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Injection in Medical Technology

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

... Union, SIMPONI given as a 50 mg subcutaneous injection once a month will be indicated for: ... in the US and Canada is a 50 mg subcutaneous injection given once a month. Important Safety ... AS, 5.8 percent of SIMPONI treated patients had injection site reactions compared with 2.2 percent in ...

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

... and Canada is 50 mg administered by subcutaneous injection once a month.) At baseline, 66 percent of ... percent, 3 percent and 1 percent of patients, and injection site reactions (ISR) through week 16 occurred in ... in the US and Canada is a 50 mg subcutaneous injection given once a month. Indications in the US: ...

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

... patients experiencing serious adverse events. injection site reactions occurred in eight percent of ... patients experiencing serious adverse events. injection site reactions occurred in 11 percent of patients ... in the US and Canada is a 50 mg subcutaneous injection given once a month. Indications in the US: ...

Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)

... 16.0%), neck pain (4.3% vs 8.5%, vs 10.0%), and injection site pain (2.2% vs 8.5% vs 2.0%) for each group, ... Period, and were treated with NT-201 (up to five injection intervals) over 1 year (48 to 69 weeks). ... rank test) at control visits during all four injection intervals and in all muscle groups. NT 201 was ...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

... CV events associated with BYETTA(R) (exenatide) injection use compared to a pooled comparator group treated ... About BYETTA(R) (exenatide) injection BYETTA is the first and only FDA-approved ... for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's ...

Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting

... [DAS] for the primary therapeutic target after injection of a 20 U/mL dilution or 50 U/mL dilution was ... from the organization WE MOVE. The individual injection pattern was adapted to patient's needs. A ... total dose was 495 units NT 201. Four weeks after injection 57.1% of patients had an at least 1-point DAS ...

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

... exenatide once weekly or BYETTA(R) (exenatide) injection for 30 weeks, followed by 74 weeks of treatment ... About BYETTA (R) (exenatide) injection BYETTA is the first and only FDA-approved ... to develop exenatide once weekly, a subcutaneous injection of exenatide for the treatment of type 2 diabetes ...

Ferring Pharmaceuticals Unveils Six-Month Efficacy Data for EUFLEXXA(R) for the Treatment of Osteoarthritis Knee Pain

... in a 1:1 ratio. Each patient received one weekly injection for 3 weeks with 9 follow-up visits over 26 weeks ... infections or skin diseases in the area of the injection site. Common adverse events reported were ... hyoscyamine sulfate), DESMOPRESSIN, DEGARELIX for injection and EUFLEXXA(R) (1% sodium hyaluronate). ...

Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy

... reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or ... (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of ... few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in two percent or less of ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, ... headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. In a study with ... There was a 23-24% incidence overall for injection site reactions or inflammation. Individual ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, ... headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. In a study with ... There was a 23-24% incidence overall for injection site reactions or inflammation. Individual ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, ... headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting. In a study with ... There was a 23-24% incidence overall for injection site reactions or inflammation. Individual ...

Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Development Projects

... compared with a commercial subcutaneous (SC) injection (2 mg dose), were demonstrated in a Phase I ... adverse effects were comparable to those after SC injection and typical of adverse effects that commonly ... apomorphine is administered by intermittent SC injection usually via a pre-filled autoinjector pen, or ...

Modigene Announces Positive Results of Pilot Toxicity Study of Its Long-Acting Human Growth Hormone hGH-CTP

... - Single injection in Primates Containing 1,000-Times the Dosage ... preliminary information on the approximate injection frequency that will be needed in human patients. ... this study also support once-weekly or bi-monthly injection frequency in humans. The pilot study ...

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

... INTRON A (Interferon alfa-2b, recombinant) for injection is contraindicated in patients with ... INTRON A; however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were ... (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, ...

U.S. Navy and U.S. Army to Develop Dengue DNA Vaccine Formulated With Vical's Vaxfectin(R) Adjuvant

... delivered with the Biojector(R) 2000 needle-free injection system (Bioject Medical Technologies Inc.) (OTC ... delivered with the Biojector(R) 2000 needle-free injection system. Preliminary results indicated that the ... adjuvant and delivered by needle-free injection using the Biojector(R) 2000, were promising. ...

Bioheart Reports Promising Results From Preclinical Study of Adipose-Derived Acute Cell Therapy

... /PRNewswire/ -- A preclinical study involving the injection of adipose-derived stem cells (ADSCs) into the ... of cardiomyocytes (heart cells) subsequent to injection of ADSCs following heart attack, or acute ... cardiomyocyte regeneration and suggest that the injection of ADSCs after AMI may have the potential to help ...

China Sky One Medical, Inc. Announces 26 New Drugs in Clinical Trials

... suppositories and Sodium ferulate injection are for the treatment of cardiovascular disease; -- Methionine Vitamin B1 injection is for improving liver function; -- Doxofylline injection is for the treatment of asthma; -- Pantoprazole ...

Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months

... that investigational olanzapine long-acting injection (LAI) therapeutic doses showed a maintenance of ... less than or equal to .05). The incidence of all injection site reactions, including injection pain, was 2.8 percent. Adverse events reported in ...

Karolinska Institutet to Test Vical's Vaxfectin(R) Adjuvant With Preventive Vaccine against HIV Under Sponsorship of Swedish Institute for Infectious Disease Control

... adjuvant with the Biojector(R) 2000 needle-free injection system (Bioject Medical Technologies Inc., OTCBB: ... delivered with the Biojector(R) 2000 needle-free injection system into either the muscle or the skin. In the ... and some with the Biojector(R) 2000 needle-free injection system into the muscle. The proposed KI/SMI ...

Karolinska Institute to Test Vical's Vaxfectin(R) Adjuvant with Preventive Vaccine against HIV Under Sponsorship of Swedish Institute for Infectious Disease Control

... adjuvant with the Biojector(R) 2000 needle-free injection system (Bioject Medical Technologies ... delivered with the Biojector(R) 2000 needle-free injection system into either the muscle or the skin. In the ... and some with the Biojector(R) 2000 needle- free injection system into the muscle. The proposed ...

Journal of the American Dental Association Publishes Key Clinical Data for the Use of OraVerse(TM) a Local Anesthetic Reversal Agent

... on the use of OraVerse (phentolamine mesylate) injection as a local dental anesthetic reversal agent in ... About OraVerse OraVerse (phentolamine mesylate) injection is the only local anesthetic reversal agent that ... deficits resulting from an intraoral submucosal injection of a local anesthetic containing ...

New Survey Explores the Impact of Insulin Injections and Communications Between Patients and Healthcare Providers

... lives." To reinforce the goals of the injection Impact Report, and to continue to address the ... to patient adherence, the AADE created the injection Impact Report Discussion Group comprised of a ... In response to the results from the injection Impact Report, the Discussion Group is developing ...

BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting

... (i.v.) peramivir administered via a single dose injection in the outpatient setting for the treatment of ... Subjects were randomized to receive an i.v. injection of placebo or one of two doses of peramivir (300 ... did not receive adequate dosing by intramuscular injection may not be correct, that HHS and the Food & ...

Bioheart Reports Promising Results From SDF-1 Modified MyoCell(R) Therapy in Heart Failure Study

... -- Results of a preclinical study involving the injection of myoblasts modified to express stromal derived ... MyoCell(R) is being delivered via a MyoStar(TM) injection catheter(2), in combination with the NOGA(R) ... Infarction(s) (2) The MYOSTAR(TM) injection Catheter is not available for sale in the U.S. It ...

Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

... observation time point of three minutes after injection -- Significantly faster and greater glucose lowering activity early after injection -- Significantly greater peak insulin levels for ... better overall glycemic control and simplified injection timing." rHuPH20 is the active ingredient in an ...

Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Association Meeting

... 66 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into ... 30 subjects) was treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into ... 30 subjects) will be treated by intramuscular injection of 60 mg of SB-509 (30 mg of SB-509 per leg) into ...

FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture

... for once-yearly Reclast(R) (zoledronic acid) injection to include the prevention of new clinical ... the brand name Zometa(R) (zoledronic acid) injection 4 mg administered every three to four weeks in ... . References 1. Reclast(R) (zoledronic acid) injection [Prescribing Information]. East Hanover, NJ: ...

Kosan's Lead Hsp90 Inhibitor, Tanespimycin, Shows High Level of Activity in Trastuzumab Resistant/Refractory HER2-Positive Breast Cancer in a Phase 2 Trial

... activity and toxicity were similar between the injection and Injectable Suspension products. -- Of ... patients enrolled, 21 were treated with Kosan's injection product (Cremophor(R)-containing formulation ... 4 of the patients treated initially with the injection formulation crossed over to receive the ...

Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytren's Contracture

... pain, swelling, bruising and pruritis at the injection site and transient lymph node swelling and pain. ... related to tendon or ligament injury (rate per injection = 0.24%). "We believe that this is a great day ... to assess the pharmacokinetics of a single injection of XIAFLEX in 16 subjects with Dupuytren's ...

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

... for NEXIUM(R) I.V. (esomeprazole sodium) for injection to seek approval for use in patients with peptic ... this indication.(2) Presently, NEXIUM I.V. for injection is indicated for the short-term treatment (up to ... sodium) for Injection NEXIUM I.V. for injection is indicated for the short-term treatment (up to ...

ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study

... a statistically significant reduction in injection site reactions when compared to Navelbine ... and President of ADVENTRX. "The improvement in injection site reactions could translate into a real ... A summary of post-hoc analyses regarding injection site reactions is set forth in the following ...

Patients Treated with Risperidone Long-Acting Injection had a Significantly Longer Time to Relapse Compared to Quetiapine in International Clinical Study

... more withdrawals due to non-compliance/refusing injection were reported for RLAI (three percent) than ... Long-Acting Injection Risperidone long-acting injection (RLAI) is a long-acting injectable atypical ... FOR RISPERIDONE AND RISPERIDONE LONG-ACTING injection (RLAI) Elderly Patients with dementia-related ...

Got Fat?: Plastic Surgeons Review Fat-Melting and Fat-Grafting Procedures

... in this year's Hot Topics program: -- injection Lipolysis (Otherwise known as Mesotherapy or ... will be discussing ASERF's Clinical Trial on injection lipolysis. The trial will study 10 patients receiving four injection lipolysis treatments to one side of their ...

Novagali Pharma Successfully Enrolls First Patient in U.S. Phase I Clinical Study with CORTIJECT(R) for Diabetic Macular Edema

... issued on January 18th, 2008). "This first injection in patient is a crucial step toward the ... Administering this emulsion through a single injection can offer real medical value to both ... suffering from DME with a single intravitreal injection (inside the eye) of CORTIJECT(R) formulation. The ...

GlaxoSmithKline Reports Further Progress of Oncology Portfolio

... Safety Information for HYCAMTIN HYCAMTIN for injection is used for the treatment of recurrent ovarian cancer. HYCAMTIN for injection is used for the treatment of small cell ... of your first treatment. HYCAMTIN for injection plus cisplatin is used for the treatment ...

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

... as follows: -- In rodent intradermal models, injection of bisphosphonates without rHuPH20 created injection site reactions characterized by erythema, ... bioavailability by subcutaneous (SC) injection with rHuPH20 was comparable to IV infusion. ...

Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids

... infusion of Reclast(R) (zoledronic acid) injection 5mg was significantly better than risedronate at ... under the brand name Zometa(R) (zoledronic acid) injection 4 mg for use in certain oncology indications(7). ... Inc.; May 2007. 5. Reclast(R) (zoledronic acid) injection [Prescribing Information]. East Hanover, NJ: ...

CVBT Appoints Dr. Nabil Dib as Principal Investigator for Phase II Heart Trial

... the NOGA(R) XP mapping system and the MyoStar(TM) injection catheter. These two devices will be used in ... receive training on the NOGA XP system or MyoStar injection catheter, and will work closely with the other ... II heart trial to ensure the safe and accurate injection of FGF-1 into the heart. "We are extremely ...

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

... (10 to 17 years old). ABILIFY(R) (aripiprazole) injection is indicated for the treatment of adults with ... ready-to-use solution for intramuscular injection 7.5 mg/mL. In adult patients, the ... associated with bipolar mania, the ABILIFY injection initial dose is 9.75 mg/1.3 mL. If ongoing ...
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