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New Legislation Seeks to Boost Participation in Clinical Trials for Rare Diseases

... introduced today would allow patients with rare diseases to participate in clinical drug studies ... prevents significant numbers of people with rare diseases from participating in clinical studies. Researchers developing drugs to treat rare diseases struggle to recruit participants for ...

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

... pain, dyspepsia and nasal congestion. In rare instances, patients taking PDE5 inhibitors ... muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than ... attention to avoid long-term injury. In rare instances, men taking prescription ED tablets ...

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

... including CIMZIA, has been associated with rare cases of new onset or exacerbation of clinical ... radiographic evidence of demyelinating disease. rare cases of neurological disorders, including ... CIMZIA in patients with these disorders. rare reports of pancytopenia, including aplastic ...

First Clinical Experience With Soliris(R) in Treating Patients With Two Rare Complement-Mediated Diseases Presented at ASH Annual Meeting

... in a limited number of patients with two other rare and severe complement-mediated diseases treated ... (aHUS) and Cold Agglutinin Disease (CAD), two rare and serious diseases. Like patients with PNH, ... effect of eculizumab in two patients with aHUS, a rare disease usually caused by a genetic mutation in ...

More Than 200 Abstracts at ASH and SABCS Reveal Potential Compelling Patient Benefits From Novartis Oncology Current and Pipeline Therapies

... Tasigna is not recommended for patients with rare hereditary problems of galactose intolerance, ... of Zometa. Hypersensitivity reactions, including rare cases of urticaria and angioedema and very rare cases of anaphylactic reaction/shock, have been ...

Enobia Initiates Infantile Enzyme Replacement Trial for Rare Bone Disease

... (ERT) with ENB-0040 for the treatment of this rare and often crippling genetic bone disorder for ... has worked as we hope it will." This rare disease leads to severe rickets in infants and ... the assistance of the Canadian Organization for rare Disorders (CORD). "CORD is delighted to ...

New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohn's Disease According to First-of-its Kind Study

... in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in ... Crohn's disease with REMICADE have developed a rare type of lymphoma that often results in death. ... skin rash and/or joint pain. There have been rare cases of serious liver injury in people ...

Continuous Treatment With Abbott's HUMIRA(R) Achieves Superior Long-Term Efficacy for Psoriasis Patients Compared to Interrupting Treatment

... information. Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic ... including HUMIRA, have been associated in rare cases with demyelinating disease including ... optic neuritis, and serious allergic reactions. rare reports of pancytopenia including aplastic anemia ...

deCODE and SGENE Consortium Discover Deletions in the Human Genome Linked to Risk of Schizophrenia

... the United States, report the discovery of three rare deletions in the human genome that confer risk of ... that we may have to identify a larger number of rare but high risk variants to understand the genetic ... others. SNP-chips are not well suited to finding rare SNPs but can, with sufficiently large sample ...

Edison Pharma Hits Milestone as A0001 Enters Phase 1 Clinical Development

... CoQ10 is a first-line therapy for many rare diseases of energy metabolism. Efforts to improve ... Edison's initial therapeutic focus is on rare inherited mitochondrial diseases. Today, there ... needed therapies for patients suffering from rare mitochondrial diseases. As we look toward the ...

Genzyme and Isis Complete Licensing of Mipomersen

... opportunity with Genzyme in CNS and certain rare diseases as part of this alliance." Deal Terms ... access to future Isis drugs for CNS and certain rare diseases. Mipomersen Development Plan The ... company's products and services are focused on rare inherited disorders, kidney ...

New Analysis Shows Efficacy of REMICADE(R) in Treatment of Ulcerative Colitis in Patients with Recent Disease Onset or Long-Standing Disease

... in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in ... Crohn's disease with REMICADE have developed a rare type of lymphoma that often results in death. ... skin rash and/or joint pain. There have been rare cases of serious liver injury in people ...

Study Shows Physician Judgment is Important in Reducing Rate of RSV-Related Hospitalizations Among High-Risk Infants

... the U.S. since its introduction in 1998. Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is ...

Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annual Meeting

... at high risk for serious RSV disease. Very rare cases (<1 per 100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. These rare reactions may occur when any dose of Synagis is ...

Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Acute Myelogenous Leukemia

... life-threatening or serious conditions that are rare and affect not more than five in 10,000 persons ... planning to test a product for use in a rare disease or condition generally characterized by a ... been stable or slowly increasing. AML is a rare form of cancer accounting for approximately ...

REMICADE-Treated Patients Experienced Rapid and Substantial Improvement in Psoriasis in Critical Regions of Body

... in patients on REMICADE or other TNF blockers are rare but occur more often than expected for people in ... Crohn's disease with REMICADE have developed a rare type of lymphoma that often results in death. ... skin rash and/or joint pain. There have been rare cases of serious liver injury in people ...

Twelve DOXIL(R) Clinical Studies to be Presented at American Society of Hematology Annual Meeting

... in discontinuation of treatment and in rare cases of death -- DOXIL may potentiate the ... have been reported in Japan. There have been rare reports of RPLS in patients receiving VELCADE. ... monitored during treatment with VELCADE. rare cases of acute liver failure have been reported ...

Biocept Announces Study to Isolate Circulating Tumor Cells from Blood

... and Extraction) technology, designed to capture rare cells from a larger heterogeneous cell ... study is ovarian cancer. "This innovation in rare cell capture offers an enhanced opportunity ... Isolation, purification and analysis of rare cells are managed within our ...

MedImmune Presents New Pharmaco-Economic Data at American Academy of Pediatrics Regarding Infants at High Risk for RSV

... visit http://www.medimmune.com . Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity ... reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on ...

Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome

... with Turner syndrome. Turner syndrome is a rare chromosomal condition caused by complete or ... unit, and we will continue to conduct research in rare disorders where there are currently treatment ... About Turner Syndrome Turner syndrome is a rare chromosomal disorder of females characterized by ...

Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome

... with Turner syndrome. Turner syndrome is a rare chromosomal condition caused by complete or ... unit, and we will continue to conduct research in rare disorders where there are currently treatment ... About Turner Syndrome Turner syndrome is a rare chromosomal disorder of females characterized by ...

MedImmune's Motavizumab Reduced RSV Hospitalizations by 83 Percent Among High-Risk Native American, Full-Term Infants in Placebo-Controlled Phase 3 study

... doses throughout the season. Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity ... reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on ...

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

... TNF-blocking agents, including SIMPONI, have been associated in rare cases with new onset or exacerbation of demyelinating disorders, including ... sensitive to latex. SIMPONI also contains sorbitol; patients with rare hereditary problems of fructose intolerance should not take SIMPONI. ...

AMT Receives EMEA Orphan Drug Designation for Acute Intermittent Porphyria

... Acute Intermittent Porphyria Acute intermittent porphyria is a rare genetic disease in which mutations in the PBGD gene result in insufficient ... such, AMT's proprietary platform holds tremendous promise for thousands of rare (orphan) diseases, especially those that are caused by one faulty gene. ...

Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples

... stomach, backache or muscle ache. As with any ED tablet, in the rare event of priapism (an erection lasting more than four hours), men should seek immediate medical attention to avoid long-term injury. In rare instances, men taking prescription ED tablets (including Cialis) reported ...

Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports

... in the formulation of Zometa. Hypersensitivity reactions, including rare cases of urticaria and angioedema and very rare cases of anaphylactic reaction/shock, have been reported. Due to the ...

OmegaGenesis Unveils Novel Nanotechnology Platform With Broad Biomedical Applications

... company's novel technology platform which employs nano-materials made of rare earth elements with angiogenic properties. Nanorod therapies for wound ... of the Mayo Clinic research team studying the properties of a number of rare earth element nano-materials as well as angiogenesis. Dr. Mukhopadhyay's ...

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

... clinical symptoms and/or radiographic evidence of demyelinating disease. rare cases of neurological disorders, including seizure disorder, optic ... in considering the use of CIMZIA in patients with these disorders. rare reports of pancytopenia, including aplastic anemia, have been reported ...

Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in Non-Alcoholic Steatohepatitis (NASH)

... Agency ("EMEA") to treat nephropathic cystinosis ("cystinosis"), a rare and genetic lysosomal storage disease. Raptor is developing cysteamine and ... is cleared for market by the FDA and EMEA to treat cystinosis, a rare and genetic lysosomal storage disease. The drug's potential to accumulate ...

CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients

... clinical symptoms and/or radiographic evidence of demyelinating disease. rare cases of neurological disorders, including seizure disorder, optic ... in considering the use of CIMZIA in patients with these disorders. rare reports of pancytopenia, including aplastic anemia, have been reported ...

CIMZIA(R) (certolizumab pegol) Reduces Intestinal Lesions and Induces Endoscopic Improvement in Crohn's Patients

... clinical symptoms and/or radiographic evidence of demyelinating disease. rare cases of neurological disorders, including seizure disorder, optic ... in considering the use of CIMZIA in patients with these disorders. rare reports of pancytopenia, including aplastic anemia, have been reported ...

RAD001 Combined with Sandostatin LAR(R) Depot and as Monotherapy Controls Growth of Rare Pancreatic Neuroendocrine Tumors

... tumor growth in patients with pancreatic neuroendocrine tumors (NET), a rare and difficult-to-treat form of cancer. These results, from the RADIANT-1 ... establish the role of RAD001 as a promising new option for patients with a rare and deadly form of cancer that historically has not responded well to any ...

Treatment Corrects Severe Insulin Imbalance in Animal Studies

... --Could Become First Effective Drug for rare Genetic Disorder in Children-- PHILADELPHIA, July 31 ... an innovative medicine for children with congenital hyperinsulinism, a rare but potentially devastating genetic disease in which insulin levels become ...

InCode BioPharmaceutics, Inc. Announces Key Data Supporting New Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH)

... the utility of their lead drug candidate rC3-1 for the treatment of the rare chronic blood disorder paroxysmal nocturnal hemoglobinuria (PNH). The ... of C3 has been shown to reduce PNH cell destruction. PNH is a rare debilitating and life-threading disease. PNH is an acquired genetic blood ...

The ED Conversation Dilemma: Forty Percent of Men with ED Don't Talk to Their Doctor, Survey Finds

... reported, sometimes with delayed onset. As with any ED tablet, in the rare event of priapism (an erection lasting more than 4 hours), seek immediate medical help to avoid long-term injury. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicine, ...

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

... acquisition brings a new addition to Shire's portfolio of treatments for rare disorders, prescribed by specialist physicians. The development of FIRAZYR ... also leverages our capabilities of building successful global products for rare diseases." Prof. Dr. Jens Schneider-Mergener, chairman of Jerini AG's ...

Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling Hemolysis

... improved the often disabling fatigue experienced by patients with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH) independent of ... can benefit from Soliris should have access to it." About PNH PNH is a rare blood disease that affects an estimated 8,000 to 10,000 people in North ...

Multiple Clinical Trials of VELCADE(R) (Bortezomib) for Injection Based Therapies Demonstrate High Complete Remission Rates in Patients with Newly Diagnosed Multiple Myeloma

... proportion of these events have been reported in Japan. There have been rare reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in ... counts (CBC) should be frequently monitored during treatment with VELCADE. rare cases of acute liver failure have been reported in patients receiving ...

Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Breast Cancer

... in the formulation of Zometa. Hypersensitivity reactions, including rare cases of urticaria and angioedema and very rare cases of anaphylactic reaction/shock, have been reported. Due to the ...

VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multiple Myeloma

... proportion of these events have been reported in Japan. There have been rare reports of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) in ... counts (CBC) should be frequently monitored during treatment with VELCADE. rare cases of acute liver failure have been reported in patients receiving ...
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(Date:9/16/2014)... 16, 2014 (HealthDay News) -- Although magnesium sulfate is ... preterm delivery, new research suggests it won,t provide any ... effects of magnesium sulfate given to pregnant women, researchers ... behavioral, growth or functional outcomes among those children when ... old. The new findings don,t negate the fact ...
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