Safety in Medical News

Orexigen(R) Therapeutics Announces Second Quarter 2009 Financial Results

... include statements regarding the efficacy and safety of Contrave(R), the potential for, and timing of, ... with the Company's interpretation of efficacy and safety results; the FDA's draft guidance on general ... product candidate; the potential for adverse safety findings relating to Contrave or Empatic to delay ...

Patient Safety Technologies Reports Second Quarter Results

... Calif., Aug. 6 /PRNewswire-FirstCall/ -- Patient safety Technologies, Inc. (OTC Bulletin Board: PSTX) ... H. Kane, Chief Executive Officer of Patient safety Technologies. "An increasing number of the ... prestigious medical institutions are adopting the safety Sponge((TM)) System as the solution to the ...

Wrongful Death Lawsuit for Tyler R. Hill Against Ambassadors Group, docleaf, et al., Officially Settled

... REFORM: Traveling Youth's Standards of safety Legislation The Hill's mission for the safety of kids participating in travel programs is far ... law and the Traveling Youth's Standards of safety (TY's SOS legislation), and have engaged Senator ...

U.S. Navy Awards Entegrion Contracts for $4 Million for the Development of Critical Blood Products

... company's proprietary technologies to improve the safety and availability of blood-derived products for ... company's proprietary technologies to improve the safety and availability of blood -derived products for ... civilian medical operations by ensuring both the safety and timely availability of blood products to ...

News briefs from the August issue of Chest

... NEW REVIEW DEBATES NEED FOR ADDITIONAL LABA safety TRIALS In a new commentary, Malcolm R. Sears, ... Canada, discusses the familiar debate about the safety of using long-acting β2-agonists (LABA) in ... metaanalysis recently undertaken by the FDA of safety outcomes of 60,954 individuals in 110 LABA ....

DSM Announces SafeBridge(R) Potent Compound Safety Certification

... facility has received the( )Potent Compound safety Certification from SafeBridge((R)) Consultants, ... eight organizations have achieved Potent Compound safety Certification. The DSM North Carolina facility ... involved in the SafeBridge((R)) Potent Compound safety Certified program to date. DSM ...

100+ Nurses to Rally in SF Wed. to Demand Stronger Swine Flu Safety Protections: California Hospitals Remain Unprepared Despite First Nurse Death

... to protest gaps by California hospitals in safety preparation for the H1N1 pandemic, the California ... has uncovered, including systemic problems with safety gear for nurses and infection control procedures ... public awareness of the fragility of the public safety net, and legislative action to assure ...

Amgen and Wyeth Statement on FDA Announcement About Tumor Necrosis Factor (TNF) Blockers

... (FDA) announcement regarding the results of a safety review of Tumor Necrosis Factor (TNF) blockers ... pegol) and Simponi(R) (golimumab)]. This safety review was the subject of an FDA Early ... Amgen and Wyeth are committed to patient safety and support the continued evaluation of the ...

Medicines Top Source of Kids' Poisonings

... Daniel Budnitz, director of the CDC's Medication safety Program in the division of health-care quality ... drug manufacturers must create better child safety caps, including caps that limit the dose that can ... to encourage the implementation of new "passive" safety caps, Budnitz said. These caps do not require ...

Bionovo Presents Positive Results from Phase 1B Trial of Bezielle for Metastatic Breast Cancer

... In the trial, Bezielle showed an excellent safety and tolerability profile, and also showed ... with early signs of clinical efficacy. safety Analysis In comparison to other oral cytotoxic ... testing as the drug continues to have an improved safety profile over currently available chemotherapeutic ...

Arena Pharmaceuticals Announces Second Quarter 2009 Financial Results and Recent Developments

... Officer. "Based on its emerging efficacy, safety and tolerability profile, lorcaserin has the ... the second of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management, ... the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management, ...

Journal of Clinical Oncology Publishes TREANDA Study Demonstrating Significant Improvement in Overall Response and Progression-Free Survival in Chronic Lymphocytic Leukemia

... open-label study evaluated the efficacy and safety of TREANDA compared to chlorambucil in previously ... compared to chlorambucil with a tolerable safety profile." The study also showed that ... In the study, TREANDA demonstrated a tolerable safety profile; the most common adverse events included ...

Synthetic biology -- opportunities and risks

... research fields, current challenges, and the safety and ethical issues raised by the forward-looking ... the existing laws aimed at ensuring biological safety (biosafety) and at eliminating potential misuse ... assigned to the Central Commission for Biological safety (ZKBS). The "Synthetic Biology" statement is ...

Keryx Biopharmaceuticals Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial of KRX-0401 (Perifosine) in the Treatment of Multiple Myeloma

... 3 Randomized Study to Assess the Efficacy and safety of Perifosine Added to the Combination of ... trial comparing the efficacy and safety of KRX-0401 vs. placebo when combined with ... double-blind trial comparing the efficacy and safety of KRX-0401 to placebo when combined with ...

Cheerleading is Leading Cause of Catastrophic Injury in Young Women

... and schools monitor activities, coaching and safety precautions more closely ANN ARBOR, ... medicine. Data from the Consumer Product safety Commission shows that rates of injuries from ... Miller Bohn believes there aren't enough safety measures in place in schools. Many athletes will ...

Boehringer Ingelheim to Commence Phase III Study Investigating the Role of BIBW 2992 as First-Line Treatment for Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Mutations

... LUX-Lung 3 trial will compare the efficacy and safety of the single-agent BIBW 2992 to that of standard ... two Phase III trials assessing the efficacy and safety of BIBW 2992 in various NSCLC patient populations ... a Phase II study investigating the efficacy and safety of the compound in patients with relapsed ...

Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)

... of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase 3 clinical ... response letter must include an update of safety data from all on-going studies. Additionally, the ... the complete response letter and the efficacy and safety of KRYSTEXXA are forward-looking statements. ...

INVEGA(R) Approved as the First and Only Treatment for Schizoaffective Disorder

... to be efficacious with a demonstrated tolerable safety profile treating both the psychotic and affective ... illnesses." Please see the Important safety Information below. For more information, please ... important product information. IMPORTANT safety INFORMATION FOR INVEGA(R) INVEGA(R) is ...

Statement by Jim O'Hara, Director, Produce Safety Project, in Response to the FDA's Announcement Regarding Guidance on Produce Safety

... is a statement by Jim O'Hara, Director, Produce safety Project: We commend the FDA for moving forward on initiatives to improve the safety of fresh produce. The proposed guidance ... Science-based, risk-based, enforceable safety standards will restore consumer confidence in ...

Pelosi: Food Safety Act Will Protect Lives and Prevent Illness

... statement today on House passage of the Food safety Enhancement Act, which will give the Food and ... tools and funding to better ensure food safety and prevent food contamination. The House passed ... are widespread problems with our current food safety system, as we rely on a more global and ...

Pew Statement on House Passage of Food Safety Legislation

... to modernize and strengthen the nation's food safety system. This historic action takes a major step ... Americans can have increased confidence in the safety of their food. "Foodborne disease kills ... Drug Administration, which is responsible for the safety of over 80 percent of the foods we eat, has been ...

GMA Applauds U.S. House for Passage of Landmark Food Safety Bill

... Representatives for passing H.R. 2749, The Food safety Enhancement Act of 2009. The bill passed the ... of 283-142. "House passage of The Food safety Enhancement Act of 2009 marks an important ... legislation will strengthen our nation's food safety net by placing prevention as the cornerstone of ...

FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

... over those taking placebo (p<0.0005). The safety and effectiveness in patients with underlying ... type 5 inhibitor. Important safety Information for TYVASO TYVASO is a ... use only with the TYVASO Inhalation System. The safety and efficacy of TYVASO have not been established ...

rL Solutions to Sponsor 2009 MITSS HOPE Award

... the leading provider of healthcare quality and safety software, announced today that it will be ... to help healthcare organizations improve patient safety and healthcare quality. rL Solutions brings ... of partners to give its 600 clients a complete safety and quality solution. With products that are easy ...

MDS Nordion Submits Expression of Interest Proposal to Government of Canada on Medical Isotope and Generator Production

... them to be licensed by the Canadian Nuclear safety Commission (CNSC) for safe operation. During ... Cycle and Facilities Regulation, Canadian Nuclear safety Commission, stated "The issue is not whether, ... a mismatch between the (value) predicted in their safety case in the computer codes that said it should be ...

Eagles to Host 2nd Annual American Red Cross Training Camp Blood Drive

... The Blood Drive is part of the Eagles Health and safety Day activities taking place from 7-11 a.m. at the ... Presented by Teva Pharmaceuticals, Health and safety Day will feature important information and interactive displays on fire prevention and police safety with the Bethlehem Fire and Police Departments, ...

BioCryst Reports Second Quarter 2009 Financial Results And Provides Corporate Update

... body of data characterizing the efficacy and safety of peramivir as a potential treatment for ... seasonal influenza comparing the efficacy and safety of a single dose of peramivir (either 300 mg or ... Oncology (ASCO). This poster reviewed the safety and efficacy of forodesine for CTCL patients of ...

Top-Five Global Pharmaceutical Company Names NewCardio as its Provider of Automated Thorough QT Solution

... company evaluated several automated cardiac safety solutions before choosing QTinno(TM) as its ... demonstrates their commitment to quality, safety and the use of new technologies to drive ... of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug ...

BD Announces Results for Third Fiscal Quarter

... COMPANY SUPPLEMENTAL REVENUE INFORMATION safety REVENUES (Unaudited; Amounts in thousands) ... ---- -------- ------- ------ TOTAL safety REVENUES --------------------- United ... ---- -------- ------- ------ TOTAL safety REVENUES --------------------- United ...

Tyco International Reports Third Quarter Earnings from Continuing Operations Before Special Items of $0.58 Per Share and GAAP Earnings of $0.51 Per Share

... of lower volume and lower steel spreads. safety Products ... Fire Suppression, Electronic Security and Life safety businesses. These businesses experienced weaker ... Metal Products 320 652 safety Products 380 ...

Michigan IT Companies Helping the University of Miami Center for Patient Safety Tackle a Leading Cause of Death Using an RTLS Solution to Monitor Staff Hand-Washing Compliance

... The University of Miami UM-JMH Center for Patient safety has successfully launched a hand hygiene ... occurred. "Nothing matters more than the safety of our patients. That's why we are working with ... practices and fostering a culture of safety and accountability. Hospitals are able to ...

Industry And FDA Leaders To Discuss The Evolving Science Of Cardiovascular Safety (CV) And Diabetic Drug Development

... will host a two-day workshop on Cardiovascular safety and Development of Type 2 Diabetes Mellitus ... will host a two-day workshop on Cardiovascular safety and Development of Type 2 Diabetes Mellitus ... examine evolving scientific data surrounding CV safety and diabetic drug development, future methods to ...

Less Common Procedures, Less Common Than Thought

... Although 'fringe' procedures are underperformed, safety still needs to be a priority. When asked ... indicated they were most concerned about safety (88.8%) and cost (81.8%). Information on ... society whose members are dedicated to patient safety and physician education in cosmetic surgery. ...

New Agreement Between Amerinet and B. Braun

... with B. Braun Medical Inc. (B. Braun) for safety IV catheters. (Logo: ... user activation, providing an added measure of safety to healthcare professionals. About B. ... issues of infection prevention, medication safety and environmental responsibility by promoting ...

Carboxytherapy and Mesotherapy Unproven, Warns The Physicians Coalition for Injectable Safety

... 2009 -- The Physicians Coalition for Injectable safety today issued a consumer warning about ... medical journal, measuring both the efficacy and safety of mesotherapy," says Coalition leader Mark ... MD, Eugene, Oregon. "We don't know the safety or efficacy of these compounds and, until there ...

QuatRx Announces Further Positive Phase 3 Results For Ophena(TM) (Ospemifene Tablets) in Postmenopausal Vaginal Atrophy

... has also successfully completed two long term safety extension studies from its first pivotal Phase 3 ... first Phase 3 study. Phase 3 Long Term safety Update In January 2008, QuatRx announced ... . The Company has since completed two long term safety extensions from this first Phase 3 trial. Women ...

NHLBI stops study of pulmonary hypertension treatment in sickle cell patients

... sickle cell disease nearly one year early due to safety concerns. In an interim review of safety data from 33 participants who completed 16 weeks ... randomized clinical trial to test the safety and effectiveness of sildenafil for pulmonary ...

Seven Tips for Safer Home Swimming Pools and Hot Tubs

... in hot tubs, the need for home pool and hot tub safety is urgent. The American Red Cross and ... want all home pool and hot tub owners to make safety their priority by following these safety guidelines: Secure your pool with ...

Kaiser Permanente Approves $11 Million in Community Benefit Grants

... hospitals. Strengthening Communities' safety Net The Effort, a Sacramento, Calif., ... in San Diego County. The National Patient safety Foundation in Boston, Mass., received a $718,010 grant over two years for the "Patient safety Initiative at America's Public Hospitals." This ...

MSA Announces Second Quarter Results

... manufacture and supply of sophisticated safety products that protect people's health and safety. Sophisticated safety products typically integrate any combination of ... provides a broad range of consumer and contractor safety products through retail channels. These products ...