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

... of SIMPONI(TM) (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, ... in the European Union, SIMPONI given as a 50 mg subcutaneous injection once a month will be indicated for: ... step closer to becoming the first once-monthly subcutaneous anti-TNF therapy for the treatment of rheumatoid ...

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

... Demonstrated Improvement With Every-Four-Week subcutaneous SIMPONI Despite Previous Medication or Reason for ... necrosis factor (TNF)-alpha agents and received subcutaneous injections of SIMPONI(TM) (golimumab) once every ... "The study demonstrates that every four-week subcutaneous injections of golimumab may benefit these ...

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

... Data in Patients Receiving Every-Four-Week subcutaneous SIMPONI Presented at 2009 EULAR Annual Congress ... placebo-controlled Phase 3 studies showed that subcutaneous (SC) injections of SIMPONI (TM) (golimumab) 50 ... study, patients receiving every-four-week subcutaneous treatment with SIMPONI experienced sustained ...

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

... treatment considerations and the potential for subcutaneous infusion, among others, ViroPharma is ... Abstract book page 46: subcutaneous Infusion of Cinryze in Pigs ... results of a comparative pharmacokinetic study of subcutaneous and intravenous doses of C1 Inhibitor in an ...

Genaera Presents Promising Preclinical Data for Trodusquemine (MSI-1436) at Keystone Symposia

... - subcutaneous Administration of MSI-1436 in DIO Rats ... Diet-Induced Obese Rats" concluded that a single subcutaneous dose of MSI-1436 leads to marked reductions in ... impact in this class of drugs. These initial subcutaneous studies of MSI-1436 exhibit dose-related ...

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

... endpoints. Abstract #329 subcutaneous Alemtuzumab (Campath) in Fludarabine-Refractory ... Markers The multicenter trial evaluated subcutaneous alemtuzumab given three times weekly at 30 mg in ... of alemtuzumab. Median age was 63 years. subcutaneous treatment was performed on an outpatient basis in ...

Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer

... to one of two treatment arms: once-daily subcutaneous injections of nadroparin (3,000 IU) or placebo. ... similar efficacy and safety between once-weekly subcutaneous injections of idraparinux with standard treatment ... thrombosis were randomized to receive weekly subcutaneous injections of 3 mg idrabiotaparinux (385 ...

Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis

... Patients Receiving Every Four-Week subcutaneous Golimumab Also Experienced Improvements ... that patients receiving every four-week subcutaneous injections of golimumab (CNTO 148) 50 mg and 100 ... therapy for patients who may benefit from monthly subcutaneous injections for RA and related rheumatic ...

Genmab A/S - Company Announcement Ofatumumab in Subcutaneous Study in Rheumatoid Arthritis Summary: Subcutaneous Administration of Ofatumumab Investigated in Phase I/II Study

... announced today a Phase I/II study to evaluate a subcutaneous route of administration of ofatumumab ... by GlaxoSmithKline. "The addition of a subcutaneous method of administrating ofatumumab is a great ... the pharmacokinetics/pharmacodynamics of subcutaneous dosing. Patients in both Part A and Part B are ...

New England Journal of Medicine Publishes Results From a RELISTOR Phase 3 Clinical Study

... trial of RELISTOR(TM) (methylnaltrexone bromide) subcutaneous injection in the May 29, 2008 issue of the ... four hours of receiving their first dose of subcutaneous RELISTOR than patients receiving placebo, without ... relief. RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid ...

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

... analgesic effects on the CNS. About subcutaneous RELISTOR On April 24, 2008, the United States Food and Drug Administration approved RELISTOR subcutaneous injection for the treatment of OIC in patients ... in April. Important Safety Information for subcutaneous RELISTOR -- RELISTOR is contraindicated in ...

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

... delivered by inhaled, oral, intravenous and subcutaneous routes of administration. "It has always been ... appears safe with efficacy maintained. subcutaneous Treprostinil In subcutaneous Treprostinil for Severe PAH: Hemodynamic and ...

BioMarin Initiates Phase 1 Clinical Study of PEG-PAL in PKU

... to assess the safety and tolerability of single, subcutaneous injections of PEG-PAL in subjects with PKU. The ... are to evaluate the pharmacokinetics of single, subcutaneous injections of PEG-PAL administered at escalating ... in the PKU mouse model demonstrated that weekly subcutaneous administrations of PEG-PAL resulted in a ...

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 16 ... and absorption of bisphosphonates in the skin and subcutaneous tissues with rHuPH20 could modify injection site ... models, absolute bioavailability by subcutaneous (SC) injection with rHuPH20 was comparable to IV ...

Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously

... results of a Phase I/II clinical trial, in which subcutaneous infusion (under the skin) of GAMMAGARD LIQUID ... doses and through multiple injection sites. subcutaneous administration of GAMMAGARD LIQUID with Enhanze ... Technology was applied to the development of a subcutaneous route of administration for GAMMAGARD LIQUID. ...

Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex

... R et al. Initial Experiences with subcutaneous Recombinant Human Hyaluronidase (rHuPH20). J Pall ... of other injected drugs, as an adjuvant for subcutaneous fluid administration (hypodermoclysis), and as an adjunct in subcutaneous urography for improving resorption of radiopaque ...

Research Identifies Need for Improved Understanding of Sickle Cell Disease in Adulthood

... is an oral drug, deferoxamine is administered via subcutaneous infusion. The study found that long-term use ... works as well as deferoxamine, which requires subcutaneous injection, among sickle cell patients; ... Because deferoxamine must be delivered via a subcutaneous injection, patients must typically visit their ...

MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study

... the inhaled insulin than those from the subcutaneous insulin injection -- Relative bioavailability of ... the QDose inhaled formulation compared with subcutaneous insulin. The relative bioavailability observed in ... For example, the effects of inhaled versus subcutaneous insulin. The European regulatory authority EMEA ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

... Subjects were randomized to receive exenatide once weekly 2 milligrams by subcutaneous injection weekly or insulin glargine injections administered daily in a ... and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on ...

Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study

... Subjects were randomized to receive exenatide once weekly 2 milligrams by subcutaneous injection weekly, sitagliptin 100 milligrams daily, or pioglitazone 45 ... and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on ...

Fertility Physicians of Northern California Researchers Test New Forms of Progesterone Medication for Luteal Support During IVF

... Formulations of progesterone medication which can be administered by subcutaneous injection or vaginal suppository may offer similar results with better ... compare an experimental progesterone, Progesterone-IBSA, which is given by subcutaneous injection, to an FDA approved progesterone, Endometrin(R), which is ...

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

... Poster 329 (December 8, 12:00 p.m. PST) -- subcutaneous Alemtuzumab (Campath) in Fludarabine-Refractory CLL: Final Results of the ... in two formulations, both of which are suitable for IV infusion and subcutaneous injection: Liquid: 500 mcg/mL sterile solution in ...

Study Shows Potential Benefits of Xolair(R) in Treating Children Suffering from Moderate or Severe Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

... Allergy, Asthma & Immunology (ACAAI) show that Xolair(R) (Omalizumab) for subcutaneous Use significantly reduced asthma attacks in children aged six through 11 ... Congress in October 2008. About Xolair Xolair(R) (Omalizumab) for subcutaneous Use is a humanized monoclonal antibody for moderate-to-severe allergic ...

MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes

... inhalations of Technosphere Insulin (the TI group) versus prandial subcutaneous injections of insulin aspart (the comparator group). Both groups also received daily subcutaneous injections of a basal insulin (insulin glargine). Study Highlights ...

Micromet Shows Feasibility of Subcutaneous Delivery of BiTE Antibody in Preclinical Primate Study

... for insulin delivery, may become an attractive alternative to repeated subcutaneous injection." Reference 1. Schlereth, B. et al. Feasibility of Repeated subcutaneous Delivery Establishes a New Route of Administration for Treating Cancer ...

Monogram Biosciences Provides Progenics Pharmaceuticals with HIV Assays for Use in Clinical Trials

... treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and post-operative ileus (intravenous formulation). In March ... Drug Application to the United States Food and Drug Administration for the subcutaneous formulation of methylnaltrexone for patients suffering from opioid-induced ...

Micromet Announces Presentation of Five Posters Related to Its Proprietary BiTE Antibody Platform at Annual Meeting of American Association for Cancer Research

... can be administered to primates with good bioavailability by subcutaneous delivery (abstract no. 2403). Jointly with its partner Medimmune, a ... References Schlereth, B. et al. Feasibility of Repeated subcutaneous Delivery Establishes a New Route of Administration for Treating Cancer ...

Immunosyn Releases Wound Healing Photographs From the First Phase 'Proof of Concept Trial' in Europe for Treatment of Diabetic Ulcers With Biopharmeceutical SF-1019

... LLC to release before and after wound healing photographs resulting from subcutaneous injections of the biopharmaceutical SF-1019 from the first phase of a ... its effect on Diabetic Polyneuropathy in Type 1 Diabetes Mellitus by both subcutaneous injection and by topical application. The first phase, which is now ...

Multiple Dose Clinical Trial of TorreyPines Therapeutics' Tezampanel Demonstrates Compound is Safe and Well-Tolerated

... met its primary endpoint for pain relief at two hours using a single 40 mg subcutaneous dose. In five previously conducted placebo-controlled, Phase II trials, ... in sequential, dose-escalating cohorts. Subjects received once-daily subcutaneous injections of placebo or 40 mg, 70 mg or 100 mg of tezampanel for four ...

Pharmacokinetic Data Suggest NGX426, TorreyPines Therapeutics' Oral Prodrug of Tezampanel, May be Effective in Treating Acute Migraine Headache

... 80 mg, oral dose of NGX426 is comparable to the AUC of a single, 40 mg, subcutaneous dose of tezampanel. With the recently demonstrated efficacy of 40 mg of ... when looked at in conjunction with the data from our evaluation of the subcutaneous form," said Neil Kurtz, M.D., President and Chief Executive Officer of ...

Phase 3 Data Show New Anti-TNF, Golimumab, Significantly Improved Arthritis, Skin and Nail Manifestations in Patients with Psoriatic Arthritis

... /PRNewswire/ -- Patients with active psoriatic arthritis receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) experienced significant and ... were sustained over time. "These Phase 3 data show that once monthly subcutaneous administrations of golimumab 50 mg and golimumab 100 mg significantly ...

New Anti-TNF Golimumab Significantly Reduced Signs and Symptoms of Ankylosing Spondylitis According to Phase 3 Study Findings

... Nov. 7 /PRNewswire/ -- More than half of patients receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) 50 mg and 100 mg experienced ... with active ankylosing spondylitis. Subjects were randomized to receive subcutaneous injections of golimumab 50 mg or 100 mg or placebo every four weeks. The ...

Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal of Medicine

... of 1,460 patients received either PROCRIT (n=733) or placebo (n=727) via subcutaneous injection on the first day of the study. For patients who remained in the ... reported in patients with chronic renal failure receiving PROCRIT by subcutaneous administration. If any patient develops a sudden loss of response to ...

Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009

... www.BYETTA.com . About Amylin, Lilly and Alkermes Amylin, Lilly, and Alkermes are working together to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes based on Alkermes' proprietary technology for long-acting medications. Exenatide once ...

Study Shows GSK's Novel Diabetes Treatment SYNCRIA(R) (albiglutide) Improves Glucose Control and Reduces Weight

... study in 356 subjects with type 2 diabetes previously treated with diet and exercise or metformin (mean baseline A1C 8%). Patients received subcutaneous placebo, albiglutide weekly, (4, 15 or 30 mg), biweekly (15, 30 or 50 mg) or monthly (50 or 100 mg), or exenatide (open-label reference arm, in ...

Bayer Announces Leukine(R) Data Presentations at 45th American Society of Clinical Oncology (ASCO) Annual Meeting

... bone marrow transplantation failure or engraftment delay. Leukine is available in two formulations, both of which are suitable for IV infusion and subcutaneous injection: Liquid: 500 mcg/mL sterile solution in multi-use vial Lyophilized powder: 250 mcg in single-use vial ready for ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... a novel pro-inflammatory target, we are actively preparing for the next stage of clinical development for MDX-1100 in RA, including the potential for subcutaneous dosing," said Geoffrey M. Nichol, M.B.Ch.B., Senior Vice President of Product Development at Medarex. "We also look forward to exploring the broader ...

Video: Partnership Unites UCB with Consumer Product Innovator OXO(R)

... had an inadequate response to conventional therapy. The new prefilled syringe is now also available to U.S. Crohn's patients taking Cimzia(R) for subcutaneous self-administration. The new syringe carries the Arthritis Foundation's Ease-of-Use Commendation, signifying a positive review of the syringe design ...

Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion

... develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST(R) (rilonacept) Injection for subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, ...

Dendreon Presents Preclinical Data Demonstrating Activity of TRPM8 Agonist, D-3263, in Benign Prostatic Hyperplasia

... Meeting in Chicago, IL, today in a poster session from 10:30 a.m. to 12:30 p.m. CDT. In a preclinical study, BPH was induced in rats through subcutaneous injection of testosterone propionate (TP). One week after initiation of BPH, either D-3263, finasteride (an inhibitor of the enzyme ...
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