http://www.lsis.com/goto/r4/rss 2010-06-23T11:10:02+01:00 text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FB%14%7E%7Dy SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced that Lars Fruergaard Jørgensen of Novo Nordisk A/S was elected to the company s Board of Directors at the annual meeting of shareholders. He replaces Lars Rebien Sørensen, a previous Novo Nordisk representative, who resigned from the Board in March 2010. Novo Nordisk holds approximately 27% of the company s outstanding shares. We look forward to his participation and contribution in the coming years. "Lars Fruergaard Jørgensen brings to our Board many years of operational, financial and strategic experience in the global pharmaceutical industry," said Bruce L.A. Carter, Ph.D., Chairman of the Board of (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FB%14%7E%7F%7D DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d7d20e/discovery_stage_pa) has announced the addition of the "Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition" report to their offering. Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition The Discovery Stage Partnering Terms and Agreements in Pharma and Biotech report detailed understanding and analysis of how and why companies enter discovery stage licensing/business development and other forms of partnering arrangement. The report provides a detailed understanding and analysis of how and why companies enter (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FC%12%7D%7F%7B DARMSTADT, Germany-(BUSINESS WIRE)-Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax (BLP25 liposome vaccine)* clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees. The resumption of the BLP25 liposome vaccine clinical program is very good news for the oncology community and NSCLC patients. If the START and INSPIRE Phase III trials are successful, BLP25 liposome vaccine could play an important role in (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97f%FD%1Ct%7C%7D ROCKLAND, Mass.-(BUSINESS WIRE)-EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that they are resuming their Stimuvax (BLP25 liposome vaccine)* clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees. œMerck KGaA remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FD%1Cxys SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that James A. Johnson, Executive Vice President and Chief Financial Officer of ZymoGenetics, will present at the Piper Jaffray Europe Conference in London on Wednesday, June 23, 2010 at 11:00 a.m. GMT. A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days. About ZymoGenetics ZymoGenetics is a biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the treatment of human diseases. The company has developed and is marketing RECOTHROM Thrombin, topical (Recombinant) in the United States. ZymoGenetics (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v4/%3B%97f%FD%13yy%7F Oligodendrocytes generate and maintain myelin, which is essential for axonal function and protection of the mammalian central nervous system. To advance our molecular understanding of differentiation by these cells, we screened libraries of pharmacologically active compounds and identified inducers of differentiation of Oli-neu, a stable cell line of mouse oligodendrocyte precursors (OPCs). We identified four broad classes of inducers, namely, forskolin/cAMP (protein kinase A activators), steroids (glucocorticoids and retinoic acid), ErbB2 inhibitors, and nucleoside analogs, and confirmed the activity of these compounds on rat primary oligodendrocyte precursors and mixed cortical cultures. (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FD%11%7Exs WALTHAM, Mass.-(BUSINESS WIRE)-Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its Central Coding ¢ application has become the first product to achieve certification by the Uppsala Monitoring Center (UMC). Launched today ( œUppsala Monitoring Centre Launches Software Certification Program for WHO Drug Dictionary Enhanced ), UMC s new certification is designed to help software developers quickly and easily integrate the WHO Drug Dictionary Enhanced. The WHO Drug Dictionary Enhanced is the world s most comprehensive dictionary of medicinal product information and the de facto standard for coding (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v4/%3B%97f%FE%12%7Ev%7B Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced the presentation of updated interim results from a Phase 1 trial of the Company's BiTE antibody MT110 in patients with advanced solid tumors. MT110 is designed to direct a patient's T cells, the immune system's most potent killer cells, against cancer cells that express the epithelial cell adhesion molecule (EpCAM). Professor Walter Fiedler, University Hospital Hamburg-Eppendorf, Germany and the study's principal investigator, presented the data today at the American Society of Clinical Oncology Annual Meeting (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FE%12%7D%7Bs LA JOLLA, Calif.-(BUSINESS WIRE)-Anaphore, Inc., an innovative developer of next generation biological therapies, today announced that Russell G. Greig, Ph. D., has joined its Board of Directors as Executive Chairman. Dr. Greig brings an extensive background in all aspects of drug discovery and development, business development, and commercial strategy, as well as first-hand experience working with emerging companies in his most recent role as President of SR One. Dr. Greig s comprehensive pharmaceutical experience will accelerate the translation of Anaphore s next generation biological therapies, Atrimers ¢, into medicines of the future. We are very pleased to attract someone of (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97f%FE%15u%7Dz Milan, Italy, June 10, 2010 Newron Pharmaceuticals S.p.A. ( œNewron ), a research and development company focused on novel CNS and pain therapies, and its partner Merck Serono, a division of Merck KGaA, Darmstadt Germany, today announced that new data on safinamide will be presented at the 14th annual meeting of the Movement Disorder Society (MDS), an international congress of Parkinson s disease and movement disorders taking place June 13 to 17, in Buenos Aires, Argentina. Safinamide is an investigational oral therapy being assessed in Phase III trials as add-on treatment to dopamine agonist or levodopa in early to late stage Parkinson s disease (PD). œThe results presented at the (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FE%15x%7Fx LIVINGSTON, N.J.-(BUSINESS WIRE)-Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced it completed enrollment in the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study last week. This randomized, double-blind, placebo controlled Phase III clinical study is evaluating the safety and efficacy of PROCHIEVE 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy. We are pleased to have completed enrollment in this important clinical program œWe are pleased to have completed enrollment in this important clinical program,  said Frank C. Condella, Jr., (…) text/html http://www.bionity.com Bionity.com http://www.lsis.com/goto/v4/%3B%97f%FF%12x%7Es 08.06.2010 - Merck KGaA announced that long-term follow-up data of a randomized Phase II study of two cilengitide doses in recurrent glioblastoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data showed that treatment of 15 patients with the investigational integrin-inhibitor for more than six months and for up to 4.5 years did not result in any treatment-related severe adverse events (Grade 3/4). In addition, 37% of patients who received the higher dose of cilengitide (2000 mg) were still alive after one year and 22% after two years. The current prognosis of patients with recurrent glioblastoma is poor with median overall survival (OS) (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FF%12%7D%7Ds LAFAYETTE, Colo.-(BUSINESS WIRE)-Aegis Analytical Corp., the leading provider of Enterprise Manufacturing Intelligence (EMI) software solutions, announced today that Human Genome Sciences Randy Maddux, vice president of manufacturing operations, will be the keynote speaker at its annual user conference, Aegis Discover 2010, to be held September 20-24 at the St. Julien Hotel in Boulder, Colorado. I am excited to be speaking at Discover 2010 Mr. Maddux s presentation will explore œAchieving OpEx in Life Sciences Manufacturing by Mitigating Process Risk to Improve Supply Chain Robustness.  "I am excited to be speaking at Discover 2010," says Mr. Maddux. œThis is an important event for (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97f%FF%12%7Cwr CHICAGO & DARMSTADT, Germany-(BUSINESS WIRE)-ASCO Abstract Numbers: 2010, TPS151, TPS152 Merck Serono, a division of Merck KGaA, Darmstadt, Germany announced today that long-term follow-up data of a randomized Phase II study of two cilengitide doses in recurrent glioblastoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data showed that treatment of 15 patients with the investigational integrin-inhibitor for more than six months and for up to 4.5 years did not result in any treatment-related severe adverse events (Grade 3/4). In addition, 37% of patients who received the higher dose of cilengitide (2000 mg) were still alive after one (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FF%13u%7Ez CHICAGO & DARMSTADT, Germany-(BUSINESS WIRE)-ASCO Abstract Numbers: 2010, TPS151, TPS152 We are excited about the results of this study, in that patients were able to receive cilengitide beyond six months with no treatment-related severe adverse events. Moreover, 10% of patients were still alive after four years. Merck Serono, a division of Merck KGaA, Darmstadt, Germany announced today that long-term follow-up data of a randomized Phase II study of two cilengitide doses in recurrent glioblastoma were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data showed that treatment of 15 patients with the investigational integrin-inhibitor for more (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97f%FF%13tx%7C SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced positive results from a Phase 2 clinical trial in metastatic melanoma with recombinant Interleukin 21 (IL-21) as a single agent. The trial met the primary endpoint of efficacy, as measured by objective response rate or lack of early disease progression. Overall response rate was 23.1%, in evaluable patients, and median progression-free survival was 4.3 months. The results were presented at the American Society of Clinical Oncology meeting. Metastatic melanoma is difficult to treat and has no effective standard of care. We look forward to extending these observations in a randomized Phase 2 study with the selected (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F6%12%7Fw%7D SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced the initiation of the second part of a Phase 2 clinical trial with PEG-Interferon lambda (IL-29) and ribavirin in treatment-naïve patients with chronic hepatitis C virus (HCV) infection. ZymoGenetics is developing the investigational compound PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company (NYSE:BMY). In part B, we expect to generate a substantial body of data to inform the design of Phase 3 studies, which will assess the potential role of PEG-Interferon lambda in addressing the unmet medical need for a safer, more effective treatment for hepatitis C. œWe ve moved forward into part B of (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v4/%3B%97g%F6%13%7D%7Br Multiple expression signatures for the prediction of the site of origin of metastatic cancer of unknown primary origin (CUP) have been developed. Owing to their limited coverage of tumor types and suboptimal prediction accuracy on distinct tumors, there is still room for alternative CUP gene expression signatures. Whereas in past studies, CUP classifiers were trained solely on data from tumor samples, we now use expression patterns from normal tissues for classifier training. This approach potentially avoids pitfalls related to the representation of genetically heterogeneous tumor subtypes during classifier training. Two expression data sets of normal human tissues have been reanalyzed to (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v4/%3B%97g%F6%10y%7E%7C Highlighted Links http:/www.niresearch.com CARDIFF, CA-(Marketwire - June 1, 2010) - NeuroInvestment has released its June issue, which reviews the status of therapeutics being developed for the treatment of multiple sclerosis. Multiple sclerosis has been a major success story for neurology, an area sorely lacking in truly effective therapeutic options. The ABC drugs have made enormous strides in slowing disease progression and allowing patients to remain functional longer, but they delay, rather than arrest, the progression of RRMS. Tysabri remains at the top of the treatment pyramid in terms of its impact upon the disease process, but it also illustrates the daunting risk-benefit (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F6%10%7E%7Bz LIVINGSTON, N.J.-(BUSINESS WIRE)-Columbia Laboratories, Inc. (Nasdaq: CBRX) announced today the signing of a $15 million subordinated term loan with Watson Pharmaceuticals, Inc. (NYSE: WPI). The proceeds from the loan are intended to be used to finance activities related to PROCHIEVE 8% (progesterone gel), the ongoing PREGNANT Study, other development programs for the preterm birth indication and other general corporate purposes. The loan bears interest at the rate of 4% per annum, compounded monthly, and is payable upon maturity on December 31, 2011. The loan is subordinate to all existing indebtedness of Columbia. If the previously announced definitive agreement for Watson to acquire (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F7%1Dx%7E%7E DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/194007/inflammatory_bowel) has announced the addition of the "Inflammatory Bowel Disease Therapeutics - Global Strategic Business Report" report to their offering. Inflammatory Bowel Disease Therapeutics - Global Strategic Business Report This report analyzes the Global market for Inflammatory Bowel Disease Therapeutics in US$ Million. Annual estimates and forecasts are provided for the period 2006 through 2015. The report profiles 69 companies including Abbott Laboratories, Biogen Idec, Inc., Cosmo Pharmaceuticals SpA, ChemoCentryx, Inc., Dr. Falk Pharma GmbH, Eisai Co., Ltd., Elan Corporation, plc, (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v4/%3B%97g%F7%12%7D%7C%7D Sarcomas comprise a heterogeneous group of mesenchymal neoplasms. They can be grouped into 3 general categories, soft tissue sarcoma, visceral and primary bone sarcoma, which have different staging and treatment approaches. Soft tissue sarcomas are typically classified on the basis of genetic alterations and light-microscopic examination of hematoxylin-eosin-stained tissue, in which recognizable morphological characteristics of normal tissues are identified. Sarcomas are further characterized by histologic grade. The 3 most important prognostic variables are grade, size, and location of the primary tumor. This review includes a discussion of both soft tissue sarcomas (unclassified sarcoma, (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F8%17%7Ey%7E NEWTON, Mass.-(BUSINESS WIRE)-Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company s New Drug Application (NDA) for vilazodone for the treatment of major depressive disorder (MDD). Vilazodone is a dual-acting potent and selective serotonin reuptake inhibitor and a 5-HT1A receptor partial agonist. The NDA will be subject to a standard review. The acceptance of the NDA for review by the FDA is another positive step toward our goal of bringing vilazodone to market, and if approved, vilazodone will offer a novel treatment to the millions of people suffering from depression œThe acceptance of the NDA for (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F9%1D%7D%7Dx SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) announced that final progression-free survival results will be presented from a Phase 2 clinical trial in patients with Stage 4 metastatic melanoma at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on June 5, 2010 in an oral presentation. The open-label multi-center clinical trial evaluated 3 dose regimens of Interleukin 21 (IL-21) in 40 patients with no prior systemic therapy for metastatic melanoma. We selected 30 µg/kg/day as the dose for further investigation and are planning a randomized Phase 2b study with the National Cancer Institute of Canada Clinical Trials Group that will seek to further (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F9%1D%7D%7Fr DARMSTADT, Germany-(BUSINESS WIRE)- We believe we have helped spearhead a movement within the oncology community to drive innovations that may change cancer management. ASCO Abstract Numbers: 51160, 54275, e16016, 2010, TPS152, 43866, e13025 In alignment with the theme œAdvancing quality through innovation  of the forthcoming annual meeting of the American Society of Clinical Oncology (ASCO, June 4-8 in Chicago), Merck Serono, a division of Merck KGaA, Darmstadt, Germany, will present new data from across its oncology franchise. Data included at the meeting will highlight the impact of KRAS testing and personalized therapy, an area of innovation which the company has championed. (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v4/%3B%97g%F9%13yx%7D The discovery of a novel series of CXCR3 antagonists is described. Starting from an HTS positive, iterative optimization gave potent compounds (IC(50) 15nM in a chemotaxis assay). The strategy employed to improve the metabolic stability of these derivatives is described. |-| Bioorg Med Chem Lett. |-| Crosignani S, Missotten M, Cleva C, Dondi R, Ratinaud Y, Humbert Y, Mandal AB, Bombrun A, Power C, Chollet A, Proudfoot A. |-| Merck Serono SA, 9 Chem. des Mines, 1202 Geneva, Switzerland. text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97g%F9%17u%7E%7C DARMSTADT, Germany-(BUSINESS WIRE)- In alignment with the theme œAdvancing quality through innovation  of the forthcoming annual meeting of the American Society of Clinical Oncology (ASCO, June 4-8 in Chicago), Merck Serono, a division of Merck KGaA, Darmstadt, Germany, will present new data from across its oncology franchise. Data included at the meeting will highlight the impact of KRAS testing and personalized therapy, an area of innovation which the company has championed. Further, additional data for Erbitux (cetuximab) underscore the positive impact the treatment has had in metastatic colorectal cancer (mCRC) and head and neck cancer. New data for cilengitide, the first integrin (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F9%17zv%7C DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/38408a/multiple_sclerosis) has announced the addition of the "Multiple Sclerosis Therapeutics - Global Strategic Business Report" report to their offering. Multiple Sclerosis Therapeutics - Global Strategic Business Report This report analyzes the worldwide markets for Multiple Sclerosis Therapeutics in US$ Billion. The report provides separate comprehensive analytics for the US, Japan, Europe and Rest of World. Annual estimates and forecasts are provided for each region for the period 2006 through 2015. The report profiles 45 companies including Bayer Schering Pharma AG, Biogen Idec Inc., Elan (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%F9%14t%7C%7B DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d5a60b/neurodegenerative) has announced the addition of the "Neurodegenerative Drugs - Global Strategic Business Report" report to their offering. Neurodegenerative Drugs - Global Strategic Business Report This report analyzes the worldwide markets for Neurodegenerative Drugs in US$ Million by the following disease types: Alzheimers Disease, Parkinsons Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, and Other Neurodegenerative Diseases. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for each region for (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97g%FA%12%7B%7B%7B Apitope Starts New Clinical Trial Of Its Investigational Multiple Sclerosis Treatment Bristol, UK / Hasselt, Belgium 18 May 2010: Apitope, the European biotech company developing therapeutic peptides to treat autoimmune and allergic diseases, today announced the start of its second Phase I clinical trial of ATX-MS-1467, in patients with Multiple Sclerosis (MS). MS is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling neurological disease in young adults, with most sufferers developing the disease between the ages of 20 and 40. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide with women (…) text/html http://www.bionity.com Bionity.com http://www.lsis.com/goto/v4/%3B%97g%FA%12%7B%7Dx 19.05.2010 - Apitope announced the start of its second Phase I clinical trial of ATX-MS-1467, in patients with Multiple Sclerosis (MS). ATX-MS-1467, an investigational peptide-based therapeutic derived from Apitope s proprietary technology platform, has already completed successfully a Phase I clinical trial in six patients with secondary progressive MS (SPMS). This new Phase I study aims to build on the results from the initial study and investigates safety and proof-of-principle of ATX-MS-1467 in 40 patients with relapsing forms of MS (RMS). The clinical trial will be carried out at up to ten sites across the UK. The primary end point of the trial is safety and tolerability but secondary (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FA%12x%7Cx LIVINGSTON, N.J.-(BUSINESS WIRE)-Columbia Laboratories, Inc. (Nasdaq: CBRX) has renewed its license and supply agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for CRINONE (progesterone gel) for an additional five-year term. Under the existing agreement and the renewal, Merck Serono has marketing rights worldwide, except the United States. CRINONE is currently approved in 63 countries, including China, where it was approved at the end of 2008. We are pleased to continue our longstanding relationship with Merck Serono for CRINONE œWe are pleased to continue our longstanding relationship with Merck Serono for CRINONE,  said Frank C. Condella, Jr., Columbia s (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97g%FA%16%7C%7F%7E LIVINGSTON, N.J.-(BUSINESS WIRE)-Columbia Laboratories, Inc. (Nasdaq: CBRX) has renewed its license and supply agreement with Merck Serono, a division of Merck KGaA, Darmstadt, Germany, for CRINONE (progesterone gel) for an additional five-year term. Under the existing agreement and the renewal, Merck Serono has marketing rights worldwide, except the United States. CRINONE is currently approved in 63 countries, including China, where it was approved at the end of 2008. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v4/%3B%97g%FA%15%7D%7Ds The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of cetuximab (Merck Serono) to submit evidence for the clinical and cost effectiveness of cetuximab in combination with platinum-based chemotherapy (CTX) for the treatment of patients with recurrent and/or metastatic squamous cell cancer of the head and neck (SCCHN) according to the Institute's Single Technology Appraisal (STA) process. The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned to act as the Evidence Review Group (ERG). This article summarizes the ERG's review of the evidence submitted by the manufacturer. A summary of the Appraisal Committee (AC) (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v4/%3B%97g%FB%17z%7Dz eyeforpharma's SFE 2011, April 27-29, Barcelona was an undisputed success. With over 560 attendees and more than 50 industry leaders including Jane Griffiths (IVP, Janssen Cilag), Charlotte Sibley (SVP, Shire) Javed Alam (VP Sales, Novartis) offering keen insights on all of the latest trends and challenges, it's no wonder 92% of this year's delegates said they would recommend the conference to a friend. Hot topics, top speakers Francesco Frattini, Business Development Director, Roche told attendees about his company's initiatives around CSO & outsourcing. He analysed the impact of their sales results and management time - and shared the lessons learned. Francesco explained that with the (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FD%13x%7Br LIVINGSTON, N.J.-(BUSINESS WIRE)-Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced financial results for the three-month period ended March 31, 2010. Key financial results of the quarter and subsequent events include: Our domestic progesterone business grew dramatically during the first quarter of 2010 Net revenues from U.S. progesterone products increased 34% over the first quarter of 2009 on a 46% volume increase. This increase was dampened by higher reserves for returned goods. Net revenues from international sales of CRINONE 8% (progesterone gel) increased 11% over the first quarter of 2009 on a 15% volume increase. Total progesterone net revenues increased 25% over the (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97g%FD%11%7E%7D%7B MILAN, Italy - Newron Pharmaceuticals S.p.A. ("Newron" SIX: NWRN), a research and development company focused on novel CNS and pain therapies, today announced top-line results of its SERENA study, a phase IIb/III study of ralfinamide in patients with at least moderate Neuropathic Low Back Pain (NLBP). The 12-week SERENA study enrolled 411 patients with chronic NLBP of at least moderate severity and evaluated the safety and efficacy of two dose regimens of ralfinamide compared to placebo. Available results on the primary endpoint of the study, the change from baseline for the 11-point Likert Scale, did not detect any significant difference between ralfinamide and placebo. Ralfinamide was (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FD%16%7B%7C%7E AUCKLAND, New Zealand-(BUSINESS WIRE)-Innate Therapeutics today announced funding support from Fast Forward, LLC, a not-for-profit organization established by the U.S. National Multiple Sclerosis Society and EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany. The award of funds will help support the conduct of a Phase 2A clinical trial in patients with progressive forms of MS using MIS416, a naturally occurring agent derived from bacteria. œWe are delighted to gain this substantial funding as well as to be able to work with Fast Forward and their collaborative partner, EMD Serono,  said Simon Wilkinson, the Chief Executive Officer of Innate Therapeutics. We are delighted to (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FD%16%7B%7Cy SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) announced today that Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics, will present at the Bank of America Merrill Lynch Health Care Conference in New York City on Wednesday, May 12, 2010 at 10:40 a.m. Eastern Time. A live webcast of the presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 30 days. About ZymoGenetics ZymoGenetics is a biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the treatment of human diseases. The company has developed and is marketing RECOTHROM Thrombin, topical (Recombinant) in the United (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FD%16z%7D%7D LYON, France-(BUSINESS WIRE)-Flamel Technologies (Nasdaq: FLML) today announced its financial results for the first quarter of 2010. Highlights from the first quarter and the period since the Company s last conference call included: Entering into three new feasibility relationships, including one with a new top-five pharmaceutical partner; Expiration of Hatch Waxman exclusivity for Coreg CR with no generic formulation yet approved; The Company filed a citizen s petition with the FDA requesting that any generic formulation be held to the same standards regarding minimum blood plasma concentrations over 24 hours (Cmin) as Coreg CR; and Continued progress with existing programs with Pfizer, (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FD%16z%7C%7F ROCKLAND, Mass. & NEW YORK-(BUSINESS WIRE)-EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt Germany, and Fast Forward, LLC, a not-for-profit organization established by the National Multiple Sclerosis Society to accelerate the development of discoveries into new or improved therapies, today announced the first four recipients of funding designed to speed research advances in mutually selected high potential areas of MS research. The awards total nearly $1.5 million. Two are allocated to development programs which are available to for-profit entities and two are allocated to innovation projects, available to university-based investigators and seed-stage for-profit entities. EMD (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v4/%3B%97g%FD%17%7Dx%7D PURPOSE Invasion and migration are key processes of glioblastoma and are tightly linked to tumor recurrence. Integrin inhibition using cilengitide has shown synergy with chemotherapy and radiotherapy in vitro and promising activity in recurrent glioblastoma. This multicenter, phase I/IIa study investigated the efficacy and safety of cilengitide in combination with standard chemoradiotherapy in newly diagnosed glioblastoma. PATIENTS AND METHODS Patients (age /= 18 to text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v4/%3B%97g%FD%15x%7Br LIVINGSTON, N.J.-(BUSINESS WIRE)-Columbia Laboratories, Inc. (Nasdaq: CBRX - News) announced today that the Company's interim chief executive officer, Frank C. Condella, Jr., has been named president and chief executive officer. œWe are pleased that Frank Condella has agreed to continue as Columbia's president and CEO, a role we believe he is best suited to fill based upon his present leadership position with Columbia and his in-depth familiarity with the Company's business and industry,  said Steve Kasnet, Chairman of Columbia s Board of Directors. œWe look forward to his ongoing leadership as the Company emerges, following the close of the Watson Transaction, as a debt-free (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FD%15%7Czr SEATTLE-(BUSINESS WIRE)-ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported its financial results for the quarter ended March 31, 2010. For the first quarter of 2010, the company s net loss declined to $2.4 million, or $0.03 per share, an improvement from the $18.1 million, or $0.26 per share, reported for the first quarter of 2009. The decreased loss resulted from higher revenues as well as lower operating expenses. With last year s significant changes to our strategy and operations behind us, we re pushing forward in 2010 focused on our key assets, including randomized comparative Phase 2 studies of PEG-Interferon lambda for hepatitis C and IL-21 for cancer œWith last year s significant (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FE%1Cuxr WALTHAM, Mass.-(BUSINESS WIRE)-Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced the latest version of the Phase Forward ¢ Clinical Development Center (CDC), a centralized solution for integrating, managing and analyzing clinical information. This new release focuses on streamlining the preparation of clinical trial data for analysis by providing a flexible and effective workflow to track, manage and reconcile data discrepancies that can be found within different data sources. Our customers are looking for a centralized solution to efficiently process the increasing amounts of data collected within clinical (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FE%11t%7E%7E NORWALK, Conn.-(BUSINESS WIRE)-Gerard WM van Odijk , President & CEO of Teva Pharmaceuticals Europe B.V., will get face-to-face with an audience of senior biopharma executives at Windhover Conferences 17th annual Euro-Biotech Forum, to be held June 28-30 in Paris. Also on tap is a three-way panel to discuss three of the most strategically interesting deals of the year with the dealmakers who created them: Iain Buchanan, CEO, Novexel SA on the AstraZeneca/Novexel deal; Jean-Luc Belingard, Chairman and CEO, Ipsen, on the Ipsen/Inspiration deal; and Beth Fordham-Meier, Senior Director of Business Development, Targacept, on the AstraZeneca/Targacept deal. Euro-Biotech Forum, this year (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FE%11%7Bw%7C ROCKLAND, Mass.-(BUSINESS WIRE)-EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced it has been named as one of the best places to work in the industry by The Scientist magazine. EMD Serono ranked number 24 among the top institutions; more than 240 companies participated in the survey overall. It s an honor to earn recognition from The Scientist as one of the top companies to work for in the industry œIt s an honor to earn recognition from The Scientist as one of the top companies to work for in the industry,  said Bernhard Kirschbaum, Head of Global Research and Development, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. œIt is the (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FF%12%7F%7Ez CHICAGO-(BUSINESS WIRE)-2010 BIO International Convention takes place May 3 6, 2010 at McCormick Place in Chicago. Start with Us and Stay with Us Links to important information: Schedule of Events Attendee Registration Media Registration Information about the Biotechnology Industry Organization (BIO) Follow @BIOConvention on Twitter Breaking news releases, advisories, photos, and multimedia from 2010 BIO International Convention exhibitors are available at TradeshowNews.com, Business Wire's trade show, conference, and event news resource. Listed below are 2010 BIO International Convention exhibitor profiles. Company: AC Immune Media Contact: Eva Schier Phone: 41 21 693 91 34 E-mail: (…) text/html http://www.bionity.com Bionity.com http://www.lsis.com/goto/v4/%3B%97g%FF%11%7Cy%7B 29.04.2010 - All four divisions of the Merck Group recorded increases in first-quarter 2010 revenues – most notably the Chemicals divisions – indicating that the company weathered the global economic crisis of 2009 and is now back on track. Merck Group total revenues rose 13% in the first quarter to EUR 2,099 million from EUR 1,859 million in the year-ago quarter as the Chemicals divisions returned to their pre-crisis levels and the Merck Serono prescription drugs division continued on its growth path. Revenues increased at a faster rate than production costs, resulting in a gross margin increase of 15% to EUR 1,612 million. Research and development costs rose by 11% to EUR 347 million (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v4/%3B%97g%FF%16zw%7F WALTHAM, Mass.-(BUSINESS WIRE)-Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, will participate in four industry events in April including CDISC Interchange Europe 2010, April 26-30 at the Lancaster London Hotel in London. Building an eCRF CDASH Library A Case Study At CDISC Interchange Europe, Phase Forward representatives will lead two talks on key industry data standards and drug safety related issues: Who: Alison Sanders, Principal Clinical Design Consultant, Phase Forward What: œBuilding an eCRF CDASH Library A Case Study  When: Wednesday, April 28, 11:00 a.m. 12:30 p.m. GMT Who: Wayne Kubick, Vice President, (…)