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2012-02-05T11:10:14+01:00text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed02.02.2012 | NCBI PubMed: Characterization of Asthma Exacerbations in Primary Care Using Cluster Analysis.
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Rationale. Patients with a history of asthma exacerbations are at a higher risk for future episodes of severe asthma exacerbations. Characterization of asthma phenotypes could help improve asthma management, including reducing exacerbations. Aim. The aim of this study is to identify distinctive patient characteristics associated with a history of asthma exacerbations using cluster analysis. Methods. We used data assessing asthma control from two cross-sectional surveys of adult and pediatric (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed02.02.2012 | NCBI PubMed: Scaling of pharmacokinetics across paediatric populations: the lack of interpolative power of allometric models.
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Aims:? The objective of this investigation was to assess the performance of an allometric model as the basis for interpolating drug exposure in the context of pharmacokinetic bridging across paediatric subpopulations. Methods:? Midazolam was selected as a paradigm compound. Two nonlinear mixed effects models were developed to describe midazolam pharmacokinetics in infants, toddlers and adults (model 1) and in children and adolescents (model 2). Subsequently, systemic drug exposure, (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed31.01.2012 | NCBI PubMed: Rosiglitazone, Myocardial Ischemic Risk, and Recent Regulatory Actions (February).
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OBJECTIVE:To review the evidence surrounding rosiglitazone and ischemic cardiovascular risk and discuss the Food and Drug Administration (FDA) decision to revise safety information and restrict access to the drug.DATA SOURCES:A literature search was conducted through MEDLINE (1950-January 2012), PubMed (1966-January 2012), and International Pharmaceutical Abstracts (1970-December 2011) using the search terms rosiglitazone and cardiovascular risk. Regulatory documents from the FDA and the (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.04.2006 | NCBI PubMed: Testing for inverse agonism with constitutive receptor systems.
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This unit discusses the use of constitutive 7-transmembrane/G protein coupled receptor (7TM/GPCR) activity for screening new drug entities. Following an introduction to constitutive 7TM/GPCR activity, the unit centers on the three basic components of a constitutive screening system: the receptor, the receptor coupling components (G protein), and the response reporting system. The design of specific assays to detect inverse agonism and the application of such systems to drug screening are also (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.11.2011 | NCBI PubMed: Contamination by porcine circovirus type 1: findings, investigations, and learnings.
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CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA). |-| PDA J Pharm Sci Technol. |-| Piérard I. |-| GlaxoSmithKline Biologicals, Rixensart, Belgium.text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.11.2002 | NCBI PubMed: Tissue expression profiling using real-time PCR.
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The recent development of real-time PCR allows for the rapid and accurate quantitation of gene expression in cells and tissues. Real-time PCR instrumentation is designed for the simultaneous quantitation of gene expression from a few samples up to 384 samples. The normal tissue expression profile of a gene can provide useful insights into its potential role in normal physiological processes. When combined with the tissue expression profile of the gene in diseased tissues, information (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.09.2010 | NCBI PubMed: Label-free imaging and temporal signature in phenotypic cellular assays: a new approach to high-content screening.
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Some drug targets are not amenable to screening because of the lack of a practical or validated biological assay. Likewise, some screening assays may not be predictive of compound activity in a more disease-relevant scenario, or assay development may demand excessive allocation of resources (i.e., time, money or personnel) with limited knowledge of the actual tractability of the target. Label-free methodologies, implemented in microtiter plate format, may help address these issues and (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.09.2008 | NCBI PubMed: Overview of receptor interactions of agonists and antagonists.
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Historically, the earliest methods used to quantitatively measure the fundamental properties of drugs (namely affinity and efficacy) employed isolated tissues, and it is in this realm that the null methods used to define "receptor pharmacology" were described. This unit describes these methods and their use to specifically classify agonists (through potency ratios and determination of relative affinities and efficacies) and antagonists (through analysis of surmountable and insurmountable (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.06.2008 | NCBI PubMed: Receptor theory.
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Receptor theory assigns mathematical rules to biological systems in order to quantify drug effects and define what biological systems can and cannot do, leading to the design of experiments that may further modify the model. Drug receptor theory also furnishes the tools for quantifying the activity of drugs in a system-independent manner, essential because drugs are almost always studied in test systems somewhat removed from the therapeutic system for which they are intended. Since biological (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.02.2003 | NCBI PubMed: In vitro enzymatic assays for ser/thr-selective protein kinases.
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Medium and high throughput methods for measuring the activities of Ser/Thr-selective protein kinases are described. These methods utilize radiochemical detection, fluorescence polarization, and ultraviolet spectroscopy to monitor transfer of the gamma-phosphoryl group of ATP to protein or peptide substrates. These assays have utility in characterizing protein kinase inhibitors and in mechanistic studies. |-| Curr Protoc Pharmacol. |-| Bramson HN. |-| GlaxoSmithKline, Research Triangle Park, (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.06.2010 | NCBI PubMed: Pharmacological applications of baculovirus-mediated protein expression in Mammalian cells.
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The development of cell-based assays for cellular receptors, ion channels, and transporters requires the delivery and expression of transgenes. Viral-mediated gene delivery is a particularly attractive approach for this purpose because of its efficiency and potential to deliver genes to a wide variety of cell types. Recombinant baculoviruses, long used to deliver genes to insect cells for overexpression, also effectively transfer genes to mammalian cells. The only required modification to the (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.06.2009 | NCBI PubMed: Models of aspects of schizophrenia: behavioral sensitization induced by subchronic phencyclidine administration.
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Presented in this unit is a protocol using subchronically administered phencyclidine (PCP) for establishing a behavioral sensitization model of aspects of schizophrenia. This model is validated using haloperidol and risperidone. The end-point of the assay is locomotor hyperactivity, which is induced by PCP challenge following subchronic treatment with this NMDA receptor antagonist. The antipsychotics haloperidol, risperidone, and quetiapine all reduce hyperactivity in a dose-dependent and (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.07.2006 | NCBI PubMed: Head-out plethysmography in safety pharmacology assessment.
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The importance of the ability to accurately evaluate respiratory function in animals has been underscored by the classification of the respiratory system as a vital organ system by regulatory agencies in the United States, the European Union, and Japan. A comprehensive assessment of respiratory function should include an evaluation of ventilatory function, including rate and volume measurements, overall pulmonary ventilation (i.e., minute volume), and lung function, including resistance to (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.05.2002 | NCBI PubMed: Characterization of cannabinoid receptors.
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This unit describes the use of cannabinoid radioligands in competitive binding assays for determining affinity parameters (IC(50), K(i) of unlabeled compounds at cloned CB1 and CB2 receptors expressed in cells. |-| Curr Protoc Pharmacol. |-| Cox RF, Rash V. |-| GlaxoSmithKline, Research Triangle Park, North Carolina.text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.05.2004 | NCBI PubMed: Methods of measuring internalization of g protein-coupled receptors.
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This unit provides detailed protocols for measuring receptor internalization. The techniques are sufficiently generalized to be applicable to most receptors in a wide variety of cell types. Both radioactive and non-radioactive techniques are described that may be used to quantify receptor internalization, and the differences between the two are highlighted. This unit discusses how quantification of internalization may be achieved, and the advantages and drawbacks of each technique. Low- and (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.12.2006 | NCBI PubMed: Approaches to the molecular modeling of 7-transmembrane helical receptors.
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7-Transmembrane helical receptors (7TMs) represent the single most important class of target for drug therapy; therefore, a great deal of effort has gone into computational studies of their structures. Historically, these were based on low resolution electron diffraction data, together with the use of computational methods such as multiple sequence alignments, distance geometry, and molecular mechanics calculations. In the year 2000 the situation changed when the first crystal structure of a (…)text/htmlhttp://www.biospace.comBioSpace02.02.2012 | BioSpace: Drugmakers Including GlaxoSmithKline (GSK) Scuttle Plan for Approval System Pushed by Biotechs
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Drugmakers including GlaxoSmithKline Plc have fought off a U.S. senator s proposal that would have approved medicines for diseases that are fatal, or have no existing treatments, based on fewer human trials. The plan, drafted by Democratic Senator Kay Hagan of North Carolina, was being pushed by biotechnology companies to speed up approvals and make the process less expensive. It would have created a program with the flexibility to allow drugs to be cleared based on any testing that shows they (…)text/htmlhttp://www.biospace.comBioSpace02.02.2012 | BioSpace: GlaxoSmithKline (GSK) Settles 20,000 Lawsuits Over Avandia, Lawyer Says
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GlaxoSmithKline Plc (GSK), which is paying $3 billion to resolve government claims that it illegally marketed drugs such as the Avandia diabetes medication, agreed to settle more lawsuits over the pills, a lawyer said. Glaxo, the U.K. s biggest drugmaker, agreed last month to resolve more than 20,000 cases alleging Avandia causes heart attacks, said Paul Kiesel, a lawyer for former users. The accord, reached in court-ordered mediation, included a case that was set for trial in state court in (…)text/htmlhttp://www.biospace.comBioSpace02.02.2012 | BioSpace: Theravance, Inc. (THRX) to Present at Investor Conferences in February 2012
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SOUTH SAN FRANCISCO, CA-(Marketwire - February 01, 2012) - Theravance, Inc. (NASDAQ: THRX) announced today that Rick E Winningham, Chief Executive Officer, is scheduled to present at the following investor conferences in February 2012: Leerink Swann Global Healthcare Conference Waldorf Astoria, New York, NY Thursday, February 16, 2012 9:30 a.m. EST RBC Capital Markets' Global Healthcare Conference New York Palace, New York, NY Tuesday, February 28, 2012 8:30 a.m. EST Citi Global Healthcare (…)text/htmlhttp://www.biospace.comBioSpace02.02.2012 | BioSpace: Ligand Pharmaceuticals Inc. (LGND) Presents Full Data from Successful Phase II Trial of Captisol-Enabled, Propylene Glycol-Free Melphalan at the BMT Tandem Meetings
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SAN DIEGO-(BUSINESS WIRE)- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND - News) announced that results from the Phase II study of its Captisol-enabled, propylene glycol-free (PG-free) Melphalan program were featured this evening in a poster presentation at the combined annual meetings of the Center for International Blood & Marrow Transplant Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT) in San Diego. The Phase II study was completed in late 2011 (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed30.01.2012 | NCBI PubMed: The Importance of Adjuvant Formulation in the Development of a Tuberculosis Vaccine.
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An effective protein-based vaccine for tuberculosis will require a safe and effective adjuvant. There are few adjuvants in approved human vaccines, including alum and the oil-in-water-based emulsions MF59 (Novartis Vaccines and Diagnostics), AS03 and AS04 (GlaxoSmithKline Biologics), AF03 (Sanofi), and liposomes (Crucell). When used with pure, defined proteins, both alum and emulsion adjuvants are effective at inducing primarily humoral responses. One of the newest adjuvants in approved (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed30.01.2012 | NCBI PubMed: Drug interaction profile for GSK2248761, a next-generation non-nucleoside reverse transcriptase inhibitor.
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Aims:? To evaluate potential drug interactions with antiretroviral therapies or supportive therapies for use in conjunction with the once-daily, next-generation non-nucleoside reverse transcriptase inhibitor GSK2248761 in patients with HIV-1 infection. Methods:? A series of phase I drug interaction studies was conducted. Results:? GSK2248761 was shown to be a weak CYP3A4 and CYP2D6 inhibitor in a clinical study with probe cocktail. Mean plasma concentration-time profiles for atazanavir, (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.01.2012 | NCBI PubMed: Comparing health outcomes and costs of general vaccination with pneumococcal conjugate vaccines in sweden: a markov model.
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Two new pneumococcal conjugate vaccines were licensed to immunize infants and young children against pneumococcal disease. |-| Clin Ther. |-| By A, Sobocki P, Forsgren A, Silfverdal SA. |-| GlaxoSmithKline AB, Solna, Sweden.text/htmlhttp://www.biospace.comBioSpace31.01.2012 | BioSpace: GlaxoSmithKline (GSK), Eli Lilly and Company (LLY), Pfizer Inc. (PFE) Said to be Interested in Turkey's MN Pharma
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GlaxoSmithKline Plc (GSK), Eli Lilly & Co. and Pfizer Inc. (PFE) are among about half a dozen companies interested in buying a stake in Mustafa Nevzat Ilac Sanayii AS in a deal that may value the Turkish drugmaker at $1 billion, three people with knowledge of the situation said. The owners of Mustafa Nevzat, or MN Pharmaceuticals as the Istanbul-based company is known, have hired Bank of America Merrill Lynch to advise on the stake sale, said the people, who declined to be identified because (…)text/htmlhttp://www.biospace.comBioSpace30.01.2012 | BioSpace: New Actavis/Bioton S.A. Alliance to Shake Up Diabetes Market
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WARSAW, POLAND-(Marketwire - January 30, 2012) - Global managed-care offering to help bring down treatment costs for 366 million diabetics Warsaw, Poland, 30 January 2012 - Actavis and Bioton (WSE: BIO) announced today that they have formed a joint venture company for the development and registration of insulins, including analogue insulins. Within the framework of the joint-venture, Bioton will be responsible for the development and manufacture of insulin products, while Actavis will be (…)text/htmlhttp://www.biospace.comBioSpace30.01.2012 | BioSpace: GlaxoSmithKline (GSK) Seeking Acquisition in Turkey
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GlaxoSmithKline Plc (GSK), the U.K. s largest drugmaker, is seeking an acquisition in Turkey as it struggles to become profitable in the country, Hurriyet said, citing the company s emerging markets president. Potential targets include producers of cardiovascular drugs or businesses with production facilities that would add value to Glaxo s operations, Hurriyet cited Abbas Hussain as saying. Glaxo has failed to make a profit or increase revenue in Turkey in the past three years as a result of (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.06.2010 | NCBI PubMed: Qualitative Development of the Rhinitis Control Assessment Test (RCAT), an Instrument for Evaluating Rhinitis Symptom Control.
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: Effective management of allergic rhinitis requires ongoing monitoring of its control. This article describes the qualitative phase of development of a patient-completed instrument, the Rhinitis Control Assessment Test (RCAT), designed to assist patients and providers in the detection of problems with rhinitis symptom control. |-| Patient. |-| Nathan RA, Dalal AA, Stanford RH, Meltzer EO, Schatz M, Derebery J, Mintz M, Thompson MA, Dibenedetti DB. |-| 1 Asthma and Allergy Associates, Colorado (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed25.01.2012 | NCBI PubMed: Statins Reduce Short- and Long-Term Mortality Associated With Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: Impact of Postoperative Atrial Fibrillation and Statin Therapy on Survival.
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BACKGROUND: Postoperative atrial fibrillation (POAF) is a frequent complication of coronary artery bypass grafting (CABG) surgery. The objective of this study was to determine the impact of POAF on both short- and long-term mortality following isolated CABG. HYPOTHESIS: POAF is associated with a poorer short and long-term mortality following CABG. METHODS: We retrospectively analyzed the preoperative and operative data of 6728 consecutive patients undergoing a first isolated CABG. RESULTS: The (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed10.01.2012 | NCBI PubMed: Identifying improved TSPO PET imaging probes through biomathematics: The impact of multiple TSPO binding sites in vivo.
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To date, (11)C-(R)-PK11195 has been the most widely used TSPO PET imaging probe, although it suffers from high non-specific binding and low signal to noise. A significant number of 2nd generation TSPO radioligands have been developed with higher affinity and/or lower non-specific binding, however there is substantial inter-subject variation in their affinity for the TSPO. TSPO from human tissue samples binds 2nd generation TSPO radioligands with either high affinity (high affinity binders, (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed23.01.2012 | NCBI PubMed: Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial.
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BACKGROUND: We aimed to investigate the safety and efficacy of dutasteride, a 5?-reductase inhibitor, on prostate cancer progression in men with low-risk disease who chose to be followed up with active surveillance. METHODS: In our 3 year, randomised, double-blind, placebo-controlled study, undertaken at 65 academic medical centres or outpatient clinics in North America, we enrolled men aged 48-82 years who had low-volume, Gleason score 5-6 prostate cancer and had chosen to be followed up (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed17.01.2012 | NCBI PubMed: Effect of estrous cycle phase on clinical pathology values in beagle dogs.
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BACKGROUND: In dogs, the diestrus phase is considerably longer than in most domestic animals, and is characterized by high circulating progesterone concentrations that may influence clinical pathology values. OBJECTIVE: The objective of this retrospective study was to investigate differences in clinical pathology data in dogs in diestrus compared with data from dogs in all other phases of the estrous cycle. METHODS: Phase of the estrous cycle was determined by histologic evaluation of (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed16.01.2012 | NCBI PubMed: Lapatinib versus trastuzumab in combination with neoadjuvant anthracycline-taxane-based chemotherapy (GeparQuinto, GBG 44): a randomised phase 3 trial.
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BACKGROUND: We compared the efficacy and safety of the addition of lapatinib versus trastuzumab to anthracycline-taxane-based neoadjuvant chemotherapy. METHODS: In the GeparQuinto randomised phase 3 trial, patients with untreated HER2-positive operable or locally advanced breast cancer were enrolled between Nov 7, 2007, and July 9, 2010. Patients were eligible if their tumours were classified as cT3/4a-d, or hormone receptor (HR)-negative, HR-positive with clinically node-positive and cT2 (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed28.02.2012 | NCBI PubMed: Identification of isobaric amino-sulfonamides without prior separation.
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Direct analysis mass spectrometry (DAMS) techniques offer increased speed of analysis without the need for sample preparation or prior separation. A feature of these techniques is that all ionisable species will typically be analysed at the same time which makes the ability to distinguish between isobaric compounds increasingly important. |-| Rapid Commun Mass Spectrom. |-| Barry SJ, Wolff JC. |-| GlaxoSmithKline, Analytical Sciences, Medicines Research Centre, Gunnels Wood Road, Stevenage, (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.02.2012 | NCBI PubMed: Targeting phosphoinositide 3-kinase ? for allergic asthma.
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Chronic inflammation in the lung has long been linked to the pathogenesis of asthma. Central to this airway inflammation is a T-cell response to allergens, with Th2 cytokines driving the differentiation, survival and function of the major inflammatory cells involved in the allergic cascade. PI3K? (phosphoinositide 3-kinase ?) is a lipid kinase, expressed predominantly in leucocytes, where it plays a critical role in immune receptor signalling. A selective PI3K? inhibitor is predicted to (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed23.01.2012 | NCBI PubMed: Place your BETs: the therapeutic potential of bromodomains.
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Therapeutic targeting of the processes that regulate histone modification is a growing area of scientific exploration. Although most interest has concentrated on the various families of enzymes that contribute to these processes, this review focuses on emerging data demonstrating the chemical tractability and therapeutic potential of a hitherto underexplored family of proteins, namely the bromodomain (BRD) family of reader proteins. These proteins perform a crucial role in translating histone (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed27.01.2012 | NCBI PubMed: Lead-oriented synthesis: a new opportunity for synthetic chemistry.
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The pharmaceutical industry remains solely reliant on synthetic chemistry methodology to prepare compounds for small-molecule drug discovery programmes. The importance of the physicochemical properties of these molecules in determining their success in drug development is now well understood but we present here data suggesting that much synthetic methodology is unintentionally predisposed to producing molecules with poorer drug-like properties. This bias may have ramifications to the early (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.12.2008 | NCBI PubMed: How does patients' quality of life guide their preferences regarding aspects of asthma therapy?: a patient-preference study using discrete-choice experiment methodology.
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Previous work has suggested that people with poor health-related quality of life (HR-QOL) as a result of asthma are willing to pay the most for successful therapy. There is also evidence that preferences are an important influence on adherence to therapy. We report a patient preference study using a discrete-choice experiment (DCE) to elicit willingness to pay (WTP) of patients with asthma in Spain, the Netherlands, and the UK. |-| Patient. |-| Lloyd A, McIntosh E, Williams AE, Kaptein A, Rabe (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.01.2012 | NCBI PubMed: A digital examination of medicine.
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Nat Genet. |-| Green HA. |-| Emerging Markets Research and Development at GlaxoSmithKline, Brentford, UK.text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed25.01.2012 | NCBI PubMed: Combining PET biodistribution and equilibrium dialysis assays to assess the free brain concentration and BBB transport of CNS drugs.
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The passage of drugs in and out of the brain is controlled by the blood-brain barrier (BBB), typically, using either passive diffusion across a concentration gradient or active transport via a protein carrier. In-vitro and preclinical measurements of BBB penetration do not always accurately predict the in-vivo situation in humans. Thus, the ability to assay the concentration of novel drug candidates in the human brain in vivo provides valuable information for derisking of candidate molecules (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed16.01.2012 | NCBI PubMed: Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial.
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BACKGROUND: The anti-HER2 monoclonal antibody trastuzumab and the tyrosine kinase inhibitor lapatinib have complementary mechanisms of action and synergistic antitumour activity in models of HER2-overexpressing breast cancer. We argue that the two anti-HER2 agents given together would be better than single-agent therapy. METHODS: In this parallel groups, randomised, open-label, phase 3 study undertaken between Jan 5, 2008, and May 27, 2010, women from 23 countries with HER2-positive primary (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed01.02.2012 | NCBI PubMed: Evaluation of the Menopause-Specific Quality of Life Questionnaire: a factor-analytic approach.
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Despite being used in multiple studies, the Menopause-Specific Quality of Life Questionnaire (MENQOL) has not been assessed with factor analysis, a common method of item reduction in quality of life tools. |-| Menopause. |-| Van Dole KB, Devellis RF, Brown RD, Jonsson Funk ML, Gaynes BN, Williams RE. |-| From the Departments of 1Epidemiology and 2Health Behavior and Health Education, University of North Carolina at Chapel Hill, Chapel Hill, NC; 3GlaxoSmithKline, Research Triangle Park, NC; and (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed26.01.2012 | NCBI PubMed: Development of an In Vitro Model to Assess Deposition of Aerosol Particles in a Representative Replica of the Rat's Respiratory Tract.
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Abstract Background: Small rodents continue to be the mainstay for the assessment of pharmacological and toxicological data of inhaled therapeutics. For meaningful interpretation of the results information about deposition of aerosol particles in the respiratory tract is warranted, but not trivial to obtain for animals with nose-only aerosol exposure. The purpose of this study was to develop and evaluate a general method to characterize the deposition of inhaled test particles in an in vitro (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed18.01.2012 | NCBI PubMed: Adaptive trials in paediatric development: dealing with heterogeneity and uncertainty in pharmacokinetic differences in children.
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Aim:? to assess whether an adaptive design in early clinical trials based on the paradigm variable dosing - controlled exposure can provide better dosing recommendations compared to the standard fixed dose approach. Methods:? in a clinical trial simulation (CTS) setting, a paediatric study was simulated using a pharmacokinetic model previously developed for abacavir. Plasma concentrations following the current recommended dose (8 mg/kg) were taken at standard sampling times, exposures (…)text/htmlhttp://www.ncbi.nlm.nih.govNCBI PubMed13.01.2012 | NCBI PubMed: Complement factor H genetic variant and age-related macular degeneration: effect size, modifiers and relationship to disease subtype.
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BACKGROUND: Variation in the complement factor H gene (CFH) is associated with risk of late age-related macular degeneration (AMD). Previous studies have been case-control studies in populations of European ancestry with little differentiation in AMD subtype, and insufficient power to confirm or refute effect modification by smoking. METHODS: To precisely quantify the association of the single nucleotide polymorphism (SNP rs1061170, 'Y402H') with risk of AMD among studies with differing (…)text/htmlhttp://www.biospace.comBioSpace27.01.2012 | BioSpace: Theravance, Inc. (THRX) to Report Fourth Quarter and Full Year 2011 Financial Results on February 9, 2012
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SOUTH SAN FRANCISCO, CA-(Marketwire - January 26, 2012) - Theravance, Inc. (NASDAQ: THRX) announced today that it will release financial results for the fourth quarter and full year ended December 31, 2011 after market close on Thursday, February 9, 2012. An accompanying conference call will be held at 5:00 p.m. Eastern Standard Time. To participate in the live call by telephone, please dial (877) 837-3908 from the U.S., or (973) 890-8166 for international callers. Those interested in (…)text/htmlhttp://www.biospace.comBioSpace27.01.2012 | BioSpace: James Murdoch to Quit GlaxoSmithKline (GSK) Board
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News Corp executive James Murdoch, under pressure from a phone-hacking scandal at the News of the World tabloid, is to quit the board of drug maker GlaxoSmithKline to spend more time on his media roles. "James Murdoch has decided to stand down from the board with effect from this year's AGM (in May)," GSK Chairman Christopher Gent said in a statement, as Britain's biggest pharmaceutical company announced a raft of other changes to its board that would take place at a later date. GSK said (…)text/htmlhttp://www.biospace.comBioSpace25.01.2012 | BioSpace: Lonza Inc. Boots Out CEO as 2011 Profit Plunges
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Swiss drugs industry supplier Lonza (LONN.VX) (LONZ.SI) kicked out chief executive Stefan Borgas after profits for 2011 plunged by a third and said 2012 was set to pose further challenges because of the difficulties faced by pharmaceutical firms. The Basel-based group, which is battling currency headwinds and volatile raw material prices, said the board took the decision to replace Borgas in the last 48 hours. "CEOs have a responsibility to deliver on expectation and I think our company over (…)text/htmlhttp://www.biospace.comBioSpace25.01.2012 | BioSpace: ProSensa B.V. Raises Around $30 Million to Progress Exon-Skipping Antisense Oligonucleotides
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LEIDEN, Netherlands-(BUSINESS WIRE)- Prosensa, the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet needs, announced today that it has raised ¬23 million in new equity financing. The financing was led by new investor New Enterprise Associates (NEA) and was supported by existing Prosensa investors, Abingworth, Life Sciences Partners, Gimv, Idinvest Partners and MedSciences Capital. David Mott, General Partner of NEA, will join Prosensa (…)text/htmlhttp://www.biospace.comBioSpace24.01.2012 | BioSpace: Coldstream Laboratories Inc. Announces Manager of Technology Transfer
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LEXINGTON, KY-(Marketwire - January 23, 2012) - Highlighted Links Coldstream Laboratories Inc. Coldstream Laboratories, Inc., a provider of drug product research and manufacturing services specializing in high potency and cytotoxic parenteral products, has named Sholto Maclean as Manager of Technology Transfer. In the newly created position, Maclean will work closely with Coldstream's pharmaceutical development team to scale up processes for sterile liquid and lyophilized drug products for (…)text/htmlhttp://www.uspto.gov/USPTO05.12.2007 | USPTO: Bicyclic compounds and use as antidiabetics
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United States Patent: 8101634 |-| Title: Bicyclic compounds and use as antidiabetics |-| Inventors: Fang; Jing (Durham, NC), Tang; Jun (Durham, NC), Carpenter; Andrew J (Durham, NC), Peckham; Gregory (Durham, NC), Conlee; Christopher R (Durham, NC), Du; Kien S (Durham, NC), Katamreddy; Subba Reddy (Durham, NC) |-| Assignee: GlaxoSmithKline LLC (Philadelphia, PA) |-| The present invention relates to novel compounds that are useful in the treatment of metabolic disorders, particularly type II (…)