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Pharma Industry / Biotech Industry News From Medical News Today

USP Chief Science Officer Darrell Abernethy To Receive ACCP Distinguished Service Award
Sat, 19 Jul 2008 11:00:00 -0700
The U.S. Pharmacopeial (USP) Convention is pleased to announce that its chief science officer, Darrell Abernethy, M.D., Ph.D., will be honored with the American College of Clinical Pharmacology's (ACCP) Nathaniel T. Kwit Memorial Distinguished Service Award at the 2008 ACCP Annual Meeting in Philadelphia, Pa., September 14-16. Dr. Abernethy is being recognized for his lasting contributions to cardiovascular clinical pharmacology. As chief science officer of USP, Dr.
By 2012, Legitimate Generics Will Account For 20% Of Brazil's Pharmaceuticals And Healthcare Market
Sat, 19 Jul 2008 01:00:00 -0700
Research and Markets has announced the addition of the "Brazil Pharmaceuticals and Healthcare Report Q2 2008" report to their offering. The "Brazil Pharmaceuticals and Healthcare Report" provides independent forecasts and competitive intelligence on Brazils pharmaceuticals and healthcare industry. Brazil's pharmaceutical market remains one of the bright spots globally, having posted 17.0% growth in 2007 and reaching an estimated value of US$12.9bn in final consumer prices.
Massachusetts House Approves Bill That Aims To Control Health Care Spending
Fri, 18 Jul 2008 08:00:00 -0700
The Massachusetts House on Wednesday approved legislation that aims to rein in health care spending, the AP/Boston Herald reports (AP/Boston Herald, 7/16). Members of the Massachusetts House
Patent System For Drugs 'Morally Unacceptable'
Fri, 18 Jul 2008 00:00:00 -0700
Major drugs companies are using fierce lobbying tactics to protect a pharmaceutical patent system that is "simply morally unacceptable", a world-leading political philosopher told a major meeting of UK and European pharmacologists.
European Biotech Industry Identifies The Real Culprits Causing Food Price Rises
Thu, 17 Jul 2008 00:00:00 -0700
The European Biotech Industry Association (EuropaBio) questions the premises and the methods used by recent reports, including the recently leaked and unofficial World Bank internal note which claims that 75% of the recent price increase of food is due to increasing demand for biofuel.
SEM Thought-Leaders To Gather For Eyeforpharma's Search Engine Marketing Summit 2008
Wed, 16 Jul 2008 15:00:00 -0700
eyeforpharma has announced the launch of the premier pharmaceutical Search Engine Marketing Event on October 22nd in Boston. The conference has been highly anticipated and in a sneak preview of the agenda, Gerard Moore, the Event Producer, has announced that the following Search experts will be speaking at the event.

Annals of Pharmacotherapy PAP Articles

Racial Differences in Sleep Medication Use: A Cross-Sectional Study of the Johnston County Osteoarthritis Project (September)
Allen, K. D, Renner, J. B, DeVellis, B., Helmick, C. G, Jordan, J. M Tue, 15 Jul 2008 00:00:00 -0000
BACKGROUND: Little is known about racial differences in the use of sleep medications. OBJECTIVE: To compare sleep medication use among African Americans and whites with self-reported current sleep problems. METHODS: Participants were 1910 individuals (69% female, 34% African American, 66% white) from the Johnston County Osteoarthritis Project. We examined racial differences in self-reported current use of prescription, nonprescription, herbal, and other medications for sleep. Multivariable logistic regression models controlled for age, sex, education, health insurance, symptomatic hip or knee osteoarthritis, depressive symptoms, obesity, fair or poor general health, and self-reported annual days of sleep problems. Models were conducted separately for the whole sample and for men and women. RESULTS: Among participants with current sleep problems, 31% were using one or more types of sleep medication: 17% prescription, 12% nonprescription, 1% herbal, and 3% other products. African Americans were less likely than whites to be using any sleep medication (25% vs 35%; p < 0.001), prescription sleep medication (14% vs 19%; p = 0.003), and nonprescription sleep medication (10% vs 13%; p = 0.048). These racial differences persisted in multivariable models. In sex-stratified analyses, there were significant racial differences in sleep medication use only among women. CONCLUSIONS: African Americans were less likely than whites to report current use of prescription and nonprescription sleep medications; these results appeared to be largely driven by racial differences among women. Additional research should study possible underlying factors and determine whether these racial differences impact clinical outcomes.
Altered Acetaminophen Pharmacokinetics and Hepatotoxicity Associated with Premature Cessation of Intravenous N-Acetylcysteine Therapy (September)
Smith, S. W, Howland, M. A., Hoffman, R. S, Nelson, L. S Tue, 15 Jul 2008 00:00:00 -0000
OBJECTIVE: To report a case of erratic absorption, double peak serum concentrations, and hepatotoxicity following premature cessation of intravenous Nacetylcysteine (NAC) treatment in the setting of a massive acetaminophen overdose. CASE SUMMARY: A 78-year-old man reportedly ingested approximately 96 immediate-release acetaminophen 500-mg tablets (48 g) over a one-hour period in an apparent suicide attempt. The acetaminophen concentration at 2.25 hours was 264 µg/mL. Intravenous NAC was initiated 5 hours postingestion. At 6.25 hours postingestion, the acetaminophen concentration was 281 µg/mL. Following administration of intravenous NAC for 21 hours, therapy was discontinued despite a residual acetaminophen concentration of 116 µg/mL. The patient experienced hepatotoxicity, coagulopathy, and renal injury. Pharmacokinetic analysis revealed significantly prolonged acetaminophen absorption and a second peak acetaminophen concentration of 228 µg/mL approximately 48 hours postingestion. Direct in-hospital monitoring of the patient made a second ingestion unlikely. DISCUSSION: Acetaminophen overdose is usually effectively managed with NAC. Patients with massive ingestions may have altered absorption kinetics due to acetaminophen's solubility being exceeded, physiologically or chemically altered gastrointestinal emptying or motility, or other factors. These patients may benefit from gastrointestinal decontamination and prolonged NAC therapy. CONCLUSIONS: In patients with massive acetaminophen ingestion, erratic absorption may occur, and toxic serum concentrations may persist beyond a standard 21-hour course of intravenous NAC therapy. Acetaminophen concentrations and aminotransferase levels should be evaluated at the completion of therapy intravenous NAC infusion to ensure complete elimination of acetaminophen and absence of hepatotoxicity and to exclude the need for prolonged treatment.
Famciclovir-Induced Leukocytoclastic Vasculitis (September)
Te, C. C, Le, V., Allee, M. Tue, 15 Jul 2008 00:00:00 -0000
OBJECTIVE: To report a case of famciclovir-induced leukocytoclastic vasculitis (LCV). CASE SUMMARY: A 67-year-old white female presented to the hospital for evaluation of large, bilateral palpable purpura; coalescing ulcers with central eschars; and small, red violaceous papules on her legs and groin. Approximately 2 months prior to this hospitalization, the woman was diagnosed with shingles of her left T1-T2 nerve distribution and was treated with famciclovir 500 mg 3 times daily, which was her first exposure to this medication. Her shingles resolved; however, on day 4 of treatment, she began to notice red spots on both of her legs that began to progressively blister and increase in size. She discontinued famciclovir at that time. The rash persisted and spread to her abdomen, groin, legs, feet, and toes. She underwent punch biopsy that revealed LCV. Workup was negative for antinuclear antibody, rheumatoid factor, hepatitis B and C virus, perinuclear-staining antineutrophil cytoplasmic antibodies, cytoplasmic-staining antineutrophil cytoplasmic antibodies, antibodies to extractable nuclear antigens, proteinase 3, and myeloperoxidase. The patient improved with daily oral steroids and local wound care. DISCUSSION: LCV has been reported only once before in the English literature as of January 2008. The most common cause of LCV is medication use, but it is a diagnosis of exclusion. It is hypothesized that drugs act as haptens, which cause an immune response. An objective causality assessment using the Naranjo probability scale suggested that famciclovir was the probable cause of LCV in this patient. CONCLUSIONS: Healthcare professionals should be aware of the possible development of famciclovir-induced LCV.
Concepts in Immunology and Immunotherapeutics, 4th Edition (September)
Grabenstein, J. D Tue, 15 Jul 2008 00:00:00 -0000

Association Between Selective Serotonin-Reuptake Inhibitors, Second-Generation Antipsychotics, and Neuroleptic Malignant Syndrome (September)
Stevens, D. L Tue, 15 Jul 2008 00:00:00 -0000
OBJECTIVE: To review the published reports of neuroleptic malignant syndrome (NMS) associated with the use of selective serotonin-reuptake inhibitors (SSRIs) and second-generation antipsychotics. DATA SOURCES: Information was selected from a MEDLINE search of English language literature (1950-May 2008). Manual search of all published cases indexed in MEDLINE (English language only) of NMS associated with second-generation antipsychotics was also performed. STUDY SELECTION AND DATA EXTRACTION: Pertinent information from all reports obtained was included, with specific emphasis on patient age, sex, second-generation antipsychotic involved, SSRI or other antidepressant involved, time of onset of NMS symptoms in relation to medication changes, treatment administered, and outcome of the reaction. DATA SYNTHESIS: NMS has been reported with every second-generation antipsychotic agent. It is unclear whether concomitant therapy with other agents may increase the risk of NMS development via pharmacodynamic or pharmacokinetic mechanisms or both. The suggested pharmacodynamic mechanism for increased risk of NMS with concomitant use of SSRIs is the effect of serotonin on dopamine release. Serotonin further inhibits dopamine release and thereby may worsen a hypodopaminergic state induced by antipsychotics. Pharmacokinetic factors may also play a role in some NMS cases involving an SSRI by increasing antipsychotic concentrations. An examination of case reports seems to indicate that at least in some cases, a temporal relationship exists with the addition of an SSRI to existing antipsychotic therapy. CONCLUSIONS: The use of SSRIs may be associated with an increased risk of NMS development in those receiving second-generation antipsychotics. Clinicians should closely monitor patients for the potential development of NMS.
Tigecycline for the Treatment of Acinetobacter Infections: A Case Series (September)
Gallagher, J. C, Rouse, H. M Wed, 09 Jul 2008 00:00:00 -0000
BACKGROUND: Acinetobacter infections resistant to multiple classes of antibiotics have become prevalent in many institutions. Tigecycline has in vitro activity against Acinetobacter spp. and has been suggested as a therapeutic option in these infections. OBJECTIVE: To describe the clinical and microbiologic outcomes of patients who received tigecycline for the treatment of infections caused by Acinetobacter spp. at our institution. METHODS: A retrospective review was conducted of the medical records of 29 sequential patients who received tigecycline for treatment of Acinetobacter infections. The outcomes assessed for efficacy were clinical improvement or cure and microbiologic cure in evaluable patients. RESULTS: Patients received tigecycline a median of 30 days into hospitalization for a median of 11 days. Common indications were pneumonia (15 pts.), bacteremia (6), and urinary tract infection (3). Positive clinical outcomes (clinical cure or improvement) were seen in 8 (28%) of 29 patients. Of the 25 microbiologically evaluable patients, 11 (44%) had resolution of their cultures. Eleven patients had susceptibility testing performed, and the median minimum inhibitory concentration was 4 µg/mL (range 3-8). CONCLUSIONS: In this case series, most patients did not have clinically or microbiologically favorable outcomes with tigecycline therapy. No patient had an isolate that was fully susceptible to tigecycline. Data from more studies are needed before tigecycline can be recommended for the treatment of Acinetobacter infections.

Clinical Pharmacology & Therapeutics

In This Issue
In This Issue Clinical Pharmacology & Therapeutics 83, 373 (March 2008). doi:10.1038/sj.clpt.6100521
Pharmacoecology: A New Name for an Old Science
C Flexner Pharmacoecology: A New Name for an Old Science Clinical Pharmacology & Therapeutics 83, 375 (March 2008). doi:10.1038/sj.clpt.6100499 Author: C Flexner
News and Views
News and Views Clinical Pharmacology & Therapeutics 83, 380 (March 2008). doi:10.1038/sj.clpt.6100522 Author:
News and Views
News and Views Clinical Pharmacology & Therapeutics 83, 382 (March 2008). doi:10.1038/sj.clpt.6100520
Principles of Clinical Pharmacology, 2nd Edition
SG Carruthers Principles of Clinical Pharmacology, 2nd Edition Clinical Pharmacology & Therapeutics 83, 384 (March 2008). doi:10.1038/sj.clpt.6100485 Author: SG Carruthers
Special Cells, Special Considerations: The Challenges of Bringing Embryonic Stem Cells From the Laboratory to the Clinic
RC AddisJWM BulteJD Gearhart Special Cells, Special Considerations: The Challenges of Bringing Embryonic Stem Cells From the Laboratory to the Clinic Clinical Pharmacology & Therapeutics 83, 386 (March 2008). doi:10.1038/sj.clpt.6100384 Authors: RC Addis, JWM Bulte & JD Gearhart

 
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Moulin, Frederic: Department of Pharmacology, Michigan State University.