FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
... that is more frequent
and severe than is typically observed in individuals at a comparable level of
development.(17,18) The specific
etiology of ADHD is unknown and there is no
single diagnostic test for this syndrome.(12) Adequate diagnosis requires the
use of medical and special ...
Carbapenems and Other Agents that Provide Broad-Spectrum Activity are Preferred by Surveyed Physicians for the Treatment of Intra-Abdominal Infections
... as the leading attribute in antibiotic selection. Intra-abdominal infections are often polymicrobial in nature and involve anaerobes specific to the
etiology of the infection, so activity against these organisms is advantageous even without bacterial confirmation.
"Physicians also rank availability ...
New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)
... that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific
etiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special ...
Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
... that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific
etiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate
diagnosis requires the use of medical and special ...
Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State
... center of Quest Diagnostics. "Since its launch in mid-2007, physicians outside of New York have used our ClariSure test to identify the genetic
etiology of congenital anomalies, autism and other disorders for dozens of patients whose conditions had eluded prior diagnostic efforts. We look forward to ...
ISTA Pharmaceuticals Announces Positive Results for Phase IIb Study of Ecabet Sodium
... versus placebo. This result is important because it indicates an effect on basal tear secretion, which is one of the main factors in the
etiology of dry eye disease. In addition, the percentage of patients who responded to ecabet sodium was greater than that seen in the trials that led to the ...
Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma
... no risk factors for decreased left ventricular ejection fraction. There have been reports of acute diffuse infiltrative pulmonary disease of unknown
etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these ...
Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System
... surgery for mitral stenosis. At 12 months no
important differences were reported between the use of one or two MitraClip(R)
devices or based on the
etiology of MR.
The analysis was conducted to assess diastolic mitral valve function after
percutaneous repair. Echocardiographic measurements of MVA ...
Parents Make Donations to National Autism Association for Cutting-Edge Research
... suffered with gastrointestinal
problems seriously." She added, "We are honored to be able to support Dr.
Wakefield as he continues to pursue the
etiology and effective treatments
for those diagnosed with autism."
NAA's main research focus is on the environmental component of autism
spectrum ...
New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients
... no risk factors for decreased left
ventricular ejection fraction. There have been reports of acute diffuse
infiltrative pulmonary disease of unknown
etiology such as pneumonitis,
interstitial pneumonia, lung infiltration and Acute Respiratory Distress
Syndrome in patients receiving VELCADE. Some of these ...
Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients
... of these disorders in
patients prior to Clolar administration and/or previous therapy or
concurrent illness in patients receiving Clolar makes the
etiology of these
disorders unclear.
Clolar may cause fetal harm when administered to a pregnant woman.
Women of childbearing potential should be advised to ...
Ception Therapeutics Initiates Phase II/III Clinical Trial for Its Lead Product Reslizumab in Eosinophilic Esophagitis (EE) in Children
... and the absence of acid reflux or failure to respond to
acid reduction therapy.(1)
Allergic responses have been strongly implicated in the
etiology of
EE.(1) The overexpression of the cytokine IL-5 by T helper type 2 cells is
thought to play a major role in the pathogenesis of the ...
Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
... of these disorders in
patients prior to Clolar administration and/or previous therapy or
concurrent illness in patients receiving Clolar makes the
etiology of these
disorders unclear.
Clolar may cause fetal harm when administered to a pregnant woman.
Women of childbearing potential should be advised to ...
Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout
... effect and its mechanism of action, as these may
influence further development plans.
Current Treatment Options
Despite the well-understood
etiology of gout, current treatment options
are limited. There have been no new therapies approved by the FDA for the
treatment of hyperuricemia associated ...
Cutanea Announces Promising Phase II Results in Rosacea with Omiganan
... J. Bitterman, President and CEO of
Cutanea. About Rosacea Rosacea is a chronic dermatologic disorder with no current cure and a
poorly understood
etiology that afflicts an estimated 14 million Americans.
Symptoms primarily manifest on the facial skin and include facial flushing,
central facial ...
Accentia Biopharmaceuticals Scientific Presentations Demonstrate
Increasing Acceptance of Fungal Etiology of Chronic Sinusitis at
the Annual Meeting of the American Academy of Allergy, Asthma, and
Immunology
... (CS), the knowledge and attitudes of
the fungal
etiology of CS, and the differences in treatment
practices ... (88%).
The second poster, entitled "Fungal
etiology of Chronic
Sinusitis: Knowledge and Attitudes ... been substantiated to support a fungal
etiology to CS.
Additionally, 74.9% of the U.S. and 75.4% ...
Dong-A PharmTech Co., Ltd. Announces Positive Results for Udenafil,
Its New Long Acting Drug For Erectile Dysfunction
... to investigate the efficacy and safety of udenafil in
patients with ED. Following a 4-week non-drug baseline period, 340
men with ED of broad
etiology and severity were randomized to one
of four treatment groups: Placebo, udenafil 50mg, udenafil 100mg or
udenafil 150mg. The drug treatment period was ...
Callisto Intends to Move Guanilib into Clinical Trials in
Ulcerative Colitis
... earlier evidence of down-regulation of interleukin-17
(IL-17), IL-23, and tumor necrosis factor (TNF), key cytokines that
are known to be involved in
etiology of IBD in humans. Guanilib
treatment also improved stool consistency and removed intestinal
blockage in treated animals.
"These are important ...
Millennium Discovers Biomarkers Potentially Predictive of Response
to Velcade (Bortezomib) for Injection
... factors
for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of
unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these ...
Five Days of LEVAQUIN(R) as Effective as 10 Days of Ciprofloxacin
in Complicated Urinary Tract Infections and Acute Pyelonephritis
... components of this product. Serious and occasionally
fatal events, such as hypersensitivity and/or anaphylactic
reactions, as well as some of unknown
etiology have been reported
in patients receiving therapy with quinolones, including
LEVAQUIN.
These reactions may occur following the first dose or ...
Promising Results with Epratuzumab and Chemotherapy in Children
with Acute Lymphoblastic Leukemia
... occurred during the initial infusions only. Two
non-hematological dose-limiting toxicities occurred. One patient
had a grade-4 seizure of unclear
etiology and one patient had
asymptomatic grade-3 transaminase elevation that returned to
baseline prior to the time for the next treatment cycle. ...
New Data on Market-Leading Velcade (Bortezomib) for Injection
Further Strengthen Role in Previously Treated Multiple Myeloma
... factors
for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of
unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these ...
Geron's Telomerase Inhibitor Cancer Drug Demonstrates Good
Pharmacokinetics and Tolerability in Phase I/II Trial
... cells. This patient experienced a transient reduction in
absolute lymphocyte count of 48% that persisted for approximately
two weeks. The
etiology of this finding is uncertain at this time
given the lack of measured telomerase inhibition in this
patient.
"We are encouraged by the results," ...
Velcade (bortezomib) for Injection Survival Data in Front-Line
Multiple Myeloma Patients to be Featured at 11th International
Myeloma Workshop
... factors
for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of
unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these ...
Second Successful Quigley QR-443 Study Suggests Method of Action
Relevant to Broad Range of Chronic Inflammatory Diseases - Human
Study to Follow -
... IL-6 and dramatic weight loss. These
findings are in agreement with several previous studies
demonstrating the increased presence of IL-6 in the
etiology of
cachexia and other diseases related to inflammation.
The purpose of the study was to replicate positive oral dose
response trials in BALB/C mice ...
Tranzyme Pharma Presents Initial Phase IIa Data for its Novel
Ghrelin Agonist, TZP-101, in Patients with Diabetic Gastroparesis
... satiety,
nausea and vomiting. The three most common etiologies of
gastroparesis are diabetes (an estimated 30% of gastroparesis
patients), unknown
etiology (36%), and post-surgical causes (13%).
The prevalence rate of gastroparesis is especially high among
diabetic patients, as up to 50% of diabetics ...
Velcade (bortezomib) for Injection Based Therapies Achieved
Survival Rates as High as 100 Percent in Newly Diagnosed Multiple
Myeloma Patients
... factors
for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of
unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these ...
Velcade (Bortezomib) for Injection Based Therapies Produced
Complete Remission Rates as High as 54 Percent in Patients With
Previously Treated Multiple Myeloma
... factors
for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of
unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these ...
Velcade (bortezomib) for Injection Based Induction Therapy
Delivered High Post-Transplant Complete Remission Rate, a Critical
Marker for Increased Overall Survival
... factors
for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of
unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these ...