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Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

LEXINGTON, Massachusetts, August 3 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, today reported positive results from the first of three Phase III studies of velaglucerase alfa, its enzyme replacement therapy in development fo...

Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease

LEXINGTON, Massachusetts, July 16 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement t...

Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease

LEXINGTON, Massachusetts, July 6 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY ), the global specialty biopharmaceutical company, announces that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment fo...

Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma

HOUSTON, July 1 /PRNewswire/ -- Agennix Incorporated today announced the publication of final results from a Phase 2 monotherapy trial with talactoferrin alfa in patients who had failed previous treatment for advanced or metastatic renal cell carcinoma (RCC). Results from the study, which were...

Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment Of Lung Cancer Meeting

Company Also Announces Receipt of Fast Track Designation from FDA, Favorable Scientific Advice from EMEA and Phase 3 Plans for the Non-Small Cell Lung Cancer Monotherapy Indication SANTA MONICA, Calif., Feb. 26 /PRNewswire/ -- Dr. Giuseppe Giaccone, Chief of the Medical Onco...

Preliminary Data From Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa

BRIDGEWATER, N.J., Sept. 17 /PRNewswire/ -- Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke. In this study, patients suffering acute ischemic stroke who were treated with ...

Two Phase III clinical trials on corifollitropin alfa (Org 36286) reach randomization target

OSS, the Netherlands, June 27, 2007-Organon, the human healthcare business unit of Akzo Nobel, announced today that two out of three Phase III clinical trials with corifollitropin alfa (Org 36286), a new long-acting fertility hormone, have reached their randomization target. Corifollitropin al...

Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma

... HOUSTON, May 19 /PRNewswire/ -- Agennix announced today that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carc...

Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial

... was to assess whether Bronchitol further improves lung function in patients already being treated with the most commonly used CF therapeutic, dornase alfa (Pulmozyme(TM)). This endpoint was also successfully achieved. For patients being treated with concurrent dornase alfa, FEV1 improved after 6 months...

Human Genome Sciences Reports Positive Late-Breaker Results at EASL from ACHIEVE Phase 3 Trials of Albuferon(R) in Patients with Chronic Hepatitis C

...Week 48 for ACHIEVE 2/3. About Albinterferon Alfa-2b (Albuferon) Albinterferon alfa-2b is a genetic fusion of human albumin and interferon alfa created using the proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circu...

Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib

...hose cancer progressed despite prior treatment with sunitinib, sorafenib or both sequentially. In addition, prior therapy with bevacizumab, interferon alfa and interleukin-2 was allowed. Patients were randomized to receive Afinitor (10 mg) daily or placebo, in conjunction with best supportive care. The pr...

Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C

...f albinterferon alfa-2b. About Albinterferon Alfa-2b (Albuferon) Albinterferon alfa-2b is a genetic fusion of human albumin and interferon alfa created using the proprietary HGS albumin-fusion technology. Human albumin is the most prevalent naturally occurring blood protein in the human circu...

Late-Breaking Data Highlighting Research Advances in Several Blood Disorders to Be Presented At the American Society of Hematology Annual Meeting

...s conducted of 13,933 patients with cancer enrolled in 53 randomized, controlled clinical trials comparing epoetin alfa, epoetin beta, and darbepoetin alfa plus red blood cell transfusions versus red blood cell transfusions alone for the prevention or treatment of anemia during or after receiving anticanc...

Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion

...noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important Safety Infor...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for rec...

Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting

...tential use of extended-dosing regimens of Epoetin alfa in this patient population," said Pablo E. Pergola...surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Impor...Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also ma...

Modigene Platform Validated in Independent Phase III Trial of CTP Technology

...n Board: MODG) today noted the successful completion of a Phase III clinical trial by Schering-Plough of long-acting fertility hormone corifollitropin alfa (FSH-CTP). FSH-CTP uses the naturally occurring CTP peptide to extend the duration of action of the hormone. Modigene is using the same naturally occu...

Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant

... Corifollitropin alfa meets primary endpoints in ENGAGE Trial KENILWOR...erence of +1.2 was in favor of the corifollitropin alfa 150 mcg treatment arm. Further results will be s... were randomized to receive either corifollitropin alfa 150 mcg or a daily dose of 200 IU recombinant FSH,...

Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent

...maceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF (Beta) 3) and veleglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesyla...

Observational Studies Assess the Potential Impact of Limiting Erythropoiesis-Stimulating Agent Availability on Frequency of Blood Transfusions

... noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important U.S. Safety Informat...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recu...

Two DOXIL(R) Studies to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

...nd marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious il...

New Data Highlighting Possible Impact of ESA Reimbursement Policies on Patient Care, Nation's Blood Supply, to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

...nd marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious il...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting

...ns, M. et al. Poster W1004, Abstract No. 441859, Wednesday, May 21, 8:00 a.m. - 5:00 p.m., Sails Pavilion. Rapid Virologic Response to Peginterferon alfa and Ribavirin Treatment of Chronic Hepatitis C Predicts Sustained Virologic Response and Relapse. Poordad, F. et al. Poster W1007, Abstract No. 439219...

Results of the Phase III Pivotal Study of VYVANSE(TM) (Lisdexamfetamine Dimesylate) for the Treatment of ADHD in Adults Presented at National Scientific Meeting of Psychiatrists

...armaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesyla...

New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months

...armaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesyla...

Shire's Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose

...armaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesyla...

Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting

...armaceutical research, product development including, but not limited to the successful development of JUVISTA(R) (Human TGF(beta)3) and veleglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesyla...

Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase 2 Study of Oral Talactoferrin in Severe Sepsis

.../PRNewswire/ -- Agennix, Inc. announced today that it has initiated a randomized, double-blind, placebo-controlled Phase 2 study of oral talactoferrin alfa in patients with severe sepsis. This is the first clinical trial of talactoferrin in sepsis and is based on both the mechanism of action of talactofer...

Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting

...VR) is dependent on baseline characteristics in the retreatment of previous alfa interferon/ribavirin (I/R) nonresponders (NR): final results from the EPIC3...16, Saturday, April 26, 4:00 p.m. Hall A. Colchicine versus peginterferon alfa 2b long term therapy: results of the 4 year COPILOT trial. Afdhal, N.H. et ...

Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings

...atterns and costs of PROCRIT (EPO) and darbepoetin alfa (DARB), evaluate medical costs related to chronic ... on Drug Utilization Patterns and Costs of Epoetin alfa and Darbepoetin Alfa -- Abstract: Assessment ...d Management Tool -- Abstract: Use of Epoetin alfa in Maintaining Hemoglobin Control Through a So...

Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote

... noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important U.S. Safety Informat...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recu...

Totality of Available Data Reaffirms PROCRIT(R) (Epoetin alfa) Is Safe and Effective When Used Appropriately as Labeled to Treat Chemotherapy-Induced Anemia

... noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important U.S. Safety Informat...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recu...

Observational Data Show Transfusion Patterns in Chemotherapy-Induced Anemia Patients Receiving Erythropoiesis-Stimulating Agents

... noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important U.S. Safety Informat...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recu...

MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders

... KGaA in Darmstadt, Germany. EMD Serono is a leader in fertility treatments, with Gonal-f (R) (follitropin alpha for injection), Luveris (R) (lutropin alfa for injection) and Ovidrel (R) Prefilled Syringe (choriogonadotropin alpha injection). The company has strong market positions in neurodegenerative di...

PROCRIT(R) (Epoetin Alfa) Data to be Presented at American Society of Hematology Annual Meeting

...vs. Standard Intervention With an Extended Epoetin alfa (EPO) Dose Regimen of 120,000 Units (U) Every ...ed either to "early" intervention with Epoetin alfa or to "standard" intervention with Epoetin alfa when hemoglobin decreased to <11 g/dL. -- Abstra...

Human Genome Sciences Announces Presentation at AASLD of Results of Phase 2b Trial of Albuferon(R) for Chronic Hepatitis C

...ment-naive patients with genotype 1 chronic hepatitis C. This Phase 2b study demonstrated that, with half as many injections as Pegasys (peginterferon alfa 2a), Albuferon was just as effective in achieving sustained virologic response (SVR) - an undetectable amount of virus in the blood at 24 weeks follow...

Pivotal MIRCERA(R) Study First to Convert Dialysis Patients From Frequent Dosing Directly to Once Every Two Weeks or Once Every Four Weeks

... (Hb) concentrations within the target range as effectively as ESAs epoetin alfa or beta, which are typically given three times a week. "Our findings demon...were randomly assigned to either of the MIRCERA arms or to continue epoetin alfa or beta at their current dose and administration interval. Patients randomi...

Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label

... noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important U.S. Safety Informati...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recu...

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

... noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ. Important U.S. Safety Informati...Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recu...

Affymax Announces Results From Phase 2 Clinical Trial of Hematide for the Treatment of Anemia in Dialysis Patients

...switch trial in patients previously treated with three-times weekly Epoetin alfa (EPO) demonstrated that mean hemoglobin (Hgb) levels can be maintained at c...ith stable baseline Hgb levels between 10 and 12.5 g/dL on previous Epoetin alfa therapy. The endpoints were Hgb and reticulocyte levels, Hematide dose adju...

Idenix Reports Results from Two Phase IIb Studies of the Combination of Valopicitabine and Pegylated Interferon in Hepatitis C Genotype-1 Patients at the 42nd Annual Meeting of the European Association for the Study of the Liver

...revir (SCH 503034), will be presented at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL). Pegylated interferon alfa and ribavirin therapy, the current standard of care, is successful in treating 42 - 46 percent of treatment-naive HCV genotype-1 infected patients.(1,...
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