Pharma Industry / Biotech Industry News From Medical News Today

FDA Approval, Oversight Of Mifeprex 'Consistent' With Other Drugs, GAO Report Says
Wed, 20 Aug 2008 05:00:00 -0700
FDA's approval process and postmarket oversight of Danco Laboratories' medication abortion drug Mifeprex, also known as RU-486, were "consisten[t]" with how the agency handles other drugs with restricted distribution, according to a Government Accountability Office report released Tuesday,
University Of Queensland Prescribes A New Way For Medicine
Wed, 20 Aug 2008 03:00:00 -0700
University of Queensland research into how hospital doctors prescribe medication is leading to safer patient outcomes. Dr Ian Coombes, a trained pharmacist, undertook research into safe prescribing practices for junior doctors as part of his PhD with UQ's Schools of Pharmacy and
Journal Of Cardiovascular Electrophysiology Publishes Data Showing Ranolazine Shortened QT Interval And Improved Cardiac Relaxation
Wed, 20 Aug 2008 02:00:00 -0700
CV Therapeutics, Inc. (Nasdaq: CVTX) announced that the Journal of Cardiovascular Electrophysiology has published a study of ranolazine showing that ranolazine significantly (p
Vion Pharmaceuticals Enters Into Agreement With HOVON To Conduct A Phase III Clinical Trial Of Cloretazine(R)
Wed, 20 Aug 2008 02:00:00 -0700
VION PHARMACEUTICALS, INC. (Pink Sheets: VION) announced that it had entered into an agreement with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (the "HOVON") to conduct a clinical trial of laromustine (Cloretazine(R) (VNP40101M)) with standard remission-induction therapy in patients aged 18-65 with previously untreated acute myelogenous leukemia (AML) and high-risk myelodysplasia (MDS).
Karolinska Institute To Test Vical's Vaxfectin(R) Adjuvant With Preventive Vaccine Against HIV
Wed, 20 Aug 2008 02:00:00 -0700
Vical Incorporated (Nasdaq: VICL) announced a research collaboration with the Karolinska Institute, a leading European medical university, and the Swedish Institute for Infectious Disease Control (SMI), a governmental expert agency, to evaluate Vical's Vaxfectin(R) adjuvant with the Biojector(R) 2000 needle-free injection system (Bioject Medical Technologies Inc., OTCBB:BJCT) for a multivalent preventive DNA vaccine against HIV. Professor Eric Sandstrom, M.
Clinical News From Annals Of Internal Medicine
Wed, 20 Aug 2008 00:00:00 -0700
Vitamin D Deficiency Puts Older Women at Risk for Hip Fracture Previous studies of the effect of low blood vitamin D levels on the risk for hip fractures in older women have given inconsistent results. In this study, researchers took blood to measure vitamin D levels and gathered information about fracture risk from 800 women between the ages of 50 and 79. After following the women for up to nine years, the researchers re-examined them to see who developed hip fractures.

The Seattle Times: Biotech


News on biotechnology pharmaceutical from BioPortfolio.com

Australia Pharmaceuticals and Healthcare Report Q3 2008
Mindbranch:
China Shenghuo Pharmaceutical Holdings, Inc
BioSpace:
JHP Pharmaceuticals
BioSpace:

The Economist: Biotechnology

Gene doping:
Thu, 31 Jul 2008 12:10:21 -0000
What athletes may or may not do ought to be decided on grounds of safety, not fairnessANOTHER Olympics, another doping debate. And this time it is a fervent one, as recent advances in medical science have had the side-effect of providing athletes with new ways of enhancing performance, and thus of putting an even greater strain on people’s ethical sensibilities. This is especially true of gene therapy. Replacing defective genes holds out great promise for people suffering from diseases such as muscular dystrophy and cancer. But administered to sprightly sportsmen, the treatment may allow them to heave greater weights, swim faster and jump farther (see article). And that would be cheating, wouldn’t it? ...
Gene doping:
Thu, 31 Jul 2008 12:10:21 -0000
On the eve of the Beijing Olympics, we examine the prospect of athletes using gene therapy to enhance their performance—and of catching them if they tryFOR as long as people have vied for sporting glory, they have also sought shortcuts to the champion’s rostrum. Often, those shortcuts have relied on the assistance of doctors. After all, most doping involves little more than applying existing therapies to healthy bodies. These days, however, the competition is so intense that existing therapies are not enough. Now, athletes in search of the physiological enhancement they need to take them a stride ahead of their opponents are scanning medicine’s future, as well as its present. In particular, they are interested in a field known as gene therapy. Gene therapy works by inserting extra copies of particular genes into the body. These extra copies, known as “transgenes”, may cover for a broken gene or regulate gene activity. Though gene therapy has yet to yield a reliable medical treatment, more than 1,300 clinical trials are now under way. As that number suggests, the field is reckoned to be full of promise. ...
Tech.view:
Fri, 18 Jul 2008 07:27:30 -0000
Peering into your medical future is riskyIT HAS already delivered ever cheaper and more powerful computers. Now Moore’s Law—the prediction four decades ago by Gordon Moore, one of the founders of Intel, that computer chips would roughly double in performance every 18 months or so—is promising to turbo-charge our health care as well. The “genome chip”—a matchbox-sized micro-array, fabricated on a slither of silicon or quartz, that can detect 1m or more specific genetic variations in an individual’s DNA at a time—is following an even steeper price-performance curve than Mr Moore ever imagined. ...

 

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Associates (Kasa) - Provides clinical, regulatory, marketing, training and authorized representative services to medical device, pharmaceutical and biotechnology companies to facilitate market introduction in Europe and continuing compliance of new and existing products.

3ClinicalResearch - Operates clinical pharmacology research units, including a sleep lab, and provides multicenter trials management, medical writing, data management, biostatistics, psychometrics and psychophysiology, and consulting services. Germany.

ASCO Pharm - Providing monitoring, data management, biostatistics, clinical writing and project management services. Paris, France.
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Aster Cephac - Clinical and bioanalytical contract research specialized in phase I, phase II and proof of concept studies for the pharmaceutical and cosmetic industries. Headquartered in France.

Axess - Provides clinical data management, statistics and reporting quality services to the pharmaceutical industry. Also offers specialised recruitment service in the clinical trials arena, providing staff as an interim management project or direct recruitment into your organisation.

Bio-Kinetic Europe, Ltd. - Providing support to the pharmaceutical industry by conducting clinical trials to determine safety, tolerance, and efficacy in Belfast, North Ireland

Biotrial - Provides a wide range of services including clinical pharmacology phase I studies in its two research centres in Rennes and Paris (more than 100 beds total), multinational clinical trials and preclinical pharmacology.
Meta Description: [ Biotrial is a contract research organization (CRO) providing a wide range of services: clinical pharmacology (phase I studies in its two research centres in Rennes and Paris; more than 100 beds together), multinational clinical trials management (phase II - IV), data management and biostatistics,... ]

CEPHA s.r.o. - Headquartered in the Czech Republic, conducts Phase I-IV clinical trials, bioavailability and bioequivalence studies, and offers bioanalytical and statistical services.
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ChemCon GmbH - Company in Germany specialized in contract research and custom synthesis of active pharmaceutical ingredients as well as chemical specialties in small quantities.

ClinResearch, GmbH - A European full service clinical contract research organisation offering clinical monitoring, data management, statistical consulting and programming, and medical writing.
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Clintria - Offers clinical trial services and consulting for phase 1 through phase 4 trials in Central Europe.

ClinTrial Ltd - Based in Hungary and providing clinical trial services, statistical analysis, medical writing, clinical quality assurance and assessment of cost-effectiveness.

Cognatec Research Centre - Provides phase II-IV clinical trials conduct and management in the Northwest of England, specializing in mental health disorders.

CRID Pharma - Offers full service preparation of clinical trial materials for phase I-IV studies into human and veterinary drugs. Features details of each stage. St Gely du Fesc, France.
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CTO Clinical Trial Operations - A full-service European contract research organisation based in the Netherlands providing clinical trials services to the pharmaceutical, biotechnology and medical device industries.
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d-Target - Swiss clinical research organization specializing in clinical research, regulatory services and medical marketing support for medical devices and in-vitro diagnostics.
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Dr. M. Koehler GmbH - Providing support to pharmaceutical industry and medical research in design, conduct, analysis and data management in their clinical trials.

Euphamed - Performs clinical and post marketing surveillance trials using an internet-based electronic data capture (EDC) system.

FOCUS Clinical Drug Development - Based in Germany and offering clinical development services, including a phase I unit with laboratory and data management services.

FOVEA Group - Provides assistance with study conception, biometry, monitoring, and audit. Includes details of certification and specificity. Rueil-Malmaison, France.
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Hungaro Trial - Services include project feasibility analysis, site selection, site initiation, monitoring, audits and project closure. Hungary.

Imro Tramarko Contract Research Organisation - Experienced conducting studies for international and domestic programs in Phases I - IV. Diverse therapeutic expertise gathered over 10 years can be applied to both single and full service projects.
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Independent Clinical Research Consulting (ICRC) - Provides data management, biometrics and medical writing for phase I-IV clinical studies and expert scientific consulting.
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Institut fur Klinische Pharmokologie GmbH (IKP) - Conducting Phase 1 through Phase 4 multinational clinical studies. Facilities include three specialized Phase 1 clinical pharmacology units and bioanalytical laboratories.

500 IST GmbH - Headquartered in Mannheim, Germany and offers services such as phase II/III clinical studies, medical writing/publishing, drug safety affairs, MedDRA coding, data management.

M.A.R.C.O. - Institute for Biomedical Statistics - Provides medical data management, monitoring, analysis, medical and statistical expert reports, consultancy and biometrical expertises for international pharmaceutical research companies.

Medical Statistics Consultancy - Provides biostatistical and epidemiological consultancy in clinical trials and other medical research projects. Expertise in multivariate statistical analysis, survival analysis, factor analysis, meta-analysis, multi-level modeling and other advanced statistical analysis.
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Medico Chemical Lab - Provides initiation and management of medical research projects for medical drugs and devices and also regulatory consultancy and filings

Midian Clinical Ltd. - Offers project management and staff resourcing services. United Kingdom.
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Monipol - Specializing in the implementation and management of clinical trials in Poland.

NorthWise Services - Offers a range of services, including data management, statistics, and medical writing, to the pharmaceutical industry, and other services through strategic partnerships.
Meta Description: [ NorthWise Services (NWS) is a contract research organisation (CRO) offering a range of services and products in support of the complete clinical trial process. ]

Nottingham Clinical Research Group - Providing a broad range of sophisticated services supporting clinical trial programs ranging from small studies to international megatrials, for a wide variety of indications, since 1984.
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PFC Pharma Focus - Based in Switzerland and Germany and offering services in clinical research, regulatory affairs and training programs.
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Pharm PlanNet - Performs safety and tolerance (including first in man), pharmacokinetic, bioavailability and bioequivalence trials in a 36 bed research facility in Mönchengladbach Germany.
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Pharmalog - Offers complete clinical research programs or a modular approach involving monitoring, data management or biometrics. Based in Germany. [English and German]

PharmaPart AG - Founded in Zürich to promote therapy and prevention of disease by enabling pharmaceutical and biotechnology companies to develop and register products, medical devices, and functional food.
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PhaVista - Planning and implementing post-marketing surveillance studies.
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PSI Pharma Support Inc - Operating in Central Europe, Russia, and other CIS (Commonwealth of Independent States) countries. Provides design, setup, and conduct of clinical trials, particularly large Phase II and III international studies involving hundreds of patients all across the CIS.

RCC Ltd. - An independent research service institute. Provides testing and assessment of the human and environmental safety of products from pharmaceutical, chemical and biotechnology industries. Located in Switzerland.
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Remedium Clinical Research - Offers comprehensive management of clinical trials in Scandinavia and the Baltic states.
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Russian Clinical Trials - Provides site and investigator identification, monitoring, regulatory board and ethics committee clearances, customs clearance and clinical trial logistics.
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Scope International - Provides phase I-IV clinical research services throughout Europe. Offers all clinical trial services, data management, statistics, medical writing, project managing, monitoring and GCP auditing.

Sedoc Pharmaceutical Medicine AB - A Scandinavian contract research organization based in Stockholm, Sweden. We perform clinical project management, data management and pharmacovigilance for international pharmaceutical and medical device companies.

500 SiteSupport - Danish company located in Medicon Valley, Denmark offers professional freelance nursing assistance to investigators in Europe for faster recruitment and higher quality of data.
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Spadille ApS - Offering data management, biostatistics, medical writing, monitoring and other services needed to plan, initiate, conduct and report clinical trials.
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Squarepoint-Pointcarré - Providing consultancy to the pharmaceutical and biopharmaceutical industry: medical writing (IBs, preclinical and clinical reports, publications), datamanagement (CRF, double encoding), biostatistics (sample size, RAP, reports)and regulatory affairs.
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Swiss Pharma Contract - Specializes in clinical trials, providing services in clinical pharmacology (owned clinical research unit), clinical research (phases II to IV), data management, statistics, consulting, and project management.
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Synexus, Ltd. - Site management organisation (SMO) with ten professional, dedicated investigation sites, exclusively focused on patient recruitment for clinical trials in the UK.
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404 T Paradigm - Executes classical phase 1 trials in Belgium in which pharmacokinetics, drug interactions, tolerability and safety of compounds are evaluated in healthy volunteers.
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Urodoc Limited UK - Strategic planning and medical education consultancy with experience in phase I and II product development and clinical trial management for urological disorders.

Winicker Norimed GmbH - Manages phase II-IV clinical trials and offers services for post-marketing surveillance, quality assurance auditing, biometrics, medical writing and medical device trials and registration. Germany.
Meta Description: [ This is the internet site of the German CRO Winicker Norimed. Profound experience in conducting clinical studies including planning, performance and evaluation ]