http://www.lsis.com/goto/r43/rss 2010-06-23T11:10:17+01:00 text/html http://www.sciencedaily.com ScienceDaily http://www.lsis.com/goto/v43/%3B%97f%FA%15%7Cv%7D ScienceDaily (June 22, 2010) Patients with a specific kind of lung cancer may benefit from a Phase III clinical trial offered by the Moores UCSD Cancer Center. The new drug, crizotinib, under development by Pfizer, showed dramatic results in reducing lung cancer tumors in some patients during Phase I and II clinical trials. See Also: Health & Medicine Lung Cancer Colon Cancer Diseases and Conditions Cancer Lung Disease Brain Tumor Reference Clinical trial Metastasis Lung cancer Tumor suppressor gene The results of the first two trials have been very encouraging, said Lyudmila Bazhenova, MD, assistant clinical professor at UC San Diego School of Medicine and a member of the Moores UCSD (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v43/%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/v43/%3B%97f%FB%1Cuzr PHILADELPHIA & HARRISBURG, Pa.-(BUSINESS WIRE)-CoventryCares, a Medicaid managed care organization currently serving southeastern Pennsylvania, has partnered with The Maternity Care Coalition and the Healthy Mothers, Healthy Babies (HMHB) Coalition, to launch the Philadelphia text4baby campaign. CoventryCares will use the new program to help educate and encourage the use of the service to its Bright Expectations prenatal program members. Text4baby is a free, mobile information service designed to promote maternal and child health by providing pregnant women and new moms with detailed health tips, via SMS text message, to assist them in caring for themselves and their children. The (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%1Cu%7C%7E WALTHAM, Mass.-(BUSINESS WIRE)-ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the promotion to vice president of two executive directors Godfrey Amphlett, Ph.D., and Robert J. Lutz, Ph.D. who have played central roles in establishing ImmunoGen s highly successful product development capabilities. These functions complement the Company s strong research capabilities in ImmunoGen s advancement of its own novel anticancer compounds and the industry-leading target-to-commercial product expertise the Company provides to its partners. ImmunoGen has transitioned from being an organization with strong research to one (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%1Cu%7E%7B CAMBRIDGE, Mass.-(BUSINESS WIRE)-Ensemble Discovery today announced that it will begin operating as Ensemble Therapeutics Corporation to reflect the Company s progress and emerging pipeline by applying its macrocycle drug platform to develop novel therapeutics. The new name, Ensemble Therapeutics, conveys the company s leadership and advancement in developing novel macrocycle drug compounds that are small molecules with expanded therapeutic properties of large molecule biological drugs. We also are delighted to announce the addition of Kisco Ltd. to our syndicate of top-tier investors. As an advanced materials specialty company, they have keen eye for innovative technologies and found (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%1Cxx%7C 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/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%1Dty%7F ABSTRACT Background: Canadian oncology decision-makers have reimbursed cancer drugs at incremental cost-effectiveness ratios (ICER) higher than those considered acceptable in other therapeutic areas. Sunitinib is a multitargeted receptor tyrosine kinase inhibitor, indicated for metastatic renal-cell carcinoma (MRCC) of clear cell histology. Canadian decision-makers evaluated sunitinib funding in the presence of important data limitations (including interim analysis of a surrogate outcome) and in the context of a high ICER. Methods: First, a description was presented of the cost-effectiveness analysis submitted for sunitinib reimbursement decision-making in Canada before conclusive survival (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%12uvz The artificial stomach-duodenum (ASD) apparatus was designed and constructed to assess the in vitro performance of bulk drugs and their formulations in a device which is able to simulate different species and physiological conditions. As a continued demonstration of its application to a pharmaceutical problem, screening experiments were performed on three different solid forms of a drug candidate, PNU-141659. This compound exhibited poor solubility and permeability, and presented a significant problem in the development of a successful dosage form. Simple formulations of an anhydrous form, a hydrated form and an amorphous form of the drug were all assessed with the ASD set up to simulate (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FB%10%7E%7Ex Journal Star - Employment at Lincoln's Pfizer plant will grow even though the company plans to cut its animal health division by 20 percent. text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%11u%7C%7E SAN DIEGO-(BUSINESS WIRE)-Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that it will webcast its Investor and Analyst Day at the Eventi hotel in New York City on June 24, 2010 from 4:15 p.m. to 5:45 p.m. Eastern time (1:15 p.m. to 2:45 p.m. Pacific). Overview of Muscle Disorders/Wasting and the Role for a SARM Therapeutic Presenters will include: John Higgins, President and Chief Executive Officer John Sharp, Vice President of Finance and Chief Financial Officer Robert McKay, Associate Director of Business Development Syed Kazmi, PhD, Vice President of Business Development Nezam Afdhal, MD, Chief of Hepatology, Beth Israel Deaconess in Boston œPresentation on (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%11t%7C%7B NEEDHAM, Mass.-(BUSINESS WIRE)-Three leading scientists in the field of cardiac safety in pre-clinical drug development are gathering to discuss Improved Strategies for Pre-clinical Cardiac Testing in a free webinar on June 23 at 11:00 a.m. EDT, sponsored by the Drug Safety Council (DSEC). most trusted and most used fee-for-service provider The panel features Arthur œBuzz  Brown, M.D., Ph.D., founder, president and CEO of ChanTest www.chantest.com, David J. Gallacher, BSc., Ph.D. senior director, Center of Excellence for Cardiovascular Safety Research, Johnson & Johnson Pharmaceutical Research & Development, a division of Janssen Pharmaceutica, Belgium www.jnjpharmarnd.com, and Gary (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%11t%7F%7D CAMBRIDGE, Mass.-(BUSINESS WIRE)-Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced the election of Eve E. Slater, M.D., F.A.C.C., to the Company's Board of Directors as a class III director. Dr. Slater is board certified in internal medicine and cardiology and has extensive experience in the pharmaceutical industry, most recently serving as senior vice president for worldwide policy at Pfizer, Inc. Prior to joining Pfizer, she served in senior management positions at Merck Research Laboratories. In addition, Dr. Slater was the Assistant Secretary for Health and served as chief health policy advisor for the U.S. Department of Health and Human Services. Idera has created a strong (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FB%11%7Bw%7D CAMBRIDGE, Mass.-(BUSINESS WIRE)-Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today announced the election of Eve E. Slater, M.D., F.A.C.C., to the Company's Board of Directors as a class III director. Dr. Slater is board certified in internal medicine and cardiology and has extensive experience in the pharmaceutical industry, most recently serving as senior vice president for worldwide policy at Pfizer, Inc. Prior to joining Pfizer, she served in senior management positions at Merck Research Laboratories. In addition, Dr. Slater was the Assistant Secretary for Health and served as chief health policy advisor for the U.S. Department of Health and Human Services. text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FB%11%7B%7B%7B Bloomberg - Counterfeit versions of Pfizer Inc. s Viagra were found in two Australian states, prompting a nationwide search for the source of the fake medicine. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%11y%7Bz Tang, S., Xiao, J., Guo, G., He, J., Hao, Z., Xiao, X. Preparation of a newly formulated long-acting ceftiofur hydrochloride suspension and evaluation of its pharmacokinetics in pigs. J. vet. Pharmacol. Therap.33, 238-245. A new long-acting ceftiofur hydrochloride preparation was formulated and its physical properties, stability, and pharmacokinetics were investigated in this study. The prepared ceftiofur hydrochloride suspension demonstrated a milk white consistency, was easy to re-disperse and was stable in light, heat and humidity stability tests. Its other physical properties such as flowability, syringeability, settling volume ratio, particle size and distribution were perfectly (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%14%7B%7Cz N Engl J Med. |-| Malozowski S, Katzeff BS, Silva-Fernández L, Andreu JL, Cummings SR, Thompson J, Eastell R. |-| National Institutes of Health, Bethesda, MD, sm007@nih.gov, Albert Einstein College of Medicine, New Rochelle, NY, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain, California Pacific Medical Center Research Institute, San Francisco, CA, scummings@sfcc-cpmc.net, Pfizer Global Research and Development, New London, CT, University of Sheffield, Sheffield, United Kingdom. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%14yy%7F 5-F substitution of an aminothiazole moiety within a series of thrombopoietin receptor agonists leads to potent agents with an improved hepatic safety profile in rodent toxicology studies. |-| Bioorg Med Chem Lett. |-| Antipas AS, Blumberg LC, Brissette WH, Brown MF, Casavant JM, Doty JL, Driscoll J, Harris TM, Jones CS, McCurdy SP, McElroy E, Mitton-Fry M, Munchhof MJ, Reim DA, Reiter LA, Ripp SL, Shavnya A, Smeets MI, Trevena KA. |-| Pfizer Worldwide Research and Development, Groton, CT 06340, USA. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%14z%7E%7C BACKGROUND: Congenital adrenal hyperplasia is a group of disorders caused by defects in the adrenal steroidogenic pathways. In its most common form, 21-hydroxylase deficiency, patients develop varying degrees of glucocorticoid and mineralocorticoid deficiency as well as androgen excess. Therapy is guided by monitoring clinical parameters as well as adrenal hormone and metabolite concentrations. CONTENT: We review the evidence for clinical and biochemical parameters used in monitoring therapy for congenital adrenal hyperplasia. We discuss the utility of 24-h urine collections for pregnanetriol and 17-ketosteroids as well as serum measurements of 17-hydroxyprogesterone, androstenedione, and (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v43/%3B%97f%FB%14%7F%7C%7F Inotek Pharmaceuticals Corp., a leader in the development of innovative drug candidates to address significant diseases of the eye, announced that it has initiated dosing in a multiple-dose Phase 2 clinical trial to evaluate the efficacy and safety of its novel eye-drop INO-8875 in patients with glaucoma. In an earlier Phase 1/2 single ocular dose clinical trial, INO-8875 was shown to significantly reduce intraocular pressure (IOP) in glaucoma patients. As a highly-selective adenosine-1 receptor agonist, INO-8875 reduces IOP by enhancing a natural mechanism for clearing protein material that clogs the major outflow pathway - the trabecular meshwork - as the eye with glaucoma ages. (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v43/%3B%97f%FB%14%7Ex%7C News outlets report on the pharmaceutical industry and a new requirement by the Food and Drug Administration. The Washington Post: "The Food and Drug Administration this week began posting online the results of safety evaluations of recently approved drugs and vaccines. The action follows a law enacted in 2007 that requires the agency to provide more safety information to consumers and health professionals. The evaluations must be conducted 18 months after a new drug comes on the market. Rare and sometimes serious side effects are often discovered only when a drug is used by a much larger and more varied group of patients than exposed to it in clinical trials leading to its approval. FDA (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%14%7Ez%7E MUMBAI, India-(BUSINESS WIRE)-Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Xanax, alprazolam tablets. These generic alprazolam tablets, equivalent to Pfizer s Xanax tablets, include four strengths: 0.25 mg, 0.5 mg, 1 mg and 2 mg. Annual sale in US for these strengths of branded and generic alprazolam tablets is estimated at $145 million. Alprazolam tablets are indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety. It is also indicated for the treatment of panic disorder, with or without agoraphobia. Xanax is a registered trademark of Pfizer. About Sun (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%14%7E%7Cz OTTAWA-(BUSINESS WIRE)-At its 2010 annual general meeting in Montreal yesterday, the national biotechnology association, BIOTECanada, confirmed a national team of industry leaders, whose expertise will ensure Canada keeps growing what today is an $84 billion bio-economy. As we face a new wave of technological innovation across agri-business and industrial and environmental biotechnologies, I am pleased to join this pan-Canadian group of industry leaders in raising awareness of the value our technologies bring to Canada s future The cross-sectoral team comes from companies across the country involved in industrial, agricultural, and health biotechnology including: crop DNA modification, (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FB%14%7E%7F%7D DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/d7d20e/discovery_stage_pa) has announced the addition of the "Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition" report to their offering. Discovery Stage Partnering Terms and Agreements in Pharma, Biotech and Diagnostics, 2nd Edition The Discovery Stage Partnering Terms and Agreements in Pharma and Biotech report detailed understanding and analysis of how and why companies enter discovery stage licensing/business development and other forms of partnering arrangement. The report provides a detailed understanding and analysis of how and why companies enter (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FB%15t%7F%7E BACKGROUND: Tranexamic acid can reduce bleeding in patients undergoing elective surgery. We assessed the effects of early administration of a short course of tranexamic acid on death, vascular occlusive events, and the receipt of blood transfusion in trauma patients. METHODS: This randomised controlled trial was undertaken in 274 hospitals in 40 countries. 20 211 adult trauma patients with, or at risk of, significant bleeding were randomly assigned within 8 h of injury to either tranexamic acid (loading dose 1 g over 10 min then infusion of 1 g over 8 h) or matching placebo. Randomisation was balanced by centre, with an allocation sequence based on a block size of eight, generated with a (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%1Cxx%7C Drug Saf. |-| Hauben M, Norén GN. |-| Pfizer Inc., New York, New York, USA. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%12tx%7D Drug-induced liver injury is a major issue of concern and has led to the withdrawal of a significant number of marketed drugs. An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems. This process can be supported by the use of existing toxicity data and mechanistic understanding of the biological processes for related compounds. In the published literature, this information is often spread across diverse sources and can be varied and unstructured in quality and content. The current work has explored whether it is (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FC%12%7Bv%7F NEW YORK, June 18 (Reuters) - A new type of biotech arthritis drug being developed by Pfizer Inc (PFE.N) was significantly better at reducing knee pain than a placebo at all three tested doses in a late-stage trial, according to data presented on Friday. text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FC%12%7Byx June 18 (Bloomberg) - Pfizer Inc. faces a Texas trial over its hormone-replacement drugs after a judge overseeing lawsuits over the medicines sent 200 cases back to their home courts. text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FC%12%7B%7B%7F Melbourne, June 18, 2010 - (ABN Newswire) - Benitec Limited (ASX:BLT) (PINK:BNIKF) are pleased to announce that US Patent 7727970 "Multiple promoter expression cassettes for simultaneous delivery of RNAi agents targeted to Hepatitis C virus" has been granted by the United States Patent and Trademark Office (USPTO). The granted claims cover the use of an RNA interference construct (with multiple promoters) to inhibit the level of Hepatitis C virus in animal cells, tissues and organs. Moreover, the USPTO has granted Benitec an additional 805 days patent term in recognition of the delays in examining the patent application. Additional related applications remain pending to extend the scope of (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v43/%3B%97f%FC%12z%7Bs Highlighted Links Kalorama Information Pharma & Biopharma Pipeline NEW YORK, NY-(Marketwire - June 17, 2010) - The pharmaceutical market may soon see the result of an increase in research and development at Big Pharma over the past few years, according to healthcare market research publisher Kalorama Information. The top fifty pharmaceutical companies in the world have some 550 projects in late stage development, and Kalorama Information estimates that these projects have the potential to add a value of more than $70 billion in additional revenues to the pharmaceutical market by 2015. This is according to Kalorama Information's new market research report "World Pharmaceutical and (…) text/html http://www.medicalnewstoday.com Medical News Today http://www.lsis.com/goto/v43/%3B%97f%FC%12%7Fv%7E Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced that the European Commission has granted Orphan Medicinal Product Designation for QPI-1002 (also referred to as "I5NP") for the prophylaxis of delayed graft function (DGF) in kidney transplant patients. QPI-1002 is a synthetic siRNA targeting p53 mRNA and is the first synthetic siRNA to be administered systemically to humans. The designation is granted under the name of the European sponsor, Verius, Ltd. of the United Kingdom. Dr. Daniel Zurr, Quark's Chief Executive Officer, stated, "The addition of orphan designation for the European Union, following the US FDA orphan (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FC%12%7D%7Bx EXTON, Pa.-(BUSINESS WIRE)-Adolor Corporation (NasdaqGM: ADLR) today announced results from a Phase 2a clinical trial of ADL5859 and ADL5747 in patients with osteoarthritis (OA). The trial was a randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate the safety, tolerability and clinical activity of ADL5859 and ADL5747 in patients with OA of the knee. The study enrolled over 400 patients aged 18 and older in four arms. In the three drug arms, patients were given either ADL5859 (150 mg), ADL5747 (150 mg) or oxycodone CR (20 mg) twice daily for two weeks. The primary efficacy endpoint was reduction in pain score as measured by the numeric pain rating scale (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%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.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FC%12%7Cxs DUBLIN-(BUSINESS WIRE)-Research and Markets (http:/www.researchandmarkets.com/research/8dd459/medicated_skin_car) has announced the addition of the "Medicated Skin Care in France" report to their offering. The beginning of de-regulation of OTC products came at the wrong moment. From July 2008, more than 200 OTC products, such as Activir by GlaxoSmithKline Sant Grand Public SAS in skin care, were available self-service, but only in chemists/pharmacies. For such self-service medicated skin care brands, consumers no longer had to ask the chemist/pharmacist to be able to buy the products. This change was said to have a positive impact on sales, because consumers could take time to choose (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%13zvy Certain compounds that induce liver injury clinically are not readily identified from earlier preclinical studies. Novel biomarkers are being sought to be applied across the pharmaceutical pipeline to fill this knowledge gap and to add increased specificity for detecting drug-induced liver injury in combination with aminotransferases (alanine and aspartate aminotransferase) - the current reference-standard biomarkers used in the clinic. The gaps in the qualification process for novel biomarkers of regulatory decision-making are assessed and compared with aminotransferase activities to guide the determination of safe compound margins for drug delivery to humans where monitoring for (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%13x%7Fz Comprehensive two-dimensional gas chromatography (GCxGC) offers an interesting tool for profiling bacterial fatty acids. Flow modulated GCxGC using a commercially available system was evaluated, different parameters such as column flows and modulation time were optimized. The method was tested on bacterial fatty acid methyl esters (BAMEs) from Stenotrophomonas maltophilia LMG 958(T) by using parallel flame ionization detector (FID)/mass spectrometry (MS). The results are compared to data obtained using a thermal modulated GCxGC system. The data show that flow modulated GCxGC-FID/MS method can be applied in a routine environment and offers interesting perspectives for chemotaxonomy of (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%13%7C%7Ds The quinuclidine PHA-0568487(1) is an agonist of the alpha7 nicotinic acetylcholine receptor that was designed to mitigate the bioactivation associated with the core scaffold and subsequently remove associated liabilities with in vivo tolerability. The drug metabolites of 1 in nonclinical species were identified in plasma and urine of rats, dogs and monkeys receiving oral administrations of 1. The in vitro biotransformation of 1 was subsequently investigated in multiple species employing cryopreserved hepatocytes, hepatic subcellular fractions and recombinantly-expressed human P450 enzymes. In addition, in vitro metabolism of synthetically prepared metabolite precursors were instrumental (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%11%7Ew%7B OBJECTIVE: To compare the US EQ-5D with the UK EQ-5D and the SF-6D in patients with rheumatoid arthritis (RA). To provide mappings for each of the scales based on clinical variables. METHODS: We studied 12,424 patients with RA with 66,958 longitudinal observations using linear regression. In our mapping models we used the Health Assessment Questionnaire (HAQ) as a continuous predictor variable and as individual items. More complex models included the addition of a visual analog pain scale, the mood scale from the SF-36, and demographic and comorbidity covariates. We compared various models using root mean squared error (RMSE), in-sample and out-of-sample mean absolute error (MAE), and (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%16%7Byr Pharm Stat. |-| Padmanabhan SK, Stone A. |-| Pfizer, Collegeville, PA, USA. text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%16%7Bvx Oxidation of N-alkyl-substituted amides is a common transformation observed in metabolism studies of drugs and other chemicals. Metabolism at the alpha carbon atom can produce stable carbinolamide compounds, which may be abundant enough to require complete confidence in structural assignments. In a drug discovery setting, rapid structural elucidation of test compounds is critical to inform the compound selection process. Traditional approaches to the analysis of carbinolamides have relied upon the time-consuming synthesis of authentic standards or purification of large enough quantities for characterization by nuclear magnetic resonance (NMR). We describe a simple technique used in (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%17y%7E%7E Scientific researchers and regulators are focusing attention on trace quantities of pharmaceuticals in wastewater effluents and surface waters, resulting in an increased level of concern regarding the potential environmental impact of these compounds. The current European regulatory guideline requires evaluation of the chronic effects of active pharmaceutical ingredients on Daphniamagna. Based on the life cycle of D.magna, chronic studies to establish survival and reproductive endpoints require a 21d exposure period. A similar organism, Ceriodaphniadubia, has a shorter life cycle and therefore survival and reproductive endpoints may be established following 7d of exposure. No observed (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%14%7Fwy Varenicline is a novel selective alpha4beta2 nicotinic acetylcholine partial agonist developed for smoking cessation. Single- and multiple dose studies were conducted to investigate pharmacokinetics, safety, and tolerability of varenicline in healthy male Japanese smokers. The single-dose study was conducted as a double-blind, placebo-controlled, 4-way crossover study. Subjects received varenicline (0.25, 0.5, 1.0, 2.0 mg) or placebo at an interval of 2 weeks. The double-blind, placebo-controlled multiple-dose study was conducted as 2 cohorts, each consisting of 8 subjects randomized to varenicline tablets twice daily (0.5 or 1.0 mg) and 4 subjects randomized to placebo administered for 14 (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%14%7C%7Fs Peptides and monoclonal antibodies have both emerged as important therapeutic modalities, but each has challenges which limit their use. Non-recombinant chemical conjugation of peptides onto antibodies has the potential to minimize or eliminate altogether many of these limitations. Once such approach, pioneered by CovX has created the possibility for rapid stoichiometric fusion of pharmacophores to a single antibody platform. These molecules, called CovX-Bodies, maintain both the pharmacologic properties of a given peptide and the pharmacokinetic properties of a monoclonal antibody. The result is a new class of molecules wherein each component contributes desirable traits. In this paper, (…) text/html http://www.ncbi.nlm.nih.gov NCBI PubMed http://www.lsis.com/goto/v43/%3B%97f%FC%15%7Dyx A simple procedure is described to identify acyl-glucuronides by coupled liquid chromatography/mass spectrometry after derivatization to a hydroxamic acid with hydroxylamine. The reaction specificity obviates the need for isolation of the acyl-glucuronide from an extract. Glucuronides derived from carbamic acids, and alkyl- and aromatic amines, are inert to the derivatization reaction conditions, making the hydroxamic acid derivative a fingerprint for acyl-glucuronides. Copyright (c) 2010 John Wiley & Sons, Ltd. |-| Rapid Commun Mass Spectrom. |-| Vaz AD, Wang WW, Bessire AJ, Sharma R, Hagen AE. |-| Department of Pharmacokinetics, Dynamics, and Metabolism, Pfizer Global Research and (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FD%1Cu%7D%7B Reuters - Pfizer Inc (PFE.N) has sued Mylan Inc (MYL.O), accusing the generic drugmaker of infringing patents on its cancer drug Sutent, according to court papers filed on Wednesday. text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FD%1Ct%7Ex LEXINGTON, MA-(Marketwire - June 17, 2010) - Highlighted Links Inotek Pharmaceuticals Corp. Inotek Pharmaceuticals Corp., a leader in the development of innovative drug candidates to address significant diseases of the eye, today announced that it has initiated dosing in a multiple-dose Phase 2 clinical trial to evaluate the efficacy and safety of its novel eye-drop INO-8875 in patients with glaucoma. In an earlier Phase 1/2 single ocular dose clinical trial, INO-8875 was shown to significantly reduce intraocular pressure (IOP) in glaucoma patients. As a highly-selective adenosine-1 receptor agonist, INO-8875 reduces IOP by enhancing a natural mechanism for clearing protein material that (…) text/html http://www.biospace.com BioSpace http://www.lsis.com/goto/v43/%3B%97f%FD%1Ct%7E%7B VANCOUVER, BRITISH COLUMBIA-(Marketwire - 06/17/10) - Aquinox Pharmaceuticals Inc., a private, venture-backed, biopharmaceutical company developing novel and targeted small molecule therapeutics for the treatment of inflammatory disease and cancer, announced today that it has secured U.S. $25 million in the close of a Series B financing led by Ventures West Capital. New investor Pfizer Venture Investments (PVI) participated in the financing along with all other existing investors: Johnson & Johnson Development Corporation, Baker Brothers Investments and BC Advantage Funds (VCC) Ltd. Mr. Kenneth Galbraith, General Partner of Ventures West Capital, commented, "We are very pleased to welcome (…) text/html http://www.marketwire.com Marketwire http://www.lsis.com/goto/v43/%3B%97f%FD%1Cz%7B%7D Highlighted Links Blue Chip Patient Recruitment NORTHBROOK, IL-(Marketwire - June 15, 2010) - Blue Chip, an independent, full-service global marketing agency, announced today the launch of Blue Chip Patient Recruitment (BCPR), a division dedicated to serving pharmaceutical and biotech clients with clinical trial recruitment marketing. This new division reflects Blue Chip's 15 years of continued growth in patient recruitment and leverages the resources of a full-service agency with deep expertise in direct response media, retail brand marketing and clinical site recruitment management. BCPR's first client is BioSante Pharmaceuticals, Inc. "We are pleased to launch the new division with a (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FD%1Cx%7By WATERTOWN, Mass.-(BUSINESS WIRE)-pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its president and CEO, Dr. Paul Ashton, will be a speaker at the upcoming Glaucoma & Retinopathies 2010 conference. The conference will take place in London June 21 and 22. Dr. Ashton will join speakers from companies that include Pfizer, GlaxoSmithKline, Allergan, Bausch & Lomb, NicOx, Neurotech, Quark Pharmaceuticals, Fovea Pharmaceuticals (Sanofi Group) and academics from University of Iceland, University of Oxford and University College London to discuss the growing area of (…) text/html http://www.businesswire.com Business Wire http://www.lsis.com/goto/v43/%3B%97f%FD%1C%7Fvr ALLENDALE, N.J. & CORK, Ireland-(BUSINESS WIRE)-Eisai Machinery U.S.A. Inc. of Allendale, New Jersey, one of the world s leading pharmaceutical equipment manufacturers, and Crest Solutions of Cork, Ireland, a software and solution provider to both the medical device and pharmaceutical industries, today announced the launch of PharmaMarker ¢, a new track and trace packaging system for pharmaceutical products. The PharmaMarker system was developed to help pharmaceutical manufacturers meet the challenges of more stringent local and international regulations in the areas of coding and traceability of pharmaceutical products. The PharmaMarker is an easy-to-integrate, easy-to-validate (…)