Navigation Links
MGI Pharma Announces Positive Results from a Pivotal Phase 3 Study,of Aquavan Injection in Patients Undergoing Bronchoscopy

MINNEAPOLIS--(BUSINESS WIRE)--Mar 20, 2007 - MGI PHARMA, INC. (NASDAQ: MOGN), a biopharmaceutical company focused in oncology and acute care, today announced that a randomized, double-blind, multi-center, pivotal phase 3 trial of Aquavan(R) (fospropofol disodium) Injection for sedation of patients undergoing bronchoscopy successfully met its primary endpoint of sedation success as well as all secondary endpoints. Among patients who received an initial bolus dose of 6.5 mg/kg of Aquavan, the sedation success rate was 88.7% compared to 27.5% of patients in the control arm (p less than 0.001). Results of this trial also indicate that the safety profile of the 6.5 mg/kg dose of Aquavan was predictable and similar to the safety profile of the control.

Data from the phase 3 bronchoscopy trial, together with the results from a phase 3 trial in patients undergoing colonoscopy and an open-label study in patients undergoing minor surgical procedures, will form the foundation of the Aquavan New Drug Application (NDA). MGI PHARMA plans to submit the Aquavan NDA to the U.S. Food and Drug Administration (FDA) early in the third quarter of 2007. As is consistent with standard medical practice, the three trials comprising the Aquavan pivotal program were conducted without monitored anesthesia care (MAC) sedation, and study drugs were administered by medical personnel as dictated by local investigative site guidelines.

"With more than 40 million procedures per year in the U.S. requiring moderate sedation, Aquavan may address a significant market opportunity," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "The results of this pivotal program, together with completed pharmacokinetic studies, indicate that Aquavan has a pharmacokinetic and pharmacodynamic profile which may facilitate achievement and maintenance of targeted, controlled sedation by proceduralists. This unique profile may allow pati
'"/>




Page: 1 2 3 4 5 6

Related medicine technology :

1. Sygnis Pharma AG announces date for presentation of clinical results
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
10. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
11. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
Post Your Comments:
(Date:7/27/2015)... 2015 Even the Score today announced the ... as scientific co-chair for the coalition. Dr. Larkin will ... an expert voice in the important conversation regarding the ... with Hypoactive Sexual Desire Disorder (HSDD), women,s most common ... honored to join Even the Score as its co-chair ...
(Date:7/27/2015)... 20, 2015 Research and Markets ( http://www.researchandmarkets.com/research/t63pbj/medical_device ... Device Regulation in Asia/Pacific Markets Seminar" conference to ... Medical Device market is well established, the next growth ... China , together with other countries in this ... of implementing, their own medical device regulations. This seminar ...
(Date:7/27/2015)... 27, 2015 Research and Markets ... of the "Wound Care -Traditonal, Advanced ... Analysis And Forecasts" report to their ... evaluation of the global Wound Care products ... product offerings, competitive shares, financial performance, technology ...
Breaking Medicine Technology:Dr. Lisa Larkin Joins the Even the Score Coalition as Scientific Co-Chair 2Dr. Lisa Larkin Joins the Even the Score Coalition as Scientific Co-Chair 3Medical Device Regulation in Asia/Pacific Markets Seminar: London, UK - 21st, 22nd of September 2015 2Global Wound Care Markets 2015-2020 - Traditonal, Advanced And Regenerative: Competitors And Opportunities 2
... Biopharmaceuticals, Inc. (NASDAQ: KERX ), a biopharmaceutical ... medically important pharmaceutical products for the treatment of cancer ... will be held on Monday, August 8, 2011 at ... quarter ended June 30, 2011 and a business outlook ...
... and SYDNEY, Aug. 4, 2011 HeartWare International, Inc. ... innovator of less invasive, miniaturized circulatory support technologies that ... announced revenues of $20.4 million for the second quarter ... increase from $9.8 million in revenues for the same ...
Cached Medicine Technology:Keryx Biopharmaceuticals, Inc. to Host Conference Call on Second Quarter 2011 Financial Results 2HeartWare International Reports Second Quarter 2011 Revenues of $20.4 Million; 109% Increase From $9.8 Million in Second Quarter 2010 2HeartWare International Reports Second Quarter 2011 Revenues of $20.4 Million; 109% Increase From $9.8 Million in Second Quarter 2010 3HeartWare International Reports Second Quarter 2011 Revenues of $20.4 Million; 109% Increase From $9.8 Million in Second Quarter 2010 4HeartWare International Reports Second Quarter 2011 Revenues of $20.4 Million; 109% Increase From $9.8 Million in Second Quarter 2010 5HeartWare International Reports Second Quarter 2011 Revenues of $20.4 Million; 109% Increase From $9.8 Million in Second Quarter 2010 6
(Date:7/28/2015)... ... July 28, 2015 , ... The joint SCAN ... such as reducing high-risk medication use and improving compliance with diabetes treatment guidelines. ... behaviors and outcomes, this unique-in-the-industry Quality Network Program may be paving the way ...
(Date:7/28/2015)... ... July 28, 2015 , ... Headaches are the number one neurological ... close second. Clients suffering from headaches and back pain often find relief by seeking ... The Joint 's nine offices in the St. Louis area welcome new clients ...
(Date:7/28/2015)... ... 28, 2015 , ... North American Seminars will present seventeen ... 2015 . These seventeen courses are pre-approved for CME credit for Physical ... in the Older Adult , August 22, 2015 - August 23, 2015 ...
(Date:7/28/2015)... ... July 28, 2015 , ... ... for Invisalign. Invisalign is a revolutionary orthodontic treatment that allows patients to straighten ... Mozafari’s expertise and 3D computer imaging technology. You wear each set of aligners ...
(Date:7/27/2015)... ... July 28, 2015 , ... Dr. Robert G. Schwartz ... practice has teamed up with Realief Neuropathy Centers in order to offer his patients ... the signs and symptoms of peripheral neuropathy. , Peripheral neuropathy is a disease caused ...
Breaking Medicine News(10 mins):Health News:SCAN/Express Scripts MA Pharmacy Quality Network Program to be Featured in Upcoming AIS Webinar 2Health News:SCAN/Express Scripts MA Pharmacy Quality Network Program to be Featured in Upcoming AIS Webinar 3Health News:The Joint St. Louis Offers “2 for Thursday” Special, Chiropractic Care Services, Affordable Back Pain Relief 2Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 2Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 3Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 4Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 5Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 6Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 7Health News:North American Seminars receives California PT Board approval for Seventeen Continuing Education Courses presented in the Fall of 2015. 8Health News:Cupertino Invisalign Dentist, Dr. Setareh Mozafari, is Now Offering Complimentary Consultations for Invisalign 2Health News:Piedmont Physical Medicine & Rehabilitation, P.A. Partners with Realief® Neuropathy Centers to Offer Peripheral Neuropathy Laser Treatment 2
... a further death linked to the superbug Clostridium// difficile (C-diff). ... diarrhea and more serious intestinal conditions such as colitis. ... at the James Paget University Hospital (JPH), Gorleston, linked to ... people have had to undergo major bowel surgery. ...
... for space with stories on bird flu. After all, it ... that pets may be the only ones who need to ... insight, an arsenic-based additive that forms an ingredient in chicken ... this chicken. , ,Roxarsone, the wide spread arsenic-based ...
... for bipolar disorder, increases the amount// of gray matter ... ,The research is featured in the ... currently available online. ,Carrie Bearden, a ... and Paul Thompson, associate professor of neurology at the ...
... – Type 1 diabetic patients could be bailed out with ... ,Stem cell therapy proved helpful for patients suffering Type-1 ... for months and in one particular case a patient went ... participated in the testing, 13 completely stayed-off insulin injections. ...
... sufferer among Indian cities with flash rains, floods and fall ... an international report on climate change. ,According to the ... (IPCC), the rise in sea level and flooding of villages ... ,"Since Mumbai has reclaimed ocean land substantially, they are ...
... seeking judicial intervention for enactment of a law on the ... to instead approach the government. ,A division bench ... advocate Namita Roy to approach the ministries of social welfare ... valid laws, rules and regulation on the sensitive issue. ...
Cached Medicine News:Health News:Hospital Infection Deaths Continue in UK 2Health News:Lithium Increases Gray Matter in Bipolar Brains 2Health News:Kolkata, Mumbai to Face Maximum Brunt of Climate Change 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: