MPA

Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkin's Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy

Positive interim results prompt request for meeting with FDA SEATTLE, July 11, 2007 /PRNewswire-FirstCall/ -- CellTherapeutics, Inc. (CTI) announced today that interim results ofits phase II/III trial comparing CPOP-R, in which pixantrone issubstituted for doxorubicin in standard CHOP-R first-line treatmentof patients with aggressive non-Hodgkin's lymphoma (NHL), resultedin essentially al...

Lupus Foundation of America Statement on Results for Clinical Study of CellCept Released by Aspreva Pharmaceutical Company

Statement by Sandra C. Raymond, President & CEO of the LupusFoundation of America, Inc. WASHINGTON, June 27, 2007 /PRNewswire-USNewswire/ -- The LupusFoundation of America, Inc. and more than 1.5 million Americanswith lupus have been awaiting the preliminary findings of the PhaseIII clinical trials for CellCept(R), a potential treatment forlupus kidney disease being tested by Aspreva...

Genetics Journal Thimerosal/Autism Study the 'Best Science Drug Company Money Can Buy'

Critique of Industry-Funded Immune Globulin Study Uncovers SampleManipulation, Design Flaws NIXA, Mo., June 26, 2007 /PRNewswire-USNewswire/ -- An analysisreleased today critically examined a recent industry-sponsoredstudy ruling out a link between autism and Rh immune globulin(RhIg) injections, some of which contained the mercury-basedpreservative thimerosal. Besides extensive design fla...

Data Demonstrated Saxagliptin Added to Metformin Improved Glycemic Control in Subjects with Type 2 Diabetes Compared to Metformin Alone

-- Additional Findings Reported Safety & Tolerability Profilein Subjects with Type 2 Diabetes and Healthy Subjects -- CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- Phase III datapresented this week at the annual meeting of the American DiabetesAssociation demonstrated that saxagliptin, an inhibitor ofdipeptidyl-peptidase-4 (DPP-4) in development by Bristol-MyersSquibb Company and A...

Data Demonstrated Saxagliptin Added to Metformin Improved Glycemic Control in Subjects with Type 2 Diabetes Compared to Metformin Alone

Additional Findings Reported Safety & Tolerability Profilein Subjects with Type 2 Diabetes and Healthy Subjects CHICAGO, June 25 /PRNewswire-FirstCall/ -- Phase III datapresented this week at the annual meeting of the American DiabetesAssociation demonstrated that saxagliptin, an inhibitor ofdipeptidyl-peptidase-4 (DPP-4) in development by Bristol-MyersSquibb Company (NYSE: BMY...

Publication on Pixantrone Preclinical Studies Demonstrates Reduced Cardiotoxicity Compared to Equiactive Doses of Doxorubicin and Mitoxantrone

Interim results in a randomized phase II/III clinical trialanticipated later this year SEATTLE, June 26, 2007 /PRNewswire-FirstCall/ -- CellTherapeutics, Inc. (CTI) announced the publication of preclinicalstudies, which demonstrate that treatment with pixantrone (BBR2778) resulted in minimal or no significant cardiotoxicity, whiledoxorubicin and mitoxantrone induced significant cardiac da...

Phosphagenics Announces Positive Proof of Concept Results from Studies Utilizing Company's Dermal Drug Delivery Technology

MELBOURNE, Australia, June 25, 2007 /PRNewswire-FirstCall/ --Phosphagenics Limited (AIM: PSG) announced today positive resultsfrom pre-clinical studies of its TPM-02 dermal drug deliverytechnology formulated with retinoic acid, a leading topicaltreatment for severe acne and an active ingredient used inanti-aging cosmetics. The proof of concept studies showed a three-fold increase i...

Orexigen Therapeutics to Present Data on Contrave Impact on Visceral Fat and Insulin Resistance at American Diabetes Association 67th Scientific Sessions in Chicago June 23

SAN DIEGO, June 21, 2007 /PRNewswire-FirstCall/ -- Orexigen(TM)Therapeutics, Inc. , a biopharmaceutical company focused on thetreatment of central nervous system disorders with an initial focuson obesity, today announced that the Company will present dataabout its lead obesity product candidate Contrave(TM) and itseffect on markers of cardiovascular disease (visceral fat, serumcholestero...

Research Documents Scalable Production, Survival Following Engraftment and Positive Impact on Cardiac Function in Infarcted Rats for Geron's Human Embryonic Stem Cell-Based Therapeutic for Heart Failure

MENLO PARK, Calif.--(BUSINESS WIRE)--Jun 19, 2007 - GeronCorporation (Nasdaq: GERN) today reported that research documentingthe scalable production, survival following engraftment andpositive impact on cardiac function in infarcted rats was presentedtoday for GRNCM1, the company's human embryonic stem cell(hESC)-based therapeutic for heart failure, at the InternationalSociety for Stem Cell...

Prexige Study Shows Significantly Less Impact on Blood Pressure Than Ibuprofen in Osteoarthritis Patients with Controlled Hypertension

* New data from 741-patient trial show those treated withPrexige experienced significantly smaller impact on blood pressurecompared to ibuprofen[1] * Many patients with osteoarthritis also have high bloodpressure; even small changes in blood pressure can impactcardiovascular risk[2],[3] * Prexige approved in more than 50 countries and currently underreview in US for use in o...

Lumiracoxib Study Showed Significantly Less Impact on Blood Pressure Than Ibuprofen in Osteoarthritis Patients with Controlled Hypertension

New data From 741-patient Trial Show Those Treated with LumiracoxibExperienced Significantly Smaller Impact on Blood Pressure Comparedto Ibuprofen EAST HANOVER, N.J., June 15, 2007 /PRNewswire/ -- Patients withosteoarthritis who also have controlled hypertension experienced aslight decrease in average daily blood pressure when treated withthe investigational selective COX-2 inhibitor lumi...

Actemra (tocilizumab) Significantly Improves Symptoms of Rheumatoid Arthritis Compared to a Current Standard of Care

NUTLEY, N.J., June 15, 2007 /PRNewswire/ -- Results of theOption (TOcilizumab Pivotal Trial in Methotrexate InadequaterespONders) trial, the first multinational Phase III study outsideof Japan, showed that patients treated with Actemra (either 4mg/kgor 8mg/kg) plus methotrexate achieved a significant and clinicallyimportant improvement in the signs and symptoms of moderate tosevere rheum...

Repros Reports That Proellex Has Demonstrated Superior Efficacy and Safety in Endometriosis When Compared to Standard of Drug Care

THE WOODLANDS, Texas--(BUSINESS WIRE)--Jun 11, 2007 - ReprosTherapeutics Inc. (NasdaqGM:RPRX) today released top-line findingsfrom its six month study of Proellex in the treatment ofendometriosis. This study, conducted in Europe, enrolled 39premenopausal women and has completed six months of dosing. Thestudy included three dose levels of Proellex(TM) as well as apositive control arm. The po...

Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial as Compared to Neostigmine

OSS, The Netherlands, June 11, 2007 /PRNewswire/ -- Sugammadex -the novel selective relaxant binding agent (SRBA) being developedby Organon, the human healthcare business unit of Akzo Nobel -demonstrated in a Phase III pivotal trial a 9-12 times fasterreversal of neuromuscular blockade as compared to neostigmine,without evidence of post operative residual curarization (PORC) orre-occurre...

Myriad Genetics Presents Mathematical Comparison of Disease Modification Trial Designs at Alzheimer's ConferenceCurrent Flurizan Phase 3 Study Design May Demonstrate Disease Modification

SALT LAKE CITY, UT, June 11, 2007 (MARKET WIRE via COMTEX NewsNetwork) -- Myriad Genetics, Inc. (NASDAQ: MYGN) (<a target="_blank" href="http://www.myriad.com/">www.myriad.com )announced today that it presented a mathematical comparison of a"Staggered Start" and a "Randomized Withdrawal" clinical trialdesign with a "Natural History Staggered Start" clinical trialdesign at the Alzheime...

Organon's Sugammadex Demonstrated a 9-12 Times Faster Recovery in Phase III Pivotal Trial Compared to Neostigmine

OSS, the Netherlands, June 11, 2007-Sugammadex - the novelselective relaxant binding agent (SRBA) being developed by Organon,the human healthcare business unit of Akzo Nobel - demonstrated ina Phase III pivotal trial a 9-12 times faster reversal ofneuromuscular blockade as compared to neostigmine, without evidenceof post operative residual curarization (PORC) or re-occurrence ofmuscle relax...

IMPAX Presents at Movement Disorder Society's 11th International Congress of Parkinson's Disease and Movement Disorders

HAYWARD, Calif.--(BUSINESS WIRE)--Jun 8, 2007 - IMPAX Laboratories,Inc. (OTC:IPXL) today announced that two poster presentations,highlighting the company's compound, IPX054, a combined immediate-and extended-release carbidopa/levodopa (CD/LD) product to bemarketed as VADOVA(TM), were presented at the Movement DisorderSociety's 11th International Congress of Parkinson's Disease andMovement D...

OREXIGEN Therapeutics Announces Sustained-Release Formulation of Zonisamide Shows Improved Tolerability When Compared to Immediate Release Formulation

Orexigen(TM) is evaluating zonisamide SR as a novel component inEMPATIC(TM) Phase IIb obesity trial SAN DIEGO, June 07, 2007 /PRNewswire-FirstCall/ -- Orexigen(TM)Therapeutics, Inc. , a biopharmaceutical company focused on thetreatment of central nervous system disorders with an initial focuson obesity, today announced results from a Phase I trial evaluatingsafety and pharmacokinetics of...

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

CHICAGO – June 2, 2007 – Long-term treatment withpegylated interferon alfa-2b in stage III melanoma had asignificant and sustained impact on relapse-free survival (RFS),according to the results of the largest adjuvant trial everconducted in patients with stage III melanoma. Results of the PhaseIII study, led by...

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 tablets have met their primarypharmacokinetic (PK), pharmacodynamic (PD) and safety objectives.Zolpidem tablets a...

Pharmion's Amrubicin Shows Encouraging Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer

Interim Analysis of Phase 2 Clinical Data Published at the AmericanSociety of Clinical Oncology 43rd Annual Meeting CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- PharmionCorporation today released interim findings from its Phase II,multi-center clinical study of Amrubicin, the company'sthird-generation synthetic anthracycline currently in developmentfor the treatment of small cell lung...

Hyperthermia Plus Chemotherapy Nearly Doubles Disease-Free Survival Compared to Chemotherapy Alone for Sarcoma Cancer Patients

SALT LAKE CITY, June 04, 2007 /PRNewswire-FirstCall/ -- BSDMedical Corp. announced today that the results of a 340 patientrandomized Phase III clinical trial testing the benefit of addinghyperthermia therapy to chemotherapy were presented at the annualAmerican Society of Clinical Oncology (ASCO) conference underway inChicago, Illinois. According to the results of this clinical study,whic...

Lilly Studies Try to Shed Light on Impact of Race on Lung Cancer Treatment

Company Launches 1,000-Patient Lung Cancer Diversity Study CHICAGO, June 01, 2007 /PRNewswire-FirstCall/ -- Statistics showlung cancer is the leading cause of cancer death inAfrican-Americans, with 21,550 new cases expected to be diagnosedand 16,700 deaths expected this year.(i) Equally devastating, lungcancer is the leading cause of cancer death in Hispanic men and thesecond leading caus...

Surfaxin (Lucinactant) Long-Term Survival Advantage vs. Comparators Published in Pediatrics

WARRINGTON, Pa., May 31, 2007 (PRIME NEWSWIRE) -- DiscoveryLaboratories, Inc. (Nasdaq:DSCO) announces publication of theone-year follow-up results from its SELECT and STAR Phase 3clinical trials for Surfaxin(r), in Pediatrics, the premier medicaljournal for pediatric healthcare practitioners. The long-term datafrom the SELECT and STAR trials concluded that Surfaxindemonstrated a statisti...

New Study Suggests no Significant Impairment in Middle-of-the-Night Balance, Mobility or Memory in Older Adults Using Ramelteon

SAN DIEGO, May 22, 2007 /PRNewswire/ -- A new study presentedtoday showed that ramelteon did not impair middle-of-the-nightbalance, mobility or memory performance in older adults withinsomnia, relative to placebo. This study also demonstrated, as inprevious studies, that patients treated with zolpidem did haveimpaired performances on these measures, as compared to placebo.The results of...

Vical's Vaxfectin Adjuvant With Needle-free Delivery Enhances DNA Vaccine Performance; Yields Antibody Responses Comparable to Electroporation Without Tolerability Issues

MALAGA, Spain, May 23, 2007 /PRNewswire-FirstCall/ -- VicalIncorporated today announced that in a recently completed animalstudy, a DNA vaccine formulated with the company's patentedVaxfectin(TM) adjuvant and delivered by needle-free injectionyielded significantly higher antibody responses than anunformulated DNA vaccine delivered by needle and syringe. In aseparate animal study, electro...

Efficacy of OrbusNeich's Genous Bio-Engineered R Stent Compares Favorably to Drug-Eluting Stents

Risk of Late Thrombosis is Minimized with Genous Stent BARCELONA, Spain, May 23, 2007 /PRNewswire/ -- The efficacy ofOrbusNeich's Genous(TM) Bio-engineered R stent compares favorablyto that of drug-eluting stents, while the risk of late thrombosisis minimized with the Genous stent, according to an interimanalysis of post-marketing data presented today by Robbert deWinter, M.D., Ph.D., at...

Pooled Studies Showed Desvenlafaxine Succinate Significantly Improved Painful Symptoms and Anxious Symptoms Associated with Major Depressive Disorder in Adults, Compared With Placebo

Pooled Findings Presented at 2007 APA Meeting Also Showed NoSignificant Impact on Weight for Desvenlafaxine Succinate COLLEGEVILLE, Pa., May 21, 2007 /PRNewswire-FirstCall/ --Findings from two separate pooled analyses - one examining theeffect of desvenlafaxine succinate on anxious symptoms and theother on painful symptoms associated with major depressive disorder(MDD) -- as well as a sep...

FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.

Company Misrepresented Prescription PainReliever to Health Care Professionals ROCKVILLE, Md., May 10, 2007-The U.S. Food and DrugAdministration's (FDA) Office of Criminal Investigations (OCI)announced today that The Purdue Frederick Company, Inc. has agreedto pay more than $700 million to resolve criminal charges and civilliabilities in connection with...

Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril

Comparison of BENICAR HCT 40/12.5 and 40/25 mg/day and Amlodipine +Benazepril 5/20 and 10/20 mg/day Presented at American Society ofHypertension Twenty-Second Annual Scientific Meeting PARSIPPANY, N.J., May 21, 2007 /PRNewswire/ -- New datapresented today at the American Society of Hypertension'sTwenty-Second Annual Scientific Meeting (ASH 2007) in Chicagodemonstrated that the fixed-dose...

Baraclude (Entecavir) Treatment Demonstrated Greater Viral Load Reduction Compared to Adefovir at 48 Weeks in Study of Antiviral-Naive Chronic Hepatitis B E-Antigen Positive Patients

WASHINGTON, May 21, 2007/PRNewswire-FirstCall/ -- Bristol-MyersSquibb Company (NYSE: BMY) today announced new data from studyETV-079, which showed that treatment with Baraclude (entecavir)demonstrated greater viral load reduction than adefovir at 48 weeks-- a result that was also seen at weeks 12 (primary endpoint) and24. These data from an open-label, randomized viral kinetics studyof 6...

AGI Dermatics Presents Comparative Data That Indicates OCTN-1 Skin Cells Have the Ability to Recognize, Transport and Utilize L-ergothioneine (EGT) As A Protector Against Oxidative Damage

Clinical Poster Presented at Society for Investigative Dermatology FREEPORT, N.Y., May 16, 2007 /PRNewswire/ -- AGI Dermaticsrecently announced new comparative clinical data that indicatesthat OCTN-1 skin cells have the ability to recognize, transport andutilize L-ergothioneine (EGT) as a protector against oxidativedamage, and importantly, that (EGT) acts as a more powerful andefficient a...

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...

Catalyst Pharmaceutical Partners, Inc. Announces Top-Line Results of Its Bioequivalence Study of CPP-109 (Vigabatrin), the Company's Investigational Drug to Treat Cocaine and Methamphetamine Addiction

CORAL GABLES, Fla., May 09, 2007 /PRNewswire-FirstCall/ --Catalyst Pharmaceutical Partners, Inc. announced today positiveinitial, top-line results from a bioequivalence study demonstratingthat CPP-109 (Catalyst's Vigabatrin Tablets) is bioavailable andbioequivalent to Sabril Tablets, the version of vigabatrin marketedin Europe by Sanofi Aventis. These data potentially provide a basisfor...

Drug for Treatment of Heart Failure Does Not Improve Survival, Compared to More Widely-used Medication

CHICAGO, May 1, 2007—The drug levosimendan did not improvesurvival for patients with decompensated heart failure whencompared with a more widely-used treatment for this condition,dobutamine, according to a study in the May 2 issue of Acute decompensated heart failure (ADHF; severe heart failurecharacterized by inability of the heart to maintain adequate bloodci...

Ties Between Physicians and Drug Companies Still Too Strong: the Prescription Project Offers Solutions to Prevent Conflicts of Interest

BOSTON--(BUSINESS WIRE)--Apr 26, 2007 - A new study published todayin the New England Journal of Medicine ("A National Survey ofPhysician-Industry Relationships") on the extent of doctor andpharmaceutical company relationships, highlights the need forprofession-wide and public policy reforms promoted by ThePrescription Project. The article concludes that the existing,voluntary PhRMA (Pharma...

Peregrine Pharmaceuticals Highlights Significant Advances in the Company's Clinical and Preclinical Cancer Programs Presented This Week at the AACR Annual Meeting

- New Study Demonstrated the Clinical Potential of Peregrine'sUnique Selective Anti-VEGF Antibodies, Which Were as Effective asAvastin(R) in Animal Cancer Models TUSTIN, Calif., April 20, 2007 /PRNewswire-FirstCall/ --Peregrine Pharmaceuticals, Inc. , a clinical stagebiopharmaceutical company developing targeted monoclonal antibodiesfor the treatment of cancer and hepatitis C virus infect...

MIV Therapeutics Announces Pivotal Test Results Further Validating Company Stent Coatings Meet Critical FDA Fatigue Guidelines

ATLANTA--(BUSINESS WIRE)--Apr 5, 2007 - MIV Therapeutics Inc.(OTCBB:MIVT) (FWB:MIV), a leading developer of next-generationbiocompatible coatings and advanced drug delivery systems forcardiovascular stents and other implantable medical devices, todayannounced that a recent Company sponsored bench test confirmed thatmerging Biosync Scientific's certified bare metal stent platform,which MIVT...

Low-Dose Steroid Combined With Lenalidomide Prolongs Survival Compared With High-Dose Steroid for Multiple Myeloma Treatment

WASHINGTON, April 4, 2007-Preliminary results from a large,randomized clinical trial for patients with newly diagnosedmultiple myeloma, a cancer typically found in bone marrow, hasshown that the use of a low dose of the steroid dexamethasone(Decadron ®), in combination with lenalidomide (Revlimid ®)is associated with improved survival when compared to a treatmentregimen with lenalid...

Targanta Reports Improved Ability of Oritavancin to Stop Bacteria Growth In Vitro Compared With Other Glycopeptide Antibiotics

Three Oritavancin Studies Presented at ECCMID/ICC MUNICH, Germany, April 03, 2007 /PRNewswire/ -- TargantaTherapeutics today announced results from two studies showing theimproved potency of oritavancin to stop bacterial growth in vitrowhen tested with a common wetting agent (polysorbate 80) and onestudy demonstrating the activity of oritavancin against S.pneumoniae in a mouse model of pn...