events in Medical Technology

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

THOUSAND OAKS, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN ) today announced positive top-line results from a pivotal Phase 3 head-to-head trial evaluating denosumab administered subcutaneously versus Zometa((R)) (zoledronic acid) administered as an intraveno...

Analysis of Edoxaban Phase II Data Provides Insight Into Reduced Bleeding Events Seen in Once-Daily Dosing

BOSTON and EDISON, N.J., July 15 /PRNewswire/ -- A sub-analysis of a Phase IIb multinational study(1) with edoxaban(2) - an investigational oral Factor Xa inhibitor - provides insights into why patients with non-valvular atrial fibrillation (AF) receiving edoxaban once daily (QD) experie...

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 Prospectively Assessed in Large Outcomes Trial NEW ORLEANS, June 8 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) today announced results from a meta-analysis of ...

National Hemovigilance Pilot Program Launches to Track Adverse Events Associated with Blood Transfusion

Goal is to Enhance Patient Safety and Reduce Health Care Costs BETHESDA, Md., May 7 /PRNewswire-USNewswire/ -- Beginning today, nine hospitals will join in a pilot program, contributing data on adverse events associated with blood transfusions. By analyzing the data collected, it w...

Micromet Key Events for 2009

BETHESDA, Md., Jan. 5 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI ), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, provides an outlook on key events anticipated for the year 2009. Mic...

Can Implantable Devices for Heart Failure Help Assess Risk of Future Adverse Events for Heart Failure Patients?

ICDs monitoring intrathoracic fluid identify patients at a high risk for subsequent adverse events in heart failure patients TORONTO, Sept. 24 /PRNewswire/ -- Today a clinical trial "PARTNERS HF: Multi-Site Program to Access and Review Trending Information and Evaluate Correlation to ...

Prasugrel Head-to-Head Study Showed Reduced Cardiovascular Events in Diabetes Patients by 30 Percent Compared with Clopidogrel

Sub-group analysis of landmark trial showed prasugrel substantially reduced risk of heart attack and stent thrombosis compared with clopidogrel among ACS patients with diabetes MUNICH, Germany, Aug. 31 /PRNewswire-FirstCall/ -- Patients who were diabetic and diagnosed with...

XIENCE(TM) V Drug Eluting Stent from Abbott Outperforms Market-Leading Stent in Reducing Major Adverse Cardiac Events at Two Years

Patients Treated with XIENCE V in SPIRIT III Trial Experience Better Long-Term Clinical Outcomes, Lower Rates of Stent Thrombosis than Patients Treated with TAXUS BARCELONA, Spain, May 13 /PRNewswire-FirstCall/ -- Long-term data presented for the first time today f...

New Data Show High Frequency of Medical Claims for Gastrointestinal Events by Patients on Antiplatelet Therapy

Review of Insurance Claims Tracked Ulcers and Bleeding Among 368,000 Patients Prescribed Clopidogrel TORONTO, May 6 /PRNewswire/ -- A review of medical claims from more than 70 managed care plans showed that 6.2 percent of patients prescribed the antiplatelet medicine clop...

Lotrel, a Single-Pill Combination for Treating High Blood Pressure, Reduced Cardiovascular Events by 20% in High-Risk Patients

- ACCOMPLISH first study to compare two single-pill combinations of commonly used high blood pressure medicines in reduction of cardiovascular events - RAS inhibition with an ACEI was the foundation of the combination therapies in this study and exceptional b...

Recent Findings from the Framingham Offspring Study Show Low Numbers of LDL Particles (LDL-P) by NMR are Associated With Fewer Heart Disease Related Events than Equivalently Low Levels of LDL Cholesterol (LDL-C).(1)

RALEIGH, N.C., Dec. 13 /PRNewswire/ -- The most recent study from the landmark Framingham trial demonstrates the clinical significance of knowing the number of LDL particles (LDL-P) by NMR in the management of a patient's risk for heart disease. This longitudinal outcomes study shows that low ...

FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)

WILMINGTON, Del., Dec. 10 /PRNewswire-FirstCall/ -- The US Food and Drug Administration (FDA) today issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN...

Abbott's XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial

One-year Data Demonstrate Continued Safety, Consistently Positive Clinical Results with XIENCE V WASHINGTON, Oct. 22 /PRNewswire-FirstCall/ -- Data presented today from Abbott's SPIRIT III U.S. pivotal clinical trial demonstrated continued positive, statistically signifi...

Head-to-Head Study Showed Prasugrel Statistically Superior to Clopidogrel in Reducing Recurrent Cardiovascular Events

New analysis of landmark study showed patients taking prasugrel had lower risk of combined endpoint of recurrent heart attack, stroke or cardiovascular death after first event than those taking clopidogrel TOKYO and INDIANAPOLIS, Aug. 21 /PRNewswire-FirstCall/ -- A new, pre-specified analy...

Data Presented at the American Psychiatric Association (APA) Annual Meeting Demonstrate Iloperidone's Efficacy and Safety, With Low Rates of Movement and Metabolic Adverse Events

Pharmacogenetic Findings May Lead to Individualized Treatment for Schizophrenia WASHINGTON, MAY 6 /PRNewswire-FirstCall/ -- Data presented today on Vanda Pharmaceuticals Inc.'s (Nasdaq: VNDA ) investigational drug candidate, iloperidone, included its 4-week, sho...

REACH Registry Demonstrates That Multiple Arterial Disease Locations Sharply Increase the Risk of Major CV Events in Outpatients With Atherothrombosis

- The Reduction of Atherothrombosis for Continued Health (REACH) - Registry 1-Year Results PARIS, March 20, 2007 /PRNewswire/ --The REACH Registry 1-year results paper published today in the Journal of the American Medical Association (JAMA) show that outpatients with atherothrombosis have a s...

ProNAi Announces Preclinical Success for PNT2258 Therapeutic - Curative Events in Xenograft Mice for Difficult-to-Treat Non-Hodgkin's Lymphoma

LOS ANGELES--(BUSINESS WIRE)--Apr 17, 2007 - ProNAi Therapeutics, Inc., a biopharmaceutical company pioneering a new class of nucleic-acid drugs based on DNA interference (DNAi), today announced that its lead oncology therapeutic candidate, PNT2258, has successfully demonstrated preclinical in vivo...

Hypertension Vaccine CYT006-AngQb Achieves Strong Blood Pressure Reduction During Important Early Morning Period When Most Adverse Cardiovascular Events Occur

- Blood pressure reduction achieved at 8 am versus placebo: - 25 / - 13 mm Hg (systolic / diastolic, p - Blood pressure reduction dependent on vaccine dose and induced antiangiotensin II antibody levels - Detailed results presented today at the Seventeenth European Meeting on Hypertension in Mil...

Lipitor Reduced the Risk of Coronary Events by Half and Stroke by Nearly One-Third in High-Risk Patients with Type 2 Diabetes Who Experienced a Recent Stroke

CHICAGO--(BUSINESS WIRE)--Jun 25, 2007 - Pfizer announced today that Lipitor (atorvastatin calcium) Tablets 80 mg reduced the risk of stroke, coronary heart disease events and major coronary events in type 2 diabetes patients who had no known coronary heart disease but who had experienced a recent ...

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

...ntibody in combination with oxaliplatin-based chemotherapy, including known events such as skin toxicity, hypomagnesemia and diarrhea. Originally desig...pies work by blocking the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, it is hypothesized that in patie...

SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application Suite

...live with Oracle Siebel Clinical Trial Management System and Oracle Adverse events Reporting System. "We are excited to have the rollout of the entire...is comprised of Siebel Clinical Trial Management System 8.0 (CTMS), Adverse events Reporting System 4.6 (AERS), Oracle Clinical 4.5.3 (OC), Remote Data Captur...

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

...k BMD by 4.1 percent compared with 2.2 percent for the Forteo(R) group. BA058 was generally safe and well tolerated in this study, with adverse events similar between the BA058 and placebo/Forteo(R) groups. In addition, the occurrence of hypercalcemia was half that of Forteo(R) in the highest dose of...

NewCardio Announces Master Services Agreement With Dedicated Phase I

... that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available informati...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...ents, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process i...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

...ined in this press release. The company undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: Jennifer Ruddock Nektar Therapeutics 650-631-4954 Susan Noonan The SAN Group 212-966-3650 ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

...caregivers and patients. In clinical trials, the most common adverse events (incidence greater than or equal to 5% and occurring at least twice as ofte...ate any forward-looking statements as a result of new information or future events or developments.) Contacts: Media Srikant Ramaswami: ...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

...s found to be generally well tolerated with no drug-related serious adverse events reported in the trial. No patients withdrew from the trial due to an adverse event. Most of the drug-related adverse events were reported in association with velaglucerase alfa infusions, all of whic...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

...no discontinuations. There were no serious adverse events and no dose-related trends in adverse events or laboratory abnormalities. "We are very ...cluding, without limitation, the risk that adverse events could cause the cessation or delay of any of the o...

Diabetes Gene Raises Odds of Lower Birth Weight

...ht. The finding sheds light on a possible genetic influence on how prenatal events may set the stage for developing diabetes in later childhood or adulthood. ...abetes . "It's a bit unusual to find a gene linked to both prenatal events and to a disease that occurs later in life," said study leader Struan F.A. ...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

...dustry. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise. ...

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

...o evaluated during these pivotal trials and safety data showed that adverse events reported by participants using INTUNIV were generally mild to moderate in s... transient and mild to moderate in severity.(1,2) Treatment-related adverse events greater than 10 percent included somnolence (32 percent), headache (26 perc...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

...s and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forwa...ts, whether as a result of new information, future events or otherwise. (i) Wucherpfennig KW, W...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

...rgent adverse events, breast pain, serious adverse events and withdrawals due to adverse events were similar among the active treatment groups and...concern. The incidences of breast pain and adverse events were similar between BZA/CE and placebo. ...

Cryo-Cell Announces C'elle(SM) Research and Development Collaboration with Cryopraxis Cryobiology Ltd.

...sion. The foregoing list is not exhaustive, and the Company disclaims any obligations to subsequently revise any forward-looking statements to reflect events or circumstances after the date of such statements. Readers should also carefully review the risk factors described in other documents the Company fil...

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

... effect at three months. The most frequent adverse events were as expected from the earlier TASKi trials and... common clinically meaningful drug-related adverse events noted in TASKi3 were diarrhea and hypertension. D...ith minimal safety issues. The most common adverse events in the trial overall were related to infections, t...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

...r medications. In asthma clinical trials, the most common adverse events reported with FORADIL AEROLIZER were viral infection, bronchitis, and chest infection. In COPD clinical trials, the most common adverse events reported with FORADIL AEROLIZER were upper respiratory infection, back pain...

Cardica Announces Publication of Pivotal PAS-Port(R) Proximal Anastomosis System Clinical Trial Results

...fficacy endpoint of non-inferiority in patency at nine-month follow up compared to hand-sewn anastomoses. In addition, of the 12 major adverse cardiac events (MACEs) reported that may possibly be related to target vessel revascularization, four (33%) may have been related to the PAS-Port system with eight (...

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

...g platinum-based cancer therapies. Results to date suggest that hematologic events are common but manageable. Kidney toxicity (nephrotoxicity) and nerve toxic...igation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrenc...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

... Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. ...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

...untreated, patients with high blood pressure are at risk for cardiovascular events such as stroke, heart attack and heart failure. Of US adults being treated,...ents contained in this press release as a result of new information, future events or otherwise. About Novartis Pharmaceuticals Corporation ...