Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis
... of 76 patients receiving SIMPONI 50 mg who
switched to SIMPONI 100 mg in early escape also achieved ... of 56 patients receiving SIMPONI 50 mg who
switched to SIMPONI 100 mg in early escape also achieved ... patients with inadequate arthritis response were
switched to SIMPONI 50 mg (patients originally receiving ...
VIDEO from Medialink and the Epilepsy Foundation: New Study Suggests Different Versions of the Same Epilepsy Medication Can Be Harmful
... or sudden death when their medications are
switched from one version of an antiepileptic drug (AED) ... worsened for 59 percent of people who had
switched from a brand-name to a generic AED, while side ... seizures worsened for 15 percent of those who had
switched from a generic to brand AED, while side effects ...
New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
... percent of patients who completed the study were
switched successfully, meeting the primary endpoint.
... was the proportion of patients successfully
switched (no worsening of UPDRS II+III >15 percent from ... trial, of which 84.5 percent were successfully
switched (with or without dose adaptation) to the ...
After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008
... This study also showed that
patients who
switched from BYETTA(R) (exenatide) injection after 30 ... either remained
on exenatide once weekly or
switched from BYETTA to exenatide once weekly
for an ... FPG
-47+/-3 mg/dL (LS mean+/-SE)]. Patients who
switched from BYETTA to
exenatide once weekly had further ...
Ustekinumab (CNTO 1275) Phase 3 Data Show Long-Term Improvement Of Chronic Plaque Psoriasis
... with 64 percent and 62 percent of
patients
switched to placebo (P less than or equal to 0.001 for 45 ... with 37 percent
and 38 percent of patients
switched to placebo.
"The Phase 3 efficacy and safety ... continue treatment with ustekinumab or were
switched to placebo.
Through week 12 (the ...
Generic Substitutes Less Effective/Safe Than Branded Medications in Treating Lower Urinary Tract Symptoms
... branded alpha blockers or 5-ARIs with an average age of 64, who were
switched to generic alternatives by their primary care physician or due to ... function and the prevalence of adverse events.
In the men who were
switched to generic medications, the IPSS and PVR rates increased and Qmax ...
Data From Investigational Use of PROCRIT(R) (Epoetin alfa) Presented at American Society of Nephrology Annual Meeting
... QW and Q2W) and treated for
44 weeks. Subjects receiving PROCRIT TIW were
switched to QW dosing after
22 weeks. A dose-adjustment algorithm was used to ... PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of ...
Sanofi Aventis: People With Type 2 Diabetes Treated With LANTUS(R) and APIDRA(R) Achieved Greater Reductions in A1C Than Those Treated With Pre-mixed Insulin
... One patient (1%) randomized
to the LANTUS(R)/APIDRA(R) treatment therapy
switched to the pre-mixed
insulin therapy, relative to 9 (10%) randomized to pre-mixed
switched to
the LANTUS(R)/APIDRA(R) treatment therapy.
Additional study findings ...
New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes
... state levels of
insulin in the body. At the end of the week, subjects were
switched to the
other insulin.
Both insulins were titrated to achieve blood ... need to be adjusted to reduce the risk of hypoglycemia in patients
being
switched to Levemir from other intermediate or long-acting insulin
preparations. ...
Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
... as the dosage of ASMANEX should be reduced slowly.
If you or your child took steroids by mouth and are having them decreased or are being
switched to ASMANEX, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal ...
ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients
... as the dosage of ASMANEX should be reduced slowly.
If you or your child took steroids by mouth and are having them decreased or are being
switched to ASMANEX, you should be followed closely by your health care provider and the oral steroids should be reduced slowly. Deaths due to adrenal ...
New Small and Medium Sized Enterprises Join TI Pharma by Signing Two New Projects
... are dependent on the formation of new blood
vessels. Furthermore, angiogenesis is an early event in the development of
tumors, being already
switched on in pre-cancerous events and long before
visible or clinically relevant tumor mass is present. Schaapveld: "These two
features make angiogenesis an ...
AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain
... from oral medication. Patients appear to tolerate the Sufentanil NanoTabs well, and following the end of the 12-hour study period when they were
switched to IV PCA morphine, many requested that they be returned to study drug. To me, these patients' requests are as demonstrative as any more quantitative ...
Infant Formula Company Teams With the University of Virginia Pediatrics Department to Conduct Clinical Studies
... M.D., Ph.D., U.Va. Department of Pediatrics and lead researcher on studies involving PBM formulas, it is very common for formula-fed infants to be
switched from one formula to another during the first year of life.
"It's important to remember that all infant formulas manufactured and sold in the ...
Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk
... randomized to remain on lorcaserin for Year 2 maintained a significantly greater amount of weight loss compared to the lorcaserin patients who
switched to placebo at Week 52 in both the ITT-LOCF and per protocol populations.
Secondary Endpoint Analysis
New data demonstrate that treatment ...
Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders
... measurements, amino acids, and urine collections were completed in a study unit after seven days of on-study treatment. Each patient was then
switched to HPN-100 at a dose providing the same amount of the active ingredient (PBA). After seven days of HPN-100 dosing, patients were re-admitted for the ...
Molecular Marker Identifies Normal Stem Cells as Intestinal Tumor Source
... Prominin1 cells generate the covering of the entire small intestine and are therefore the stem cell of this tissue.
Next, the researchers
switched on cancer-producing machinery in the Prominin1 intestinal stem cells and used a fluorescent tracer to follow the offspring of these cells. Those ...
Observational Study Finds Changes in Medicare Reimbursement for Erythropoiesis-Stimulating Agents Associated With Increased Need for Blood Transfusion
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins.
The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Novexel's NXL104/ceftazidime Combination Commences Phase II Clinical Trial in Hospital Patients With Complicated Urinary Tract Infections
... evaluation will be based on
the Test of Cure visit five to nine days post-therapy. After at least 4
days of IV antibiotic therapy, patients may be
switched to oral
ciprofloxacin, if they meet protocol-defined criteria. The total duration
of antibiotic therapy for each patient should be 7 to 14 days. The ...
Arpida Completes Enrolment in Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
... intravenous (IV) vancomycin
for the first two days of treatment and were then randomised to either
continue to receive IV vancomycin or to be
switched to oral iclaprim for
eight additional days. A total of 60 patients have been randomised for this
study.
The key objective of the study is to assess ...
European CHMP Issues Positive Opinion on Cymbalta for the Treatment of Generalised Anxiety Disorder
... the
likelihood of relapse in those patients who initially responded to
duloxetine and were maintained on treatment for six months compared with
those
switched to placebo.(7) The most common side effects in these studies
included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia,
decreased ...
Video: Clinical Study Shows Liraglutide Reduced Blood Sugar, Weight, and Blood Pressure in Patients with Type 2 Diabetes
... better glucose control than glimepiride. Patients previously
treated with diet and exercise had greater decreases in HbA1c, as compared
to subjects
switched from an OAD to liraglutide.
In addition, there was significant weight loss, as compared to weight
gain with glimepiride, and significantly greater ...
Observational Studies Assess the Potential Impact of Limiting Erythropoiesis-Stimulating Agent Availability on Frequency of Blood Transfusions
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Arpida Enrols First Patients in "Intravenous-to-Oral" Switch Trial With Oral Iclaprim
... from cSSSI receive i.v.
vancomycin for the first two days of treatment and are then randomised to
either continue to receive i.v. vancomycin or to be
switched to oral
iclaprim for eight additional days. A total of 60 patients will be
randomised for this study.
Dr Paul Hadvary, Head of Development of ...
Treprostinil Data Presented at American Thoracic Society Conference Demonstrates Significant Clinical Progress in All Four Routes of Administration
... Dr. Omar A. Minai of the Cleveland Clinic presented
data from an ongoing single-center, 8-week study of treatment satisfaction
of PAH patients who
switched from epoprostenol (Flolan(R)) to intravenous
Remodulin. Rapid switch from Flolan to Remodulin occurred by directly
switching the infusion pump ...
Abbott Presents Long-Term Data From Extension Study Showing Adult Crohn's Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission
... from the open-label arm of CHARM received their
previous open-label regimens [40 mg EOW or every week (EW)]. Patients in
the OLE study could be
switched to EW dosage for flare or non-response. The
results from both HUMIRA doses were pooled for the analyses.
About the CHARM Trial
The CHARM (Crohn's ...
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
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Ortho Biotech Statement on U.S. Food and Drug Administration Oncologic Drugs Advisory Committee Vote
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Totality of Available Data Reaffirms PROCRIT(R) (Epoetin alfa) Is Safe and Effective When Used Appropriately as Labeled to Treat Chemotherapy-Induced Anemia
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Statement from the American Diabetes Association Related to ACCORD Trial Announcement
... less than 6 percent or a
standard treatment program with an A1C between 7 percent and 7.9 percent.
The intensive participants in ACCORD are now being
switched to the standard
treatment program because of an increased death rate in the intensive
treatment program (14 deaths per 1000 patients per year versus ...
Observational Data Show Transfusion Patterns in Chemotherapy-Induced Anemia Patients Receiving Erythropoiesis-Stimulating Agents
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Research Identifies Need for Improved Understanding of Sickle Cell Disease in Adulthood
... were equally effective at reducing liver iron
concentration. In this four-year extension study, all patients stayed on
deferasirox (n=132) or were
switched to the therapy (n=53). The trial
showed that deferasirox demonstrated dose-dependent efficacy in patients
with sickle cell disease, with a manageable ...
PROCRIT(R) (Epoetin Alfa) Data to be Presented at American Society of Hematology Annual Meeting
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. -- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
... treatment of schizophrenia for 16 weeks (n=197) were randomized
and either continued on SEROQUEL XR (n=94; 400-800 mg/day, flexibly dosed)
or were
switched to placebo (n=103). The primary endpoint was the time from
randomization to psychiatric relapse (hospitalization for worsening
schizophrenia, ...
New Anti-TNF Golimumab Significantly Reduced Signs and Symptoms of Ankylosing Spondylitis According to Phase 3 Study Findings
... the placebo or 50 mg group demonstrating less than 20 percent
improvement from baseline in both total back pain and morning stiffness
measures were
switched to either golimumab 50 mg (previously receiving
placebo) or golimumab 100 mg (previously receiving golimumab 50 mg). Through week 24, golimumab was ...
New MIRCERA(R) Data Analyses to be Featured at the American Society of Nephrology Annual Meeting
... November 4: 10:00 a.m. - 12:00 p.m. PST. Exhibit Hall, Moscone Center)
-- C.E.R.A. maintains hemoglobin in dialysis patients directly
switched from epoetin (EPO) without increasing iron therapy requirements. A. Nissenson et al. (F-PO855. November 2: 10:00 a.m. - 12:00 p.m. PDT. ...
Progen Announces PI-88 Phase 2 Lung Cancer Results
... in patients with non small cell lung
cancer that have failed platinum based first line therapies is warranted.
However, nine patients in the study
switched to PI-88 after experiencing
toxicity or disease progression with docetaxel monotherapy. The data for
this patient group suggests a potential survival ...
Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins. * The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...
Results from Study Evaluating PROCRIT(R) in Intensive Care Unit Patients Published in New England Journal of Medicine
... antibodies. If erythropoietin antibody-mediated anemia is confirmed, PROCRIT should be permanently discontinued and patients should not be
switched to other erythropoietic proteins.
-- The safety and efficacy of PROCRIT therapy have not been established in patients with a known history of a ...