LSIS Feed - Boehringer Ingelheim
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2010-06-23T11:10:59+01:00text/htmlhttp://www.medicalnewstoday.comMedical News Today22.06.2010 | Medical News Today: Advisory Panel Says FDA Should Not Approve Drug To Address Female Sexual Dysfunction
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On Friday, an FDA advisory panel voted 11-0 against recommending FDA approval of a proposed treatment for hypoactive sexual-desire disorder, which decreases women's sex drive, the Wall Street Journal reports. The Reproductive Health Drugs Advisory Committee reviewed an application seeking FDA approval of the drug flibanserin, also known as the "pink pill" or "female Viagra." Although the agency is not required to follow the panel's recommendation, it typically does (Corbett Dooren, Wall Street Journal, 6/18).The drug's effects on women's sexual drive was "not robust enough to justify the risks," which included dizziness, fatigue and nausea, particularly with long-term daily use, according (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today22.06.2010 | Medical News Today: ENS 2010 Prof. Einhaupl: Innovative Drugs Which Can Be Taken Orally Reduce Stroke Risk Among Patients With Atrial Fibrillation
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"Worldwide, strokes are the most common cause of death. This makes it a top priority for medicine to expand prevention in this area," says Prof. Dr. Karl Max Einhaupl, from the University Clinic Charite in Berlin, who is co-chair of the Annual Meeting of the European Neurological Society (ENS) taking place in Berlin from 19 to 23 June, 2010. Atrial fibrillation is of particular importance in stroke prevention. It is a heart arrhythmia which affects around 300,000 people in Germany, and which greatly increases the risk of stroke. "Blood thinning drugs can reduce the risk of stroke by up to 80% here," says Prof. Einhäupl. New substances such as dabigatran and rivaroxaban which can be taken (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed17.06.2010 | NCBI PubMed: Risk factors for ischaemic and intracerebral haemorrhagic stroke in 22 countries (the INTERSTROKE study): a case-control study.
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BACKGROUND: The contribution of various risk factors to the burden of stroke worldwide is unknown, particularly in countries of low and middle income. We aimed to establish the association of known and emerging risk factors with stroke and its primary subtypes, assess the contribution of these risk factors to the burden of stroke, and explore the differences between risk factors for stroke and myocardial infarction. METHODS: We undertook a standardised case-control study in 22 countries worldwide between March 1, 2007, and April 23, 2010. Cases were patients with acute first stroke (within 5 days of symptoms onset and 72 h of hospital admission). Controls had no history of stroke, and were (…)text/htmlhttp://www.businesswire.comBusiness Wire21.06.2010 | Business Wire: Reminder: Exelixis Announces June 21 Webcast of Conference Call Update on Development Collaboration with Bristol-Myers Squibb Company for XL184 | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (Nasdaq:EXEL) will provide an update on its collaboration with Bristol-Myers Squibb Company for XL184 on Monday, June 21, 2010 before the markets open. The announcement will be followed by a live webcast at 5:00 a.m. PT/ 8:00 a.m. ET. The webcast may be accessed in the Event Calendar page under Investors at http:/www.exelixis.com. An audio replay of the webcast will be available until 11:59 p.m ET/ 8:59 p.m. PT on July 5, 2010. Access numbers for the replay are: 888-286-8010 (domestic) and 617-801-6888 (international), and the passcode is 21140740. About Exelixis Exelixis, Inc. is a development-stage biotechnology company (…)text/htmlhttp://www.businesswire.comBusiness Wire21.06.2010 | Business Wire: BioSante Pharmaceuticals Says FDA Advisory Committee Recommendation Against Flibanserin has No Impact on LibiGel | Business Wire
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LINCOLNSHIRE, Ill.-(BUSINESS WIRE)-BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD). The FDA Advisory Committee voted that flibanserin for treatment of HSDD did not show that its benefits outweighed its side effects, among which are daytime sleepiness, dizziness, nausea, and fatigue. Importantly, the Committee concluded that HSDD is a significant medical issue for (…)text/htmlhttp://www.biospace.comBioSpace21.06.2010 | BioSpace: Exelixis, Inc. (EXEL) Regains Full Rights to Develop and Commercialize XL184; Bristol-Myers Squibb Company (BMY) will Make $17 Million Payment in Connection with Return of Drug
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. today announced that it has regained full rights to develop and commercialize XL184. Exelixis and Bristol-Myers Squibb Company (BMS) entered into a global development collaboration for XL184, the clinically most advanced MET inhibitor, in December 2008. Under the agreement, BMS and Exelixis had originally agreed to certain clinical development plans, and Exelixis maintained key rights regarding timing and funding of current and future clinical trials. Given the recent progress of BMS wholly-owned oncology pipeline and positive data generated by XL184, Exelixis and BMS were not able to align on the scope, breadth and pace of the (…)text/htmlhttp://www.biospace.comBioSpace21.06.2010 | BioSpace: BioSante Pharmaceuticals, Inc. (BPAX) Says FDA Advisory Committee Recommendation Against Flibanserin has No Impact on LibiGel(R)
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LINCOLNSHIRE, Ill.-(BUSINESS WIRE)-BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD). The FDA Advisory Committee voted that flibanserin for treatment of HSDD did not show that its benefits outweighed its side effects, among which are daytime sleepiness, dizziness, nausea, and fatigue. Importantly, the Committee concluded that HSDD is a significant medical issue for (…)text/htmlhttp://www.bionity.comBionity.com21.06.2010 | Bionity.com: Evotec Earns Milestone in Oncology Programme as Part of its Research Alliance with Boehringer Ingelheim
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21.06.2010 - Evotec AG announced that it has achieved a milestone as part of its research alliance with Boehringer Ingelheim and will receive a payment of EUR 2.5 million. The milestone was achieved for the selection of a candidate compound for pre-development studies in an oncology programme. Dr Werner Lanthaler, Chief Executive Officer of Evotec commented: "We are particularly pleased about achieving this milestone in the oncology programme, as the alliance was only expanded to this therapeutic area in late 2009. We are very proud of the high value we continue to bring to Boehringer Ingelheim's research efforts and the ongoing fruitful relationship between the research teams from both (…)text/htmlhttp://www.sciencedaily.comScienceDaily18.06.2010 | ScienceDaily: In Pursuit of the Energy of Life: Researchers Decipher Makeup of Generators in Cellular Power Plants
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ScienceDaily (June 18, 2010) Scientists from the Institute of Biochemistry and Molecular Biology and Collaborative Research Center 746 of the University of Freiburg have discovered a new mechanism which plays an essential role in the assembly and growth of mitochondria, the power plants of the cell. See Also: Health & Medicine Human Biology Nervous System Genes Plants & Animals Cell Biology Molecular Biology Genetics Reference Organelle Chloroplast Cell membrane Plant cell These organelles make energy stored in food ready for use by the cell. The generators in the cellular power plants are biological membranes located inside the mitochondria. Even minute errors in the composition of the (…)text/htmlhttp://www.businesswire.comBusiness Wire18.06.2010 | Business Wire: Exelixis Announces June 21 Webcast of Conference Call Update on Development Collaboration with Bristol-Myers Squibb Company for XL184 | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (Nasdaq:EXEL) will provide an update on its collaboration with Bristol-Myers Squibb Company for XL184 on Monday, June 21, 2010 before the markets open. The announcement will be followed by a live webcast at 5:00 a.m. PT/ 8:00 a.m. ET. The webcast may be accessed in the Event Calendar page under Investors at http:/www.exelixis.com. An audio replay of the webcast will be available until 11:59 p.m ET/ 8:59 p.m. PT on July 5, 2010. Access numbers for the replay are: 888-286-8010 (domestic) and 617-801-6888 (international), and the passcode is 21140740. About Exelixis Exelixis, Inc. is a development-stage biotechnology company (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today18.06.2010 | Medical News Today: FDA Scientists Cite Ineffectiveness, Side Effects In Review Of Female Libido Drug
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An FDA background document released Wednesday found that a pill aimed at treating female sexual dysfunction failed to make a significant difference in two studies, although some women reported slightly more sexually satisfying experiences, the AP/Detroit Free Press reports. On Friday, an FDA panel of experts will consider the drug - flibanserin - for premenopausal women who report a lack of sexual desire. The agency is not required to follow the panel's advice. According to the FDA document, two studies conducted by the drug's maker, Boehringer Ingelheim, failed to show a significant increase in female participants' libido, as recorded by the women in a daily journal. Although some women (…)text/htmlhttp://www.businesswire.comBusiness Wire18.06.2010 | Business Wire: Boehringer Ingelheim Comments on June 18th FDA Advisory Committee Meeting | Business Wire
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INGELHEIM, Germany-(BUSINESS WIRE)-The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee s advice as part of its final assessment of the NDA. We are disappointed with the advisory committee s recommendations and will work with the FDA to address questions raised by the advisory committee The committee recognised the significant unmet medical need for women with HSDD and the lack of (…)text/htmlhttp://www.businesswire.comBusiness Wire18.06.2010 | Business Wire: Research and Markets: Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics - the Updated 2nd Edition | Business Wire
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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/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed26.05.2010 | NCBI PubMed: Parallel chemistry libraries for the discovery of biologically active substances.
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Drug Discov Today. |-| Johnedwards P. |-| Vice President, Chemistry, Boehringer Ingelheim, Research & Development, 2100 rue Cunard, Laval, Quebec, CanadaH7S 2G5.text/htmlhttp://www.marketwire.comMarketwire17.06.2010 | Marketwire: REMINDER: Interview Advisory: Leading Women's Health Advocate to Testify to FDA Panel About Breakthrough Medication for Women's Sexual Disorders - Michelle King Robson of EmpowHER to Provide Personal Story of Need for New Treatments for Women
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Highlighted Links EmpowHER Web site SCOTTSDALE, AZ-(Marketwire - June 17, 2010) - WHAT: Michelle King Robson http:/www.empowher.com/michelle, one of the nation's leading women's health and wellness advocates and Founder, Chairperson and CEO of EmpowHER, a health media company for women, will share her personal testimony with a panel of the Food and Drug Administration on June 18, 2010 about women's sexual health, and a condition called Hyposexual Desire Disorder (HSDD), also known as low libido. "I am speaking about my personal story following my hysterectomy and its adverse affects on my own sexual health. And, I'm bringing with me the voice of millions of women who come to EmpowHER.com (…)text/htmlhttp://www.businesswire.comBusiness Wire16.06.2010 | Business Wire: Research and Markets: Analgesics in Germany - Forecasts to 2014 - OTC Obesity Drugs Enter Market | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/ba034b/analgesics_in_germ) has announced the addition of the "Analgesics in Germany" report to their offering. In recent years, Germany has seen increasing health awareness and trend towards more health-conscious lifestyles. Rather than relying on medicine to treat the symptoms of illnesses that were developed due to negligent attitudes to the body, Germans are now keen on retaining healthy diets and active lifestyles in an attempt to support their personal health. This has negatively affected demand for analgesics, which are some of the most common and most consumed remedies when treating illnesses. (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed14.06.2010 | NCBI PubMed: Evaluation of the impact of sodium lauryl sulfate source variability on solid oral dosage form development.
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Objective: The objective of this study was to investigate the effects of sodium lauryl sulfate (SLS) from different sources on solubilization/wetting, granulation process, and tablet dissolution of BILR 355 and the potential causes. Methods: The particle size distribution, morphology, and thermal behaviors of two pharmaceutical grades of SLS from Spectrum and Cognis were characterized. The surface tension and drug solubility in SLS solutions were measured. The BILR 355 tablets were prepared by a wet granulation process and the dissolution was evaluated. Results: The critical micelle concentration was lower for Spectrum SLS, which resulted in a higher BILR 355 solubility. During wet (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed15.06.2010 | NCBI PubMed: Dabigatran acylglucuronide, the major human metabolite of dabigatran: in vitro formation, stability and pharmacological activity.
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Glucuronidation of the carboxylate moiety is the major human metabolic pathway of dabigatran (beta-Alanine, N-[2-[4-(aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl). It results in the formation of the 1-O-acylglucuronide. Four isomeric acylglucuronides of dabigatran were isolated and purified from urine of dosed Rhesus monkeys. NMR analysis confirmed the structures of the four metabolites as the 1-O-acylglucuronide (beta anomer) and the 2-O-, 3-O-, and 4-O-acylglucuronides (alpha and beta anomers). Experiments with the purified 1-O-acylglucuronide and its isomeric rearrangement products revealed equipotent prolongation of the activated (…)text/htmlhttp://www.biospace.comBioSpace17.06.2010 | BioSpace: Evotec AG (EVTG.F) Earns Milestone in Oncology Programme as Part of Its Research Alliance With Boehringer Ingelheim Corporation
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HAMBURG, Germany, June 17, 2010 (GLOBE NEWSWIRE) - Evotec AG (Frankfurt:EVT) (TecDAX) today announced that it has achieved a milestone as part of its research alliance with Boehringer Ingelheim and will receive a payment of EUR 2.5 million. The milestone was achieved for the selection of a candidate compound for pre-development studies in an oncology programme.text/htmlhttp://www.biospace.comBioSpace17.06.2010 | BioSpace: Neurocrine Biosciences, Inc. (NBIX), Boehringer Ingelheim Corporation to Develop Diabetes Drug; Neurocrine to Get $10 Million Upfront; up to $225 Million in Milestone Payments
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SAN DIEGO, June 17 /PRNewswire-FirstCall/ - Neurocrine Biosciences, Inc. (Nasdaq:NBIX - News) announced today that they have established a worldwide collaboration with Boehringer Ingelheim to research and develop small molecule GPR119 agonists for the treatment of Type II diabetes and other indications. The companies will work jointly to identify and advance candidates into pre-clinical development. Boehringer Ingelheim is responsible for the global development and commercialization of potential GPR119 agonist products. Under the terms of the collaboration agreement, Neurocrine Biosciences will receive a $10 million upfront payment, research funding to support discovery efforts and is (…)text/htmlhttp://www.biospace.comBioSpace16.06.2010 | BioSpace: Boehringer Ingelheim Corporation Sex Pill, Flibanserin May Not Aid Women, FDA Staff Say
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Bloomberg - Boehringer Ingelheim GmbH s sexual desire drug flibanserin may not be effective or safe, according to U.S. regulators weighing whether to approve the first pill designed to boost women s libidos.text/htmlhttp://www.marketwire.comMarketwire14.06.2010 | Marketwire: Interview Advisory: Leading Women's Health Advocate to Testify to FDA Panel About Breakthrough Medication for Women's Sexual Disorders - Michelle King Robson of EmpowHER to Provide Personal Story of Need for New Treatments for Women
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Highlighted Links EmpowHER Web site SCOTTSDALE, AZ-(Marketwire - June 14, 2010) - WHAT: Michelle King Robson http:/www.empowher.com/michelle, one of the nation's leading women's health and wellness advocates and Founder, Chairperson and CEO of EmpowHER, a health media company for women, will share her personal testimony with a panel of the Food and Drug Administration on June 18, 2010 about women's sexual health, and a condition called Hyposexual Desire Disorder (HSDD), also known as low libido. "I am speaking about my personal story following my hysterectomy and its adverse affects on my own sexual health. And, I'm bringing with me the voice of millions of women who come to EmpowHER.com (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed09.06.2010 | NCBI PubMed: RITA-Registry of Industrial Toxicology Animal data: The application of historical control data for Leydig cell tumors in rats.
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Historical data for Leydig cell tumors from untreated or vehicle treated rats from carcinogenicity studies collected in the RITA database are presented. Examples are given for analyses of these data for dependency on variables considered to be of possible influence on the spontaneous incidence of Leydig cell tumors. In the 7453 male rats available for analysis, only one case of a Leydig cell carcinoma was identified. The incidence of Leydig cell adenomas differed markedly between strains. High incidences of close to 100% have been found in F344 rats, while the mean incidence was 4.2% in Sprague-Dawley rats and 13.7% in Wistar rats. Incidences in Wistar rats were highly variable, primarily (…)text/htmlhttp://www.marketwire.comMarketwire14.06.2010 | Marketwire: National Business Group on Health Honors 66 U.S. Employers With "Best Employers for Healthy Lifestyles" Awards - 2010 Class Includes 13 First-Time Winners
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Highlighted Links http:/www.businessgrouphealth.org WASHINGTON, DC-(Marketwire - June 14, 2010) - A record number of U.S. employers were honored today by the National Business Group on Health for their continuing commitment to promoting healthy work environments and encouraging workers to choose healthier lifestyles. A total of 66 large employers, including 13 first-time winners, were presented with "2010 Best Employers for Healthy Lifestyles" awards at the Business Group's Institute on Innovation in Workforce Well-being Leadership Summit held in Washington, DC. "Employers all across the nation are recognizing just how important a healthy workplace and a healthy workforce are to (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today14.06.2010 | Medical News Today: Boehringer Ingelheim Affirms Safety Of Telmisartan With Analysis Of 50,000 Patients And Strongly Disagrees With The Lancet Publication (Sipahi Et Al)
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Telmisartan, an angiotensin receptor blocker, is one of the most researched drugs globally. It has been studied in clinical trials in over 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years. Following rigorous assessment of the data from these studies it was concluded that there was no association with an increased risk of cancer in the telmisartan arms. Sipahi et al published a meta-analysis in the June issue of (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today14.06.2010 | Medical News Today: Dabigatran Etexilate As Effective And Safe As Enoxaparin In Preventing Venous Thromboembolism (VTE) After Total Hip Replacement Surgery
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Data from the RE-NOVATE II study presented today at the 15th Annual Congress of the European Hematology Association (EHA) have shown that dabigatran etexilate 220mg once daily is as effective and safe as enoxaparin 40mg in preventing venous thromboembolism (VTE) after total hip replacement surgery. The results also showed that dabigatran etexilate significantly reduced the combined endpoint of major VTE and VTE-related death compared to enoxaparin.1 The double-blind non-inferiority trial randomized 2,055 patients and was designed to investigate whether treatment with dabigatran etexilate 220mg once daily was as effective as enoxaparin over 28-35 days in patients undergoing total hip (…)text/htmlhttp://www.businesswire.comBusiness Wire13.06.2010 | Business Wire: Boehringer Ingelheim affirms safety of telmisartan with an analysis of 50,000 patients and strongly disagrees with the publication of Sipahi et al in Lancet Oncology June 2010 | Business Wire
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INGELHEIM, Germany-(BUSINESS WIRE)-For NON-US Medical Media Only Telmisartan, an angiotensin receptor blocker, is one of the best researched drugs worldwide. It has been studied in clinical trials in more than 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years. Following rigorous assessment of the data from these studies it was concluded that there was no association with an increased risk of cancer in the (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.06.2010 | NCBI PubMed: Near-infrared and mid-infrared fourier transform vibrational circular dichroism of proteins in aqueous solution.
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Vibrational circular dichroism (VCD) of a series of proteins in H(2)O solution with differing secondary structure are reported for the first time in the near-infrared (NIR) region as well as the NH-stretching region. The Fourier transform (FT) near-infrared (NIR) measurements were carried out between 6000 to 4000 cm(-1). FT-VCD measurements were simultaneously carried out for the mid-infrared (mid-IR) region from 2000 to 800 cm(-1) for direct comparison to VCD in the NIR region. The NIR VCD spectra of proteins show distinct spectral features for different protein structural motifs, indicating a valuable new method to study protein conformations. The principal VCD transitions in the NIR (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed10.06.2010 | NCBI PubMed: The DPP-4 inhibitor linagliptin exhibits time and dose dependent localization in kidney, liver and intestine after intravenous dosing: results from high resolution autoradiography in rats.
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Linagliptin is an orally active dipeptidyl peptidase-4 (DPP-4) inhibitor which is under development for the treatment of Type 2 diabetes and shows dose dependent pharmacokinetics in rats and humans. Using microscopic autoradiography, the dose dependence of cellular distribution of [(3)H]linagliptin related radioactivity was investigated in kidney at 3 h following intravenous injection of 7.4, 100 and 2000 mug/kg [(3)H]linagliptin. Furthermore, distribution of radioactivity in kidney, liver and small intestine was investigated in relation to time (2 min, 3 h, 192 h) after intravenous injection of 7.4 mug/kg [(3)H]linagliptin. The localization of radioactivity in the kidney at 3 h after (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed07.06.2010 | NCBI PubMed: Control of EHV-1 viremia and nasal shedding by commercial vaccines.
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Equine herpesvirus-1 is a cause of outbreaks of abortion and neurological disease. The pathogenesis of both these diseases depends on establishment of viremia. An experiment was performed to determine the protective efficacy of two commercially available vaccines used with an optimized 3-dose vaccination regime: a modified-live viral (MLV) and a high antigen load killed vaccine licensed for abortion control. The study design was a blinded, randomized challenge trial. Three groups of 8 yearling ponies received one of three treatments: MLV vaccine (Rhinomune(R), Boehringer Ingelheim Vetmedica, Inc.); killed vaccine (Pneumabort-K(R), Pfizer Animal Health); or a placebo (control group). (…)text/htmlhttp://www.businesswire.comBusiness Wire10.06.2010 | Business Wire: Exelixis Announces June 15 Webcast of Presentation at the Goldman Sachs 31st Annual Global Healthcare Conference | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (NASDAQ: EXEL) announced today that George A. Scangos, PhD, the company s president and chief executive officer, will present at the Goldman Sachs 31st Annual Global Healthcare Conference at 1:20 p.m. PDT / 4:20 p.m. EDT on Tuesday June 15, 2010 in Los Angeles. Dr. Scangos will discuss the company s corporate strategy and development pipeline, and provide a general business update. The event will be webcast and may be accessed in the Event Calendar page under Investors at http:/www.exelixis.com. About Exelixis Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small (…)text/htmlhttp://www.businesswire.comBusiness Wire11.06.2010 | Business Wire: Dabigatran etexilate as effective and safe as enoxaparin in preventing venous thromboembolism (VTE) after total hip replacement surgery and significantly reduced the combined endpoint of major VTE and VTE-related death | Business Wire
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INGELHEIM, Germany-(BUSINESS WIRE)-For NON-US Healthcare Media Only Data from the RE-NOVATE II study presented today at the 15th Annual Congress of the European Hematology Association (EHA) have shown that dabigatran etexilate 220mg once daily is as effective and safe as enoxaparin 40mg in preventing venous thromboembolism (VTE) after total hip replacement surgery. The results also showed that dabigatran etexilate significantly reduced the combined endpoint of major VTE and VTE-related death compared to enoxaparin.1 The double-blind non-inferiority trial randomized 2,055 patients and was designed to investigate whether treatment with dabigatran etexilate 220mg once daily was as effective (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today10.06.2010 | Medical News Today: Washington Post Opinion Article Responds To Critics Of Female Sexual Dysfunction Drug
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Claims that the development of a drug to treat female sexual dysfunction amounts to "disease mongering" come "down to a delicate judgment call - that lack of female sexual satisfaction isn't really a problem," Washington Post columnist Katrina vanden Heuvel writes. On June 18, an FDA advisory committee is scheduled to consider whether to recommend approval of flibanserin - "the so-called pink Viagra" - as a treatment for hypoactive sexual desire dysfunction, vanden Heuvel notes. In addition to charges of disease mongering, "critics contend that studying the condition in a traditionally 'medical' framework at all is inappropriate," vanden Heuvel writes. "But the assumption that pink Viagra (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today09.06.2010 | Medical News Today: HDMA Honors Leading Pharmaceutical And Consumer Product Manufacturers At Inaugural Business & Leadership Conference
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The Healthcare Distribution Management Association (HDMA) recognized leading pharmaceutical and consumer product manufacturers with the presentation of 10 Distribution Industry Awards for Notable Achievements in Healthcare (DIANA). The winners were announced at the Association's inaugural Business & Leadership Conference in Orlando, Florida. "The 2010 DIANA winners demonstrate an abiding commitment to innovation and collaboration," said HDMA President and CEO John M. Gray. "These winning companies have shown creativity in introducing new products and services and establishing successful partnerships with their distributor peers in a way that benefits not just the healthcare supply chain (…)text/htmlhttp://www.medicalnewstoday.comMedical News Today09.06.2010 | Medical News Today: Micromet Presents Interim Update On Phase 1 Study Of MT110 In Patients With Advanced Solid Tumors
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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/htmlhttp://www.businesswire.comBusiness Wire08.06.2010 | Business Wire: Research and Markets: How to Get Media Exposure as a Family Doctor - Using Visibility in Magazines, Newsletters, Web Sites, Radio & TV as a Way to Enhance Your Reputation | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/6c6f49/how_to_get_media_e) has announced the addition of the "How to Get Media Exposure as a Family Doctor - Using Visibility in Magazines, Newsletters, Web Sites, Radio & TV as a Way to Enhance Your Reputation" audioconference to their offering. A credible medical resource at your convenience. In How to Get Media Exposure as a Family Doctor, ExecSense examines specific tips, tricks, and strategies for getting more visibility in different media sources and using this as a way to enhance your reputation. Take the 60 minutes to view this webinar (on your computer, mobile phone, iPod or printed out) to (…)text/htmlhttp://www.businesswire.comBusiness Wire08.06.2010 | Business Wire: Research and Markets: Best Practices for Patient Interaction and Rapport as a Radiologist: Comprehensive Webinar Providing Essential Information in 60 Minutes | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/99f35d/best_practices_for) has announced the addition of the "Best Practices for Patient Interaction and Rapport as a Radiologist" audioconference to their offering. A credible medical resource at your convenience. In Best Practices for Patient Interaction and Rapport as a Radiologist, ExecSense examines tips, tricks and techniques used by leading radiologists that are guaranteed to immediately improve your interactions with patients. Take the 60 minutes to view this webinar (on your computer, mobile phone, iPod or printed out) to learn easy-to-implement techniques that other radiologists use for (…)text/htmlhttp://www.businesswire.comBusiness Wire08.06.2010 | Business Wire: Research and Markets: Best Practices for Patient Interaction and Rapport as a Gastroenterologist: Extensive Report in 60 Minutes | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/220f04/best_practices_for) has announced the addition of the "Best Practices for Patient Interaction and Rapport as a Gastroenterologist" audioconference to their offering. Best Practices for Patient Interaction and Rapport as a Gastroenterologist In Best Practices for Patient Interaction and Rapport as a Gastroenterologist, ExecSense examines tips, tricks and techniques used by leading gastroenterologists that are guaranteed to immediately improve your interactions with patients. Take the 60 minutes to view this webinar (on your computer, mobile phone, iPod or printed out) to learn easy-to-implement (…)text/htmlhttp://www.businesswire.comBusiness Wire08.06.2010 | Business Wire: Research and Markets: Public Speaking & Presentation Skills for Dentists: Essential Information Provided in 60 Minutes | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/a3cd41/public_speaking) has announced the addition of the "Public Speaking & Presentation Skills for Dentists" audioconference to their offering. A credible medical resource at your convenience. In Public Speaking & Presentation Skills for Dentists, ExecSense examines specific tips and tricks used by leading speakers and dentists that are guaranteed to enhance your impact the next time you give a presentation or speech, lead a discussion with colleagues, or even want to steer a conversation or interaction in a specific way. Take the 60 minutes to view this webinar (on your computer, mobile phone, iPod (…)text/htmlhttp://www.businesswire.comBusiness Wire08.06.2010 | Business Wire: Dr. Inder Kaul Joins Asiatic Clinical Research as Independent Director | Business Wire
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ALPHARETTA, Ga.-(BUSINESS WIRE)-Dr. Inder Kaul, MD, MPH, has joined Asiatic Clinical Research (www.asiaticlinical.com; 'Asiatic') as an Independent Director. Dr. Kaul is known globally for his expertise in directing scores of clinical trials (Phase I-IV) across many therapeutic areas such as infectious diseases, immunology, cardiovascular, rheumatology, and metabolic diseases Dr. Kaul brings his experience in clinical development on both sides of the table in drug development and CRO services. Dr. Kaul has two decades of progressive experience with small to large size companies in the product development programs of drugs, biologics and devices. He has extensive clinical experience in (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed03.06.2010 | NCBI PubMed: The Efficacy and Safety of BI 2536, a Novel Plk-1 Inhibitor, in Patients with Stage IIIB/IV Non-small Cell Lung Cancer Who Had Relapsed after, or Failed, Chemotherapy: Results from an Open-Label, Randomized Phase II Clinical Trial.
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OBJECTIVE: To investigate the efficacy, safety, and pharmacokinetics of two dosing schedules of BI 2536, a novel polo-like kinase-1 inhibitor, in patients with relapsed stage IIIB/IV non-small cell lung cancer. METHODS: Ninety-five patients were randomized to intravenous BI 2536 on day 1 (200 mg) or days 1 to 3 (50 or 60 mg) of a 21-day treatment course. BI 2536 doses were escalated beyond course 2 if well tolerated. The primary objective was response, and the secondary objectives were progression-free survival (PFS) and overall survival (OS), quality of life, safety, and pharmacokinetics. Primary statistical aim was to demonstrate the difference in objective response rate to historical (…)text/htmlhttp://www.businesswire.comBusiness Wire07.06.2010 | Business Wire: Exelixis Announces June 9 Webcast of Presentation at the Jefferies 2010 Global Life Sciences Conference | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (NASDAQ: EXEL) announced today that Michael M. Morrissey, PhD, the company s president of research and development, will present at Jefferies 2010 Global Life Sciences Conference at 10:00 a.m. EDT / 7:00 a.m. PDT on Wednesday June 9, 2010 in New York. Mr. Morrissey will discuss the company s corporate strategy, development pipeline, and provide a general business update. The event will be webcast and may be accessed in the Event Calendar page under Investors at http:/www.exelixis.com. About Exelixis Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule (…)text/htmlhttp://www.businesswire.comBusiness Wire07.06.2010 | Business Wire: Exelixis Reports Updated Data from Multiple Clinical Trials of the PI3K Inhibitor XL147 (SAR245408) to be Presented at ASCO | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (Nasdaq:EXEL) today reported updated interim data from three ongoing trials of XL147 (SAR245408), a selective, orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K). Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. The pathway also has been implicated as a mediator of resistance to agents targeting epidermal growth factor receptor (EGFR) family members. The presentations will be made at the 2010 Annual Meeting of the American Society of Clinical Oncology, which is being held June 4-8 in Chicago. (…)text/htmlhttp://www.businesswire.comBusiness Wire06.06.2010 | Business Wire: Exelixis Reports Updated Data from Multiple Clinical Trials of the Dual PI3K and mTOR Inhibitor XL765 (SAR245409) to be Presented at ASCO | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (Nasdaq: EXEL) today reported updated interim data from three ongoing trials of XL765 (SAR245409), an orally available small molecule inhibitor of phosphoinositide-3-kinase (PI3K) and mTOR. Activation of the PI3K pathway is a frequent event in human tumors, promoting cell proliferation, survival, and resistance to chemotherapy and radiotherapy. The pathway also has been implicated as a mediator of resistance to agents targeting epidermal growth factor receptor (EGFR) family members. The presentations will be made at the 2010 Annual Meeting of the American Society of Clinical Oncology, which is being held June 4-8 in Chicago. (…)text/htmlhttp://www.businesswire.comBusiness Wire04.06.2010 | Business Wire: Research and Markets: How to Create a Personal Brand as a Cardiologist - Using Speaking Engagements, Published Articles, TV Appearances & Social Media | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/e25269/how_to_create_a_pe) has announced the addition of the "How to Create a Personal Brand as a Cardiologist - Using Speaking Engagements, Published Articles, TV Appearances & Social Media as a Way to Make a Name for Yourself" audio conference to their offering. A credible medical resource at your convenience. In How to Create a Personal Brand as a Cardiologist, ExecSense examines specific ways to use speaking engagements, published articles, television appearances, and social media web sites as a way to establish yourself as a thought leader and get more exposure for yourself personally (apart (…)text/htmlhttp://www.businesswire.comBusiness Wire04.06.2010 | Business Wire: Research and Markets: the Top 25 European Producers of Custom Procedure Trays Profiling the Top 25 European Producers of Custom Procedure Trays | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/7e26de/the_top_25_europea) has announced the addition of the "The Top 25 European Producers of Custom Procedure Trays" report to their offering. The Top 25 European Producers of Custom Procedure Trays There are many benefits to adopting Custom Procedure Trays. They can reduce costs (reduced time, reduced inventory, reduced risk of cross contamination and reduced waste) and increase patient throughput (improved set up times and reduced emergency response times). According to Helen Staples, Procedure Pack Coordinator, Southampton University Hospitals NHS Trust and a 45 year NHS veteran, The use of (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.05.2010 | NCBI PubMed: Asthma in Adolescents and Adults.
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OVERVIEW: More than 16 million U.S. adults have asthma, a condition that prompts 2 million ED visits and nearly half a million hospital admissions annually. Management of this potentially deadly, chronic inflammatory disease depends on early diagnosis, accurate classification, appropriate treatment, and targeted patient education. This article outlines current guideline recommendations for asthma and reviews what clinicians need to teach patients about its pathophysiology, pharmacotherapy, self monitoring, and environmental control. The authors discuss the classic clinical presentation of the disease, describe how to assess severity and control, and explain how such assessments can guide (…)text/htmlhttp://www.businesswire.comBusiness Wire03.06.2010 | Business Wire: Exelixis Announces Webcasts of ASCO Investor Briefings on June 5 and June 7 | Business Wire
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SOUTH SAN FRANCISCO, Calif.-(BUSINESS WIRE)-Exelixis, Inc. (NASDAQ: EXEL) announced today that it will hold two investor briefings in conjunction with the American Society of Clinical Oncology (ASCO) Annual Meeting from 6:30 p.m. to 8:00 p.m. CDT on Saturday, June 5, 2010 and 6:00 p.m. to 7:30 p.m. CDT on Monday, June 7, 2010. The events will be available via conference call and webcast. Access numbers for the events are as follows: Saturday June 5, 2010 dial: 1-800-510-9691 (domestic) and +1-617-614-3453 (international); the participant passcode is: 44562547. Monday June 7, 2010 dial: 1-866-783-2144 (domestic) and +1-857-350-1603 (international); the participant passcode is: 72899846. (…)text/htmlhttp://www.businesswire.comBusiness Wire03.06.2010 | Business Wire: Research and Markets: Option and Evaluation Agreements in Pharma and Biotech - The Comprehensive Updated 2nd Edition | Business Wire
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DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/f8bc26/option_and_evaluat) has announced the addition of the "Option and Evaluation Agreements in Pharma and Biotech, 2nd Edition" report to their offering. Option and Evaluation Agreements in Pharma and Biotech, 2nd Edition The Option and Evaluation Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the option and evaluation partnering agreements entered into by the worlds leading biopharma companies. This report provides details of the latest option and evaluation agreements announced in the pharmaceutical and biotechnology sectors. Detailed and (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.06.2010 | NCBI PubMed: Technical refolding of proteins: Do we have freedom to operate?
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Expression as inclusion bodies in Escherichia coli is a widely used method for the large-scale production of therapeutic proteins that do not require post-translational modifications. High expression yields and simple recovery steps of inclusion bodies from the host cells are attractive features industrially. However, the value of an inclusion body-based process is dominated by the solubilization and refolding technologies. Scale-invariant technologies that are economical and applicable for a wide range of proteins are requested by industry. The main challenge is to convert the denatured protein into its native conformation at high yields. Refolding competes with misfolding and (…)