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FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

KENILWORTH, N.J., July 30 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted unanimously in favor of SAPHRIS(R) (asenapine) sublingual tablets a...

FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

ADELPHI, Md., June 10 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted that Zyprexa(R) (olanzapine), an atypical antipsychotic, is effective and acceptably safe for the acute treatment of schizophrenia or manic or mix...

Mindset Media Study Reveals Which Independent Voters Favor Obama Vs. McCain

Study Finds That Self-Proclaimed Independent Voters Who Score High in Creativity Skew toward Obama and Very Optimistic Independents Prefer McCain NEW YORK, Oct. 20 /PRNewswire/ -- Mindset Media (http://www.mindset-media.com ), which operates an online ad network that enables brand advertise...

Acuity One-Year Findings Meet All Primary Endpoints in Favor of Angiomax (Bivalirudin) Alone Treatment Group

Major Bleeding in Patients Treated for Acute Coronary Syndromes (ACS) Nearly Triples the Risk of Death at One Year NEW ORLEANS, March 26, 2007 /PRNewswire/ -- One-year findings from the landmark ACUITY trial show that acute coronary syndrome (ACS) patients in the "Angiomax(R) (bivalirudin) alone" ...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...everity (CGI-S) scale, the Montgomery Asberg Depression Rating Scale (MADRS) total score and a Responder's Analysis showed statistical significance in favor of the group administered Labopharm's trazodone. In addition, patients on Labopharm's trazodone demonstrated significant improvements versus placebo i...

Spherix Announces Positive Phase 2 Study Results

...ype. The results suggest that, in addition to minimizing the extent of atherosclerosis from carbohydrate consumption, a diet enriched in tagatose may favor a more stable plaque phenotype less likely to cause stroke or myocardial infarction. Prior Clinical Trials with Naturlose Eight healthy in...

New Poll Finds Disease Prevention is Top Priority for Americans in Health Reform

...orting investing more in prevention. "This poll shows that Americans from coast to coast and across the political spectrum are overwhelmingly in favor of investing in disease prevention," said Al Quinlan, President of Greenberg Quinlan Rosner Research. "More than three-quarters of Americans believe t...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

...-item Neurological Examination Scores. On the primary endpoint (during weeks two through five of treatment), the study demonstrated a strong trend in favor of XERECEPT(R), though it did not reach statistical significance (p=0.1). Placebo patients tolerated a 50 percent reduction in dexamethasone dosing m...

FDA Advisory Panel Recommends Approval of the SEDASYS(R) System

... Panel Votes in favor of Use by Physician/Nurse Teams to Deliver Minimal...e U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by ph...Therapy Devices Advisory Committee voted 8 to 2 in favor of approval. Conditions of approval recommended by...

SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(R) Stent System More Cost Effective Than Bypass Surgery in Patients With Complex Coronary Artery Disease

...term benefit for PCI versus CABG surgery, with no significant difference at one year, but with a gain in quality adjusted life years (QALY) of 0.02 in favor of PCI. The analysis also included a detailed calculation of total medical costs at one year for all patients treated in the U.K., the country wi...

Johnson & Johnson Announces Support for Kohl-Grassley Physician Payments Sunshine Act of 2009

...tted to begin voluntarily disclosing payments made to physicians by its U.S. pharmaceutical, medical device and diagnostics companies. "We are in favor of greater transparency regarding the relationships between healthcare companies and physicians," said Johnson & Johnson chairman and CEO William ...

Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients

...l. AEs were collected via direct questioning. Results The treatment difference in the JRS severity subscore was statistically significant in favor of NT-201 (p<0.001). These results were confirmed in all secondary endpoints. AEs were reported in 70.3% subjects in the NT-201 group and 61.8% su...

FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)

...Call/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) announced today that the Cardiovascular and Renal Drugs Advisory Committee voted 10 to 3 in favor of the approval of Multaq(R) by the U.S. Food and Drug Administration (FDA) to treat patients with non-permanent atrial fibrillation (AF). As d...

Congressional 'Sting' Operation Uncovered By Coast IRB

...her IRBs to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of the FDA and in favor of greater regulatory oversight. Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, vio...

FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

... not involved in the conduct of the procedure. On May 7, 2008, the FDA Advisory Committee on Anesthetic and Life Support Drugs voted 6 to 3 in favor (with one abstention) of approval of LUSEDRA for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or...

Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery

...follow-up times at the date of crossover to letrozole. In this analysis, a 19% reduction in risk of death (HR=0.81, 95% CI: 0.69-0.94) was observed in favor of Femara. The International Breast Cancer Study Group (IBCSG) presented these results from the BIG 1-98 trial today at the 31st Annual CTRC-...

ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%

... trial experience with bromfenac ophthalmic solution. Despite the unexpected results reported for the ER Phase III study, there were strong trends in favor of statistical efficacy. In addition, both Phase III studies showed highly statistically significant results in the proportion of subjects w...

Dramatic JUPITER Findings Fail to Sway Prescribing Behavior, Poll Shows

...search and time have shown their efficacy in lowering cardiovascular events," countered a general practitioner. Speaking for the minority of those who favor statins among the healthy elderly, he commented, "As family physicians, we are intended to [practice] preventive medicine." The combination of LDL <...

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

...Administration (FDA) recommended that the FDA approve febuxostat for the treatment of hyperuricemia in patients with gout. The vote was 12 to zero in favor of approval, with one panel member abstaining. The vote followed presentations by Takeda Global Research & Development Center, Inc., the FDA, and ...

NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study

...SBP by 1.5 mmHg from baseline, while naproxcinod lowered it by 2.3 mmHg, resulting in a difference between the two treatments of 3.8 mmHg (p=0.011) in favor of naproxcinod. Michele Garufi, Chairman and CEO of NicOx, commented: "These excellent results are an important addition to the consistent data we a...

Minster Pharmaceuticals Plc Announces Positive Results from Phase II Trial of Migraine with Aura

...nts including the number of attacks of migraine headache and the number of auras followed by any headache. All secondary endpoints were numerically in favor of tonabersat compared with placebo. Migraine with aura affects around 30 percent of migraine sufferers and is a type of migraine in which the heada...

Vical Expands Applications of Vaxfectin(R) Adjuvant for Infectious Disease and Cancer Vaccines; 80% to 100% of High-Dose Responders in H5N1 Clinical Trials Still Responding at 6 Months

...tial increases in either antibody or T-cell responses, without reducing the other type of response, compared with unformulated vaccine. The ability to favor primarily antibody or T-cell responses could provide important advantages in developing vaccines for specific applications. H5N1 Pandemic Influenza ...

Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings

... Novacea and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from its stockholders in favor of the proposed transaction. Information about the directors and executive officers of Novacea and their respective interests in the proposed transact...

MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes

...ne or more hypoglycemic events (95.2%) compared to the proportion affected in the comparator group (98.9%). This difference in overall hypoglycemia in favor of Technosphere Insulin was statistically significant (odds ratio = 0.222; p<0.02). Over the entire 52-week treatment period, Technosphere Insulin w...

Tolerx Announces Achievement of Milestones upon anti-CD4 Antibody Program Advancement and Initiation of Phase 1 Clinical Trial

... the CD4 receptor found on both effector and regulatory T cells. MTRX1011A is designed to block the activation and function of T effector cells and to favor dominance of T regulatory cells. This unique mechanism of action has the potential to ameliorate autoimmune disease symptoms not only through its dire...

Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

... patients with clinically non-palpable (microscopic) lymph node disease, the HR for RFS was 0.73 (99 percent CI, 0.53-1.02, P=0.016, log-rank test) in favor of peginterferon alfa-2b treatment, as compared to 0.86 (99 percent CI, 0.68-1.10) in patients with clinically palpable nodes. Similarly, the HR in pa...

Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant

...cle). The number of oocytes retrieved (co-primary endpoint) was within the limits of clinical equivalence, and the estimated difference of +1.2 was in favor of the corifollitropin alfa 150 mcg treatment arm. Further results will be submitted for presentation at a future medical meeting. Study Design ...

CherryPharm First All-Natural Food to Improve Sleep

... of .047 and .011 respectively, these results are statistically significant. Modest trends, although not statistically significant, were also shown in favor of CherryPharm versus placebo with Sleep Efficiency and Total Sleep Time. "This clinical trial suggests that CherryPharm, a natural juice, improves ...

Study Confirms That Avastin Significantly Increases Chance of Living Without Disease Progression in Metastatic Breast Cancer

...DO study was not powered to detect a difference in efficacy between the two doses, however, there was a numerical advantage for efficacy parameters in favor of the 15 mg/kg dose arm. These results, and those of the other landmark study (E2100), support use of this dose (5mg/kg/week). Overall survival data ...

FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids

...nd Gynecology at Duke University Medical Center. "An evidence-based review concluded that if fibroids distort the uterine cavity, there is evidence in favor of removing them to increase pregnancy rates and decrease the rate of miscarriage. Unfortunately, since fibroids that have grown on the wall of the ut...

Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update

...(1 gram) for the treatment of fever in 81 adult volunteers with experimentally-induced fever. In this study, a statistically significant difference in favor of Acetavance was observed compared to oral acetaminophen for the primary efficacy endpoint of WSTD2 (the weighted sum of temperature differences over...

Dr. Calvin Grant Presents Results from Xibrom(TM) Combination Therapy with Lucentis(R) at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO)

...s only received 4.5 +/- 0.41 injections (p=0.0002). The original abstract, which was published in February 2008, stated there was a numerical trend in favor of the Combination Group on improvement in visual acuity but this difference did not achieve statistical significance. However, upon rigorous review a...

Study Finds Taxus(R) Drug-Eluting Stent Beneficial in Treatment of Large Vessels

... Results from TAXUS IV and V randomized clinical trials favor DES compared to bare-metal stents NATICK, Mass. and CHICAGO, April 1, 2008 /PRNewswire-FirstCall/ -- Boston Scientific Corp...

New Data Showed ACTOS(R) (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes

...ing of the coronary arteries. The analysis demonstrated a statistically significant difference in percent change in coronary artery atheroma volume in favor of ACTOS treatment compared to glimepiride treatment. The data showed that patients treated with glimepiride, a sulfonylurea and commonly used diabe...

BioNumerik Pharmaceuticals and ASKA Pharmaceutical Co. Announce Results from Phase III Clinical Trial of Tavocept(TM)

...e neuropathy was approximately 50% lower in the Tavocept arm of the trial compared to the placebo arm. While this outcome represents a strong trend in favor of Tavocept (p = 0.1565), the results are not statistically significant (p < 0.05). BioNumerik and ASKA believe the lack of statistical significance i...

NeurogesX Announces Preliminary Results from Second Phase 3 Clinical Trial in HIV-DSP

... However, our initial evaluation of the data suggests that the NGX-4010 treatment arms behaved similarly to our other studies and there was a trend in favor of treatment. We will continue to evaluate whether the cumulative clinical data from our clinical studies may be able to support evidence of efficacy ...

ISTA Pharmaceuticals Announces Physician-Sponsored Clinical Study of Xibrom(TM) Combination Therapy with Lucentis(R)

...one received significantly more (2.83 times) injections of ranibizumab (p=0.0002) than those receiving the combination. There was a numerical trend in favor of the combination treatment group on improvement in visual acuity but this difference did not achieve statistical significance. These data are expect...

Long-Term Data from a Landmark Phase III Trial Show Survival Benefit at Three- and Four-Years in Patients with Glioblastoma multiforme

...diotherapy alone. The hazard ration (HR) for overall survival was 0.63 (95 percent CI for HR equal to 0.52-0.75) with a log-rank p less than 0.0001 in favor of the TEMODAR arm. About Glioblastoma multiforme Glioblastoma multiforme is a rapidly growing tumor of the central nervous system, most often locat...

Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple Sclerosis

...interferon beta-1a. This difference was highly statistically significant in favor of the alemtuzumab patients with a p-value less than the pre-specified valu...d with interferon beta-1a. This difference was statistically significant in favor of the alemtuzumab patients with a p-value less than the pre-specified valu...

Feeling Anxious or Distracted? New Research Shows a Cup of Tea Could Help

... function; -- Tea drinking may play a role in gene expression that is involved in cancer cells; -- Tea may play a role in shifting metabolism to favor weight loss and better manage blood sugar levels; -- Tea is a major contributor of flavonoids in the US diet. The symposium, which was sponsored...
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