Safety in Medical Technology

Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA

... by new clinical data, immunogenicity and safety data will be made available through clinical ... Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine ... 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to ...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

... KRAS mutations." Detailed efficacy and safety data according to KRAS status will be submitted ... the world are pending. Important Product safety Information Dermatologic Toxicity: ... conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. ...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

... 221-patient Phase 2 clinical trial was to assess safety and evaluate the effect of three doses of BA058 ... "The results of this study affirm BA058's safety and bone-building activity and support its ... and India and was designed to evaluate the safety and efficacy of BA058 in the treatment of ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... collectively called SREs. Full safety and efficacy data will be submitted for ... on-study SREs, and to assess the safety and tolerability of denosumab compared with ... conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only ...

Covance Receives Highest Level of Phase I Accreditation

... and studies meet the industry's highest safety standards. This accreditation was ... the highest level of data quality and patient safety for first-in-human trials, which is confirmed by ... introduced to ensure the highest level of patient safety for early clinical development by providing more ...

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

... panel's careful consideration of the efficacy and safety data for SAPHRIS," said Thomas P. Koestler, ... efficacy combined with an attractive metabolic safety profile. SAPHRIS has the potential to address a ... the committee voted on the overall balance of safety and efficacy by counts of 12/0/0 and 9/1/2 for ...

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

... the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV in the Complete ... guanfacine for the treatment of ADHD.(6) safety was also evaluated during these pivotal trials and safety data showed that adverse events reported by ...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... Osteitis: inflammation of the bone safety Results Similar to TASKi2, the most common ... completed the clinical trial with minimal safety issues. The most common adverse events in the ... a corporate partner," he added. safety Results Tables ...

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

... today announced results from a Phase 1 cardiac safety study of picoplatin, a new generation ... This study evaluated the cardiac safety of picoplatin by determining its effect on the ... demonstrated. "With these new picoplatin safety data, we continue to make progress toward our ...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

... in each test, RK-023 seems to hardly cause any safety problem in the human body. As the first ... double blind method to evaluate the safety and pharmacokinetics of the drug. In the ... the vertex region in order to investigate the safety in the entire body and scalp. No serious adverse ...

UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

... effects of chemotherapy and has shown promising safety and efficacy results in patients with solid ... response rate (ORR), and to further evaluate the safety and tolerability of BSI-201 in combination with ... with adverse events (AEs) consistent with known safety profiles of G/C regimens. J Clin Oncol ...

New Results From ARTEN Study of Nevirapine Plus Tenofovir and Emtricitabine (TDF/FTC) Versus Boosted Protease Inhibitor Regimen of Atazanavir/Ritonavir Plus TDF/FTC Revealed

... large study to directly compare the efficacy and safety of nevirapine and ritonavir-boosted atazanavir ... is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been ... is not indicated for once-daily dosing. The safety and efficacy of once-daily dosing have not been ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

... that of placebo plus standard of care, while the safety profile was comparable overall to placebo. ... and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus ... care therapy in addition to the study medication. safety is reviewed by an independent Data Monitoring ...

BioCryst Pharmaceuticals Reports Positive Results of Shionogi & Co. Sponsored Phase 3 Studies of i.v. Peramivir for Influenza

... of i.v. peramivir that compared the efficacy and safety of a single dose of peramivir (either 300 mg or ... secondary efficacy endpoints and detailed safety is underway. Additional data will be submitted ... Peramivir has demonstrated clinical activity and safety in prior human studies. In laboratory tests, ...

Schering-Plough Expands Vicriviroc Phase II Study in Treatment-Naive Patients With HIV

... a formal interim analysis was conducted and the safety results were reviewed by an independent Data safety Monitoring Board. Based on these results, the ... it has been shown to have a more favorable lipid safety profile than other drugs in the PI class. ...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

... via a mild electric current, has demonstrated safety and efficacy in a Phase 2 clinical trial. ... placebo-controlled, two-arm study evaluating the safety and efficacy of the administration of lidocaine ... and were asked if they would use the IDDS again. safety of the treatment was also monitored during the ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... and sustained efficacy, combined with a good safety profile, supports Rigel's plans to conduct ... was the qualifying biomarker). safety Results The most common clinically meaningful ... completed the clinical trial with minimal safety issues. The most common adverse events in the ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... collectively called SREs. Full efficacy and safety data will be submitted for presentation at an ... on-study SREs, and to assess the safety and tolerability of denosumab compared with ... conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only ...

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets

... from the ASCEND studies [Assessing the safety and Clinical Efficacy of a New Dose of 5-ASA (4.8 ... HD in Moderately Active UC The efficacy and safety of Asacol HD was evaluated in the ASCEND studies. ... food, for a total daily dose of 4.8 g. The safety and effectiveness of Asacol HD beyond 6 weeks has ...

New AHRQ Study Finds Mixed Evidence on Use of Radiofrequency Catheter Ablation for Treating Atrial Fibrillation

... post approval studies (PAS) to collect long term safety data. The mandated studies apply only to ... is a post approval registry, which will collect safety (adverse event) data and operator experience ... The study will also collect data on long term safety (adverse events) data, such as death, stroke, ...

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

... showed similar effects on retinopathy and overall safety in the two treatment groups. This is the longest ... designed to further characterize the retinal safety profile of Lantus(R) versus NPH in 1024 patients ... was designed to further characterize the retinal safety profile of insulin glargine (glargine) and human ...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

... the second Phase 2 clinical study evaluating the safety and efficacy of its ARX-01 Sufentanil ... from the first Phase 2 study which evaluated the safety and efficacy of ARX-01 Sufentanil NanoTabs in ... where there is an unmet need for improved safety and efficacy. The company applies its proprietary ...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

... data continue to demonstrate the efficacy and safety of Zebinix(R) in the treatment of partial onset ... at the IEC further reinforce the efficacy and safety of eslicarbazepine acetate in the treatment of ... acetate has demonstrated a favourable safety profile(5). This has been further reinforced by a ...

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

... of experience, sanofi-aventis stands behind the safety of Lantus (R) ," said Jean-Pierre Lehner, ... registries are not conclusive." Patient safety is the primary concern of sanofi-aventis. The Group will continue to vigorously monitor the safety of Lantus(R) in close collaboration with ...

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... rheumatology community." The efficacy and safety of SIMPONI have been studied in a comprehensive ... injection given once a month. Important safety Information In Europe, SIMPONI is ... demyelinating disorders. There is limited safety experience of SIMPONI treatment in patients who ...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

... ) today announced that the Company is presenting safety and efficacy data for ACUROX(R) and EMBEDA(TM) ... III study evaluated the analgesic efficacy and safety of ACUROX(R) in adults with moderate to severe ... to severe chronic pain. This 12 month open-label safety study evaluated the plasma concentrations of ...

ThromboGenics' Microplasmin Phase III Program Progressing According to Schedule

... Treatment of Eye Disease With No Reported safety Issues ThromboGenics NV (Euronext ... The safety review was the final of two safety reviews, and had been scheduled to take place ... one month. Additional measures of efficacy and safety will also be assessed at various intervals over ...

Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease

... The Phase 3 trial will evaluate the efficacy, safety and pharmacodynamics of Amigal in males and ... histology. Secondary endpoints will include safety and tolerability, kidney GL-3 as measured in ... recommended a registration trial evaluating the safety and efficacy of Amigal in males and females with ...

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

... -- According to a report issued today, drug safety leaders in pharmaceutical and biotechnology ... or through partnerships, to comply with the safety regulations recently issued by the U.S. Food and ... European Medicines Agency (EMEA). The report - safety First: The Impact of New Regulations on ...

Neurocrine Biosciences Presents Elagolix Data

... reports results from a Phase II study where the safety of elagolix was evaluated in 252 women with a ... and other hormone dependent diseases. These safety results support selection of the appropriate ... for endometriosis suffer from both efficacy and safety shortcomings. The current standards of care such ...

Study Demonstrates Efficacy of Pitavastatin in Elderly Patients

... dyslipidemia in elderly patients, with a similar safety and tolerability profile to low-dose pravastatin. ... LDL-cholesterol lowering with no significant safety difference across all doses, and may represent a ... study was conducted for 12 weeks to compare the safety and efficacy of pitavastatin (1 mg, 2 mg and 4 ...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

... 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with ... endpoints are evaluated at 24 months. Longer term safety and efficacy data from patients who complete the ... patient-reported outcome measures in addition to safety and efficacy data. Information about the PROTEGE ...

VIA Pharmaceuticals Meets With FDA to Discuss Next Steps For VIA-2291 and Phase 3 Outcome Trial in Cardiovascular Disease

... safety and Biologic Activity Data Reviewed in End of ... Drug Administration (FDA). The Company reviewed safety and biologic activity data from the VIA-2291 ... without limitation, with respect to the safety and efficacy of VIA-2291; -- if the results ...

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

... trial to assess the efficacy and safety of Zyprexa in 72 adolescents (aged 13-17 years ... trial to assess the efficacy and safety of Zyprexa in 107 adolescents (aged 13-17 years) ... studies, the Committee reviewed extensive Zyprexa safety data relevant to adolescents. Increased weight, ...

New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

... by DAS28. Investigators reported that the safety profile of SIMPONI among anti-TNF-alpha ... trial that demonstrates the efficacy and safety of an anti-TNF-alpha agent in patients previously ... marketed by Xian-Janssen. Important safety Information SIMPONI(TM) is a prescription ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... the Go limumab - A R andomized EV aluation of safety and E fficacy in Subjects with Psoriatic A ... Research Institute. "The sustained efficacy and safety SIMPONI demonstrated through two years of ... marketed by Xian-Janssen. Important safety Information SIMPONI(TM) is a prescription ...

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

... in more than 100 countries. Important safety Information for ADCIRCA ADCIRCA should not be ... CYP3A, such as rifampin, should be avoided. The safety and efficacy of combinations of ADCIRCA with ... 1-800-545-5979 (1-800-LILLY-RX). Important safety Information for CIALIS (tadalafil) CIALIS is ...

Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)

... the following three abstracts: Efficacy and safety of NT-201 (Xeomin(R); botulinum neurotoxin type A ... cervical dystonia patients, Efficacy and safety of NT-201 (Xeomin; botulinum neurotoxin type A ... First Study -Title Efficacy and safety of NT-201 (Xeomin(R), botulinum neurotoxin type A ...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

... Cardiovascular safety and Potential Benefits of Exenatide to be ... cardiovascular outcomes trial to further evaluate safety and to determine if there are cardiovascular benefits of exenatide treatment." "Patient safety is of utmost concern at Amylin and Lilly," said ...

Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections

... Second Generation Oxazolidinone Demonstrates safety and Efficacy with Once-Daily, 200 milligrams (mg) ... from its Phase 2 clinical trial evaluating the safety and efficacy of oral torezolid (TR-701), its ... study achieved its primary goals of establishing safety and efficacy in all doses evaluated. In the ...