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Idiopathic in Medical Technology

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... studies evaluating pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) were presented today in ... Shionogi in that country. About IPF idiopathic pulmonary fibrosis (IPF) is a disabling and ... InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus ...

Novel Therapeutic Approaches May Transform Treatment and Improve Patient Outcomes in Several Platelet Disorders

... new combination therapy for previously untreated idiopathic thrombocytopenic purpura (ITP), an ... in adult patients with previously untreated idiopathic thrombocytopenic purpura (ITP). The results of ... the Long-Term Treatment of Patients With Chronic idiopathic Thrombocytopenic Purpura (ITP): Results of a ...

CHMP Recommends Approval of New Indication for Enbrel(R) as Treatment for Severe Psoriasis in Paediatric Patients

... (RA) in adults, and polyarticular juvenile idiopathic arthritis (JIA) in children.(1) ... physical function. Polyarticular juvenile idiopathic arthritis Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to ...

New AMITIZA 8 mcg Phase III Studies Demonstrated Overall Symptom Improvement in Adult Women with Irritable Bowel Syndrome with Constipation (IBS-C)

... at a 24 mcg dose for the treatment of Chronic idiopathic Constipation in adults. These data were among ... About AMITIZA(R) (lubiprostone) for Chronic idiopathic Constipation and IBS-C Indication AMITIZA(R) ... AMITIZA(R) (lubiprostone) in the U.S. for Chronic idiopathic Constipation in adults and Irritable ...

InterMune Announces Progress on Pirfenidone in IPF

... long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The roll-over study ... Clinical Trial of Pirfenidone in Patients with idiopathic Pulmonary Fibrosis in Japan" [Session C95], ... at http://www.thoracic.org . About IPF idiopathic pulmonary fibrosis (IPF) is a disabling and ...

U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older

... to severely active polyarticular juvenile idiopathic arthritis (JIA). ORENCIA may be used as ... such as MTX or TNF antagonists. "Juvenile idiopathic arthritis is the most prevalent form of ... while on open-label treatment. About Juvenile idiopathic Arthritis (JIA) JIA -- also commonly known as ...

FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria

... allergies, as well as the treatment of chronic idiopathic urticaria. XYZAL(R) tablets received FDA approval ... runny nose, and itchy eyes. Studies in chronic idiopathic urticaria patients showed levocetirizine ... of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age ...

Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome

... Studies in Patients with Moderate-to-Severe idiopathic RLS SP 790 * In a multi-center, double-blind, ... efficacy in patients with moderate-to-severe idiopathic RLS who were treated for 24 months * A total ... States for the treatment of early-stage idiopathic Parkinson's disease and in Europe for the ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. ACTEMRA (known as RoACTEMRA in ...

Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients

... in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. ACTEMRA (known as RoACTEMRA in ...

New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting

... are indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD) and for moderate-to-severe primary restless legs ... and Drug Administration for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD). Boehringer Ingelheim Pharmaceuticals, Inc. ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, ... pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The ...

Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab)

... in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. The serious adverse ...

New Study Demonstrated ACTEMRA(R) (tocilizumab) Inhibited Progression of Joint Damage in Rheumatoid Arthritis Patients

... in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. The serious adverse reactions ...

ACTEMRA (R) (tocilizumab) Significantly Reduced Signs and Symptoms of Rheumatoid Arthritis in Patients Who Failed Prior Treatments

... in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. The serious adverse reactions ...

Early Data Show Potential for Imatinib Mesylate Tablets to Treat Life-Threatening Form of Pulmonary Artery Disease

... research with imatinib mesylate in another non-oncology disease called idiopathic pulmonary fibrosis (IPF), a condition in which the lungs become ... data analysis 6. National Library of Medicine Medical Encyclopedia. idiopathic pulmonary fibrosis. Gleevec(R) (imatinib mesylate) tablets prescribing ...

U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease

... tablets) in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Requip XL is the first and only oral once-daily ... are indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease and are administered once daily. Prescription Requip ...

ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies

... in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan. The serious adverse events ...

InterMune Announces Receipt of Fast Track Designation for Pirfenidone From FDA

... that its program for the development of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) has received "Fast Track" designation from the ... hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The ...

New Study Demonstrates ACTEMRA(R) (tocilizumab) Inhibits Progression of Joint Damage in Rheumatoid Arthritis Patients

... ACTEMRA was approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis in Japan. The serious adverse events reported in ACTEMRA ...

FDA Grants Priority Review for PROMACTA(R) (eltrombopag)

... . Accessed November 12, 2007. (2)Cines DB, Blanchette V. idiopathic thrombocytopenic purpura. N Engl J Med. 2002;364: 995-1008. (3)Feudjo-Tepie M, Robinson N, Bennett D. Prevalence estimates of adult chronic idiopathic thrombocytopenic purpura (ITP). J Thromb Haemost. 2008 doi: ...

Keppra XR(TM) Extended-Release Tablets Filed with the FDA

... tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Keppra(R) injection is indicated as adjunctive ... neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with ...

UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets

... tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Keppra(R) injection is indicated as adjunctive ... neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with ...

Neupro(R) (Rotigotine Transdermal System) Effective in Controlling Early Morning Motor Impairment and Generally Well-Tolerated for Long-Term Use in Patients with Parkinson's Disease

... United States for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, and in Europe for the treatment of patients with ... is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. Some patients treated with Neupro(R) reported falling ...

Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)

... oral gel capsules, twice daily) is indicated for the treatment of Chronic idiopathic Constipation in adults. AMITIZA should not be used in patients with a ... should consult their health professional. In clinical trials for Chronic idiopathic Constipation (24 mcg, oral gel capsules, twice daily), the most common ...

ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review

... (abatacept) for the treatment of pediatric patients with juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more ... signal required for full T-cell activation. About Juvenile idiopathic Arthritis JIA -- also commonly known as juvenile rheumatoid arthritis ...

Telik Announces Publication of Positive Phase 1 Results of a Multicenter Study of Ezatiostat Hydrochloride (TELINTRA(R), TLK199) Tablets In Patients With Myelodysplastic Syndrome

... support the further development of TELINTRA. Phase 2 studies are ongoing in MDS (enrollment completion expected by year end), and Severe Chronic idiopathic Neutropenia. Reprints of both publications are available from Telik. Background on MDS and TELINTRA MDS is a heterogeneous group of ...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

... patients they treat." About the Study The randomized, double-blind, 16-week, placebo-controlled Phase 3 study monitored 405 patients with idiopathic PAH or PAH associated with anorexigen use, connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital ...

FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension

... indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. "Today, thanks to the clinical development efforts ...

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

... buffered saline (IA-SA) for level of pain following a 50-Foot Walk Test, measured by 100 mm visual analog scale (VAS). The 586 patients with chronic idiopathic knee OA were randomized to treatment with either product in a 1:1 ratio. Each patient received one weekly injection for 3 weeks with 9 follow-up ...

Ipsogen Expands its US Market Presence Through Licensing Agreement With ARUP Laboratories for the Commercialization of JAK2 Molecular Diagnostic Assays

... This team identified the key role played by this mutation of the JAK2 gene in the development of MPN such as Vaquez disease (Polycythemia Vera), idiopathic Myelofibrose or Essential Thrombocythemia. Following this agreement, the company developed and marketed a complete portfolio of tests for the ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary ...

InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)

... the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has an R&D portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes pirfenidone for which a Phase 3 program in ...

Positive Data From Lung Study May Lead to First FDA Approved Treatment for Pulmonary Fibrosis

... such as scleroderma or rheumatoid arthritis. However, in many instances, no known cause can be established. When this is the case, it is called idiopathic pulmonary fibrosis (IPF). About the CPF The CPF is a 501(c)(3) nonprofit organization, founded in 2001 to accelerate research efforts ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... study was a six-month (24-week), randomized, double-blind, placebo-controlled international trial. It enrolled 669 patients with mid- to late-stage idiopathic Parkinson's disease (more than three years of disease duration) receiving stable doses of levodopa, who had motor fluctuations with >1.5 hours of ...

InterMune to Announce Results of Phase 3 CAPACITY Program of Pirfenidone in IPF Tomorrow, February 3

... -- InterMune, Inc. (Nasdaq: ITMN ) today announced that it will report results from its Phase 3 CAPACITY program of pirfenidone in idiopathic pulmonary fibrosis (IPF) prior to market open on Tuesday, February 3. InterMune will conduct a conference call and webcast, with accompanying slide ...

InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009

... the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is ...

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

... CYTOPENIAS, INFUSION REACTIONS, AND INFECTIONS Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30mg or cumulative ...

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

... . Accessed November 12, 2007. 2. Feudjo-Tepie M, Robinson N, Bennett D. Prevalence estimates of adult chronic idiopathic thrombocytopenic purpura (ITP). J Thromb Haemost. 2008; 6(4): 711 - 712. ...

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

... CYTOPENIAS, INFUSION REACTIONS, AND INFECTIONS Cytopenias: Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving Campath. Single doses of Campath greater than 30mg or cumulative ...
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