology 2011; 54: 868-878.<br />    <br />- GLOBOCAN.  Liver Cancer Incidence and Mortality Worldwide in 2008.  http://globocan.iarc.fr/factsheets/cancers/liver.asp accessed 28 June 2011.]]></description>
		<pubDate>Fri, 03 Feb 2012 08:00:00 +0100</pubDate>
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		<title>Boston Scientific Announces CE Mark Approval and European Launch for New Infinion(TM) 16 Percutaneous Lead for Precision Plus? Spinal Cord Stimulator System</title>
		<category>Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61867</link>
		<author>global@prnewswire.co.uk (Boston Scientific)</author>

		<description><![CDATA[PARIS and MIAMI BEACH, Florida, February 3, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces CE Mark approval of the Infinion? 16 Percutaneous Lead for its Precision Plus(TM) Spinal Cord Stimulator (SCS) System, the first rechargeable SCS device for chronic pain management.  The first patient implant in Europe using the Infinion(TM) 16 Lead was performed by Kliment Gatzinsky, M.D., Ph.D., and David Revesz, M.D., of the Neurosurgery Department atthe Sahlgrenska University Hospital in Guldheden, Sweden.<br /><br />The Infinion 16 Lead is the world's first and only 16-contact percutaneous lead and the latest innovation in Boston Scientific's comprehensive percutaneous lead portfolio.  The Company announced the approvaltoday at the World Institute of Pain (WIP) Congress, which runs from February 4 - 6 in Miami Beach.  The Infinion 16 Lead is currently commercially available in the U.S. and will be introduced in CE Mark countries immediately.<br /><br />SCS leads are designed to deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain (known as paresthesia).  Until now, percutaneous leads have offered a maximum of eight stimulating contacts.  By providing twice the number of contacts than any previous percutaneous lead, the Infinion 16 Lead is designed to offer more coverage of the spinal cord for the management of chronic pain.<br /><br />"I appreciate that for the first time, it is possible to place 16 contacts with a single percutaneous lead using a small insertion needle," said Dr. Gatzinsky.  "This lead will provide me with more options to optimize the paresthesiacoverage to bring relief for chronic pain patients." Dr. Revesz added, "The Infinion 16 Lead is very responsive, with excellent steering that allows easy placement in the target area.""The Infinion 16 Lead is the latest advance in SCS lead technology and an exciting addition to our unrivaled percutaneous lead portfolio," stated Maulik Nanavaty, Senior Vice President and President of the Boston Scientific Neuromodulation Division.  "We believe that the European launch of the Infinion 16 Lead, coupled with increased awareness of pain management treatment alternatives, will allow us reach a wider patient population. Boston Scientific continues its commitment to innovation by offering pain management physicians more choices to help optimize pain relief for their patients."<br /><br />About Boston Scientific Neuromodulation<br /><br />Boston Scientific Neuromodulation is an innovation leader in implantable pain management technology.  The Precision Plus Spinal Cord Stimulator System, powered by SmoothWave Technology, uses pulses of electricity delivered directly along nerve fibers through the spinal cord to mask pain signals to the brain.  Through investments in technology, clinical science, and world-class service, Boston Scientific Neuromodulation is committed to Making life smoother(TM) for physicians and patients.  For more information on Precision Plus technology, visit:http://www.controlyourpain.com/.<br /><br />About Boston Scientific<br /><br />Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com/.<br /><br />Cautionary Statement Regarding Forward-Looking Statements<br /><br />This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, future innovation, product performance and competitive offerings.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.   ]]></description>
		<pubDate>Fri, 03 Feb 2012 08:00:00 +0100</pubDate>
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		<title>Stryker Presents Results of the TREVO Prospective Clinical Study at the International Stroke Conference</title>
		<category>Salute e Benessere/Healthcare, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61863</link>
		<author>global@prnewswire.co.uk (Stryker)</author>

		<description><![CDATA[KALAMAZOO, Michigan, February 2, 2012 /PRNewswire/ -- Trevo® Pro System Restored 55% of Patients who Suffered a Severe Acute Ischemic Stroke to a Good Functional Outcome<br /><br />(Logo:  http://photos.prnewswire.com/prnh/20120202/NY46927LOGO )<br /><br />The TREVO Study was designed to assess the ability of the Trevo® System to remove the blood clots that cause strokes and to restore blood flow to the brain. Revascularization was measured by an independent core lab.<br /><br />The results were presented at the International Stroke Conference in New Orleans, LA by Professor Nils Wahlgren, co-Principal Investigator of the Study and Professor of Neurology at Karolinska University Hospital, Solna, Sweden. The results demonstrated high revascularization rates of 91.7% of patients. 46% of patients achieved a good outcome in just seven days and at 90 days, the good outcomes rate increased to 55%. These patients with good outcomes were functionally independent (modified Rankin score of 2 or less). A low symptomatic intracranial hemorrhage rate of 5% was also reported.<br /><br />Professor Wahlgren commented: "The TREVO Study represents an important step forward in the evidence supporting the treatment of patients with moderate and severe strokes with mechanical thrombectomy devices, such as the Trevo System. The rigorous conduct of this prospective multicenter trial provides more confidence not only in patient selection, but in the successful procedural and clinical outcomes that can be achieved for these patients."<br /><br />Clinical evidence remains key for wider adoption of interventional, device-based therapies for the treatment of Acute Ischemic Stroke. The prospective design and rigorous conduct of the TREVO Study underscores Stryker's commitment to building robust evidence to support the adoption of important technologies like the Trevo System by physicians for their stroke patients.<br /><br />About Stryker<br /><br />Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit http://www.stryker.com/.<br /><br />Media Contact:<br />Tamara Cutler<br />Vice President, Public Affairs<br />269-389-7253<br />tamara.cutler@stryker.com]]></description>
		<pubDate>Thu, 02 Feb 2012 22:30:00 +0100</pubDate>
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		<title>International Phase I Trial Results of Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) Show All Pharmacokinetic Parameters Significantly Improved in Patients With Severe Hemophilia B</title>
		<category>Salute e Benessere/Healthcare, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61861</link>
		<author>global@prnewswire.co.uk (CSL Behring)</author>

		<description><![CDATA[ST. GALLEN, Switzerland, February 2, 2012 /PRNewswire/ ---  Results from the Phase I of the PROLONG-9FP trial program demonstrate clinical safety and improved pharmacokinetics of rIX-FP compared to current treatment options<br /><br />http://www.cslbehring.com/ today announced the results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia B.  Results of the study, which were presented during an oral session at the Gesellscaft fur Thrombose- und Hameostasegorschung (GTH) congress in Switzerland, showed that rIX-FP was well tolerated in all patients and lasted longer in the body, due to its prolonged half-life, compared with current Factor IX treatment options.CSL Behring, in collaboration with its parent company, http://www.csl.com.au/ (ASX:CSL), is developing rIX-FP for the prophylaxis and treatment of bleeding episodes in patients with congenital Factor IX (FIX) deficiency as part of the PROLONG-9FP clinical study program."Hemophilia B is a rare and serious bleeding disorder that prevents normal blood clotting and requires frequent infusion of Factor IX concentrates to restore clotting ability," said Elena Santagostino, M.D., Ph.D., Professor in the Medical School of Clinical and Experimental Hematology at the University of Milan/IRCCS Maggiore Hospital. "The results of this study suggest that rIX-FP is a promising investigational agent for improvement of prophylactic and on-demand treatment for patients with hemophilia B."<br /><br />In this analysis, no serious adverse events (including no hypersensitivity reactions), presence of inhibitors to Factor IX, or antibodies to rIX-FP were reported.  Terminal half-life (a measure of how long the drug lasts in the body) was more than five-times longer in comparison to values associated with current recombinant FIX therapy. Incremental recovery and area under the curve (a measure of total exposure to the drug) were also significantly improved in comparison to values associated with current recombinant FIX therapy. "The development of this new recombinant investigational agent further adds to CSL Behring's long heritage of identifying innovative treatments to improve outcomes for those living with rare bleeding disorders," said Dr. Stefan Schulte, Vice President of Research and Development, CSL Behring. "We look forward to further exploring the potential of rIX-FP in patients with hemophilia B."<br /><br />CSL Behring and CSL Limited have engineered the rIX-FP albumin fusion protein to extend the half-life of Factor IX while minimizing tolerability issues. In the process, recombinant albumin -- a carrier protein with an inherently long half-life -- is used as a fusion partner.  A specifically designed linker connects the recombinant factor IX and recombinant albumin as a means of optimizing the efficacy of rIX-FP.<br /><br />About the Phase I Study<br /><br />The Phase I study, part of the PROLONG-9FP clinical program, was a multi-center, international open-label trial evaluating rIX-FP in patients with documented severe hemophilia B (FIX < or = 2%). The primary objective was to determine the safety of rIX-FP up to 28 days following intravenous injection of 25, 50, or 75 IU/kg.  The secondary objective was to evaluate the pharmacokinetics of rIX-FP.  More information about the study design can be found at http://www.clinicaltrials.gov/.<br /><br /><br />About Hemophilia<br /><br />Hemophilia is an inherited bleeding disorder characterized by prolonged or spontaneous bleeding, especially into the muscles and joints. In nearly all cases, it affects only males. The disease is caused by deficient or defective blood coagulation proteins known as factor VIII or IX. The most common form of the disease is hemophilia A, or classic hemophilia, in which the clotting factor VIII is either deficient or defective. Hemophilia B is characterized by deficient or defective factor IX. Hemophilia A affects approximately 1 in 5,000 to 10,000 people. Hemophilia B affects approximately 1 in 25,000 to 50,000 people. The recommended treatment for patients who are factor deficient is to treat by replacement factor therapy.<br /><br /><br />About CSL Behring<br /><br />CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hereditary angioedema, haemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.  ]]></description>
		<pubDate>Thu, 02 Feb 2012 15:45:00 +0100</pubDate>
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		<title>Kerry to Expand Center of Excellence with New Cell Science Laboratory Serving Bio-Pharma Customers Globally</title>
		<category>Salute e Benessere/Healthcare, alimentazione / Food, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61832</link>
		<author>global@prnewswire.co.uk (Kerry Inc.)</author>

		<description><![CDATA[BELOIT, Wisconsin, January 31, 2012 /PRNewswire/ -- Kerry Ingredients &amp; Flavours is expanding its customer center of excellence in Beloit, Wisconsin, to include a new Cell Science laboratory. Building on the success of its companion site in Almere, The Netherlands, the new Cell Science laboratory will incorporate state-of-the-art technologies and media supplementation expertise to engage globally with Kerry's bio-pharma customers and technology partners.<br /><br />"The new Cell Science laboratory expands our Media Enhancement Services capabilities for Cell Culture, Vaccines, Microbial Fermentation, and Diagnostics. Additionally, this new research and applications center with leading R&amp;D expertise will advance our ability to customize cell media supplements to meet the evolving needs of the bio-pharma market globally," stated Christopher Wilcox, Kerry's Director of R&amp;D overseeing Cell Culture &amp; Media Supplementation technologies.<br /><br />Kerry is investing more than $10 million in the expansion of the Cell Science laboratory and Kerry customer center of excellence, which includes a consumer nutrition center, extensive flavor labs and product ideation and customer collaboration suites.<br /><br />"Expanding our Cell Science laboratory in the Kerry center allows us to advance our media ingredients and supplements portfolio while capturing greater synergies with Kerry's extensive analytical, research, development and applications expertise," stated Edmond Scanlon, President of Kerry's pharma and bio-pharma ingredients business. "This ultimately helps us deliver greater innovation and overall value for customers."<br /><br />The expansion is expected to be complete by August 2012 and will add nearly 50 new jobs and an additional 30,000 square feet to the existing 260,000 square foot facility.<br /><br />Serving the global pharmaceutical and bio-pharma markets under the trade name Sheffield Bio-Science, Kerry provides bio-pharma customers with a renowned product portfolio of media supplements including the industry-preferred HyPeps, Hy-Soy, NZ Amines, Primatones and Hy-Yests; as well as innovative new products such as Sheffield rInsulin ACF, Sheff-CHO ACF, Sheff-Vax ACF and Hy-Express systems.<br /><br />Additionally, Kerry offers the pharmaceutical and nutrition markets a high quality excipient product line. including pharma-grade lactose, tablet coatings and pharma flavors, as well as custom developed innovative ingredient solutions to help customers succeed in the ever changing global marketplace.<br /><br />http://www.kerry.com/ ]]></description>
		<pubDate>Tue, 31 Jan 2012 15:35:00 +0100</pubDate>
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		<title>Interventional Spine®, Inc. Announces Issuance of Patent No. 8,105,382, Covering the Company's Unique Expandable Interbody Fusion Device, the Opticage(TM)</title>
		<category>Salute e Benessere/Healthcare, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61826</link>
		<author>global@prnewswire.co.uk (Interventional Spine, Inc.)</author>

		<description><![CDATA[IRVINE, California, January 31, 2012 /PRNewswire/ -- Interventional Spine®, Inc. today announced that the United States Patent Office has issued U.S. Patent No. 8,105,382, entitled Intervertebral Implant. This patent includes key claims that provide patent protection on the Company's unique expandable interbody fusion device, the Opticage.<br /><br />Along with the Optiport(TM) access instrumentation, which provides unparalleled percutaneous access to the disc space, the Opticage(TM) is a key component of Interventional Spine's new PerX360 System(TM). The PerX360 System(TM) provides surgeons the capability of performing a completely percutaneous lumbar interbody fusion procedure via two incisions smaller than 15mm in less than 45 minutes and, if appropriate, under local anesthesia / sedation. This patent significantly strengthens Interventional Spine's portfolio, placing the Company in the forefront of lumbar fusion technologies intended to significantly reduce surgery times, hospital duration and overall patient pain.<br /><br />Mr. Walter A. Cuevas, Chief Executive Officer of Interventional Spine, commented "The issuance of this key patent will further cement Interventional Spine's unique leadership position in providing spinal surgeons the right, forward thinking tools for the next decade. Working together with surgeons from two continents, our engineers have developed a revolutionary technology that, in my opinion, will transform the way the world treats lumbar pain via fusion. We are grateful to all of the contributors who were involved in the development of this system."<br /><br />Interventional Spine®, Inc. is the leading innovator of percutaneous technologies in the treatment of back pain with over 12,000 patients being treated to date with the Company's products worldwide.<br /><br />Interventional Spine, Inc. is a privately held company based in Irvine, California that designs, develops, and markets patented implantable devices for the spine that can be deployed via percutaneous techniques. Supported by the Company's unique product introduction systems, Interventional Spine's products provide benefits to patients, surgeons, and hospitals alike. More information on the Company and its products can be found at: http://www.i-spineinc.com/.]]></description>
		<pubDate>Tue, 31 Jan 2012 12:00:00 +0100</pubDate>
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		<title>New Clinical Study Finds Use of Tissuemed's Sealant Film TissuePatchDural "Encouraging" in Prevention of CSF Leaks</title>
		<category>Salute e Benessere/Healthcare, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61818</link>
		<author>global@prnewswire.co.uk (Tissuemed Ltd)</author>

		<description><![CDATA[LEEDS, England, January 31, 2012 /PRNewswire/ -- UK surgical sealant film company Tissuemed Ltd. has announced the publication of a new clinical paper in World Neurosurgery relating to its self-adhesive dural sealant film products.<br /><br />Authored by Dr Paolo Ferroli, Professor Giovanni Broggi and co-workers at the Carlo Besta Institute, Milan, this is a single centre retrospective study detailing 119 patients who underwent elective neurosurgery.  All patients received TissuePatchDural to reinforce dural closure following identification of a CSF leak after routine microsuture closure.<br /><br />This was a mixed population of patients including 22 assessed as being high risk for reasons including previous surgery, radiotherapy, long term corticosteroid use and hydrocephalus. Supratentorial, Infratentorial and Spinal patients were also included. Overall CSF leaks were detected in 11 of the 119 patients (9.2%), all occurring within two weeks of surgery. Patients were additionally assessed at 2 and 6 months following treatment and none were found to be suffering CSF leakage.<br /><br />In the 22 patients considered high risk there was a higher (36.3%) percentage of CSF leaks, compared to a 3.1% leak rate in 97 cases without additional risk.  All leaks were treated conservatively and no patient required readmission or repeat surgery.  In conclusion, the authors commented "In our experience the product appears to be safe and no adverse reaction was evident throughout the study. Results in terms of CSF leak prevention are promising."<br /><br />Dr David Mandley, Tissuemed's CEO, commented: "This latest paper, the third in 12 months published by European Neurosurgeons, represents the largest patient cohort receiving TissuePatchDural to be investigated and reported to date.  As we approach four years since the launch of TissuePatchDural I'm delighted to have such positive clinical experience and published data from the Carlo Besta Institute, a highly regarded and world renowned centre of excellence in the field of neurosurgery."<br /><br />About TissuePatchDural<br /><br />The technology used in TissuePatch products is based on the in-situ bonding of synthetic polymers to bodily tissues.  The products are thin, synthetic, films which bond covalently to amine groups on the surface of internal tissues to provide a watertight seal.  As such these films are used as an adjunct to traditional suturing or stapling in a variety of surgical procedures where achieving a secure closure is paramount.The data also supports use of TissuePatchDural's sister product ObexNeurofilm(TM), which is distributed by Medtronic's Neurosurgical Technologies Division]]></description>
		<pubDate>Tue, 31 Jan 2012 10:00:00 +0100</pubDate>
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		<title>New Actavis / Bioton Alliance to Shake up Diabetes Market</title>
		<category>Salute e Benessere/Healthcare, Economia e Finanza/Economy and Finance, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61799</link>
		<author>global@prnewswire.co.uk (Actavis Group)</author>

		<description><![CDATA[WARSAW, Poland, January 30, 2012 /PRNewswire/ -- Actavis and Bioton (WSE:BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be granted an exclusive licence to commercialise those products under the Actavis brand throughout the European Union and the United States of America, as well as in Albania, Bosnia &amp; Herzegovina, Croatia, Iceland, Japan, Kosovo, Lichtenstein, Macedonia, Montenegro, Norway, Serbia and Switzerland. In Poland, both companies will offer the insulin products under their respective brands, Bioton being a Polish company.The announcement, at a press conference in Warsaw today, was made jointly by Ryszard Krauze, Chairman of the Supervisory Board of Bioton, and Claudio Albrecht, CEO of the Actavis Group and Chairman of the Actavis Board of Directors.<br /><br />Actavis has agreed to remunerate Bioton with the aggregate amount of EUR 55.5 million, of which EUR 22.25 million at signing today. The remainder (EUR 33.25 million) will be paid in instalments in accordance with agreed milestones relating to the registration process involving recombined human insulin (RHI).<br /><br />Based on the sales volumes estimated by the parties, the Actavis' revenues from the sale of the Insulins by Actavis into the markets in the initial period of 7 years from launch are expected to exceed EUR 1.5 billion. Pursuant to the agreement, the parties will share on an equal '50/50' basis the profits from the sale of the insulins performed by Actavis, as well as the development and registration costs related to Bioton insulins.<br /><br />In addition to the above, the Bioton Group have also signed memoranda of understanding with Actavis for the sale of insulins in 24 additional territories, including Turkey and Australia. Actavis will pay an additional consideration of up to EUR 1,900,000, including EUR 1,000,000 at signing. Both parties expect that sales of Bioton's recombinant human insulin by Actavis into some of the additional territories shall commence on the turn of 2012 and 2013. The profits from the sale of the insulins in these additional territories will again be shared on an equal basis (50/50). Formal documentation of these arrangements is expected to be concluded in the following weeks.<br /><br />New data released by the International Diabetes Federation (IDF) indicates that more than 366 million people worldwide are living with diabetes. Due to poor diet and sedentary lifestyles, diabetes is rapidly becoming a global epidemic, and the number of diabetes patients is expected to rise to a figure in excess of 550 million by 2030. The World Health Organisation (WHO) projects that the global insulin market will grow from the present level of approximately USD 14 billion to USD 54 billion over that same period.On average, a patient with diabetes type 2 takes almost 30 different medicines over the course of the disease. In light of that fact, the collaboration with Bioton represents a more fundamental and strategic concept in terms of treating diabetes, according to Claudio Albrecht.<br /><br />"The diabetes idea for us is a much wider one than just promotion and sale of recombinant human insulin or insulin analogues," he said. "We are encountering competitor giants when it comes to insulin and we have to maximise the competitive advantages that we clearly have. Bioton's insulin products have a market presence of more than 10 years' standing, with an excellent safety and efficacy profile. This puts us in a situation where we can overcome more easily any potential doubts that key opinion leaders might have when it comes to biosimilars."<br /><br />"Furthermore, we differ in one aspect very strongly in comparison with the originators," Albrecht added, highlighting the extensive range of generic type-2 oral diabetes drugs that Actavis already offers. Actavis' pipeline also includes high-value 'gliptin' products and several fixed dose combinations with Metformin.<br /><br />COMPREHENSIVE CARE OFFERING<br /><br />Albrecht noted that the opportunity to market a much broader portfolio in the context of diseases related to diabetes is a great one. "Actavis is the only company that can offer such a broad diabetes- and related diseases portfolio. We can tell payers that we cover the whole diabetes segment for a cost that is probably considerably less than they have been paying to date."]]></description>
		<pubDate>Mon, 30 Jan 2012 12:15:00 +0100</pubDate>
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	<item>
		<title>Research-Based Pharmaceutical Industry Pledges 14 Billion Treatments to Help End Nine Neglected Tropical Diseases</title>
		<category>Salute e Benessere/Healthcare, Economia e Finanza/Economy and Finance, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61795</link>
		<author>global@prnewswire.co.uk (International Federation of Pharmaceutical Manufacturers &amp; Associations)</author>

		<description><![CDATA[GENEVA, January 30, 2012 /PRNewswire/ -- Today the research-based pharmaceutical industry announced donations of 14 billion treatments this decade to support the elimination or control of nine key neglected tropical diseases (NTDs). Averaging 1.4 billion treatments annually, the donations build upon companies' existing medicines donation programmes which already reach millions of people around the world. Today's announcement comes in conjunction with an NTD collaboration comprised of pharmaceutical companies, the Bill &amp; Melinda Gates Foundation, the US and UK governments, international organisations, and endemic countries' national governments.  <br /><br />At least one billion people worldwide - one person in seven - suffer from NTDs. Each year NTDs disproportionately kill or disable millions of poor people primarily in tropical and subtropical areas.  <br /><br />These donations follow a World Health Organisation (WHO) announcement of new targets for NTDs whose elimination or control is achievable with adequate supply and distribution of the relevant medicines. For maximum impact, these donations focus on those nine NTDs that represent more than 90 percent of the global NTD burden.  <br /><br />"For decades individual pharmaceutical companies have researched, developed, and donated medicines to fight disease and improve patients' lives," said Eduardo Pisani, Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). "Today the research-based pharmaceutical industry jointly pledges a further 14 billion treatments to help end these debilitating diseases. This is our commitment as partners to help end NTDs and improve patient health."<br /><br />In addition to medicine donations, the research-based pharmaceutical industry supports the fight against NTDs with capacity-building efforts in developing countries and medical innovation. The research-based pharmaceutical industry was the second largest funder of R&amp;D for neglected diseases in 2010, reaching more than USD 500 million.  The full press release and a detailed breakdown of donations are available at: http://www.ifpma.org/fileadmin/content/News/2012/IFPMA_Ending_neglected_tropical_diseases_January2012.pdf<br /><br />About the IFPMA:<br /><br />IFPMA represents the research-based pharmaceutical companies and associations across the globe. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.]]></description>
		<pubDate>Mon, 30 Jan 2012 12:00:00 +0100</pubDate>
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	<item>
		<title>German Authorities Recommend Removal of TiBREEZE Breast Implants</title>
		<category>Salute e Benessere/Healthcare, Politica e PA/Politics and Public Affairs, Altro/Miscellaneous, chimica e farmacia / Chemistry and Pharmacy, </category>
		<link>http://www.immediapress.it/sito/rss/gira.php?id=61780</link>
		<author>global@prnewswire.co.uk (International Society of Aesthetic Plastic Surgery (ISAPS))</author>

		<description><![CDATA[HANOVER, New Hampshire, January 27, 2012 /PRNewswire/ -- The International Society for Aesthetic Plastic Surgery (ISAPS) has been officially informed by the German authorities at the BfArM Institute that the former company, GfE Medizintechnik GmbH  in Germany, sold implants that were manufactured using PIP components. From September 2003 to August 2004 they were sold under the name TiBREEZE. These silicone implants were coated by GfE Medizintechnik GmbH with a titanium layer and subsequently filled by PIP in France with their silicone gel. The silicone composition was the same as in PIP and Rofil implants that were filled with industrial grade silicone since 2001. Therefore, the German authorities at the BfArM Institute today amended their recommendation of 6 January 2012 to explant PIP and Rofil implants to include explantation of TiBREEZE implants as a precautionary measure even without symptoms.<br /><br />The successor of the company stated to ISAPS that 728 implants were produced in this period of time. Most of those implants were sold in Germany where they include about 280 patients. In addition to Germany, TiBREEZE implants were delivered to the following countries: Belgium, Italy, Finland, South Africa, Switzerland, England, Austria and Lichtenstein.  A total of 400 patients worldwide are thought to be affected.<br /><br />According to Dr. Dirk Richter (Germany), Chair of ISAPS' Patient Safety Committee, "as there are no studies yet available to prove the safety of industrial grade silicone in the human body, ISAPS supports the French and German authorities' recommendations and encourages all women with TiBREEZE, PIP or Rofil breast implants produced after 2001, to check with a specialized plastic surgeon to discuss removal of the implants."]]></description>
		<pubDate>Fri, 27 Jan 2012 20:10:00 +0100</pubDate>
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