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Managing Preanalytical Processes for Patient Safety

Contributing Editor Positive patient identification (ID) is a major put by healthcare accrediting bodies for the past few years. Until recently, the costs associated with hardware and software were beyond the reach of the average hospital or laboratory. Today there are multiple vendors with devices that can be integra...

YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial

- Company Announces Lead Investigator for U.S. Trial - MISSISSAUGA, ON, July 11, 2007 /PRNewswire-FirstCall/ - YMBioSciences Inc. , an oncology company that identifies, developsand commercializes differentiated products for patients worldwide,today announced results of secondary endpoint data from its 99patient, randomized, placebo-controlled, multi-center Phase IIbtrial (DLXLEF-AP4) with...

New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV

BRIDGEWATER, N.J., July 05, 2007 /PRNewswire/ -- Results fromthe primary analysis of a randomized, controlled, open-label, Phase3 study showed that 77 percent of treatment-experienced HIV-1infected adults taking PREZISTA(TM) (darunavir) 600 mg tablets with100 mg ritonavir (PREZISTA/r) twice daily, plus an optimizedbackground regimen (OBR) of antiretroviral (ARV) agents, reached aplasma v...

Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Quadramet at International Myeloma Workshop

PRINCETON, N.J.--(BUSINESS WIRE)--Jun 28, 2007 - CytogenCorporation (NASDAQ: CYTO) reported updated data from a Phase 1dose escalation study evaluating QUADRAMET(R) (samarium Sm-153lexidronam injection) in combination with bortezomib (Velcade(R),Millennium Pharmaceuticals, Inc.) in patients with relapsedmultiple myeloma. Data from 33 patients were presented today in aposter titled, "Phase 1...

New Proof of Genistein's Efficacy and Safety for Osteopenia and Osteoporosis Published in Annals of Internal Medicine

SCOTTSDALE, Ariz.--(BUSINESS WIRE)--Jun 27, 2007 - Annals ofInternal Medicine has published the results of a two-year clinicalstudy on the impact of genistein on bone loss. The paper, "Effectsof the Phytoestrogen Genistein on Bone Metabolism in OsteopenicPostmenopausal Women-A Randomized Trial," appears in the currentissue (June 19, 2007) and details the safety and efficacy ofgenistein for...

New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir

Minimal Weight Change Reported Unlike What Is Commonly Seen InInsulin Therapy CHICAGO, June 24, 2007 – Novo Nordisk today announcedresults of a new study that further demonstrated the safety andefficacy of insulin Levemir® (insulin detemir [rDNA origin]injection). Patients with Type 2 diabetes were able to adjusttheir own dosage of Levemir® and achieve improvements i...

First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes

-- Additional Findings Reported on Glucose Homeostasis Effects inNormal and Diabetic Rats -- CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- In a 14-day,Phase IIa study of the safety profile of multiple doses of theinvestigational compound dapagliflozin, a selective inhibitor ofthe Sodium-Glucose Transporter 2 (SGLT2) administered alone orconcomitantly with metformin in subjects with Typ...

Phase IIIb Clinical Data Validate the Overall and Cardiovascular Safety Profile of Cycloset (A Quick Release Formulation of Bromocriptine Mesylate) in Patients with Type 2 Diabetes

Data Also Support Drug's Efficacy at Improving Glycemic Control andReducing Diabetic Cardiovascular Complications CHICAGO, Ill., June 23, 2007 /PRNewswire/ -- VeroScience, LLC,in conjunction with its commercialization partner S2 Therapeutics,Inc., reported today the results of its Phase IIIb clinical trialsupporting the overall and cardiovascular safety of Cycloset(TM) (Aquick release for...

New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir

Minimal Weight Change Reported Unlike What Is Commonly Seen InInsulin Therapy CHICAGO, June 25, 2007 /PRNewswire-FirstCall/ -- Novo Nordisktoday announced results of a new study that further demonstratedthe safety and efficacy of insulin Levemir(R) (insulin detemir[rDNA origin] injection). Patients with type 2 diabetes were ableto adjust their own dosage of Levemir(R) and achieve improvem...

Neurologix Announces Publication of Landmark Gene Therapy Study Demonstrating Safety and Statistically Significant Improvement in Patients With Advanced Parkinson's Disease

FORT LEE, N.J.--(BUSINESS WIRE)--Jun 21, 2007 - Neurologix, Inc.(OTCBB:NRGX) today announced the publication in the June 23 issueof the journal The Lancet of positive results from the first evergene therapy trial for Parkinson's disease and the first report ofdirect gene transfer into a patient's own brain cells for any adultneurodegenerative disease. The open label Phase 1 study, conduct...

Next Safety, Inc.'s Innovative Drug Delivery System Will Replace Cigarettes and Significantly Advance Pulmonary Medication Delivery

WEST JEFFERSON, N.C.--(BUSINESS WIRE)--Jun 15, 2007 - Next Safety,Inc. has identified basic scientific mechanisms that promise torevolutionize pulmonary drug delivery. This proprietary technologyuses a stream of purified air to deliver medications deep into thepulmonary system. It is considered superior to other drug deliverysystems because it rapidly administers aerosolized drugs to thelin...

Enbrel Safety Data for up to Eight Years in Patients with Juvenile Rheumatoid Arthritis Being Presented at EULAR

THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Jun13, 2007 - Amgen (NASDAQ:AMGN) and Wyeth Pharmaceuticals, adivision of Wyeth (NYSE:WYE), today announced the presentation ofadditional data that showed that the safety profile of Enbrel(R)(etanercept) was maintained with long-term use in patients withmoderate-to-severe juvenile rheumatoid arthritis (JRA) whocompleted up to e...

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...

Fractionated Radioimmunotherapy With (90)Y-epratuzumab in Non-Hodgkin's Lymphoma Appears Safe and Active in a Phase I/II Study

- Results Presented at the 12th Congress of European HematologyAssociation (EHA) - VIENNA, Austria, June 11, 2007 /PRNewswire-FirstCall/ --Immunomedics, Inc. , a biopharmaceutical company focused ondeveloping monoclonal antibodies to treat cancer and other seriousdiseases, today announced that data presented at the 12th Congressof EHA in Vienna, Austria, showed positive responses in patie...

Studies Show Efficacy and Safety of Alexion's Soliris in Broad Population of PNH Patients

- Data presented at 12th Congress of European Hematology - CHESHIRE, Conn., June 11, 2007 /PRNewswire-FirstCall/ -- AlexionPharmaceuticals, Inc. today announced results from three analysesof Phase III studies examining Soliris(TM) (eculizumab) for thetreatment of paroxysmal nocturnal hemoglobinuria (PNH) at the 12thCongress of European Hematology, organized by The EuropeanHematology Assoc...

Archimedes Pharma Presents Positive Efficacy and Safety Data on Nasalfent at European Association for Palliative Care Congress

Nasalfent shows clinically meaningful pain relief within 5minutes of dosing and is well-tolerated READING, England, 7 June 2007 - Archimedes Pharma Ltd("Archimedes"), a European specialty pharmaceutical company, todaypresented new clinical data from a Phase II study of Nasalfent(r),an innovative fentanyl citrate nasal spray aimed at providing afast, effective and convenient treatme...

Vical Interim Clinical Results Demonstrate Safety and Tolerability of Inovio Biomedical's Electroporation DNA Delivery Technology

SAN DIEGO--(BUSINESS WIRE)--Jun 7, 2007 - Inovio BiomedicalCorporation (AMEX:INO), focused on the development of DNA vaccinesfor cancers and infectious diseases and a novel alternative tosurgery to treat localized cancers, announced today that thecompany's partner, Vical Incorporated, presented positive interimsafety and tolerability data on 18 subjects from an ongoing Phase Iclinical trial...

Newly Published Data from Large Study Support Cardiovascular Safety of Avandia (Rosiglitazone Maleate)

Results show risk of heart attackcomparable to two widely used diabetes medicines - A studyof more than 33,000 type 2 diabetes patients in a real-worldsetting was published today. This study shows that the incidence ofhospitaliations f...

Repeated Radioimmunotherapy With 131I-Labetuzumab Appears Safe and Effective in Colorectal Cancer with Liver Metastases

- Initial Phase II Study Results Presented at Society of NuclearMedicine Annual Meeting - WASHINGTON, June 04, 2007 /PRNewswire-FirstCall/ --Immunomedics, Inc. , a biopharmaceutical company focused ondeveloping monoclonal antibodies to treat cancer and other seriousdiseases, today announced that its anti-carcinoembryonic antigen(CEA) antibody, labetuzumab, labeled with the radioisotope,i...

Bionovo's MF101 Shows Positive Safety, Tolerability and Efficacy in Phase 2 Trial

EMERYVILLE, Calif., June 04, 2007 /PRNewswire-FirstCall/ --Bionovo, Inc.'s lead drug candidate, MF101, showed positive Phase 2results for the treatment of hot flashes associated with menopause.Two hundred and seventeen women were enrolled in the company'sdouble-blind, placebo- controlled, randomized Phase 2 trial.Postmenopausal women with 50 or more moderate to severe hot flashesper week...

GenVec Announces Update of Safety and Efficacy Data from Pivotal Phase II/III PACT Study of TNFerade at ASCO

GAITHERSBURG, Md.--(BUSINESS WIRE)--Jun 4, 2007 - GenVec, Inc.(Nasdaq: GNVC) announced today that updated preliminary safety andefficacy data from the clinical development program of its leadproduct TNFerade(TM) was presented in a poster session ongastrointestinal cancers at the annual meeting of American Societyfor Clinical Oncology in Chicago, IL by Dr. Mitchell Posner, of theUniversity o...

Kosan Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Epothilone KOS-1584 at ASCO

HAYWARD, Calif., June 04, 2007 /PRNewswire-FirstCall/ -- KosanBiosciences Incorporated presented data from a Phase 1 clinicaltrial showing that KOS-1584/R1645, an epothilone underco-development with Roche, demonstrated promising antitumoractivity and tolerability in patients with solid tumors.KOS-1584/R1645 showed activity in 32% of patients (13 of 41evaluable) including activity in pati...

Poniard Pharmaceuticals Announces Promising Data From Interim Safety Analysis of Phase 1 Combination Trials of Picoplatin in Colorectal and Prostate Cancers

- Company Planning to Initiate Phase 2 Trials in Colorectal Cancerand in Hormone-Refractory Prostate Cancer in Q307 - SOUTH SAN FRANCISCO, Calif., June 01, 2007/PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. , abiopharmaceutical company focused on oncology, today announcedpromising results from an interim safety analysis of two Phase 1dose-escalating trials of picoplatin, a new ge...

Inovio Biomedical's DNA Delivery Technology Shows Safety and Enhances Gene Expression & Tumor Responses in Interim Melanoma Clinical Study Results

SAN DIEGO--(BUSINESS WIRE)--May 24, 2007 - Inovio BiomedicalCorporation (AMEX:INO), focused on the development of DNA-based DNAvaccines for cancers and infectious diseases and a novelalternative to surgery to treat localized cancers, announced todaythat interim clinical trial results demonstrated that a DNA-basedimmunotherapy delivered by Inovio's electroporation technology wassafe and tole...

Medtronic Updates Long-Term ENDEAVOR I-II Clinical Data Showing Sustained Safety and Significant Reductions in Repeat Procedures

BARCELONA, Spain--(BUSINESS WIRE)--May 22, 2007 - Medtronic(NYSE:MDT) today presented new long-term data from the ENDEAVORclinical trial program reinforcing the existing safety and efficacyprofile of the Endeavor(R) drug-eluting coronary stent system.Four-year results from the 100-patient first-in-man ENDEAVOR Itrial and three-year results from the nearly 1,200 patient ENDEAVORII trial demo...

Analysis of Ulcerative Colitis (UC) Remission Rates from Long-term Safety Study of Lialda (mesalamine) Presented at DDW

Post-hoc analysis shows nearly nine out of ten patients takingonce-daily Lialda remained relapse free at the end of 12 months WASHINGTON, D.C., May 22, 2007 /PRNewswire-FirstCall/ -- Along-term phase III, open-label 12-14 month extension study (303)presented at the British Society of Gastroenterology (BSG) meetingin Glasgow, Scotland in March 2007 showed Shire plc'sLialda(mesalamine) is w...

FDA Announces Audio Broadcasts on Emerging Drug Safety Information

ROCKVILLE, Md., April 20,2007-The U.S. Food and DrugAdministration (FDA) is alerting health care professionals andconsumers to the availability of audio broadcasts that provideemerging drug safety information. The broadcasts, commonly known aspodcasts, can be transmitted to personal computers and personalaudio players. The service is part of the agency's ongoing effort to broadena...

Senate Passes Drug-Safety Reforms to Prevent Future Vioxx-type Disasters; House Urged to Act on Strong Drug Safety Bill

First significant drug safety measure in 45 years; focus moves toHouse WASHINGTON, May 09, 2007 /PRNewswire-USNewswire/ -- The Senatetoday overwhelmingly passed significant prescription drug safetyreforms to give the Food and Drug Administration more power to dealwith unsafe medicines on the market, moving the issue of drugsafety to the House, where a strong bill has been introduced buth...

FDA Issues Safety Alert on Avandia

ROCKVILLE, Md., May 21, 2007-The U.S. Food and Drug Administration(FDA) is aware of a potential safety issue related to Avandia(rosiglitazone), a drug approved to treat type 2 diabetes. Safetydata from controlled clinical trials have shown that there is apotentially significant increase in the risk of heart attack andheart-related deaths in patients taking Avandia. However, otherpublished a...

Efficacy and Safety Profile of Basilea's Alitretinoin for Severe Refractory Chronic Hand Eczema Confirmed by Data Shown at European Dermatology Congress

BASEL, Switzerland, May 21, 2007 - Results from phase IIIclinical trials and further human pharmacology studies werepresented at the 16th Congress of the European Academy ofDermatology and Venereology (EADV). These data highlighted theefficacy and safety profile of alitretinoin as a potential oncedaily oral treatment for patients with severe refractory chronichand eczema. Currentl...

Staphylococcus aureus vaccine development on track ? safe and immunogenic in Phase I clinicaltrials

VIENNA, Austria, May 18, 2007 – Intercell AG (VSE,“ICLL”) has been informed by its strategic partnerMerck & Co., Inc. on the results of a Phase I study involvingin total over 120 adult healthy volunteers comparing safety andimmunogenicity of different doses of the Staphylococcus aureusvaccine. The Staphylococcus aureus vaccine is based on a conserved prote...

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...

Data Presented at the American Academy of Neurology's Annual Meeting Provide Update on Utilization and Safety of Tysabri in Patients with Multiple Sclerosis

BOSTON--(BUSINESS WIRE)--May 3, 2007 - Biogen Idec (NASDAQ: BIIB)and Elan Corporation, plc (NYSE: ELN) announced today that new datafrom the TOUCH Prescribing Program(TM) and TYGRIS safety studyconfirm the safety profile from previous clinical studies ofTYSABRI(R) (natalizumab). Also presented at the 59th annual meetingof the American Academy of Neurology in Boston, MA were extensionstudy d...

Immediate Treatment of Early MS Patients with Betaferon Significantly Delayed Permanent Disability

Risk to confirmed EDSS progression reduced by 40 percent comparedto delayed treatment BERLIN, May 1, 2007 – Bayer Schering Pharma AG,Germany, announced today new data, which show that immediateinitiation of Betaferon® (interferon beta-1b) treatment inpatients with a first event suggestive of multiple sclerosis (MS)can significantly reduce the risk of permanent neurolog...

Avanir Pharmaceuticals Presents IEED Prevalence and Updated Zenvia Long-Term Safety Data at AAN Annual Meeting

ALISO VIEJO, Calif.--(BUSINESS WIRE)--May 1, 2007 - AvanirPharmaceuticals (NASDAQ:AVNR) today announced that data on thelong-term safety of the investigational drug Zenvia(TM)(dextromethorphan / quinidine) and the prevalence of InvoluntaryEmotional Expression Disorder (IEED) were presented today during aposter session at the American Academy of Neurology (AAN) 59thAnnual Meeting in Boston....

Evaluating the Efficacy and Safety of Once-Daily Anti-Inflammatory Dose Doxycycline for the Treatment of Rosacea

NEWTOWN, Pa.--(BUSINESS WIRE)--Apr 30, 2007 - CollaGenexPharmaceuticals, Inc. (NASDAQ:CGPI) today announced that a newreport in the May 2007 issue of the Journal of the American Academyof Dermatology evaluating two randomized phase III clinical trials,demonstrated the efficacy and safety of anti-inflammatory dosedoxycycline (Oracea(R), 40-mg doxycycline, USP capsules) for thetreatment of ro...

Calando Pharmaceuticals Announces Preclinical Efficacy and Safety Data of Targeted, Systemic Delivery of siRNA at AACR Annual Meeting

Data Indicate Significant Anti-Tumor Effects of Targeted, SystemicsiRNA Therapeutic at Doses Significantly Lower Than the Limits ofSafe Administrations in Rodent and Non-Human Primates PASADENA, Calif., April 16, 2007 /PRNewswire/ -- CalandoPharmaceuticals, a leading siRNA therapeutics company and amajority-owned subsidiary of Arrowhead Research Corporationpresented positive results of pr...

Kosan Presents Preclinical Antitumor and Safety Data On Next-Generation Epothilone KOS-1803 at AACR

HAYWARD, Calif., April 16, 2007 /PRNewswire-FirstCall/ -- KosanBiosciences Incorporated today presented preclinical data onKOS-1803, a next-generation epothilone, showing a high level ofantitumor activity and a favorable pharmacokinetic and safetyprofile in a broad range of in vitro tests and in vivo cancermodels. KOS-1803 has been chemically engineered to have a favorabletissue distribu...

Kosan Presents Data on Cardiac Safety Profile of Hsp90 Inhibitor Tanespimycin (KOS-953) at AACR

Tanespimycin Shown to Have No Effect on QTc Interval HAYWARD, Calif., April 16, 2007 /PRNewswire/ -- KosanBiosciences Incorporated today presented safety data frompreclinical and clinical studies of its lead Hsp90 inhibitor,tanespimycin (KOS-953). Serial electrocardiogram (ECG) monitoringof patients was conducted in four Phase 1 trials of tanespimycin.Cardiac monitoring analyses were cond...

Data Analyses Outline Efficacy and Safety of Mircera for the Treatment of Renal Anemia Associated With Chronic Kidney Disease

ORLANDO, Fla. and NUTLEY, N.J., April 12, 2007/PRNewswire-FirstCall/ -- Data analyses from the largest initialregistration clinical trial program ever undertaken in the renalanemia arena provide efficacy and safety information on theinvestigational anemia therapy MIRCERA(TM) for the treatment ofrenal anemia associated with chronic kidney disease (CKD) inpatients on dialysis and not on di...