Intravenous in Medical Technology

Scientific Data Relating to Cinryze(TM) Presented at 6th Annual C1 Inhibitor Deficiency Workshop

... pharmacokinetic study of subcutaneous and intravenous doses of C1 Inhibitor in an abstract entitled, 'Subcutaneous (SQ) Versus intravenous (IV) Infusion of C1 Inhibitor (INH) on Blood ... after treatment of episodes of swelling with intravenous C1 inhibitor. Abstract ...

Cadence Pharmaceuticals Submits Acetavance New Drug Application for the Treatment of Acute Pain and Fever

... approved, Acetavance would become the first new intravenous analgesic approved in the United States in more than 20 years and the only approved intravenous agent for the treatment of fever in the United ... more than 53 million patient exposures to intravenous acetaminophen in countries outside the United ...

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

... safety of five days of therapy with either 200 mg intravenous (i.v.) peramivir per day, 400 mg i.v. peramivir ... Ison. "Peramivir holds promise as a once-daily intravenous treatment that is safe and potentially effective ... influenza, utilizing either an intramuscular or intravenous formulation. A Phase 2 trial in outpatient ...

Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B

... IB1001, an intravenous Recombinant Factor IX (rFIX) Product for the ... of a Phase 1 clinical trial of IB1001, an intravenous (IV) recombinant Factor IX (rFIX) product for ... disorders." About IB1001 IB1001 is an intravenous recombinant Factor IX product for the acute and ...

Cytopia Concludes Phase I Oral Trial for Vascular-Disrupting Agent, CYT997

... the broad clinical potential of CYT997 in both intravenous and oral forms," said Mr. Andrew Macdonald, CEO. ... has already commenced Phase II studies for the intravenous form of CYT997 and intends to undertake similar ... twofold higher than those observed in the Phase I intravenous infusion study at a comparable dose, indicating ...

Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic in Acute Post-Operative Pain

... evaluate the analgesic efficacy and safety of intravenous CR845 during the post-operative period in women ... previous Phase Ia single-center clinical trial of intravenous CR845 evaluated the safety, tolerability, ... randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female ...

FDA Approves LUSEDRA(TM) (fospropofol disodium) Injection for Monitored Anesthesia Care (MAC) Sedation

... abstention) of approval of LUSEDRA for use as an intravenous sedative-hypnotic agent for sedation in adult ... prodrug of propofol that, after intravenous injection, is converted by alkaline phosphatase enzymes in the body into propofol. LUSEDRA is an intravenous sedative-hypnotic agent indicated for monitored ...

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

... results from a Phase 2 clinical trial with the intravenous form of its novel anionic quinolone antibiotic, ... The Company is developing both the oral and intravenous formulations of delafloxacin for the over $9.9 ... quinolones). Currently in development for an intravenous formulation, delafloxacin has also been shown to ...

Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome

... (FDA) has voted 17 to 2 against the approval of intravenous iclaprim, an antibiotic currently in development ... the European Medicines Agency (EMEA) accepted intravenous iclaprim for review August 2008. In September 2008, Arpida filed a New Drug Submission for intravenous iclaprim in Canada. Arpida continues to ...

Poniard Pharmaceuticals Announces Final Top-Line Results from Phase 1 Trial Demonstrating Positive Bioavailability with Oral Picoplatin

... were randomized to a single dose of either intravenous (120 mg/m squared) or oral picoplatin (200, 300 ... chemotherapy drugs. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by ...

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

... meeting in Washington, DC. In these studies, intravenous iclaprim, a novel antibiotic, showed high ... to linezolid. A New Drug Application for intravenous iclaprim in cSSSI will be discussed at the ... the U.S. filing of the New Drug Application for intravenous iclaprim for the treatment of cSSSIs. The ...

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

... III. Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets ... first patients in a Phase II clinical study with intravenous iclaprim in the treatment of patients with ... trial. Iclaprim could be offered not only as an intravenous therapy for hospital use in acute situations, ...

PharmAthene Presents Data for Protexia(R) and Valortim(R) at 2008 BARDA Industry Conference / PHEMCE Stakeholders Workshop

... Reported In a poster entitled, "Efficacy of intravenous Valortim(R), an Anti-toxin Monoclonal Antibody, ... ECL; a second cohort of 6 AGMs was treated with 2 intravenous doses of 10 mg/kg Valortim(R) (the first given ... and a third cohort of 6 AGMs was treated with one intravenous dose of 20 mg/kg Valortim(R) when positive by ....

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

... Patients suffering from cSSSI received intravenous (IV) vancomycin for the first two days of ... a medical need and could add significant value to intravenous iclaprim. Marketing applications for intravenous iclaprim have been filed in the U.S.A., the ...

Rib-X Pharmaceuticals Initiates Phase 2 Trial for RX-3341 In Complicated Skin and Skin Structure Infections

... the initiation of a Phase 2 clinical trial for an intravenous form of antibiotic compound RX-3341 in the ... safety, tolerability and pharmacokinetics of two intravenous formulations of RX-3341. Part 1 of the study was ... and pharmacokinetics of the optimized intravenous RX-3341 formulation. Results showed that the ...

MAP Pharmaceuticals Reports Positive Pharmacological Response Data for Migraine Product Candidate at the American Headache Society Annual Meeting

... the potential treatment of migraine, compared to intravenous (IV) DHE. The study results were among six ... inhaler. DHE is currently available as an intravenous therapy which has been used in clinical settings ... of intravenous DHE while avoiding the nausea that intravenous administration can cause. About Migraine ...

Poniard Announces Positive Efficacy and Safety Data From Phase 1 Trial of Picoplatin in Multiple Tumor Types Including Ovarian Cancer

... chemotherapy drugs. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... primary endpoint. The Company is also evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial ... same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by ...

Poniard Announces Positive Preliminary Efficacy and Safety Data From Ongoing Phase 2 Trial of Picoplatin in First-Line Treatment of Colorectal Cancer

... 2 study is comparing the safety and efficacy of intravenous picoplatin given once every four weeks in ... 2 clinical trial in CRC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 ... the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by ...

AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication

... When oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be ... 20 or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or ... with any other medications through the same intravenous site and or tubing. The intravenous line should ...

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

... therapy in comparison with a full course of intravenous (i.v.) treatment with vancomycin in the treatment ... therapy could add significant potential to the intravenous formulation." About Arpida Ltd. Arpida (SWX: ... III. Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets ...

Wyeth and Progenics Announce Preliminary Clinical Trial Results for RELISTOR Oral and Intravenous Formulations

... positive activity in a phase 1 trial." RELISTOR intravenous Formulation The Progenics-conducted phase 3 study of an intravenous formulation of RELISTOR for patients with ... the earlier findings of the Wyeth phase 3 intravenous POI study announced on March 12, 2008. ...

Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration

... involved treprostinil delivered by inhaled, oral, intravenous and subcutaneous routes of administration. "It ... treprostinil to therapeutic levels. intravenous Treprostinil In intravenous Treprostinil Effect on Angiopoietin-2 Levels ...

Amikacin Inhale Shows Promising Results in Phase II Study

... to the antibiotic amikacin as compared to intravenous route of administration. This shows ... and efficient treatment is essential. intravenous therapies cannot always reach effective ... decrease resistance -- especially if concomitant intravenous antibiotic therapy can also be reduced." ...

Poniard to Present Clinical Data From Picoplatin Trials in Multiple Tumor Types at American Society of Clinical Oncology 2008 Annual Meeting

... and formulations. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... endpoint. The Company is also evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial ... the same active pharmaceutical ingredient as the intravenous formulation. Picoplatin has not been approved by ...

Poniard Pharmaceuticals Completes Enrollment of Phase 2 Picoplatin Trial in Colorectal Cancer

... trial is to compare the safety and efficacy of intravenous picoplatin given once every four weeks in the ... metastatic CRC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... primary endpoint. The Company is also evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial ...

Poniard Pharmaceuticals Announces Final Picoplatin Data from Phase 2 Small Cell Lung Cancer Trial Demonstrating Survival Benefit

... chemotherapy drugs. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials ... combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell ...

Data Presented at AAN Support Potential for Adjunctive use of Intravenous Lacosamide as Short-Term Replacement for Oral Treatment in Partial Epilepsy

... Center, Baltimore. "In this study, short-term intravenous therapy with lacosamide was well tolerated ... infused at a rate of 10, 15 and 30 minutes. intravenous lacosamide was generally well-tolerated and the ... and similar across all infusion duration groups. intravenous lacosamide was also locally well-tolerated with ...

Study Results of GAMMAGARD S/D and GAMMAGARD LIQUID in Patients with Mild-to-Moderate Alzheimer's Disease Announced

... S/D and GAMMAGARD LIQUID [Immune Globulin intravenous (IGIV)] for the treatment of ... a severe anaphylactic reaction. Immune Globulin intravenous (Human) products have been reported to ... . GAMMAGARD S/D [Immune Globulin intravenous (Human)] GAMMAGARD S/D is indicated for the ...

Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference

... - Data Support intravenous to Subcutaneous Conversion - SAN DIEGO, April ... injection site reaction (ISR) profiles from two intravenous bisphosphonate formulations, zoledronic acid and ... local irritation and facilitate conversion from intravenous infusion to a more convenient subcutaneous route ...

Poniard Pharmaceuticals' Oral Picoplatin Demonstrates Positive Bioavailability in Ongoing Phase 1 Trial

... after picoplatin dosing -- by either the oral or intravenous route -- only background levels of circulating ... chemotherapy drugs. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials ...

Arpida Provides Further Comments on the Pivotal Phase III Trials

... As reported in November 2006 and July 2007, intravenous iclaprim achieved its pre-specified primary ... studies carried out, Arpida is confident that intravenous iclaprim has compelling properties, both in terms ... III. Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets ...

Arpida Invited to Present Data on Iclaprim at Scientific Conference

... the second pivotal Phase III trial with intravenous iclaprim in complicated Skin and Skin Structure ... (cSSSI). Moreover, data from Phase I studies with intravenous iclaprim, as well as preclinical data will be ... III. Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets ...

Poniard Pharmaceuticals Announces Presentation of Clinical Data From Picoplatin Phase 2 Small Cell Lung Cancer Trial to be Presented at 1st IASLC-ESMO European Lung Cancer Conference

... chemotherapy drugs. Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... primary endpoint. The Company also is evaluating intravenous picoplatin in two ongoing Phase 2 clinical trials ... combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell ...

Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously

... the skin) of GAMMAGARD LIQUID [Immune Globulin intravenous (Human)] (IGIV) with Enhanze(TM) Technology ... PA. GAMMAGARD LIQUID is approved for intravenous administration, which due to large infusion ... was 92 percent of the traditional, monthly intravenous administration. "These early results are the ...

Poniard Pharmaceuticals Announces Positive First-line Phase 1 Safety and Efficacy Data With Picoplatin in Metastatic Prostate Cancer Patients

... Phase 1 study, the recommended Phase 2 regimen of intravenous picoplatin (120 mg/m squared) and docetaxel (75 ... this year. About Picoplatin Picoplatin is an intravenous chemotherapeutic agent that has an improved ... in patients with mHRPC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ...

Poniard Pharmaceuticals Announces Picoplatin Safety Data in Colorectal Cancer

... mid year. About Picoplatin Picoplatin is an intravenous chemotherapeutic agent that has an improved ... in patients with mCRC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... primary endpoint. The Company also is evaluating intravenous picoplatin in an ongoing Phase 2 clinical trial ...

Poniard Pharmaceuticals Provides Year-End Clinical Update at 2007 Lazard Capital Markets Healthcare Conference

... Phase 3 SPEAR Trial: Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 trial, ... Phase 2 CRC Trial: Poniard is also evaluating intravenous picoplatin as a replacement for oxaliplatin in an ... meetings throughout 2008. Phase 2 HRPC Trial: intravenous picoplatin also is under evaluation in an ongoing ...

Genta Completes Initial Clinical Dosing of G4544, a New Oral Drug for Bone Diseases

... the active ingredient in Ganite administered by intravenous or subcutaneous injections have shown clinical ... convenience and avoid the current need for intravenous pumps or hospitalization. The initial focus of ... G4544 will be to evaluate bioequivalence with the intravenous product, potentially enabling rapid regulatory ...

Poniard Pharmaceuticals Initiates Randomized Phase 2 Trial of Picoplatin for First-Line Treatment of Metastatic Colorectal Cancer

... of a randomized Phase 2 trial to evaluate intravenous picoplatin for first-line treatment of ... 2 trial in metastatic CRC, Poniard is evaluating intravenous picoplatin in an ongoing pivotal Phase 3 ... primary endpoint. The Company is also evaluating intravenous picoplatin in an ongoing Phase 2 trial in ...

CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference

... Phase II clinical trial results on intravenous belinostat in combination with carboplatin and ... trials including Phase II results evaluating intravenous belinostat monotherapy for the treatment of ... The dose regimen (referred to as BelCaP) of intravenous (IV) belinostat 1000 mg/m2/d in combination with ...