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Saturday, November 21, 2009 10:24 PM

investigational

Type: Keyphrase

Name: investigational

First Reported 11/20/2009 - Updated 15 hours ago - 2 Documents (in Health)

AstraZeneca files new drug application for heart drug

AstraZeneca has submitted a new drug application to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome, or ACS.This submission is based on the ... [Individual.com - 15 hours ago]

Entities: New Drug Application, AstraZeneca PLC, Acute Coronary Syndrome, Clopidogrel

First Reported 11/19/2009 - Updated 11/19/2009 - 3 Documents (in Medicine)

AstraZeneca (AZN) Submits NDA to U.S. FDA for Ticagrelor

AstraZeneca (NYSE: AZN) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients ... [Street Insider - 11/19/2009]

Entities: AstraZeneca PLC, Food and Drug Administration, Brilinta, Acute Coronary Syndrome, Clopidogrel

First Reported 11/19/2009 - Updated 11/20/2009 - 3 Documents

AstraZeneca PLC

BioMed News Bytes: AstraZeneca, Delcath, Unilife

Mike Havrilla submits:On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients ... [Healthcare Sector and Stocks Analysis from Seek ... - 11/20/2009]

Entities: University of South Australia Students Association, Biomed, AstraZeneca PLC, Brilinta

First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents (in Health)

New Reversible Oral Drug Reduces Cardiac Events in Primary PCI Patients

Acutely ill heart attack patients who received both aspirin and a new reversible oral anti- platelet medication (the investigational drug ticagrelor) had fewer cardiac events than patients on aspirin and clopidogrel, researchers reported in a late-breaking ... [Cath Lab Digest - 11/20/2009]

Entities: Clopidogrel, Heart Attack, investigational, Receptor, Stent

First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents (in Health)

New Blood Thinner Reduces Death, Stent Thrombosis

— A new reversible blood thinner for angioplasty patients didn't prove superior over placebo for its primary combined endpoint of heart attack, all-cause mortality and need for revascularization. However, it did reduced mortality and in-stent blood clots, ... [Diagnostic & Invasive Cardiology - 11/20/2009]

Entities: Thrombosis, Stent, blood thinner, Clopidogrel

First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents (in Biology)

Food and Drug Administration

Advanced Cell Technology seeks FDA clearance for stem cell trial

Advanced Cell Technology submitted an investigational new-drug application to conduct an early-stage trial of a stem cell the - More -The Future of Biotech Report — Yours FREE!This comprehensive report into the future of our industry provides expert advice ... [SmartBrief - 11/20/2009]

Entities: Advanced Cell Technology Inc, Stem Cell, Food and Drug Administration

First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents (in Internet & IT)

Angel licences extended after MHRA inspection

Business Financial Newswire - Angel Biotechnology Holdings manufacturers'licences have been extended for a further two years.This follows a bi-annual inspection by Medicines and Healthcare products Regulatory Agency (MHRA).The manufacturers' authorisation ... [Business Financial Newswire - 11/20/2009]

Entities: Inspection, Medicines And Healthcare Products Regulatory Ag..., investigational

First Reported 11/20/2009 - Updated 11/20/2009 - 1 Documents

FDA permits Endologix to test procedure for abdominal aortic aneurysm

The FDA has granted Investigational Device Exemption conditional approval to Endologix to allow it to test a percutaneous procedure that uses the company's IntuiTrak endovascular delivery system in the treatment of abdominal aortic aneurysms.OC Metro ... [SmartBrief - 11/20/2009]

Entities: Endologix Inc, Test Procedure, Food and Drug Administration

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents

Irvine's Endologix gets FDA approval for clinical trial

Investigational Device Exemption allows firm to test percutaneous approach to endovascular abdominal aortic aneurysm repair.Irvine-based Endologix has received Investigational Device Exemption conditional approval from the U.S. Food and Drug Administration ... [OC Metro Magazine - 11/19/2009]

Entities: Endologix Inc, Food and Drug Administration, Endovascular Aneurysm Repair, investigational, Artery

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents

BRIEF-AstraZeneca requests U.S. Brilinta approval

LONDON, Nov 19 (Reuters) - AstraZeneca PLC: * Submits U.S. new drug application for Brilinta (ticagrelor), an investigational antiplatelet agent ((London ... ... [FinanzNachrichten.de - 11/19/2009]

Entities: Brilinta, United States, New Drug Application, investigational

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents

Use of intravenous infusion sedation among mechanically ventilated patients in the United States

Pediatric Research, 11/09/09 Relevance Score: 67%Bone Marrow Transplantation, 11/12/09 Relevance Score: 66%Chinese Journal of Lung Cancer, 10/27/09 Relevance Score: 66%Journal of Clinical Anesthesia, 10/19/09 Relevance Score: 66%Expert Opinion on Investigational ... [MDLinx - 11/19/2009]

Entities: Infusion, bone marrow transplantation, United States

First Reported 11/17/2009 - Updated 11/17/2009 - 5 Documents (in Market News)

Merck's Investigational Anacetrapib Phase IIb Study Results Presented at American Heart Association Annual Scientific Sessions

the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of ... [Earthtimes.org - 11/17/2009]

Entities: Anacetrapib, American Heart Association, investigational

Quotes

...Philippe Serrano, vice president Regulatory Affairs at NicOx, declared, "We are very pleased to receive this filing communication from the US FDA and it is thanks to a collective effort by our entire R&D Department, which has provided a high-quality application. We believe that when approved, naproxcinod could represent a valuable new treatment option for osteoarthritis patients." Naproxcinod is NicOx's lead investigational compound and the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting...

NicOx gets US FDA nod for naproxcinod NDA [PharmaBiz - 11/20/2009]

"The implications of this study are two-fold. We demonstrated that PIK3CA testing is feasible and may contribute to the decision-making process when offering a patient a clinical trial. Although this study suffers from low numbers, the response rate observed in patients treated with inhibitors of PI3K/AKT/mTOR pathway based on their mutational status was well above what we usually see in Phase I clinical trials" said Filip Janku, M D , Ph D , a clinical research fellow of the University of Texas M D Anderson Cancer Center's Department of Investigational Cancer...

New biomarkers can predict patients' response to certain drugs [News-Medical.Net - 11/19/2009]

'Our strength as an organization hinges on a consistent worldwide approach to quality and strong internal quality measures,' says Mr Heyland. "Our true value proposition lies in our extensive global network of company-owned offices dedicated to and specializing in the transport of investigational drugs, biological samples and related supplies. All our people are universally trained to the same high standards, share proprietary state-of-the-art technology, systems and SOPs, and remain dedicated to delivering quality clinical trial support services worldwide. These unique attributes enable us to effectively establish and monitor global GxP standards for compliance on a truly worldwide basis."

World Courier Pioneers GxP-Compliant Status Worldwide [Pharmaceutical Technology - 11/18/2009]

"We are pleased that we have been able to move so fast with this first study of our LEAPS-H1N1 treatment" said Geert Kersten, CEL-SCI's Chief Executive Officer...

CEL-SCI Announces Start of First Clinical Study of Investigational LEAPS-H1N1 Treatment for Hospi ... [Yahoo! Canada - 11/18/2009]

More Content

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AstraZeneca files new drug application for hear... [Individual.com - 15 hours ago]
AstraZeneca seeks US FDA nod for ticagrelor for... [PharmaBiz - 16 hours ago]
Broward stockbroker crusades for medicinal mari... [South Florida Sun-Sentinel - 17 hours ago]
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Flibanserin Provides Multiple Benefits in Women... [Doctors Guide - 11/20/2009]
AstraZeneca Submits US New Drug Application for... [PharmaceuticalProcessing - 11/20/2009]
Addex finds GERD drug effective in clinical trial [Drug Store News - 11/20/2009]
What Are Clinical Trials? [Cancer Consultants - 11/20/2009]
Clinical Trials and Insurance: Understanding Yo... [Cancer Consultants - 11/20/2009]
New Blood Thinner Reduces Death, Stent Thrombosis [Diagnostic & Invasive Cardiology - 11/20/2009]
Trial Evaluates New Anti-Platelet in Preventing... [Diagnostic & Invasive Cardiology - 11/20/2009]
FDA permits Endologix to test procedure for abd... [SmartBrief - 11/20/2009]
Travoprost: A prostaglandin analogue for the tr... [Modern Medicine - 11/20/2009]
Focus on 2009: A year of novel pharmacologic ag... [Modern Medicine - 11/20/2009]
Angel licences extended after MHRA inspection [Business Financial Newswire - 11/20/2009]
Advanced Cell Technology seeks FDA clearance fo... [SmartBrief - 11/20/2009]
Merck & Co., Inc. (MRK) Receives CHMP Posit... [BioSpace - 11/20/2009]
Market Report -- Short Stories (NUVA) [Briefing.com via MSN Money - 11/20/2009]
BioMed News Bytes: AstraZeneca, Delcath, Unilife [Seeking Alpha - 11/20/2009]
Randgold, Petropavlovsk, Lonmin and Aquarius fa... [Proactive Investors.co.uk - 11/20/2009]
BG rises on Brazil update, but BP, Shell, Tullo... [Proactive Investors.co.uk - 11/20/2009]
Wolseley, Liberty International and Inmarsat fa... [Proactive Investors.co.uk - 11/20/2009]
Antofagasta, Anglo American and Xstrata push FT... [Proactive Investors.co.uk - 11/20/2009]
UK retail sales grow 3.4%, but FTSE 100 slides ... [Proactive Investors.co.uk - 11/20/2009]
Oil falls, but Cairn, Petrofac and BP climb, BG... [Proactive Investors.co.uk - 11/20/2009]
Miners tumble as metal prices weaken to drag do... [Proactive Investors.co.uk - 11/20/2009]
Genta announces preliminary results from study ... [News-Medical.Net - 11/20/2009]

Blogs

sort by: Date \| Relevance
BioMed News Bytes: AstraZeneca, Delcath, Unilife [Healthcare Sector and Stocks Analysis from Seek ... - 11/20/2009] Mike Havrilla submits:On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational ...
BioMed News Bytes: AstraZeneca, Delcath, Unilife [Biotech Sector and Stocks Analysis from Seeking ... - 11/20/2009] Mike Havrilla submits:On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational ...
BioMed News Bytes: GeoVax, Cerus, Discovery Lab... [Healthcare Sector and Stocks Analysis from Seek ... - 11/18/2009] Mike Havrilla submits:On 11/17/09, GeoVax (GOVX.OB) announced that the FDA has granted its request for a pre-IND meeting to discuss the proposed Investigational ...
BioMed News Bytes: GeoVax, Cerus, Discovery Lab... [Biotech Sector and Stocks Analysis from Seeking ... - 11/18/2009] Mike Havrilla submits:On 11/17/09, GeoVax (GOVX.OB) announced that the FDA has granted its request for a pre-IND meeting to discuss the proposed Investigational ...
A new antidepressant really turns women on [CNET News.com - 11/17/2009] To all the men (and women) I've ever heard complain about the female libido, it's time to take the batteries out of your high-tech remote-control sex toys.Flibanserin ...

Audio/Video

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Diabetes: Study using Otelixizumab for Type I D... [Mefeedia Video Tag : medicine - 06/18/2009]

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