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Safety in Medical Technology

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

SOUTH SAN FRANCISCO, Calif., July 21 /PRNewswire-FirstCall/ -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD ), a biopharmaceutical company focused on innovative oncology therapies, today announced results from a Phase 1 cardiac safety study of picoplatin, a new generation platinum-...

5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH

BRIDGEWATER, N.J., July 6 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) announced today that the results of the long-term, 5-year study of Lantus(R) (insulin glargine [rDNA] injection) versus NPH insulin on progression of retinopathy in patients with type 2 diabetes...

Sanofi-aventis Stands Behind the Safety of Lantus(R)

BRIDGEWATER, N.J., June 26 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY ) has just been made aware of data associated with a retrospective follow-up of four patient registries. The results of these data clearly show that no definitive conclusions can be drawn regarding...

New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development

DUBLIN, June 18 /PRNewswire-FirstCall/ -- According to a report issued today, drug safety leaders in pharmaceutical and biotechnology companies recognise the need to increase resources, either internally or through partnerships, to comply with the safety regulations recently issued by the U.S....

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

Data Findings Published in June Issue of Circulation SILVER SPRING, Md. and INDIANAPOLIS, June 9 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) and Eli Lilly and Company (NYSE: LLY ) today announced the results of a pivotal 16-week study showing that a once-dail...

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

Two-year study presented at the American Diabetes Association's 69th Scientific Sessions shows investigational product comparable to standard insulin therapy in pulmonary function tests NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- AFRESA(R) (insulin human [rDNA origin]) Inhalation Powder is ...

Researchers Present Safety and Efficacy Results of 429 Patients Treated With Radiofrequency Ablation for Pre-Cancerous Barrett's Esophagus

Large multi-center trial conducted in a community practice setting demonstrates comparable outcomes as trials conducted in predominantly tertiary academic centers SUNNYVALE, Calif., June 1 /PRNewswire/ -- Clinical trial results presented at the Digestive Disease Week in Chicago today reveal t...

Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy

The results of these studies will be presented during the American Transplant Congress in Boston , MA May 30 - June 3, 2009 COLUMBIA, Md., May 31 /PRNewswire/ -- The results of two large studies presented by researchers from the Starzl Transplant Institute at the University of P...

Results and Additional Analyses From Efficacy and Safety Study of Corthera's Relaxin in Acute Heart Failure to be Presented at Heart Failure Congress 2009

SAN MATEO¿ Calif.¿ May 28 /PRNewswire/ -- Results and additional analyses from the Phase II portion of a Phase II/III clinical trial of Corthera's investigational drug relaxin for the treatment of acute heart failure will be presented at the Heart Failure Congress, the annual meeting of the Heart ...

VIVUS Initiates Open Label Safety Study of Avanafil for Erectile Dysfunction

Enrollment in First Pivotal Phase 3 Avanafil Study REVIVE (TA-301) is Complete MOUNTAIN VIEW, Calif., May 13 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS ), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and s...

New Study Suggests Rx Estrogen Delivery Through the Skin May Show Safety Benefits as Opposed to Oral Delivery

NEW YORK, March 31 /PRNewswire/ -- Transdermal delivery of estrogen therapy available by prescription "seems not to alter" the risk of venous thromboembolism (VTE), or blood clotting, in postmenopausal patients when compared to oral delivery, a new study suggests. The study was conducted by res...

Results From Study Show Promising Efficacy and Safety Results for Corthera's Relaxin in Acute Heart Failure

Data Presented at Late-Breaking Clinical Trials Session at ACC 58th Annual Scientific Session; Results Published On-Line in The Lancet SAN MATEO¿ Calif.¿ March 29 /PRNewswire/ -- Corthera Inc. today announced that results from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter,...

Clinical Data Reinforce Safety and Efficacy of Boston Scientific's Two Drug- Eluting Stent Platforms

NATICK, Mass. and ORLANDO, Fla., March 29 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today welcomed three-year results from the SPIRIT II Clinical Trial and a pooled meta-analysis of two-year data from the SPIRIT II and III Trials. SPIRIT II and SPIRIT III are pros...

RenalGuard(R) Pilot Safety Clinical Trial Data to be Presented at ACC 2009

FRANKLIN, Mass., March 27 /PRNewswire-FirstCall/ -- PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that the first data from its pilot safety trial for RenalGuard(R) will be presented in a poster ...

Results From Efficacy and Safety Study of Corthera's Relaxin in Acute Heart Failure to be Presented at Late-Breaking Clinical Trials Session at ACC 58th Annual Scientific Session

SAN MATEO¿ Calif.¿ March 23 /PRNewswire/ -- Results from the Phase II portion of a Phase II/III clinical trial of Corthera's investigational drug relaxin for the treatment of acute heart failure will be presented at 10:30 a.m. EDT on Sunday, March 29, at the American College of Cardiology's (ACC...

Video: Provectus PV-10 Interim Phase 2 Safety and Efficacy Results are as Good as or Better than Phase 1 Results

- Lead Investigator Professor John F. Thompson Presented Results at The Sixth International Symposium on Melanoma and Other Cutaneous Malignancies in New York City - - Detailed Efficacy Data to be Presented at ASCO May 29-June 2, 2009 - KNOXVILLE, Tenn., March 16 /PRNewswire-FirstCall/...

Alimera Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study

ATLANTA, March 12 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported the interim 12-month safety and efficacy results from the first human ...

Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound

SOUTH SAN FRANCISCO, Calif., March 2 /PRNewswire-FirstCall/ -- Hana Biosciences (Nasdaq: HNAB ) today announced that an Independent Data Monitoring Committee (IDMC) has completed a planned, pre-specified safety review of interim data from the ongoing pivotal rALLy clinical trial of Marqibo(R...

Results of NeuroThera Effectiveness and Safety Trial - 2 (NEST-2) Presented at International Stroke Conference 2009

Encouraging Safety and Efficacy Results Support Follow-on NEST-3 Trial CARLSBAD, Calif., Feb. 20 /PRNewswire/ -- In a clinical trial sponsored by PhotoThera, Inc., transcranial laser therapy (TLT) for acute ischemic stroke within 24 hours of stroke onset demonstrated improved outcomes for pat...

Pfizer Contributes Critical Data to URMC Drug Safety Initiative

ROCHESTER, N.Y., Jan. 12 /PRNewswire-USNewswire/ -- Pfizer Inc. has agreed to provide the University of Rochester Medical Center (URMC) with a unique set of electrocardiographic data that will help researchers develop new methods to ensure the safety of experimental drugs. This is the first tim...

Sosei Confirms the Safety of SD118 in Two Phase I Trials

TOKYO, December 8 /PRNewswire-FirstCall/ -- Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), a biopharmaceutical company, today announces the successful results of two Phase I trials for its collaborative project on SD118, a compound in development for the treatment of neuropathic pain....

New Phase II Data Show Safety of Once-Daily Oral Factor Xa Inhibitor, DU-176b, Comparable to Warfarin in Patients With Non-Valvular Atrial Fibrillation

SAN FRANCISCO, Dec. 7 /PRNewswire-FirstCall/ -- Patients with non-valvular atrial fibrillation receiving either 30 mg or 60 mg once-daily dose of DU-176b, an investigational oral Factor Xa inhibitor, experienced comparable safety and tolerability compared to those taking warfarin, according to new...

Third Pivotal Phase 3 Study for NicOx' Naproxcinod Shows Positive Efficacy, Safety and Blood Pressure Results

SOPHIA ANTIPOLIS, France, November 24 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced that the third pivotal phase 3 study for naproxcinod in patients with OA of the hip showed a highly statistically significant result (p<0.001) on all three co-primary effica...

Bavarian Nordic Reports Successful Safety Data From Phase II Study With IMVAMUNE(R)

KVISTGARD, Denmark, November 6 /PRNewswire-FirstCall/ -- Bavarian Nordic has completed a clinical safety report from a large Phase II study with IMVAMUNE(R) in HIV infected subjects that confirms the excellent safety profile of IMVAMUNE(R). Within the next few days the safety report of this st...

Anadys Pharmaceuticals Announces Single Dose Safety and Pharmacokinetics Results for ANA598 in Healthy Volunteers

Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO, Nov. 1 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) announced today the results of a Phase I clinical trial of ANA598 in h...

GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition

PHILADELPHIA, Oct. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today issued the following response to a petition filed by Public Citizen to the U.S. Food and Drug Administration (FDA) on AVANDIA(R) (rosiglitazone maleate), a highly effective therapy for treating type 2 diabetes wh...

Comprehensive Safety Tests Published on Ruyan(R) Smoking Alternatives

Tests Conducted in New Zealand and Canada Find Ruyan E-cigarettes Safe; Results Apply Only to Ruyan Products MINNEAPOLIS, Oct. 28 /PRNewswire/ -- Ruyan America, Inc., announced today the publication of a report that tested the safety of its electronic smoking alternatives, spe...

Pivotal Phase III Data Confirm the Efficacy and Safety of Arpida's Intravenous Iclaprim in Treating Patients With Complicated Skin and Skin Structure Infections

Iclaprim also achieved high eradication rates for the most common pathogens, including methicillin-resistant Staphylococcus aureus (MRSA) REINACH, Switzerland, Oct. 26 /PRNewswire-FirstCall/ -- Arpida (SWX: ARPN) today presented the combined results from two pivotal Phase III clinical tri...

SYNTAX Data Show Comparable Safety for Complex Patients Treated with TAXUS(R) Express2(TM) Stents and Bypass Surgery

New SYNTAX Score shows similar safety and efficacy outcomes for two thirds of study's patients NATICK, Mass. and WASHINGTON, Oct. 14 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced 12-month left main and three-vessel disease subset ...

Interim Analysis of 12-Month Data from e-HEALING Registry Shows Good Safety and Efficacy in Real-World Use of OrbusNeich's Genous(TM) Bio-engineered R stent(TM)

Additional Data Presentation Shows Encouraging 12-Month Outcomes from Single- Center Study Involving Patients with Predominantly Complex Lesions WASHINGTON, Oct. 14 /PRNewswire/ -- OrbusNeich today announced that an interim analysis of 12-month follow-up data from the global e-HEALING regist...

Abbott's XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key Efficacy and Safety Endpoints Out to Two Years

New Analysis of SPIRIT II and SPIRIT III Data Confirms Patients Treated with XIENCE V Are at Lower Risk of Experiencing Death, a Heart Attack or a Repeat Procedure Compared to TAXUS(R) at Two Years WASHINGTON, Oct. 13 /PRNewswire-FirstCall/ -- Data from an independent meta-analysis ...

Taxus Atlas Studies Reinforce Safety and Efficacy of Boston Scientific's Next-Generation Taxus Liberte Stent

New coronary stent features thin struts designed for more uniform drug delivery NATICK, Mass., and WASHINGTON, Oct. 12 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced comprehensive data from the TAXUS ATLAS clinical program,...

Potentia Pharmaceuticals Announces Positive Safety Data and Study Expansion in Phase I Trial for Lead Drug Candidate POT-4

First complement inhibitor to be tested in AMD patients LOUISVILLE, Ky., Sept. 29 /PRNewswire/ -- Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD) announced today that the Company's leading...

Established Safety Profile of Spiriva Confirmed by 30 Rigorously Controlled Clinical Trials and the Landmark Trial UPLIFT

New Data from Landmark UPLIFT Trial Further Supports Spiriva's Safety Profile RIDGEFIELD, Conn. and NEW YORK, Sept. 23 /PRNewswire/ -- Boehringer Ingelheim and Pfizer Inc have released a new analysis of 30 rigorously controlled clinical trials, including UPLIFT, confirming the long term safe...

Nutrition 21 Reports That National Toxicology Program Studies Support the Safety of Chromium Picolinate

PURCHASE, N.Y., Sept. 11 /PRNewswire-FirstCall/ -- Nutrition 21, Inc. (Nasdaq: NXXI ), the developer and marketer of nutritional supplements under the Iceland Health Chromax(R), and Diabetes Essentials(TM) brands that help consumers manage blood sugar levels, improve cardiovascular health, en...

338 Patient Pivotal Trial Demonstrates Safety and Effectiveness of Polidocanol Sclerotherapy Product for Varicose Vein Treatment

SAN MATEO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced that the pivotal clinical study of Polidocanol, conducted in Germany by BioForm Medical's partner, Chemische Fabrik KREUSSLER & Co. GmbH (Kreussler), successfully met the study primary e...

Catheter Ablation System for Atrial Fibrillation Shows Reduced Procedure Time, Remarkable Safety Profile and Excellent Outcomes in Two Clinical Studies

Important Studies Presented at the European Society of Cardiology Continue to Bring Attention to Innovative Technology CARLSBAD, Calif., Sept. 2 /PRNewswire/ -- Ablation Frontiers, Inc., announced today that two important studies, involving its innovative atrial fibrillation ablati...

Biosensors DES Demonstrates Equivalent Safety and Efficacy to Industry Leading DES in First 'Real World, All Comers' Clinical Study

MUNICH, Germany, September 1 /PRNewswire-FirstCall/ -- Biosensors International Group, Ltd ("Biosensors", "Company"), (Bloomberg: BIG:SP), (Singapore:B20) today announced that a next-generation drug-eluting stent, developed by Biosensors, has demonstrated equal safety and efficacy as compared ...

NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension

SOPHIA ANTIPOLIS, France, July 24 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced the top-line results from the 52-week open label safety extension that was conducted following the completion of the 301 phase 3 study for naproxcinod. The results revealed no unexpecte...

FluoroPharma Announces Positive Phase I Safety Results for BFPET(TM), Myocardial Perfusion Imaging (MPI) Tracer for Positron Emission Tomography (PET)

BOSTON, July 23 /PRNewswire/ -- FluoroPharma Inc., a company developing breakthrough molecular imaging agents for the Positron Emission Tomography (PET) market, announced positive Phase I results for BFPET, its novel Fluorine-18 labeled tracer for myocardial perfusion imaging. BFPET is FluoroP...
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