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Pharma Industry / Biotech Industry News From Medical News Today
DOJ Investigates Alleged Fraud By Drugmakers; Sanctions On WellCare Lifted
Fri, 06 Nov 2009 05:00:00 -0800
News outlets focus on alleged fraud in the drug and insurance industries. "A $112 million settlement involving alleged drug kickbacks that the Justice Dept. announced with the nation's largest nursing home pharmacy and a generic drug manufacturer on Nov. 3 is part of a wide-ranging investigation of suspected Medicaid fraud by the pharmaceutical industry,"
Wall Street Journal Examines Big Pharma's 'Growing Interest' In Emerging-Market Vaccine Development, Production
Fri, 06 Nov 2009 03:00:00 -0800
The Wall Street Journal examines "big pharma's growing interest in a corner of healthcare - emerging-market inoculations," in light of a recent move by Novartis to purchase an 85 percent stake in the Chinese vaccine maker Zhejiang Tianyuan Bio-Pharmaceutical Co.
Helix BioPharma Corp. Completes Enrollment In Its Phase II Trial Of Topical Interferon Alpha-2b In Patients With Ano-Genital Warts
Fri, 06 Nov 2009 02:00:00 -0800
Helix BioPharma Corp. (TSX, FSE: "HBP" / OTCQX: HXBPF) announced that its Phase II trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (AGW) has completed patient enrollment, with the required 120th patient randomized to enter the trial. The double-blind and placebo-controlled Phase II trial is underway at multiple centers in Germany and Sweden.
Pivotal Data Published In The Journal Cancer Demonstrate That TREANDA Induced Durable Responses In Relapsed Indolent Non-Hodgkin's Lymphoma
Fri, 06 Nov 2009 02:00:00 -0800
Cephalon, Inc. (Nasdaq: CEPH) announced the journal Cancer has published a pivotal study demonstrating that TREANDA® (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab.
Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Cancer
Fri, 06 Nov 2009 02:00:00 -0800
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival.
Sunesis' Voreloxin Receives FDA Orphan Drug Designation For Acute Myeloid Leukemia
Fri, 06 Nov 2009 02:00:00 -0800
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML).
Annals of Pharmacotherapy PAP Articles
Multidrug-Resistant Enterococcus faecium Endocarditis Treated with Combination Tigecycline and High-Dose Daptomycin (December)
Schutt, A. C, Bohm, N. M OBJECTIVE: To report a case of multidrug-resistant Enterococcus faecium requiring combination antibacterial therapy. CASE SUMMARY: A 39-year-old female presented with chest pain and a history of endocarditis 3 years prior to admission. Blood cultures were positive for E. faecium. She was treated initially with daptomycin 6 mg/kg daily, which was later increased to 8 mg/kg daily despite poor gentamicin clearance. A variety of antibiotics were used in combination with daptomycin, but the patient remained febrile, with positive blood cultures revealing vancomycin minimum inhibitory concentration (MIC) greater than 256 µg/mL and daptomycin MIC 3 µg/mL (and later, 4 µg/mL). Following the addition of tigecycline, the patient experienced rapid clinical and microbiologic improvement, and blood cultures remained negative 9 weeks after discharge. DISCUSSION: Limited clinical data support the use of daptomycin for the treatment of E. faecium endocarditis, and information regarding the effects of escalating doses and combination therapy is scant. After failing multiple combination regimens, this patient responded to a combination of tigecycline and daptomycin. Daptomycin 8 mg/kg daily did not result in creatine kinase elevation in the face of evidence of possible renal dysfunction. CONCLUSIONS: Increasing doses of daptomycin may enhance efficacy without compromising safety, even in patients with some renal dysfunction. The combination of daptomycin and tigecycline may be useful for the treatment of multi-drug- resistant E. faecium.
Prevalence and Risk Factors for Acute Kidney Injury Associated with Parenteral Polymyxin B Use(December)
Mendes, C. A., Cordeiro, J. A, Burdmann, E. A BACKGROUND: The main adverse effect of polymyxin B is nephrotoxicity. There are few data on polymyxin-associated renal injury. OBJECTIVE: To assess the prevalence of and risk factors for acute kidney injury (AKI) in patients treated with polymyxin B. METHODS: The studied population included 114 patients who received at least 3 consecutive days of intravenous polymyxin B and had baseline serum creatinine (SCr) and at least one further SCr measurement during treatment. AKI was defined as an SCr increase to 1.8 mg/dL or greater in patients with baseline SCr less than 1.5 mg/dL, or an increase greater than or equal to 50% in baseline SCr when it was already greater than or equal to 1.5 mg/dL, or need for dialysis. RESULTS: AKI developed in 22% of the patients. They were older, had a higher baseline SCr, had a higher frequency of baseline SCr greater than or equal to 1.5 mg/dL, used other nephrotoxic drugs and furosemide more often, and required vasoactive drugs and mechanical ventilation more frequently. Progression to renal failure was significantly more probable when the bacteria were isolated in the abdomen, catheter, or blood. AKI patients had a higher mortality rate (92% vs 53%; p < 0.001). Logistic regression identified abnormal baseline SCr (odds ratio [OR] 3.51); need for vasoactive drugs (OR 3.03); and abdomen, blood, or catheter as the infection site (OR 3.82) as independent risk factors for AKI. CONCLUSIONS: Patients who developed AKI had a strikingly elevated mortality rate. Polymyxin B should be used with extreme caution in patients who have an abnormal baseline SCr; use vasoactive drugs; or have abdomen, blood, or catheter as the infection site.
Sorafenib-Induced Hepatic Encephalopathy (December)
Marks, A.-B., Gerard, R., Fournier, P., Coupe, P., Gautier, S.
Successful Use of Topical Voriconazole 1% Alone as First-Line Antifungal Therapy Against Candida albicans Keratitis (December)
Al-Badriyeh, D., Leung, L., Davies, G. E, Stewart, K., Kong, D. OBJECTIVE: To report the successful use of topical voriconazole 1% given alone as primary therapy against a case of Candida albicans keratitis. CASE SUMMARY: A 48-year-old previously well man presented to the emergency department with pain and foreign body sensation in the left eye following exposure to dust while driving a forklift. He wore weekly disposable soft contact lenses. Anterior stromal scar and dense infiltrate were detected in the left eye. The anterior chamber remained deep, with flare and copious white cells. Intraocular pressure was 12 mm Hg and visual acuity was 20/200. The epithelial defect persisted, with progressive thinning despite topical fluorometholone and ofloxacin 0.3% therapy for 2 days. Microbiology testing revealed C. albicans as the affecting pathogen. Hourly administration of voriconazole 1% eye drops was initiated as antifungal therapy. The corneal infiltrate began to resolve and the epithelial defect decreased in size within 2 days. Visual acuity improved to 20/120. After 4 days of voriconazole use, the epithelial defect was completely healed and visual acuity was 20/30 in the affected eye. No fungi were isolated from a second eye scrape. DISCUSSION: Topical voriconazole as salvage monotherapy to manage fungal keratitis has been previously reported. It can be argued, however, that the primary therapy has facilitated the positive response to subsequent topical voriconazole. To date, there has been no solid evidence to suggest that topical voriconazole is effective when used as primary therapy. The current report provides evidence of topical voriconazole demonstrating clinical success when used as first-line therapy to treat C. albicans keratitis. The use of topical voriconazole can reduce the costs, toxicity, and drug interactions associated with common antifungal therapies. CONCLUSIONS: Topical voriconazole 1% eye drops administered alone demonstrated success as first-line therapy against the most common fungal keratitis, C. albicans keratitis.
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds
In This Issue
Tue, 20 Oct 2009 00:00:00 -0000
In This Issue Clinical Pharmacology & Therapeutics 86, 451 (November 2009). doi:10.1038/clpt.2009.202
Nephropharmacology: Drugs and the Kidney
A J AtkinsonS-M Huang Tue, 20 Oct 2009 00:00:00 -0000
Nephropharmacology: Drugs and the Kidney Clinical Pharmacology & Therapeutics 86, 453 (November 2009). doi:10.1038/clpt.2009.191 Authors: A J Atkinson & S-M Huang
Highlights
Tue, 20 Oct 2009 00:00:00 -0000
Highlights Clinical Pharmacology & Therapeutics 86, 458 (November 2009). doi:10.1038/clpt.2009.203 Author:
ASCPT News
Tue, 20 Oct 2009 00:00:00 -0000
ASCPT News Clinical Pharmacology & Therapeutics 86, 460 (November 2009). doi:10.1038/clpt.2009.196
Clinical Physiology and Pharmacology: The Essentials
M J Avram Tue, 20 Oct 2009 00:00:00 -0000
Clinical Physiology and Pharmacology: The Essentials Clinical Pharmacology & Therapeutics 86, 462 (November 2009). doi:10.1038/clpt.2009.189 Author: M J Avram
Use of the MDRD Study Equation to Estimate Kidney Function for Drug Dosing
L A StevensA S Levey Tue, 20 Oct 2009 00:00:00 -0000
Use of the MDRD Study Equation to Estimate Kidney Function for Drug Dosing Clinical Pharmacology & Therapeutics 86, 465 (November 2009). doi:10.1038/clpt.2009.124 Authors: L A Stevens & A S Levey
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DOJ Investigates Alleged Fraud By Drugmakers; Sanctions On WellCare Lifted
Fri, 06 Nov 2009 05:00:00 -0800
News outlets focus on alleged fraud in the drug and insurance industries. "A $112 million settlement involving alleged drug kickbacks that the Justice Dept. announced with the nation's largest nursing home pharmacy and a generic drug manufacturer on Nov. 3 is part of a wide-ranging investigation of suspected Medicaid fraud by the pharmaceutical industry,"
Wall Street Journal Examines Big Pharma's 'Growing Interest' In Emerging-Market Vaccine Development, Production
Fri, 06 Nov 2009 03:00:00 -0800
The Wall Street Journal examines "big pharma's growing interest in a corner of healthcare - emerging-market inoculations," in light of a recent move by Novartis to purchase an 85 percent stake in the Chinese vaccine maker Zhejiang Tianyuan Bio-Pharmaceutical Co.
Helix BioPharma Corp. Completes Enrollment In Its Phase II Trial Of Topical Interferon Alpha-2b In Patients With Ano-Genital Warts
Fri, 06 Nov 2009 02:00:00 -0800
Helix BioPharma Corp. (TSX, FSE: "HBP" / OTCQX: HXBPF) announced that its Phase II trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (AGW) has completed patient enrollment, with the required 120th patient randomized to enter the trial. The double-blind and placebo-controlled Phase II trial is underway at multiple centers in Germany and Sweden.
Pivotal Data Published In The Journal Cancer Demonstrate That TREANDA Induced Durable Responses In Relapsed Indolent Non-Hodgkin's Lymphoma
Fri, 06 Nov 2009 02:00:00 -0800
Cephalon, Inc. (Nasdaq: CEPH) announced the journal Cancer has published a pivotal study demonstrating that TREANDA® (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab.
Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Cancer
Fri, 06 Nov 2009 02:00:00 -0800
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival.
Sunesis' Voreloxin Receives FDA Orphan Drug Designation For Acute Myeloid Leukemia
Fri, 06 Nov 2009 02:00:00 -0800
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML).
Annals of Pharmacotherapy PAP Articles
Multidrug-Resistant Enterococcus faecium Endocarditis Treated with Combination Tigecycline and High-Dose Daptomycin (December)
Schutt, A. C, Bohm, N. M OBJECTIVE: To report a case of multidrug-resistant Enterococcus faecium requiring combination antibacterial therapy. CASE SUMMARY: A 39-year-old female presented with chest pain and a history of endocarditis 3 years prior to admission. Blood cultures were positive for E. faecium. She was treated initially with daptomycin 6 mg/kg daily, which was later increased to 8 mg/kg daily despite poor gentamicin clearance. A variety of antibiotics were used in combination with daptomycin, but the patient remained febrile, with positive blood cultures revealing vancomycin minimum inhibitory concentration (MIC) greater than 256 µg/mL and daptomycin MIC 3 µg/mL (and later, 4 µg/mL). Following the addition of tigecycline, the patient experienced rapid clinical and microbiologic improvement, and blood cultures remained negative 9 weeks after discharge. DISCUSSION: Limited clinical data support the use of daptomycin for the treatment of E. faecium endocarditis, and information regarding the effects of escalating doses and combination therapy is scant. After failing multiple combination regimens, this patient responded to a combination of tigecycline and daptomycin. Daptomycin 8 mg/kg daily did not result in creatine kinase elevation in the face of evidence of possible renal dysfunction. CONCLUSIONS: Increasing doses of daptomycin may enhance efficacy without compromising safety, even in patients with some renal dysfunction. The combination of daptomycin and tigecycline may be useful for the treatment of multi-drug- resistant E. faecium.
Prevalence and Risk Factors for Acute Kidney Injury Associated with Parenteral Polymyxin B Use(December)
Mendes, C. A., Cordeiro, J. A, Burdmann, E. A BACKGROUND: The main adverse effect of polymyxin B is nephrotoxicity. There are few data on polymyxin-associated renal injury. OBJECTIVE: To assess the prevalence of and risk factors for acute kidney injury (AKI) in patients treated with polymyxin B. METHODS: The studied population included 114 patients who received at least 3 consecutive days of intravenous polymyxin B and had baseline serum creatinine (SCr) and at least one further SCr measurement during treatment. AKI was defined as an SCr increase to 1.8 mg/dL or greater in patients with baseline SCr less than 1.5 mg/dL, or an increase greater than or equal to 50% in baseline SCr when it was already greater than or equal to 1.5 mg/dL, or need for dialysis. RESULTS: AKI developed in 22% of the patients. They were older, had a higher baseline SCr, had a higher frequency of baseline SCr greater than or equal to 1.5 mg/dL, used other nephrotoxic drugs and furosemide more often, and required vasoactive drugs and mechanical ventilation more frequently. Progression to renal failure was significantly more probable when the bacteria were isolated in the abdomen, catheter, or blood. AKI patients had a higher mortality rate (92% vs 53%; p < 0.001). Logistic regression identified abnormal baseline SCr (odds ratio [OR] 3.51); need for vasoactive drugs (OR 3.03); and abdomen, blood, or catheter as the infection site (OR 3.82) as independent risk factors for AKI. CONCLUSIONS: Patients who developed AKI had a strikingly elevated mortality rate. Polymyxin B should be used with extreme caution in patients who have an abnormal baseline SCr; use vasoactive drugs; or have abdomen, blood, or catheter as the infection site.
Sorafenib-Induced Hepatic Encephalopathy (December)
Marks, A.-B., Gerard, R., Fournier, P., Coupe, P., Gautier, S.
Successful Use of Topical Voriconazole 1% Alone as First-Line Antifungal Therapy Against Candida albicans Keratitis (December)
Al-Badriyeh, D., Leung, L., Davies, G. E, Stewart, K., Kong, D. OBJECTIVE: To report the successful use of topical voriconazole 1% given alone as primary therapy against a case of Candida albicans keratitis. CASE SUMMARY: A 48-year-old previously well man presented to the emergency department with pain and foreign body sensation in the left eye following exposure to dust while driving a forklift. He wore weekly disposable soft contact lenses. Anterior stromal scar and dense infiltrate were detected in the left eye. The anterior chamber remained deep, with flare and copious white cells. Intraocular pressure was 12 mm Hg and visual acuity was 20/200. The epithelial defect persisted, with progressive thinning despite topical fluorometholone and ofloxacin 0.3% therapy for 2 days. Microbiology testing revealed C. albicans as the affecting pathogen. Hourly administration of voriconazole 1% eye drops was initiated as antifungal therapy. The corneal infiltrate began to resolve and the epithelial defect decreased in size within 2 days. Visual acuity improved to 20/120. After 4 days of voriconazole use, the epithelial defect was completely healed and visual acuity was 20/30 in the affected eye. No fungi were isolated from a second eye scrape. DISCUSSION: Topical voriconazole as salvage monotherapy to manage fungal keratitis has been previously reported. It can be argued, however, that the primary therapy has facilitated the positive response to subsequent topical voriconazole. To date, there has been no solid evidence to suggest that topical voriconazole is effective when used as primary therapy. The current report provides evidence of topical voriconazole demonstrating clinical success when used as first-line therapy to treat C. albicans keratitis. The use of topical voriconazole can reduce the costs, toxicity, and drug interactions associated with common antifungal therapies. CONCLUSIONS: Topical voriconazole 1% eye drops administered alone demonstrated success as first-line therapy against the most common fungal keratitis, C. albicans keratitis.
Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds
In This Issue
Tue, 20 Oct 2009 00:00:00 -0000
In This Issue Clinical Pharmacology & Therapeutics 86, 451 (November 2009). doi:10.1038/clpt.2009.202
Nephropharmacology: Drugs and the Kidney
A J AtkinsonS-M Huang Tue, 20 Oct 2009 00:00:00 -0000
Nephropharmacology: Drugs and the Kidney Clinical Pharmacology & Therapeutics 86, 453 (November 2009). doi:10.1038/clpt.2009.191 Authors: A J Atkinson & S-M Huang
Highlights
Tue, 20 Oct 2009 00:00:00 -0000
Highlights Clinical Pharmacology & Therapeutics 86, 458 (November 2009). doi:10.1038/clpt.2009.203 Author:
ASCPT News
Tue, 20 Oct 2009 00:00:00 -0000
ASCPT News Clinical Pharmacology & Therapeutics 86, 460 (November 2009). doi:10.1038/clpt.2009.196
Clinical Physiology and Pharmacology: The Essentials
M J Avram Tue, 20 Oct 2009 00:00:00 -0000
Clinical Physiology and Pharmacology: The Essentials Clinical Pharmacology & Therapeutics 86, 462 (November 2009). doi:10.1038/clpt.2009.189 Author: M J Avram
Use of the MDRD Study Equation to Estimate Kidney Function for Drug Dosing
L A StevensA S Levey Tue, 20 Oct 2009 00:00:00 -0000
Use of the MDRD Study Equation to Estimate Kidney Function for Drug Dosing Clinical Pharmacology & Therapeutics 86, 465 (November 2009). doi:10.1038/clpt.2009.124 Authors: L A Stevens & A S Levey
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Annual PET Pharmacokinetic Course: Course on application of PET to pharmacokinetics, open to professionals in a wide variety of fields. Held at different locations around the world, next is June 2003 in Montreal, Canada.Cytochrome P450: Identification of a novel transcriptional silencer in the protein-coding region of the human cytochrome P450 2C9 gene.
Department of Pharmacology and Toxicology, School of Medicine, University of Puerto Rico: Department of Pharmacology and Toxicology; University of Puerto Rico; Information about the department and the graduate program in Pharmacology and Toxicology., Department of Pharmacology and Toxicology; University of Puerto Rico; Information about the department and the graduate program in Pharm...
Department of Preclinical and Clinical Pharmacology, University of Florence, Italy: Information on research activities in Pharmacology.
Dissolution Solutions Network: Dissolution Solutions Network: Pharmaceutical scientists providing real answers for one another. The latest news, forum, blog and more...
DrugInfo. Searching the Web for Drug Information: A personal Website based on 30-years experience in pharmacology. Provides help to Web browsers in locating the most relevant drug information on the Web.
Elliot Brown Consulting: MedDRA training, products and pharmacovigilance by Dr Elliot Brown Consultancy.Pharmaceutical regulatory affairs, Adverse experiences, adverse events, drug safety surveillance, post marketing surveillance, EMEA, SPMP, MCA ,
FDA Drug Approvals List: Updated weekly as a service by CDER's Division of Data Management and Services.
Institute of Pharmacology University of Bern Switzerland: Information about the institute, its history, research areas and staff.
Institute of Pharmacology, Polish Academy of Sciences: Information about the Institute and its neuropharmacological research, including psychotropic drugs.
Laboratory of Pulmonary Pharmacology: research in human vascular pharmacology, reactivity of bronchial and vascular tissues, role of the eicosanoids and the cholinergic system
New York University Department of Pharmacology: Teaching of medical and graduate students, with research programs in normal growth and differentiation, development and pathology of the nervous system, and mechanisms of normal and abnormal functions of several key hormones.
Novartis Pharma: Here you'll find expert information about diseases, treatments and the full Novartis US product line, and an inside look at where we're headed.
Optimizing a Unimodal Response Function for Binary Variables: Adaptive designs for optimizing a unimodal response function for binary variables.
Ottosen Site for Drug Safety and Pharmacovigilance: Information about drug safety and clinical studies. Includes discussion forum, news and practical information about issues like safety reporting, licensing, contracts, PSUR, E2B, electronic submission.
Pharmacology and Legal Drugs - About.com: Search the power of About's network of topics
Pharmacology-Info.com: Information about pharmacology, toxicology, getting a new drug to market, and FDA approval.
SMR's Case Histories of Drug Discovery: Drug symposium organized by Society for Medicines Research, drug discovery of infliximab, zanamivir, olanzapine, alosetron, leflunomide and celecoxib.
Social Audit - the Antidepressant Web: social audit
The Lycaeum: An Entheogenic Database: The Lycaeum features an entheogen information database, drug experience archive with over 700 reports, search engine which spiders several major drug information sites, psychedelic graphics, transcribed books, community, software, audio, hosted sites, and much more.
The Ones That Stain Blue: Dr. Albert Hofmann
The Virtual Clinical Pharmacologist: Development of inpatient and outpatient anticoagulation and clinical pharmacology services. In conjunction with this we offer several multi-media CD rom products to assist the user in the development of these services. On line lectures are available .
TICTAC: The CD-ROM for drug identification of tablets & capsules
Toxicology-Info.com: Information on toxicology, drug interactions, toxicity and adverse reactions. Part of the ALtruis Biomedical Network.
University of Colorado Health Sciences Center - Department of Pharmacology: Department of Pharmacology and Graduate Program in Pharmacology at the University of Colorado Health Sciences Center at Denver and information about our pharmacology graduate program, curriculum, and research activities in the Pharmacology department. Research interests include: bioinformatics, m...
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