http://www.lsis.com/goto/r97/rss 2010-06-23T11:10:57+01:00 text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v97/%3B%97f%FA%15%7Cx%7B Pfizer Inc. announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product's safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials. Mylotarg was approved in May 2000 under the FDA's accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint - a laboratory measurement or a physical sign (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97f%FB%1Ctx%7F SAN FRANCISCO-(BUSINESS WIRE)-Ablexis, LLC, a biotechnology company dedicated to developing the AlivaMab Mouse, an innovative next-generation platform for antibody drug discovery, announced today the appointments of R. Scott Greer as chairman of the board of directors and Richard Hoffman as chief business officer. These important additions reunite three key leaders from the strategic, commercial and technical foundation of Abgenix, Inc., which was acquired by Amgen for $2.2 billion in 2006. Together, they will apply more than 60 years combined experience and know-how in the field to further enhance and execute Ablexis business strategy. Both Scott and Richard were an integral part of the (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97f%FB%1Ct%7Dz NEWTON, Mass.-(BUSINESS WIRE)-Pro-Pharmaceuticals, Inc. (OTCBB: PRWP), the leading developer of therapeutics that target Galectin receptors to treat cancer and fibrosis, today announced it has received its first purchase order for DAVANAT from PROCAPS S.A., a large, international pharmaceutical company based in Barranquilla, Colombia. Pro-Pharmaceuticals has received a purchase order for $200,000 which will be the upfront payment for this first shipment of DAVANAT. We believe DAVANAT will give physicians and patients a new treatment option that will increase survival and improve cancer patients quality of life. Further, because of its affordability, DAVANAT has the potential to treat a (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FC%1D%7Cx%7B Acetylcholine (ACh) synthesis and release from basal forebrain cholinergic neurons (BFCN) innervating the cerebral cortex and hippocampus are essential processes for normal learning, memory and attention. Bone morphogenetic protein (BMP) 9 is a cholinergic differentiation factor in the developing septum that increases ACh synthesis and choline acetyltransferase (Chat) gene expression both in vivo and in vitro. We investigated the possible induction of cholinergic trophic factors by BMP9 in murine septal cells. Nerve growth factor (NGF) protein expression and secretion into the medium was increased in cultured embryonic septal cells treated with BMP9, and partially mediated BMP9-induced (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97f%FC%12%7Cyr BLUE BELL, Pa.-(BUSINESS WIRE)-Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that Scientific American magazine has published in its July issue an article entitled œDNA Drugs Come of Age.  The article was co-authored by Dr. David Weiner, Chairman, Scientific Advisory Board, Inovio Pharmaceuticals, and Professor, Department of Pathology & Laboratory Medicine, at the University of Pennsylvania and Dr. Matthew Morrow, a post-doctorate research fellow at University of Pennsylvania. Improvements to the plasmids and new methods for delivering them have dramatically (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FC%17%7B%7Fy Background and Objectives: For patients with advanced cancers, it is important that treatment improves the quality as well as the quantity of survival. This quality-adjusted time without symptoms of progression or toxicity (Q-TWiST) analysis provides a combined measure of both the overall survival interval and the quality of survival for patients with advanced renal cell carcinoma (RCC) receiving temsirolimus, interferon (IFN)-alpha or the combination of these agents, using data from a phase III clinical trial. Methods: Overall survival was partitioned into three distinct health states: time with serious toxicity (TOX), time after progression (REL) and time without symptoms of progression (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FC%14%7E%7Ex The nuclear receptor, estrogen receptor alpha (ERalpha), controls the expression of hundreds of genes responsible for target cell phenotypic properties, but the relative importance of direct vs. tethering mechanisms of DNA binding has not been established. In this first report, we examine the genome-wide chromatin localization of an altered-specificity mutant ER with a DNA-binding domain deficient in binding to estrogen response element (ERE)-containing DNA (DBDmut ER) vs. wild type ERalpha. Using high-throughput sequencing of ER chromatin immunoprecipitations (ChIP-Seq) and mRNA transcriptional profiling, we show that direct ERE binding is required for most (75%) estrogen-dependent gene (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v97/%3B%97f%FD%11%7C%7Br Reuters - A U.S. House of Representatives committee is investigating reports that drugmaker Wyeth, now a unit of Pfizer Inc (PFE.N), promoted a transplant drug to African-Americans for unapproved uses, the panel's chairman said on Friday. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FD%16%7Cvy OBJECTIVE: This study assessed the efficacy, safety, and tolerability of the serotonin-norepinephrine reuptake inhibitor desvenlafaxine and the selective serotonin reuptake inhibitor escitalopram for major depressive disorder (MDD) in postmenopausal women. METHODS: In this randomized, double-blind study, postmenopausal outpatients (aged 40-70 y) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition MDD received flexible-dose desvenlafaxine (100-200 mg/d) or escitalopram (10-20 mg/d) for 8 weeks. Acute-phase responders, that is, women with a 50% or greater reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, were eligible (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v97/%3B%97f%FE%12%7F%7E%7C UK Premiership footballer Rory Delap, renowned for his devastating throw-in, has joined forces with a number of football heroes across Europe to support 'Back in Play', a European wide campaign to reach young men and women and raise awareness of ankylosing spondylitis (AS), a poorly understood condition which can affect the lower back. AS is a type of inflammatory arthritis, characterised by low back pain and stiffness, which is most common in young men1,2. The symptoms can be subtle and are often overlooked or confused with common back pain or sports injuries meaning it can take as long as 3-11 years to be accurately diagnosed3. The campaign, supported by the Ankylosing Spondylitis (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97f%FE%12%7Dxr TARRYTOWN, N.Y.-(BUSINESS WIRE)-Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the election of board member Peter J. Crowley as Chairman of the Board at the Company s annual meeting. Mr. Crowley replaces Kurt Briner, who is stepping down as Chairman at the end of his term while remaining a director. Mr. Crowley has over two decades of experience in healthcare finance as a senior investment banker. During his career as an investment banker Mr. Crowley often advised Progenics. We are grateful to Kurt for his years of service as Chairman, and are pleased we will continue to have his wise counsel as a director œWe are grateful to Kurt for his years of service as Chairman, (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FE%16zw%7C Smallpox was eradicated more than 30 years ago, but heightened concerns over bioterrorism have brought smallpox and smallpox vaccination back to the forefront. The previously licensed smallpox vaccine in the United States, Dryvax(R) (Wyeth Laboratories, Inc.), was highly effective, but the supply was insufficient to vaccinate the entire current US population. Additionally, Dryvax(R) had a questionable safety profile since it consisted of a pool of vaccinia virus strains with varying degrees of virulence, and was grown on the skin of calves, an outdated technique that poses an unnecessary risk of contamination. The US government has therefore recently supported development of an (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v97/%3B%97f%FF%12xyx GLOSTRUP, DENMARK-(Marketwire - June 08, 2010) - Copenhagen, 08 June 2010 Announcement no. 5, 2010 Zealand Pharma A/S ("Zealand Pharma" or "the Company") Zealand Pharma Announces An Extension of The Lixisenatide Global Licensing Agreement with sanofi-aventis for Type-2 Diabetes Zealand Pharma A/S, the biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs, is pleased to announce that the global licensing agreement with sanofi-aventis has been amended to provide for the development and commercialization of Lixisenatide (AVE0010/ZP10) in combination with Lantus, sanofi-aventis' recombinant human insulin analog. Lixisenatide is a (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v97/%3B%97f%FF%12xx%7F BASKING RIDGE, NJ, June 7, 2010 Life science services company i3 announced today that Anne Tomalin, head of i3 s strategic regulatory services group, was honored with the 2010 Canadian Society for Pharmaceutical Sciences (CSPS) Leadership Award at a gala reception during the CSPS 13th Annual Symposium, June 4, 2010, in Richmond, BC. This annual award is bestowed upon a scientist who has demonstrated leadership in advancing the cause of pharmaceutical research and development in Canada. Since founding CanReg in 1996, Anne grew the business to include more than 100 in-house consultants and staff before i3 acquired the company in 2009. Prior to starting CanReg, Anne worked for 20 years at (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97f%FF%12%7D%7By TARRYTOWN, N.Y. & CHICAGO-(BUSINESS WIRE)-Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today presented the design and rationale of an ongoing phase 1 trial of its prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) therapy at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). This phase 1 trial is assessing the safety, tolerability and initial clinical activity of progressively increasing doses of PSMA ADC in patients with progressive, metastatic, hormone-refractory prostate cancer following prior taxane chemotherapy. The results would be used to determine dosing for further evaluation in phase 2 clinical testing. First-in-human phase 1 trial (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FF%13x%7F%7C In cardiovascular disease rupture of a vulnerable atherosclerotic plaque is the major causative factor of acute coronary syndromes, myocardial infarction and stroke, and can ultimately lead to death. Identification of biomarkers that could accurately predict the risk of plaque rupture would be a significant advance in guiding treatment of patients with this disease, The use of these biomarkers would also facilitate the development of new drugs to treat cardiovascular disease, particularly those that act through novel mechanisms. There is currently a lack of specific biomarkers for vulnerable plaque, and thus, it is an area of intense research including the concepts of live detection versus (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97f%FF%17%7D%7E%7B PURPOSE: CMC-544 (inotuzumab ozogamicin) is a CD22-specific immunoconjugate of calicheamicin currently being evaluated in patients with non-Hodgkin's B-cell lymphoma (BCL). CHOP and CVP represent untargeted combination chemotherapy comprised of cyclophosphamide, vincristine and prednisone with or without doxorubicin, commonly used in the treatment of NHL. Here, we describe anti-tumor efficacy of CMC-544, CHOP or CVP against human BCL xenografts. METHODS: In vitro, human BCLs were cultured with CMC-544 or individual constituents of CHOP for inhibition of their growth. In vivo, immunocompromised mice with established BCL xenografts were administered CHOP, CVP or CMC-544 to monitor their (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v97/%3B%97f%FF%14%7F%7Fs LEIDEN, NETHERLANDS-(Marketwire - June 04, 2010) - Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced that the Annual General Meeting of Shareholders (AGM) held today in Leiden adopted the 2009 financial statements. In addition, the AGM reappointed Mr. J.P. Oosterveld as member of the Supervisory Board; Mr. W. Burns, Mr. J. Shannon and Mr. G. Siber were appointed as new members of the Supervisory Board. The shareholders of Crucell were represented in person, by proxy voting, or by voting instruction, representing a total of 36,2% of the total issued share capital entitled to vote. The shareholders approved the appointments of Mr. (…) text/html http://www.bionity.com Bionity.com http://www.lsis.com/goto/v97/%3B%97f%FF%14%7E%7Dz 04.06.2010 - EPEMED has announced the appointment of Dr. Anne Bruinvels, an entrepreneur in personalised healthcare, as Executive Director and board member. Dr. Bruinvels will be responsible for growing the start-up organisation and, together with the board of directors, for building its strategic framework in creating guidance for all those involved in progressing personalised medicine with an emphasis on European market challenges. Dr. Bruinvels started her work in personalised medicine more than 10 years ago. She has previously founded Elixior, a personalised healthcare advisory company and prior to that Curidium, a personalised medicine company identifying companion diagnostics and (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97f%FF%15tv%7B 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/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F6%12x%7Er AUSTIN, Texas-(BUSINESS WIRE)-CEDRA Corporation, a division of Worldwide Clinical Trials and provider of Phase I-IIb clinical research and bioanalytical services, announced today the appointment of Thomas L. Lloyd as Director of Automation for the Bioanalytical Group. Thomas is an enormous asset to the CEDRA team Lloyd has over 22 years of industry experience in successfully developing and automating analytical and bioanalytical processes. His specific expertise lies within the areas of automation systems and analytical instrument development, bioanalytical chemistry, in vitro DMPK studies, software programming and application, statistics, chemometrics and GLP requirements. œThomas is (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%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/v97/%3B%97g%F7%1D%7Ev%7B The safety, tolerability, and pharmacokinetics (PKs) of bapineuzumab (AAB-001), a humanized monoclonal antibody to amyloid beta, were evaluated in patients with mild-to-moderate Alzheimer disease in a phase 1, randomized, third-party unblinded, placebo-controlled, single ascending dose trial. Thirty patients received bapineuzumab infusion of 0.5, 1.5, or 5 mg/kg or placebo (6 active, 2 placebo for 0.5 and 1.5-mg/kg cohorts; 10 active, 4 placebo for 5.0-mg/kg cohort). Three patients in the highest dose cohort (5.0 mg/kg) developed magnetic resonance imaging abnormalities consistent with vasogenic edema, predominantly high signal abnormalities on fluid-attenuated inversion recovery (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%F7%10t%7F%7F This study identifies predictors of placement or death in a large ethnically/racially diverse sample of moderately impaired Alzheimer disease patients residing in the community. Patients and caregivers were followed for 18 months with 4 assessments at 6-month intervals. Multinomial regression was used to identify caregiver and patient baseline characteristics and changes over time as predictors of patient placement in a long-term care facility (n=180), patient death (not preceded by placement, n=187), or remaining in the community at home (n=583). Our findings reveal important differences between death and placement when compared with continued home care. Both death and placement are (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%10%7E%7B%7C DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/52bee2/managed_care_pull) has announced the addition of the "Managed Care Pull - Through Excellence: From Formulary Access to Increased Market Share" report to their offering. Managed Care Pull - Through Excellence: From Formulary Access to Increased Market Share Winning a favorable managed care formulary position can be a Herculean task for pharmaceutical companies today, but successful brand leaders know that position alone doesnt guarantee increased market share. Savvy brand leaders develop and carry out extensive pull-through programs to drive product sales after a formulary win. The analyst (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%10%7E%7B%7D TARRYTOWN, N.Y. & SAN DIEGO, Calif.-(BUSINESS WIRE)-Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the presentation of preclinical data on novel monoclonal antibodies against toxins produced by the bacterium Clostridium difficile (C. difficile). The monoclonal antibodies effectively neutralized the cell-killing activities of the toxins in vitro and significantly improved survival in a stringent animal model of C. difficile infection. C. difficile is the leading cause of hospital-acquired diarrhea in the United States and represents a growing global public health challenge. The monoclonal antibodies were identified as part of the Company s ongoing drug discovery efforts in (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%10%7Dw%7F DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/2ea526/expanding_a_produc) has announced the addition of the "Expanding a Product Portfolio Without Cannibalizing an Established Brand" report to their offering. Expanding a Product Portfolio Without Cannibalizing an Established Brand Managing multiple products for the same indication is a complex balancing act for bio-pharmaceutical companies today especially those that want to prevent one of their brands from gaining market share at the expense of another. Maximizing the potential of each product requires well-crafted marketing strategies and smart resource allocation plans. Marketers have to make (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%10%7Dx%7D DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/1e827b/new_product_planni) has announced the addition of the "New Product Planning: Role and Activities for Medical Marketing" report to their offering. New Product Planning: Role and Activities for Medical Marketing Leading pharmaceutical and biotech companies are increasingly under pressure to deliver effective new products in shorter time frames while minimizing development costs. The structure, activities, and resources of New Product Planning (NPP) groups are critical to focusing new product development and optimizing product portfolios. This benchmarking study examines the role and impact of NPP (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%10%7Dx%7B DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/a52258/philippines_pharma) has announced the addition of the "Philippines Pharmaceuticals and Healthcare Report Q3 2010" report to their offering. Philippines Pharmaceuticals and Healthcare Report Q3 2010 The Philippines Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on the Philippines' pharmaceuticals and healthcare industry. In our updated Asia Pacific Business Environment Ratings (BER) table for Q310, the (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v97/%3B%97g%F7%14%7Dv%7E The US Food and Drug Administration (FDA) has warned that high dose, long term use of a class of drugs known as Proton Pump Inhibitors (PPIs), for conditions such as heartburn, acid reflux and gastric ulcers, carries an increased risk of bone fractures in the wrist, hip and spine. In their warning to consumers and health care professionals on Tuesday, the FDA said the product labeling will be changed to include a safety warning about the increased potential risk. PPIs are available in the US as prescription and over the counter (OTC) drugs. Prescription PPIs are used to treat conditions such as gastroesophageal reflux disease (GERD), ulcers of the stomach and small intestine, and (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%14%7D%7D%7C DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d6ed86/psoriasis_drugs) has announced the addition of the "Psoriasis Drugs - Global Strategic Business Report" report to their offering. Psoriasis Drugs - Global Strategic Business Report This report analyzes the worldwide markets for Psoriasis Drugs in US$ Million by the following Drug Administration Routes - Systemic Drugs, and Topical Drugs. 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 69 companies including many key and niche (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F7%14%7D%7Er PHILADELPHIA-(BUSINESS WIRE)-HealthCare Innovations (HCI), a healthcare training organization specializing in customized learning solutions, has announced its company re-launch and attendance at the 39th Society of Pharmaceutical and Biotech Trainers (SPBT) annual conference, which takes place June 7-10, 2010, at the Gaylord Palms Convention Center located in Kissimmee, Florida. HCI will be located at booth 426. The overriding objective is to alter or enhance performance with the ultimate end goal of achieving better outcomes for patients. Since 1995, HCI has designed, developed and implemented impactful learning solutions for healthcare professionals. As a healthcare training (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F8%12zxz PARIS-(BUSINESS WIRE)-At 12 months the NEVO ¢ Sirolimus-eluting Coronary Stent has continued to demonstrate excellent safety and efficacy outcomes compared to Taxus Liberte according to new data presented today from the NEVO ¢ RES-I clinical trial. These results were presented as a late breaking trial at EuroPCR, the leading medical conference in Europe for physicians specializing in interventional cardiovascular medicine. NEVO ¢ is a critical component of our commitment to providing innovative new products, which are transforming expectations for patients and practitioners in the field of interventional cardiology. Through 12-month follow-up, there have been no episodes of stent (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F8%12z%7Bx DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/91188e/clinical_nutrition) has announced the addition of the "Clinical Nutrition Products - Global Strategic Business Report" report to their offering. Clinical Nutrition Products - Global Strategic Business Report This report analyzes the worldwide markets for Clinical Nutrition Products in US$ Million by the following segments: Enteral Nutrition, Infant Nutrition, and Parenteral Nutrition. The report provides separate comprehensive analytics for the US, Japan, Europe, China, and Rest of World. Annual estimates and forecasts are provided for each region for the period 2006 through 2015. The report (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%F8%16%7E%7Ex ABSTRACT: BACKGROUND: Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. METHODS: This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/L, designated as Gold + Lutein). Two hundred (…) text/html http://www.bionity.com Bionity.com http://www.lsis.com/goto/v97/%3B%97g%F8%17%7Cwr 25.05.2010 - Ablynx announced that the research collaboration which forms part of its license agreement for Nanobodies to tumour necrosis factor alpha (TNF-alpha) with Pfizer has been extended for another year. Ablynx announced the exclusive research collaboration and license agreement with Pfizer (originally signed with Wyeth Pharmaceuticals) in November 2006, a deal potentially worth $212.5 million in past and future milestone payments for commercialisation across multiple indications. In addition, Ablynx is eligible to receive royalties on product sales. Under this agreement, Pfizer has exclusive rights to develop and commercialise anti-TNF-alpha Nanobodies developed under the (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%F9%12uz%7E In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case. |-| Am J Law Med. |-| Gostanian A. |-| (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%F9%13t%7E%7F A series of 5-ureidobenzofuran-3-one indoles as potent inhibitors of PI3Kalpha and mTOR has been developed. The best potency in cells was obtained when the urea group was extended to a 4-[2-(dimethylamino)ethyl]methylamino amidophenyl group. A 7-fluoro group on the indole ring also enhanced cellular potency. Compound 18i, incorporating the optimal functional groups, showed high potency in cellular lines and was further studied in vivo. It was able to inhibit the biomarker phosphorylation for 8h when dosed at 25mg/kg iv. In the MDA-MB-361 breast cancer model, it shrank the tumor size remarkably when dosed at 25mg/kg iv on days 1, 5, and 9. |-| Bioorg Med Chem Lett. |-| Zhang N, (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v97/%3B%97g%F9%17tv%7B GHENT, BELGIUM-(Marketwire - May 20, 2010) - Ablynx (Euronext Brussels: ABLX) announced today that the research collaboration which forms part of its license agreement for Nanobodies to tumour necrosis factor alpha (TNF-alpha) with Pfizer has been extended for another year. Ablynx announced the exclusive research collaboration and license agreement with Pfizer (originally signed with Wyeth Pharmaceuticals) in November 2006, a deal potentially worth $212.5 million in past and future milestone payments for commercialisation across multiple indications. In addition, Ablynx is eligible to receive royalties on product sales. Under this agreement, Pfizer has exclusive rights to develop and (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v97/%3B%97g%F9%17%7Dvz GHENT, BELGIUM-(Marketwire - May 20, 2010) - Ablynx (Euronext Brussels: ABLX) announced today that the research collaboration which forms part of its license agreement for Nanobodies to tumour necrosis factor alpha (TNF-alpha) with Pfizer has been extended for another year. Ablynx announced the exclusive research collaboration and license agreement with Pfizer (originally signed with Wyeth Pharmaceuticals) in November 2006, a deal potentially worth $212.5 million in past and future milestone payments for commercialisation across multiple indications. In addition, Ablynx is eligible to receive royalties on product sales. Under this agreement, Pfizer has exclusive rights to develop and (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%F9%14t%7C%7B DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d5a60b/neurodegenerative) has announced the addition of the "Neurodegenerative Drugs - Global Strategic Business Report" report to their offering. Neurodegenerative Drugs - Global Strategic Business Report This report analyzes the worldwide markets for Neurodegenerative Drugs in US$ 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.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%F9%14%7D%7D%7B PURPOSE Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have had a significant impact on non-small-cell lung cancer (NSCLC) outcomes, particularly for patients with EGFR mutations. Resistance emerges after 9 to 12 months, primarily mediated by the T790M resistance mutation. We studied neratinib, an irreversible pan-ErbB TKI that may overcome T790M. PATIENTS AND METHODS Patients with advanced NSCLC underwent EGFR sequencing of available tumor tissue at enrollment. Those with /= 12 weeks of prior TKI therapy were placed in arm A if they were EGFR mutation positive or arm B if they were wild-type. Arm C included TKI-naïve patients with adenocarcinoma and light (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%F9%15y%7Cs An area of unmet medical need in clinical oncology has been optimizing patient selection for a given therapeutic with the goal of getting the right drug to the right patient. Recent studies have developed preclinical approaches to identifying molecular 'signatures of resistance' for cytotoxic therapies and prospective validation of this strategy is ongoing in the clinic. New challenges in this setting include identifying approaches to patient selection for cytostatic compounds such as signaling pathway inhibitors and stem cell targets. Here, we discuss the biomarker methodologies developed using traditional cytotoxic drugs and how these approaches can be adapted to identify biomarkers of (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%FA%1D%7Ey%7E Identification and utilization of biomarkers is vitally important for the successful development of disease-modifying osteoarthritis drugs. Biochemical and imaging platforms hold great promise to deliver such biomarkers. Studies indicate a marked increase in biochemical products arising from the breakdown and biosynthesis of collagen, extracellular matrix and bone in osteoarthritis. These molecules have been associated with disease severity and may also have prognostic value as indicators of disease progression. However, issues including biological variability and lack of tissue specificity currently hinder the utility of these molecular markers in drug development. Imaging technologies (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v97/%3B%97g%FA%1D%7F%7D%7D Rupture of a vulnerable atherosclerotic plaque is the main cause of acute coronary syndromes, myocardial infarction and death. Identification of biomarkers that accurately predict the risk of plaque rupture may be a means to establish and monitor response to therapeutic intervention. This review focuses on recent advances for the use of circulating molecular biomarkers and imaging modalities to assess atherosclerotic vulnerable plaques in both preclinical models and clinical conditions. |-| Biomark Med. |-| Wang X, Rutkowsky JL, Feuerstein GZ. |-| Wyeth Research, Translational Medicine, 500 Arcola Road, S2324, Collegeville, PA 19426, USA. wangx8@wyeth.com. text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v97/%3B%97g%FA%12%7B%7Fs NEW YORK, NY-(Marketwire - May 18, 2010) - Kantar Health, l'une des premières sociétés mondiales de conseil et d études de marketing, a annoncé aujourd hui le développement de sa méthode portant sur la valeur de la gestion en Europe de l Est et centrale (CEE) grâce à la nomination du Dr Pali Kolláth au poste de directeur régional, CEE et Méthode portant sur la valeur de la gestion. Le Dr Kolláth réside à Budapest, en Hongrie. « La région de la CEE est une partie importante et en constante évolution du marché pharmaceutique et nos clients considèrent son potentiel de développement très attirant », déclare Werner Guminski, PDG, (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v97/%3B%97g%FA%12%7B%7Ey NEW YORK, NY-(Marketwire - May 18, 2010) - Kantar Health, a leading healthcare-focused global consultancy and marketing insights company, today announced the expansion of its Treatment Value Practice into Central and Eastern Europe (CEE) with the addition of Dr. Pali Kolláth as Regional Director, CEE and Treatment Value Practice. Dr. Kolláth is based in Budapest, Hungary. "The CEE region represents a significant and growing portion of the global pharmaceutical market, and our customers view CEE as a region with an attractive growth potential," says Werner Guminski, CEO, Global Practice and Region Europe, for Kantar Health. "Furthermore, the CEE countries that have joined the European (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v97/%3B%97g%FA%12yxr In the most comprehensive study to date, neurologists have clearly identified significant differences in the ways that Alzheimer's disease (AD) affects patients with and without the apolipoprotein E µ4 gene (APOE µ4), a known genetic risk factor for the neurodegenerative disease, using a combination of cognitive and neuroanatomic measures. The study found that this gene influences the way the disease manifests, even at its mildest clinical stages. Study highlights include: - Patients with mild AD who carry the µ4 form of the APOE gene perform more poorly on memory tests and have more prominent abnormalities in brain regions critical for memory, compared with patients without this gene (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%FA%12xvy DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/8fac3e/acute_coronary_syn) has announced the addition of the "Acute Coronary Syndrome - Global Strategic Business Report" report to their offering. Acute Coronary Syndrome - Global Strategic Business Report This report analyzes the global market for Acute Coronary Syndrome Therapeutics in US$ Million. Annual estimates and forecasts are provided for the period 2006 through 2015. The report profiles 60 companies including Abbott Laboratories Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Daiichi Sankyo Company Limited, Dr. Reddys Laboratories Ltd., Eli Lilly and (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v97/%3B%97g%FA%12x%7Dz BLUE BELL, Pa.-(BUSINESS WIRE)-Inovio Pharmaceuticals, Inc. (NYSE AMEX: INO) today reported financial results for the quarter ended March 31, 2010. Total revenue for the quarter ended March 31, 2010, was $1.4 million, compared with $369,000 for the same period in 2009. Total operating expenses for the quarter ended March 31, 2010, were $5.8 million, compared with $3.9 million for the same period in 2009. The net loss attributable to common stockholders for the quarter ended March 31, 2010, was $2.3 million, or $(0.02) per share, compared with a net loss attributable to common stockholders of $3.5 million, or $(0.08) per share for the same period in 2009. Revenue The increase in revenue (…)