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Pharma Industry / Biotech Industry News From Medical News Today
Sequella Lead Drug Compound SQ109 Selected For Phase 1B Clinical Trial Program
Wed, 07 Jan 2009 00:00:00 -0800
Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational.
Chimerix Completes Phase I Study And Initiates A Phase II Multi-dose Clinical Trial For CMX001
Wed, 07 Jan 2009 00:00:00 -0800
Chimerix, Inc., a biotechnology company developing orally available antiviral therapeutics, announced today that the Company has completed a single and multi-dose Phase I study of CMX001 in healthy volunteers. This study supports the further development of the drug for multiple dsDNA infections. The Company has initiated the first Phase II multi-dose clinical trial in patients.
Phase III Studies Of EXPAREL(TM) (DepoBupivacaine) From Pacira Complete Enrollment
Wed, 07 Jan 2009 00:00:00 -0800
Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL(TM) (DepoBupivacaine) for prolonged postoperative analgesia.
Cequent To Present First Proof Of Activity Of An Oral RNAi Drug In Non-Human Primates At February Keystone Conference
Wed, 07 Jan 2009 00:00:00 -0800
Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that the company has recently completed a successful toxicology study of its candidate CEQ501, an orally administered tkRNAi therapeutic targeting the primary oncogene (beta-catenin, CTNNB1) in FAP (familial adenomatous polyposis). FAP is an inherited gastrointestinal disease that causes hundreds of polyps to form in the colon.
NYT Examines Challenges To Improving 'Personalized Medicine' For Breast Cancer, Other Diseases
Tue, 06 Jan 2009 03:00:00 -0800
The New York Times on Tuesday examined how improvements in genetic testing could affect "personalized medicine" for the treatment of breast cancer and other diseases in the future. Personalized medicine uses genetic screening and other tests to provide physicians with more information to tailor patients' treatments, the Times reports.
Pharmaceutical Research And Manufacturers Of America Enacts New Voluntary Guidelines On Physician Gifting Practices
Tue, 06 Jan 2009 02:00:00 -0800
New guidelines by the Pharmaceutical Research and Manufacturers of America to address conflicts of interest that "illuminated the once-shadowy financial dealings" between pharmaceutical companies and physicians took effect Thursday, the Boston Herald reports.
Annals of Pharmacotherapy PAP Articles
Randomized Equivalence Study Evaluating the Possibility of Switching Hemodialysis Patients Receiving Subcutaneous Human Erythropoietin Directly to Intravenous Darbepoetin Alfa(February)
Chazot, C., Terrat, J. C., Dumoulin, A., Ang, K.-S., Gassia, J. P., Chedid, K., Maurice, F., Canaud, B., , f. t. C. M. G. Tue, 06 Jan 2009 00:00:00 -0000
BACKGROUND: Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) used either intravenously or subcutaneously with no dose penalty; however, the direct switch from subcutaneous recombinant human erythropoietin (rHuEPO) to intravenous darbepoetin has barely been studied. OBJECTIVE: To establish the equivalence of a direct switch from subcutaneous rHuEPO to intravenous darbepoetin versus an indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin in patients undergoing hemodialysis. METHODS: In this open, randomized, 6-month, prospective study, patients with end-stage kidney disease who were on hemodialysis were randomized into 2 groups: direct switch from subcutaneous rHuEPO to intravenous darbepoetin (group 1) and indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin (group 2). A third, nonrandomized group (control), consisting of patients treated with intravenous rHuEPO who were switched to intravenous darbepoetin, was also studied to reflect possible variations of hemoglobin (Hb) levels due to change from one type of ESA to the other. The primary outcome was the proportion of patients with stable Hb levels at month 6. Secondary endpoints included Hb stability at month 3, dosage requirements for darbepoetin, and safety of the administration route. RESULTS: Among 154 randomized patients, the percentages with stable Hb levels were equivalent in groups 1 and 2, respectively, at month 3 (86.0% vs 91.3%) and month 6 (82.1% vs 81.6%; difference -0.5 [90% CI -12.8 to 11.8]). Mean Hb levels between baseline and month 6 remained stable in both groups, with no variation in mean darbepoetin dose. Mean ferritin levels remained above 100 µg/L in the 3 groups during the whole study, and darbepoetin was well tolerated. CONCLUSIONS: This study has shown equivalent efficacy on Hb stability without the need for dosage increase in patients switched directly from subcutaneous rHuEPO to intravenous darbepoetin.
Journal Impact Factor: What It Is and Is Not (January)
Nahata, M. C Tue, 06 Jan 2009 00:00:00 -0000
The journal impact factor is an important measure of citation frequency during a 1-year period for articles published over the previous 2 years. However, it has many limitations that should be considered in evaluating the quality of scholarship published in the journal.
Dosing Nomograms: Silos on a Slope (January)
Dager, W. E Tue, 06 Jan 2009 00:00:00 -0000
Developing dosing management guidelines or protocol approaches to pharmacotherapy can provide several benefits for standardization of care. Frequently, clinicians may need to incorporate multiple influencing factors to individualize management. In some cases, preestablished, standardized approaches may create barriers to individualized care, potentially categorizing patients into dosing categories (silos) that minimize their individualized needs. Approaches to managing direct thrombin inhibitor therapy have been recently explored and dosing approaches different from those provided in the prescribing information have been proposed. Considerations regarding individualized management of anticoagulant therapy, including the use of standardized dosing or monitoring protocols, are discussed here.
Applied Clinical Pharmacokinetics, 2nd Edition (January)
Ariano, R. E Tue, 06 Jan 2009 00:00:00 -0000
Increases in C-Reactive Protein May Predict Recurrence of Clozapine-Induced Fever (January)
Kohen, I., Afzal, N., Hussain, S., Manu, P. Tue, 06 Jan 2009 00:00:00 -0000
OBJECTIVE: To report a case of recurrent clozapine-induced fever that was associated with a rise in C-reactive protein (CRP). CASE SUMMARY: A 73-year-old man with Lewy Body dementia was admitted for psychosis. He was treated with clozapine (initial dose 12.5 mg/day, titrated to 75 mg/day over 15 days). On day 15 of clozapine therapy, he developed a benign fever (maximum 38.4 °C) that was associated with a rise in the CRP level (3.96 mg/dL). The level normalized when clozapine was discontinued. However, when the patient was rechallenged with clozapine, the CRP level became elevated (4.36 mg/dL) after 3 days of therapy, with a subsequent recurrence of fever (38.7 °C). DISCUSSION: We postulate that the elevation in CRP levels and the subsequent fever were caused by the effects of clozapine on the cytokine system via interleukin-6 and tumor necrosis factor-, resulting in an inflammatory response with an acute phase reaction. This case is unique, as it is the first reported in the literature associating a recurrence of clozapine-induced fever with the known immunomodulatory effects of clozapine on cytokines and CRP level. According to the Naranjo probability scale, this adverse effect is probably associated with clozapine. CONCLUSIONS: Clozapine-related fever is generally benign but difficult to assess and manage, as it can be confused with much more serious conditions. Further research is needed to study whether CRP is a useful tool in predicting and managing clozapine fever.
Interaction Between Warfarin and Black Tea (January)
Parker, D. L, Hoffmann, T. K, Tucker, M. A., Meier, D. J Tue, 06 Jan 2009 00:00:00 -0000
Clinical Pharmacology & Therapeutics
In This Issue
In This Issue Clinical Pharmacology & Therapeutics 85, 1 (January 2009). doi:10.1038/clpt.2008.253
Aging and Medications: Past, Present, Future
JB SchwartzDR Abernethy Aging and Medications: Past, Present, Future Clinical Pharmacology & Therapeutics 85, 3 (January 2009). doi:10.1038/clpt.2008.238 Authors: JB Schwartz & DR Abernethy
Highlights
Highlights Clinical Pharmacology & Therapeutics 85, 12 (January 2009). doi:10.1038/clpt.2008.255 Author:
ASCPT News
ASCPT News Clinical Pharmacology & Therapeutics 85, 14 (January 2009). doi:10.1038/clpt.2008.249
Dopamine Transporters: Chemistry, Biology, and Pharmacology
SP David Dopamine Transporters: Chemistry, Biology, and Pharmacology Clinical Pharmacology & Therapeutics 85, 16 (January 2009). doi:10.1038/clpt.2008.212 Author: SP David
Mesenchymal Stem Cells and Neurodegenerative Disease
AL WhoneNJ Scolding Mesenchymal Stem Cells and Neurodegenerative Disease Clinical Pharmacology & Therapeutics 85, 19 (January 2009). doi:10.1038/clpt.2008.205 Authors: AL Whone & NJ Scolding
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Sequella Lead Drug Compound SQ109 Selected For Phase 1B Clinical Trial Program
Wed, 07 Jan 2009 00:00:00 -0800
Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational.
Chimerix Completes Phase I Study And Initiates A Phase II Multi-dose Clinical Trial For CMX001
Wed, 07 Jan 2009 00:00:00 -0800
Chimerix, Inc., a biotechnology company developing orally available antiviral therapeutics, announced today that the Company has completed a single and multi-dose Phase I study of CMX001 in healthy volunteers. This study supports the further development of the drug for multiple dsDNA infections. The Company has initiated the first Phase II multi-dose clinical trial in patients.
Phase III Studies Of EXPAREL(TM) (DepoBupivacaine) From Pacira Complete Enrollment
Wed, 07 Jan 2009 00:00:00 -0800
Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL(TM) (DepoBupivacaine) for prolonged postoperative analgesia.
Cequent To Present First Proof Of Activity Of An Oral RNAi Drug In Non-Human Primates At February Keystone Conference
Wed, 07 Jan 2009 00:00:00 -0800
Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, announced that the company has recently completed a successful toxicology study of its candidate CEQ501, an orally administered tkRNAi therapeutic targeting the primary oncogene (beta-catenin, CTNNB1) in FAP (familial adenomatous polyposis). FAP is an inherited gastrointestinal disease that causes hundreds of polyps to form in the colon.
NYT Examines Challenges To Improving 'Personalized Medicine' For Breast Cancer, Other Diseases
Tue, 06 Jan 2009 03:00:00 -0800
The New York Times on Tuesday examined how improvements in genetic testing could affect "personalized medicine" for the treatment of breast cancer and other diseases in the future. Personalized medicine uses genetic screening and other tests to provide physicians with more information to tailor patients' treatments, the Times reports.
Pharmaceutical Research And Manufacturers Of America Enacts New Voluntary Guidelines On Physician Gifting Practices
Tue, 06 Jan 2009 02:00:00 -0800
New guidelines by the Pharmaceutical Research and Manufacturers of America to address conflicts of interest that "illuminated the once-shadowy financial dealings" between pharmaceutical companies and physicians took effect Thursday, the Boston Herald reports.
Annals of Pharmacotherapy PAP Articles
Randomized Equivalence Study Evaluating the Possibility of Switching Hemodialysis Patients Receiving Subcutaneous Human Erythropoietin Directly to Intravenous Darbepoetin Alfa(February)
Chazot, C., Terrat, J. C., Dumoulin, A., Ang, K.-S., Gassia, J. P., Chedid, K., Maurice, F., Canaud, B., , f. t. C. M. G. Tue, 06 Jan 2009 00:00:00 -0000
BACKGROUND: Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) used either intravenously or subcutaneously with no dose penalty; however, the direct switch from subcutaneous recombinant human erythropoietin (rHuEPO) to intravenous darbepoetin has barely been studied. OBJECTIVE: To establish the equivalence of a direct switch from subcutaneous rHuEPO to intravenous darbepoetin versus an indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin in patients undergoing hemodialysis. METHODS: In this open, randomized, 6-month, prospective study, patients with end-stage kidney disease who were on hemodialysis were randomized into 2 groups: direct switch from subcutaneous rHuEPO to intravenous darbepoetin (group 1) and indirect switch from subcutaneous rHuEPO to intravenous darbepoetin after 2 months of subcutaneous darbepoetin (group 2). A third, nonrandomized group (control), consisting of patients treated with intravenous rHuEPO who were switched to intravenous darbepoetin, was also studied to reflect possible variations of hemoglobin (Hb) levels due to change from one type of ESA to the other. The primary outcome was the proportion of patients with stable Hb levels at month 6. Secondary endpoints included Hb stability at month 3, dosage requirements for darbepoetin, and safety of the administration route. RESULTS: Among 154 randomized patients, the percentages with stable Hb levels were equivalent in groups 1 and 2, respectively, at month 3 (86.0% vs 91.3%) and month 6 (82.1% vs 81.6%; difference -0.5 [90% CI -12.8 to 11.8]). Mean Hb levels between baseline and month 6 remained stable in both groups, with no variation in mean darbepoetin dose. Mean ferritin levels remained above 100 µg/L in the 3 groups during the whole study, and darbepoetin was well tolerated. CONCLUSIONS: This study has shown equivalent efficacy on Hb stability without the need for dosage increase in patients switched directly from subcutaneous rHuEPO to intravenous darbepoetin.
Journal Impact Factor: What It Is and Is Not (January)
Nahata, M. C Tue, 06 Jan 2009 00:00:00 -0000
The journal impact factor is an important measure of citation frequency during a 1-year period for articles published over the previous 2 years. However, it has many limitations that should be considered in evaluating the quality of scholarship published in the journal.
Dosing Nomograms: Silos on a Slope (January)
Dager, W. E Tue, 06 Jan 2009 00:00:00 -0000
Developing dosing management guidelines or protocol approaches to pharmacotherapy can provide several benefits for standardization of care. Frequently, clinicians may need to incorporate multiple influencing factors to individualize management. In some cases, preestablished, standardized approaches may create barriers to individualized care, potentially categorizing patients into dosing categories (silos) that minimize their individualized needs. Approaches to managing direct thrombin inhibitor therapy have been recently explored and dosing approaches different from those provided in the prescribing information have been proposed. Considerations regarding individualized management of anticoagulant therapy, including the use of standardized dosing or monitoring protocols, are discussed here.
Applied Clinical Pharmacokinetics, 2nd Edition (January)
Ariano, R. E Tue, 06 Jan 2009 00:00:00 -0000
Increases in C-Reactive Protein May Predict Recurrence of Clozapine-Induced Fever (January)
Kohen, I., Afzal, N., Hussain, S., Manu, P. Tue, 06 Jan 2009 00:00:00 -0000
OBJECTIVE: To report a case of recurrent clozapine-induced fever that was associated with a rise in C-reactive protein (CRP). CASE SUMMARY: A 73-year-old man with Lewy Body dementia was admitted for psychosis. He was treated with clozapine (initial dose 12.5 mg/day, titrated to 75 mg/day over 15 days). On day 15 of clozapine therapy, he developed a benign fever (maximum 38.4 °C) that was associated with a rise in the CRP level (3.96 mg/dL). The level normalized when clozapine was discontinued. However, when the patient was rechallenged with clozapine, the CRP level became elevated (4.36 mg/dL) after 3 days of therapy, with a subsequent recurrence of fever (38.7 °C). DISCUSSION: We postulate that the elevation in CRP levels and the subsequent fever were caused by the effects of clozapine on the cytokine system via interleukin-6 and tumor necrosis factor-, resulting in an inflammatory response with an acute phase reaction. This case is unique, as it is the first reported in the literature associating a recurrence of clozapine-induced fever with the known immunomodulatory effects of clozapine on cytokines and CRP level. According to the Naranjo probability scale, this adverse effect is probably associated with clozapine. CONCLUSIONS: Clozapine-related fever is generally benign but difficult to assess and manage, as it can be confused with much more serious conditions. Further research is needed to study whether CRP is a useful tool in predicting and managing clozapine fever.
Interaction Between Warfarin and Black Tea (January)
Parker, D. L, Hoffmann, T. K, Tucker, M. A., Meier, D. J Tue, 06 Jan 2009 00:00:00 -0000
Clinical Pharmacology & Therapeutics
In This Issue
In This Issue Clinical Pharmacology & Therapeutics 85, 1 (January 2009). doi:10.1038/clpt.2008.253
Aging and Medications: Past, Present, Future
JB SchwartzDR Abernethy Aging and Medications: Past, Present, Future Clinical Pharmacology & Therapeutics 85, 3 (January 2009). doi:10.1038/clpt.2008.238 Authors: JB Schwartz & DR Abernethy
Highlights
Highlights Clinical Pharmacology & Therapeutics 85, 12 (January 2009). doi:10.1038/clpt.2008.255 Author:
ASCPT News
ASCPT News Clinical Pharmacology & Therapeutics 85, 14 (January 2009). doi:10.1038/clpt.2008.249
Dopamine Transporters: Chemistry, Biology, and Pharmacology
SP David Dopamine Transporters: Chemistry, Biology, and Pharmacology Clinical Pharmacology & Therapeutics 85, 16 (January 2009). doi:10.1038/clpt.2008.212 Author: SP David
Mesenchymal Stem Cells and Neurodegenerative Disease
AL WhoneNJ Scolding Mesenchymal Stem Cells and Neurodegenerative Disease Clinical Pharmacology & Therapeutics 85, 19 (January 2009). doi:10.1038/clpt.2008.205 Authors: AL Whone & NJ Scolding
Sites:
Fred K. Friedman, Ph.D.: Structure, function, mechanism and regulation of the drug and carcinogen metabolizing cytochrome P450 enzymes are studied by biochemical, biophysical and enzymology approaches, and by molecular modeling.Lorraine S. Roth, M.D.: Answers questions about psychiatry, psychopharmacology, and related forensic issues. Based in Illinois.
Moulin, Frederic: Department of Pharmacology, Michigan State University.
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