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Pneumonia in Medical Technology

Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma

... upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration ... studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), ... 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea ...

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

... in patients with cSSSIs and hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP) or healthcare-associated pneumonia (HCAP). Arpida is also pursuing the development ...

Physicians Estimate That if Approved, Ceftobiprole Will Steal Nearly a Third of Zyvox's Patient Share in the Treatment of Nosocomial Pneumonia

... Most Important Factors Driving Nosocomial pneumonia Prescribing in Hospitals Are Infectious Disease ... see how they would compete within the nosocomial pneumonia drug market. The new report entitled Hospital Anti-Infectives Insight Series: Nosocomial pneumonia found that the ceftobiprole analogue profile is ...

Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications

... of a serious complication: Ventilator Acquired pneumonia (VAP). In a peer review 2007 report in Physical ... by Stephen P. Burns MD, the incidence of SCI pneumonia for initial admitted patients was reported to be ... high as 50 percent. The associated mortality from pneumonia was reported as 28% in the first year. ...

Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia

... of adult patients with community-acquired pneumonia (CAP). Before granting approval, the FDA ... Community-Acquired Pneumonia CAP is defined as pneumonia acquired outside a hospital or long-term care ... decreased ability to function normally. Although pneumonia is not a reportable illness, it appears that up ...

Amikacin Inhale Shows Promising Results in Phase II Study

... II data for the adjunctive treatment of pneumonia in intubated and ... for the adjunctive treatment of Gram-negative pneumonia in intubated and mechanically-ventilated ... pneumonia. 'Gram-negative pneumonia' refers to pneumonia caused by a laboratory-defined group of ...

Arpida Provides Further Comments on the Pivotal Phase III Trials

... meeting discussing Community-Acquired pneumonia (CAP) in which the panel unanimously confirmed ... the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP). In January 2008, the US FDA granted ...

FDA Accepts Wyeth's Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia

... the treatment of patients with community-acquired pneumonia (CAP). The FDA now will complete its review ... System in Akron, Ohio. About Community-Acquired pneumonia CAP is defined as pneumonia not acquired in a hospital or long-term care ...

Chinese SFDA Grants Immtech Fast Track Status

... drug candidate for the treatment of Pneumocystis pneumonia (PCP). Pafuramidine is among the first drugs to ... lungs and can cause potentially life-threatening pneumonia in patients with HIV and other ... that include new oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (African ...

New Data Show Doripenem as Effective as Commonly Used Therapies in Treating Hospital-Acquired Pneumonias

... clinically cure 81% of patients with nosocomial pneumonia (NP), and 68% of patients with ... product in Japan in September 2005. Nosocomial pneumonia is acquired in either a hospital or ... 48 hours after admission. Ventilator-associated pneumonia is a form of nosocomial pneumonia which occurs in ...

Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)

... outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP) (11 positive, 3 negative, 1 abstaining). However, the committee ... approved for this or any other indication. About Community Acquired pneumonia (CAP) CAP is the sixth most common cause of death in the United ...

Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients

... events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, ... edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% ...

Rib-X Pharmaceuticals Reports Positive Top-Line Results from Phase 2 Study of Delafloxacin

... safety and efficacy of delafloxacin in the treatment of community acquired pneumonia (CAP). In this study, the compound was shown to be effective at doses as ... against methicillin-resistant S. aureus, multidrug-resistant Streptococus pneumonia and S. pyogenes. Additionally, Rib-X is developing delafloxacin, ...

Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008

... intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP). In May 2008, Arpida announced the enrolment of the first ...

Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim

... intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP). In May 2008, Arpida announced the enrolment of the first ...

New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients

... zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). ... events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, ...

Multiple Clinical Trials of VELCADE(R) (Bortezomib) for Injection Based Therapies Demonstrate High Complete Remission Rates in Patients with Newly Diagnosed Multiple Myeloma

... events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, ... arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. For more information about VELCADE clinical trials, patients ...

VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma

... events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, ... arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. For more information about VELCADE clinical trials, patients ...

Arpida Enrols First Patients in "Intravenous-to-Oral" Switch Trial With Oral Iclaprim

... intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP). In January 2008, the US FDA granted authorisation to progress ...

New Data Support High Complete Remission Rates With VELCADE(R) (Bortezomib) for Injection Based Therapies in Patients With Newly Diagnosed Multiple Myeloma

... events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, ... arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. For more information about VELCADE clinical trials, patients ...

More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL

... sought approval of TYGACIL for the treatment of community-acquired pneumonia (CAP). Wyeth's action is based on its understanding of the Committee for ... The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established -- In clinical trials, the most common ...

Arpida Invited to Present Data on Iclaprim at Scientific Conference

... intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP). In January 2008, the US FDA granted authorisation to progress ...

Immtech Focusing on Other Infectious Disease Programs Following Discontinuation of Development of Pafuramidine

... benefit and resources required relative to potential risk to pneumocystis pneumonia (PCP) patients does not support further development for this target ... Inc.'s business, including the future prospects for Pneumocystis pneumonia (PCP). Except for historical information, the matters discussed in this ...

Millennium Expands VELCADE(R) (Bortezomib) For Injection Program In Non-Hodgkin's Lymphoma

... events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, ... arrest, congestive heart failure, respiratory failure, renal failure, pneumonia and sepsis. This integrated analysis does not include the Phase III, ...

Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin

... Application (NDA) submission for cethromycin to treat community acquired pneumonia (CAP). The U.S. Food and Drug Administration (FDA) requires thorough QT ... (international), passcode 10008184. About Community Acquired pneumonia (CAP) CAP is the sixth most common cause of death in the United States. ...

Replidyne Provides Strategic Update

... faropenem in acute bacterial sinusitis (ABS) and community-acquired pneumonia (CAP) until a partner is identified. -- Business development. Replidyne ... infections including acute bacterial sinusitis (ABS), community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis (AECB). Faropenem is a ...

Immtech Reports Fiscal Second Quarter 2008 Results

... to conduct a Phase III trial with pafuramidine, to treat pneumocystis pneumonia in HIV/AIDs patients. The Company will hold a conference call on Friday, ... clinical programs that include new oral treatments for pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (African sleeping sickness or HAT), ...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

... key susceptible and resistant pathogens involved in community acquired pneumonia (CAP), while others reviewed safety data in certain special clinical ... bacterial resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 5,000 human subjects ...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

... key susceptible and resistant pathogens involved in community acquired pneumonia (CAP), while others reviewed safety data in certain special clinical ... bacterial resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 5,000 human subjects ...

US FDA Grants Orphan Drug Status to Immtech's Pafuramidine for Treatment of African Sleeping Sickness

... been granted Orphan Drug Designation for treatment of pneumocystis pneumonia (PCP) and malaria. In addition to trials for African sleeping sickness, ... clinical programs that include new oral treatments for Pneumocystis pneumonia (PCP), malaria, and trypanosomiasis (HAT or African Sleeping Sickness), ...

CMC ICOS Biologics and Implicit Bioscience Ltd Announce IC14 Antibody Manufacturing Agreement and Patent License

... leakage. ALI is caused by any stimulus of local or systemic inflammation and commonly occurs after acute insults to the body, such as trauma, severe pneumonia and sepsis. ALI is a key factor on the pathway to mortality following severe influenza infection. About IC14 IC14 is a clinical stage ...

Complications and Costs for Obesity Surgery Declining

... was driven by a reduction in the post-surgical infection rate, which plummeted 58 percent. Abdominal hernias, staple leakage, respiratory failure and pneumonia fell by between 50 percent and 29 percent. Rates for other complications, such as ulcers, dumping (involuntary vomiting or defecation), ...

Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections

... of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of endpoint has previously been used in pneumonia studies, but not in influenza. Secondary objectives of the study included evaluation of viral shedding, mortality, clinical relapse and time to ...

Three Studies Presented at the American Society of Hematology Annual Meeting Showed Response to Treatment with Campath(R) in Patients with High-Risk CLL

... bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections. Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... reported: arthralgia, rash, hypersensitivity, pulmonary hemorrhage, hemorrhage and epistaxis. Two patients in the placebo group died, one of fungal pneumonia and the other of pulmonary hemorrhage. One case of disease progression from MDS to acute myeloid leukemia was observed in the Nplate 500ug treated ...

CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors

... when administered to a pregnant woman. Nursing should be discontinued in women taking TEMODAR. Prophylaxis against Pneumocystis carinii pneumonia is required for all patients receiving concomitant TEMODAR and radiotherapy for the 42-day regimen. There may be a higher occurrence of PCP when ...

Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients

... vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), ...

Bayer Announces Upcoming Presentations of Campath(R) and Leukine(R) Data at the 50th Annual Meeting of the American Society of Hematology

... bacterial, viral, fungal, and protozoan infections can occur in patients receiving Campath. Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections. Campath is indicated as a single agent for the treatment of B-cell chronic lymphocytic ...

Wyeth Submits European Marketing Authorization Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Young Children

... all caused by the bacterium Streptococcus pneumoniae, that include invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media. Most recently, the pneumococcal serotype 19A, which is included in the candidate vaccine, has been increasing in prevalence in ...

New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria

... and pyelonephritis (2); complicated intra-abdominal infections (cIAI) (2); nosocomial pneumonia (NP), including early-onset ventilator-associated pneumonia (VAP) (1); and VAP, both early- and late-onset (1). The study results showed: -- Against ESBLE and CIPRE, doripenem was generally more potent in ...
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