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Comparators in Medical News

Lilly to Unveil More Than 30 Studies at Premier Lung Cancer Meeting

...patients with nonsquamous non-small cell lung cancer (NSCLC) histology: An analysis of three large, randomized, phase III trials (* vs. the respective comparators in these three trials) D2.6: Oral Presentation: Aug. 4, 2009, 1:30 p.m. PDT Final results of a randomized phase II trial...

Non-Hormonal Therapies Aid Breast Cancer Patients

...ensus regarding the best dosage, timing, sequence or combination of therapies for treatment of metastatic breast cancer, due to the fact that standard comparators haven't been available, Dr. Philippe Bedard and Dr. Martine Piccart-Gebhart, of the Jules Bordet Institute in Brussels, Belgium, wrote in an accompany...

GSK Revises US Labeling for Avandia(R)

...ludes data from ADOPT and RECORD plus a third long-term trial in pre-diabetic patients (DREAM) which show there was no increased risk of Avandia over comparators with regard to myocardial infarction, mortality, or other non-heart failure cardiovascular events. GSK believes data from ongoing and future clinical...

GlaxoSmithKline Responds to JAMA Articles

...Actos meta-analysis shows no statistical difference between Avandia and comparators (a hazard ratio of 1.03). In RECORD, a study specifically designed to ... cardiovascular events, no real difference was seen between Avandia and comparators (HR 0.96). In all of these analyses, the Avandia and the Actos hazard r...
Comparators in Medical Technology

New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria

...extended-spectrum Beta-lactamase producing Enterobacteriaceae (ESBLE) and ciprofloxacin-resistant Enterobacteriaceae (CIPRE) to doripenem and relevant comparators was evaluated. The data analyzed was pooled from six large, multi-national Phase III clinical trials, including trials that focused on complicated uri...

FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years

...ontrol at five years was 34 percent with glyburide, 21 percent with metformin and only 15 percent with AVANDIA. The difference between AVANDIA and the comparators was statistically significant. "GSK is pleased that the FDA has approved inclusion of the results from ADOPT, an important clinical trial that provi...

Vanda Presents Phase III Iloperidone Efficacy Data

.../day to 20-24 mg/day; similar reductions in BPRS scores were observed at six weeks for iloperidone in doses of 20-24 mg/day, as compared to the active comparators risperidone and haloperidol. The analysis further demonstrated that iloperidone had a favorable safety profile, most notably with regard to extrapyram...

Oritavancin Demonstrates Potent and Rapid In Vitro Activity Against MRSA, VRE and Other Strains of Resistant Bacteria

...Staphylococcus aureus In Vitro," researchers detailed the antibacterial efficacy of physiologically attainable concentrations of oritavancin and other comparators tested against in vitro models of slow-growing and biofilm S. aureus. Slow-growing bacteria and biofilms are notoriously tolerant to antibiotics. In t...

July Issue of Journal of Antimicrobial Chemotherapy Highlights Study of Factive Tablets for Five-Day Treatment of Community-Acquired Pneumonia

...aximum-labeled duration of 7 days. In clinical trials, the discontinuation rate due to drug-related adverse events was similar for FACTIVE tablets and comparators (2.2% versus 2.1%, respectively). FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibio...
Comparators in Biological News

Prednisone tablets less variable than marketed drugs

...ts, said William Koch, Ph.D, chief reference materials officer for USP. USP Prednisone yielded an average variability of less than five percent, while comparators averaged about 13 percent. Established metrological principles were followed to ensure the tests objectivity, and it is clear that USP Prednisone Refe...
Comparators in Biological Technology

Shire plc: IFRS Results for the Year Ending December 31, 2007

...itory License Agreement was determined to be at current market rates. The valuation of the New River Collaboration Agreements and their current market comparators has been based upon information available at the time of the acquisition and using the expectations and assumptions that have been deemed reasonable b...

GlaxoSmithKline Responds to JAMA Article on the ICES Thiazolidinediones and Cardiovascular Outcomes in Older Patients with Diabetes

...ause, showed no statistically significant difference between rosiglitazone in combination with either metformin or sulfonylurea vs. the active comparators of metformin plus sulfonylurea. In addition, the RESULT clinical study specifically examined an elderly diabetic population, ages 59 to 89, in which ...

IFRS Information - First Half of 2007

...itory License Agreement was determined to be at current market rates. The valuation of the New River Collaboration Agreements and their current market comparators has been based upon information available at the time of the acquisition and using the expectations and assumptions that have been deemed reasonable b...

New Licence for Cubicin(R) (daptomycin), the First in a Novel Class of Antibiotic, is Announced Today for the Treatment of Serious Bloodstream and Heart Infections Caused by the Most Problematic UK Organisms, Including MRSA

...cin had a faster time to cure (63% of patients successfully treated with daptomycin achieved a clinical cure within four to seven days versus 33% with comparators such as vancomyin and anti-staphylococcal penicillins).(6) Pivotal trial data published in The New England Journal of Medicine supports the use of da...
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