ENDEAVOR IV Clinical Trial Meets Primary Endpoint
MINNEAPOLIS--(BUSINESS WIRE)--Jul 2, 2007 - Medtronic, Inc.,(NYSE:MDT) today announced that a review of data from the ENDEAVORIV Clinical Trial indicates that the trial has met its primary,non-inferiority endpoint. The ENDEAVOR IV Clinical Trial is a randomized, single-blindtrial evaluating the safety and efficacy of the Endeavor(TM) DrugEluting Coronary Stent as compared to the TAXUS Pac...
Second Phase III Study Evaluating Gilead's Viread for the Treatment
of Chronic Hepatitis B Virus Meets Primary Endpoint
FOSTER CITY, Calif.--(BUSINESS WIRE)--June 25, 2007--GileadSciences, Inc. (Nasdaq:GILD) today announced that Study 103, aPhase III clinical trial evaluating the company's once-dailyanti-HIV drug Viread(R) (tenofovir disoproxil fumarate or tenofovirDF) 300 mg as a potential treatment for chronic hepatitis B virus(HBV) infection, met its primary efficacy endpoint. The data showthat Viread...
Second Phase III Study Evaluating Gilead's Viread for the Treatment
of Chronic Hepatitis B Virus Meets Primary Endpoint
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 25, 2007 - GileadSciences, Inc. (Nasdaq:GILD) today announced that Study 103, aPhase III clinical trial evaluating the company's once-dailyanti-HIV drug Viread(R) (tenofovir disoproxil fumarate or tenofovirDF) 300 mg as a potential treatment for chronic hepatitis B virus(HBV) infection, met its primary efficacy endpoint. The data showthat Viread is...
MEDIA ADVISORY: Subsets of Landmark Diabetes Trials Investigating
MacroVascular Outcomes Presented at the American Diabetes
Association 67th Scientific Sessions
Data from the PROactive and CHICAGO studies of ACTOS(R)(pioglitazone HCl) will be presented in poster format at the 67thScientific Sessions of the American Diabetes Association inChicago: -- Hospitalizations for serious adverse events in high-risk type 2 diabetes patients treated with pioglitazone for 3...
Neoprobe Phase 2 Lymphoseek Trial Meets Primary Endpoint
DUBLIN, Ohio--(BUSINESS WIRE)--Jun 20, 2007 - Neoprobe Corporation(OTCBB:NEOP), a diversified developer of innovative oncology andcardiovascular surgical and diagnostic products, today announcedpositive preliminary results from a multicenter Phase 2 clinicalstudy of its lead clinical candidate, Lymphoseek(R) (TechnetiumTc99m DTPA-mannosyl-dextran). Lymphoseek is a proprietaryradioactive tar...
New Data Presented on Micardis (Telmisartan) Tablets in
Hypertensive Patients With Type 2 Diabetes
RIDGEFIELD, Conn., June 18, 2007 /PRNewswire/ -- Today, resultsfrom AMADEO*, one of a series of studies comparing two angiotensinreceptor blockers (ARBs) in hypertensive patients with diabeticnephropathy, were presented at the 17th annual European Meeting onHypertension in Milan, Italy. The randomized, double-blind, forced titration, parallel group,multicenter study included 860 hy...
Salix Pharmaceuticals Announces Positive Top Line Results of
Balsalazide Tablets Registration Study
RALEIGH, N.C.--(BUSINESS WIRE)--Jun 18, 2007 - SalixPharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successfulcompletion and outcome of its Phase III registration trial toevaluate the safety and efficacy of a new 1100 mg tabletformulation of balsalazide disodium (balsalazide tabl
ets).Balsalazide disodium is the active ingredient in COLAZAL(R)Capsules 750 mg, an anti-inflammatory dru...
Critical Therapeutics Announces the Publication of Data for ZyfloCR
(Zileuton) Extended-Release Tablets in the Journal of Asthma
LEXINGTON, Mass.--(BUSINESS WIRE)--Jun 12, 2007 - CriticalTherapeutics, Inc. (Nasdaq: CRTX) today announced the publicationof data from a pivotal Phase III clinical trial of ZYFLO CR(TM)(zileuton) extended-release tabl
ets in the June 2007 issue of theJournal of Asthma. ZYFLO CR was approved by the U.S. Food and DrugAdministration (FDA) on May 30, 2007. Critical Therapeutics,together with it...
July Issue of Journal of Antimicrobial Chemotherapy Highlights
Study of Factive Tablets for Five-Day Treatment of
Community-Acquired Pneumonia
WALTHAM, Mass.--(BUSINESS WIRE)--Jun 12, 2007 - Results from thesuccessful clinical trial of Oscient Pharmaceuticals' (Nasdaq:OSCI) FACTIVE(R) (gemifloxacin mesylate) tabl
ets for the five-daytreatment of community-acquired pneumonia of mild to moderateseverity (CAP) have been published in the July issue of thepeer-reviewed Journal of Antimicrobial Chemotherapy, currentlyavailable in advance...
Phase III Study Evaluating Gilead's Viread for the Treatment of
Chronic Hepatitis B Virus Meets Primary Endpoint
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun 6, 2007 - GileadSciences, Inc. (Nasdaq:GILD) today announced that Study 102, aPhase III clinical trial evaluating the company's once-dailyanti-HIV drug Viread (tenofovir disoproxil fumarate or tenofovirDF) 300 mg as a potential treatment for chronic hepatitis B virus(HBV) infection, met its primary efficacy endpoint. The study showsthat Viread is no...
NovaDel Announces Positive Data from Two Studies Comparing Zolpidem
Oral Spray to Ambien Tablets
FLEMINGTON, N.J.--(BUSINESS WIRE)--Jun 5, 2007 - NovaDel PharmaInc. (AMEX: NVD), a specialty pharmaceutical company developingoral spray formulations for a broad range of marketed treatments,today announced that its two clinical studies comparing zolpidemoral spray with zolpidem tabl
ets have met their primarypharmacokinetic (PK), pharmacodynamic (PD) and safety objectives.Zolpidem tabl
ets a...
Eloxatin (oxaliplatin injection)-Based Chemotherapy Sets New
Treatment Benchmark in Patients With Metastatic Colorectal Cancer
FOLFOX4 Chemotherapy Results in Improved Long-term [Five-years]Overall Survival for these Seriously Ill Patients CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- FOLFOX4, anEloxatin(R)-based chemotherapy regimen, provided significantimprovements in long-term [five- years] overall survival (OS) andtime to disease progression (TTP) - a longer period of stabledisease - in patients with metas...
SciClone and Sigma-Tau Report Thymalfasin Meets Primary Endpoint in
Phase 2 Malignant Melanoma Trial
-- Data Presented at Annual Meeting of the American Society ofClinical Oncology -- SAN MATEO, Calif. -- June 4, 2007 -- SciClone Pharmaceuticals,Inc. (Nasdaq:SCLN) and Sigma-Tau S.p.A today announced thatSciClone's lead product candidate thymalfasin (ZADAXIN(r), thymosinalpha 1) achieved its primary endpoint in a phase 2 clinical trialtreating patients diagnosed with stage IV malig...
Clinical Trial Excellence: Shaping Markets Through Early
Communication of Clinical Trial Data
CHAPEL HILL, N.C., May 25, 2007 /PRNewswire/ -- With enormousinvestments and the success of a pharmaceutical product at play,pharmaceutical firms need to develop effective strategies forcommunicating clinical trial results early. Companies that mastertheir communication planning and execution will gain a significantadvantage in the marketplace. According to research and consulting...
Blood Levels of Paliperidone Extended-Release Tablets are Not
Increased by Common Antidepressant
Study shows paroxetine produced no significant drug interactionwith paliperidone ER SAN DIEGO, May 22, 2007 /PRNewswire/ -- After administration ofpaliperidone extended-release (ER) tabl
ets, blood levels of thedrug were not affected when given with a common antidepressant,according to new data presented today at the 160th Annual Meetingof the American Psychiatric Association. Paroxetine,...
New Study Analyses Confirm Once-Daily Seroquel XR Extended-Release
Tablets as Effective Treatment for Schizophrenia
--Study Used To Support FDA Approval of SEROQUEL XR-- WILMINGTON, Del., May 22, 2007 /PRNewswire-FirstCall/ --AstraZeneca today announced that two analyses from a large-scalestudy that investigated the efficacy of SEROQUEL XR(TM) (quetiapinefumarate) Extended-Release Tabl
ets, a once-daily medicine for thetreatment of schizophrenia in adult patients, were presented todayat the annual meeti...
Separate Sets of Research Show Treatment Improved Quality of Life
in as Early as Three Weeks; Patient Adherence to Medication is
Multifactorial
WASHINGTON, May 22, 2007 /PRNewswire/ -- Results from analyseslooking at factors contributing to successful treatment ofulcerative colitis (UC), were presented at Digestive Disease Week(DDW) this week. Both of these studies were funded by Procter &Gamble (P&G) Pharmaceuticals, Inc. Findings from one studyoffer new information on improvement of quality of life for UCpatients t...
GlaxoSmithKline’s Hib-MenCY-TT Combination Vaccine Meets
Phase II Study Endpoints of Immunogenicity and Safety Compared to
Licensed Vaccines
Investigational vaccine could offer protectionfor infants against type b andmeningococcal disease — GlaxoSmithKline (GSK) announced results from aPhase II vaccine clinical study presented this week at thePediatri...
OXiGENE Announces a Poster Presentation Highlighting Results from
its Study of ZYBRETSTAT CA4P in Myopic Macular Degeneration (Study
MMD-213) at the 47th Annual Meeting of the Association of Research
in Vision and Ophthalmology
WALTHAM, Mass.--(BUSINESS WIRE)--May 7, 2007 - OXiGENE, Inc.(NASDAQ: OXGN, XSSE: OXGN), a clinical-stage biotechnology companydeveloping novel therapeutics to treat cancer and eye diseases,announced today that the results of its Phase II combretastatin A4phosphate (CA4P) clinical trial in myopic macular degeneration(MMD) was presented at the 47th Annual Meeting of the Associationof Research...
YM BioSciences Reports AeroLEF Randomized Phase IIb Trial Meets
Primary Endpoint in Patients with Post-Surgical Pain
MISSISSAUGA, ON, May 02, 2007 /PRNewswire-FirstCall/ - YMBioSciences Inc. , an oncology company that identifies, developsand commercializes differentiated products for patients worldwide,today announced top-line results from its randomized,placebo-controlled Phase IIb trial of AeroLEF(TM) in opioid naivepatients with post-operative pain following orthopedic surgery.AeroLEF(TM) met the pr...
New Research Results Show That Investigational Drug Phenoxodiol
Targets Cancer Protein, Causing Cancer Cell Death
Worldwide pivotal phase III study in women with recurrent ovariancancer underway SYDNEY, Australia and WASHINGTON, May 01, 2007/PRNewswire-FirstCall/ -- A new study further supports the uniquemechanism of action of phenoxodiol, an investigational drug beingstudied for the treatment of ovarian cancer. The drug appears towork by targeting a certain tumor-specific protein, which triggersa s...
Lexicon-Genentech Collaboration Yields Potential Therapeutic
Targets
Data Presented at Society for Biomolecular Sciences Conference THE WOODLANDS, Texas, April 18, 2007 /PRNewswire-FirstCall/ --Lexicon Genetics Incorporated announced that data was presentedtoday highlighting potential therapeutic targ
ets related to itscollaboration with Genentech, Inc. at the Society for BiomolecularSciences 13th Annual Conference & Exhibition in Montreal,Canada. These...
DX-88 for Hereditary Angioedema Meets Primary and Secondary
Endpoints in Phase 3 Trial (EDEMA3)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 12, 2007 - Dyax Corp.(Nasdaq:DYAX) announced today positive topline results from itsPhase 3, placebo-controlled trial, EDEMA3, for its lead productcandidate DX-88 (ecallantide), for hereditary angioedema (HAE). Awebcast presentation of the EDEMA3 data is scheduled for Tuesday,April 17, 2007 at 12:30 p.m. ET. DX-88, an internally discovered, recombina...
Alexza's AZ-004 Phase IIa Trial Meets Primary Endpoint in Treating
Schizophrenic Patients With Acute Agitation
Initial Analysis Shows Statistically Significant Changes inAgitation Levels With 10 mg AZ-004 PALO ALTO, Calif., March 26, 2007 /PRNewswire-FirstCall/ --Alexza Pharmaceuticals, Inc. today announced positive initialresults from its Phase IIa clinical trial of AZ-004 (Staccato(R)loxapine) in schizophrenic patients with acute agitation. The 10 mgdose of AZ-004 met the primary endpoint of the...
Major Gene Study Uncovers Secrets of Leukemia
St. Jude Study Scans 350,000 Locations Across the Genome From 242Patients and Identifies New Mutations That Contribute to AcuteLymphoblastic Leukemia, Suggesting New Targ
ets for Improved Therapy MEMPHIS, Tenn., March 07, 2007 /PRNewswire/ -- Investigators atSt. Jude Children's Research Hospital have discovered previouslyunsuspected mutations that contribute to the formation of pediatricac...
Replidyne Phase II Pediatric Trial Meets Primary Objective
LOUISVILLE, Colo., March 06, 2007 /PRNewswire-FirstCall/ --Replidyne, Inc. announced today that it has completed its Phase IIclinical trial using faropenem medoxomil (faropenem) in pediatricpatients with acute otitis media (AOM), a common infection of themiddle ear. Initial analyses of the study results show that it metits primary objective to show that faropenem was effective ineradicat...