Schering-Plough Announces Phase II and III Data for Corifollitropin Alfa
... retrieved was the co-primary endpoint. The incidence
of ovarian hyperstimulation syndrome (OHSS) was ... confidence interval (CI) of the difference. The incidence
of moderate and severe OHSS was 3.4 percent in ... (including tenderness). They are reported with an incidence
between 1% and 6%.
Human Genome Sciences Reports Positive Long-Term Data for BENLYSTA(TM) (Formerly LymphoStat-B(R)) in Patients With Active Systemic Lupus Erythematosus
... by the safety data presented at EULAR. The incidence
rates per 100 patient years of all adverse event ... through four years of treatment. The overall incidence
of adverse events (in general and by system organ ... belimumab exposure was 1192 patient years. The incidence
rates per 100 patients in all adverse event ...
Pixantrone Significantly Increases Complete Remissions, Overall Response Rates, Frequency of Durable Remissions and Progression Free Survival in Patients with Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
... versus 19.4% on the comparator arm. However, the incidence
of grade 3, 4 febrile neutropenia was only 7.4% ... arm. Grade 3, 4 infections had a similar incidence
in both study arms (18% vs. 13%). Although the ... (1.5% vs. 1.5%), there was a slightly higher incidence
of serious cardiac disorders in patients treated ...
OncoGenex Pharmaceuticals Announces OGX-011 Treatment Provides Survival Benefit in Randomized Phase 2 Trial in Advanced Metastatic Prostate Cancer
... indicator of biological effect.
- Higher incidence
of stable disease (20 patients in OGX-011 plus
... 12 patients in docetaxel arm) with lower
of disease progression as best response (1 ... with docetaxel. There was an increase in incidence
of mild fever, chills and creatinine levels (a ...
Low Occurrence of Severe Cardiac Side Effects Despite Extensive Prior Doxorubicin Treatment Reported in Pixantrone Pivotal Trial
... reported for doxorubicin.
Clinical CHF- related or unrelated to drug
Pixantrone recipients had a low incidence
of severe neutropenia complicated by either fever ... Pixantrone patients also experienced a low incidence
of hair loss, a very common side effect of other ...
Bayer and Onyx Announce Nexavar Data Presentations at 45th American Society of Clinical Oncology Annual Meeting
... in 2.4% for Nexavar and 4% in placebo. The incidence
of treatment-emergent cardiac ischemia/infarction ... Nexavar vs. 1.3% for placebo. In RCC patients, incidence
of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence
of treatment-emergent cardiac ischemia/infarction ...
QIAGEN and Chittaranjan National Cancer Institute Partner to Establish First Large-Scale Cervical Cancer Screening Program in Kolkata
project as India has the world's highest incidence
rate of cervical cancer. We
believe that ... The impact of HPV testing on cervical cancer incidence
and death in India
was demonstrated in an ... the most
effective way to reduce cervical cancer incidence
when compared to either Pap
(cytology) testing or ...
FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
... over the 12-month study,(2) and the incidence
of pneumonia was no different for SYMBICORT compared to placebo.(2) There was a higher incidence
of potential lung infections other than pneumonia ... studies, pneumonia did not occur with greater incidence
in the SYMBICORT 160/4.5 group compared with ...
Multiple Vimpat(R) (lacosamide) Studies Presented at American Epilepsy Society Annual Meeting
... and appeared to be dose-related.
-- The incidence
of weight gain and other troublesome TEAEs such ... and psychiatric AEs appeared low:
-- The incidence
of somnolence was 7 percent for the ... group vs. 5 percent for placebo
-- The incidence
of memory impairment was 2 percent for both ...
Human Genome Sciences Announces Albuferon(R) Meets Primary Endpoint in Phase 3 Trial in Chronic Hepatitis C
... events, vs. peginterferon alfa-2a.
of severe and/or serious adverse events was ... alfa-2a treatment group.
of severe and/or serious pulmonary adverse events ... non-inferiority (p=0.0059).
of severe and/or serious adverse events was ...
Synvista Therapeutics Announces Data Further Demonstrating the Value of Haptoglobin Genotyping in Diabetic Patients During AHA Meeting
... also received vitamin E had a
significantly lower incidence
of MI compared to placebo. Also, HDL function
was ... individuals who had received vitamin E, the incidence
of MI after
stopping vitamin E treatment ... there was little
demonstrable difference in the incidence
of MI in those Hp2-2 individuals
who had received ...
Telik Announces Top-Line Results From Assist-5 Trial of Telcyta(R) in Combination With Pegylated Liposomal Doxorubicin in Platinum Refractory and Resistant Ovarian Cancer
... on the
PLD control arm.
There was a higher incidence
of hematologic adverse events (AEs) in
patients ... vomiting, and constipation, were similar in incidence
on both arms. Seventeen percent ... the PLD
control arm. Telcyta may ameliorate the incidence
and severity of
stomatitis and PPE known to be ...
Retrospective Analysis of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene/Conjugated Estrogens Comparable to Placebo on Incidence of Abnormal Mammograms
... estrogens (BZA/CE) may experience incidence
breast tenderness and abnormal mammograms no ... suggested no significant
differences in the incidence
of breast tenderness or abnormal ... and placebo or
In this study, the incidence
of treatment-emergent adverse events,
Indevus Receives Approvable Letter from FDA for NEBIDO(R)
... from clinical studies to determine
the precise incidence
of serious post-injection oil-based reactions ... intramuscular
injection, namely, to reduce the incidence
and/or severity of the serious
oil-based ... injection
technique, has an acceptably low incidence
of oil-based reactions to gain
approval. In ...
Amylin Pharmaceuticals to Present Promising Data From Diabetes and Obesity Programs at ADA 2008
... was the most frequently reported. The incidence
of nausea was higher
at the beginning of SYMLIN ... and decreased with time in most
patients. The incidence
and severity of nausea are reduced when SYMLIN ... BYETTA provides
sustained A1C control, low incidence
of hypoglycemia when used with
metformin or a ...
U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
... all) to 10 (extreme). Safety evaluations included incidence
adverse reactions, discontinuation rate due to ... than or equal
to 5 percent and at least twice the incidence
of placebo plus ADT)
associated with the use of ... fatalities, have been reported at an increased incidence
in clinical trials of elderly patients with ...
FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
... "The new, lower once-daily dose reduces the incidence
of some side
effects while preserving the ... 100 mg once daily, for chronic-phase CML. incidence
of selected adverse reactions (all grades) in the ... months for SPRYCEL and three months for
of selected adverse reactions (all grades) in the ...
Clinical Study Findings Show Safety and Procedure Success for TopSpin IntraVascular MRI Catheter for the Coronary Arteries
... The primary endpoint of the study was the incidence
major adverse cardiac events (MACE) at 24 hours. The incidence
of MACE at
24 hours was only 0.96% (1 patient), ... of
coronary artery disease and reduce the overall incidence
infarction (heart attack) and ....
New 200 mg Vial for Eloxatin(R) (Oxaliplatin Injection) Offers Greater Convenience and Efficiency of Preparation
... ( patients), which may be fatal. The combined incidence
of cough and dyspnea was 7.4% ( FU/LV arm ... the Eloxatin(R) combination arm. The combined incidence
of cough, dyspnea, and hypoxia was 43% (7% ... in the Eloxatin(R) combination arm. The incidence
of increased bilirubin was similar on both ...
PNH Patients Treated with Soliris(TM) Experienced Dramatic Reduction in Blood Clots During Clinical Trials
... 92 percent reduction in incidence
CHESHIRE, Conn., Aug. 20 ... (6) Araten DJ, Thaler HT, Luzzatto L. High incidence
of thrombosis in African-American and ... (13) Hill A, Platts PJ, Smith A et al. The incidence
and prevalence of paroxysmal nocturnal ...
Glenmark's Novel Molecule for Diabetes, Melogliptin to Enter Phase III Trials
... to be the
best-in-class in achieving glycemic control with low incidence
hypoglycemia and neutral effect on body weight
- Global ... profile. In addition, patients taking Melogliptin experienced
of hypoglycemia and neutral effect on body weight.
In this 12-week, ...
Amgen to Participate in Reproductive Health Drugs Advisory Committee Meeting in August
... prostate cancer settings, demonstrated denosumab's ability to reduce the incidence
of fractures, and all six studies showed denosumab's ability to increase ... sites measured. In the two pivotal studies with fracture endpoints, the incidence
and types of adverse events with denosumab were similar to placebo. The ...
SEP Signs REGURIN(R) Deal
... bladder and increases bladder capacity. It is well tolerated
with a low incidence
of the common anti-muscarinic side effect, dry
mouth., Regurin also does not cross the blood-eye or blood-brain
barrier,, reducing the incidence
of confusion in people taking this
AEterna Zentaris to Report Data from Safety Study of Phase 3 Program in Benign Prostatic Hyperplasia with Cetrorelix Ahead of Schedule
... at Weeks 0 and 2, and are followed up to Week 26. The main endpoint is the incidence
of possibly drug-related adverse events. More information on this trial ... and long lasting relief of BPH symptoms and was well tolerated, with a low incidence
of sexual side effects. Cetrorelix is part of AEterna Zentaris' ...
Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin Phase IIb Study
... were fatigue, nausea, flu-like symptoms, headache and diarrhea. The incidence
rates for these adverse events among treatment arms were generally comparable except with respect to diarrhea, where incidence
of diarrhea was approximately twice as common in patients receiving ...
Multiple Types of Heart Attacks Reduced by Prasugrel in TRITON-TIMI 38 Trial
... Circulation online on May 18, 2009.(2)
In this post hoc analysis, the incidence
of non-procedural heart attack in patients treated with prasugrel compared ... with 3.4 percent in those taking clopidogrel (p=0.0015).
of PCI-related heart attacks (Type 4) was 4.8 percent in prasugrel ...
InspireMD Announce the Completion of Enrollment for the MAGICAL Trial (MGuard(TM) in Acute Myocardial Infarction) at EuroPCR '09. Results Will be Presented May 21st by Dr. Dariusz Dudek at the InspireMD Cocktail Reception Debate Chaired by Prof. Martin Le
... Dudek, Jagiellonian University,
Krakow, Poland). Primary end-points are incidence
of complete ST segment
resolution measured 60 minutes post procedure and incidence
of TIMI 3 flow
after PCI. Main secondary endpoints are myocardial blush ...
PharmAthene Presents Data for SparVax(TM), a Novel Vaccine for the Prevention and Treatment of Anthrax Infection, at the 12th Annual Conference on Vaccine Research
... immunological recall following antigenic challenge. In addition, a lower incidence
of injection site reactions observed with SparVax(TM) may suggest that it ... responses comparable to the currently licensed product. The lower incidence
of injection site reactions observed with SparVax(TM) may indicate that it ...
China Pharma Holdings, Inc. Announces Clinical Trials Already Underway for Candesartan
... China(3). Hypertension is a serious problem and is linked
to an increased incidence
of other diseases, particularly brain edema,
coronary heart disease and ... develops, manufactures, and markets treatments for
a wide range of high incidence
and high mortality conditions in China,
including cardiovascular, CNS, ...
ADVENTRX Provides Update on Strategic Transaction Process
... 80 or other detergents and is
intended to reduce the severity and incidence
of hypersensitivity reactions.
Docetaxel is an anti-cancer agent that acts ... is recommended for docetaxel therapy to reduce the incidence
severity of hypersensitivity reactions. Docetaxel is approved to treat ...
InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
... 2 and in 31% and 30%, respectively, in CAPACITY 1. In both studies, the incidence
of Grade 3 or Grade 4 laboratory abnormalities was similar between ... due to a rash or photosensitivity. There was no difference in the incidence
of skin cancer between patients treated with pirfenidone or placebo.
Sunesis Pharmaceuticals Provides Year-End Clinical Update on Voreloxin
... study. Voreloxin was generally well-tolerated at 48 and 60 mg/m2, with an incidence
of febrile neutropenia of below 10%. An increase in febrile neutropenia is observed at 75 mg/m2, although the incidence
remains below 20%.
Voreloxin is a novel ...
ADVENTRX Announces Further Cost-Cutting Measures
... 80 or other detergents and is intended to reduce the severity and/or incidence
of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts ... premedication is recommended for docetaxel therapy to reduce the incidence
and severity of hypersensitivity reactions. Docetaxel is approved to treat ...
Helsinn Healthcare and Zealand Pharma Sign a Partnering Agreement for ZP1846, a Novel GLP-2 Agonist
by chemotherapy treatment, resulting in a reduction in the incidence
chemotherapy-induced diarrhea. Today, serious gastrointestinal side ... potentially life-threatening side-effect
of chemotherapy. Despite its high incidence
and severity it is often under
recognized and poorly managed: current ...
Indevus Pharmaceuticals Announces Fiscal 2008 Year End and Fourth Quarter Results
... resubmission to address FDA's
concerns about the quantification of the incidence
of serious cough reactions
in clinical trials. The NDA contained a ... a quaternary ammonium structure that may
be instrumental in the low incidence
of CNS side-effects. At therapeutic
concentrations in vitro, SANCTURA does ...
Synvista Therapeutics Announces Availability of Haptoglobin Genotyping Technology at The Annual Scientific Sessions of the American Heart Association
... and another demonstrating that tight
glycemic control reduces the incidence
of heart attack (myocardial
infarction - MI) only in Hp2-2 Diabetes.
The ... and who maintained strict glycemic
control showed a reduction in the incidence
of MI. Study investigators
concluded that the Hp2-2 genotype may have ...
Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference
... pegloticase every 2 weeks had a statistically significant lower flare incidence
and frequency compared to placebo patients in the pooled analysis. ... demonstrated that in Months 4-6 of the GOUT 1 and GOUT 2 studies, the incidence
of gout flares in the every 2 weeks dosing group was significantly ...
Custom NX(R) Drug Eluting Stent System Continues to Demonstrate Favorable Outcomes in Challenging Patient Populations at One, Two and Three Years
... Zero incidence
of Late Stent Thrombosis Reported in CUSTOM I, II, and III ... Transcatheter Cardiovascular
Therapeutics (TCT) meeting. "To date, the incidence
of late stent
thrombosis in all three CUSTOM trials is zero percent and ...
Lilly to Acquire ImClone Systems in $6.5 Billion Transaction
... electrolytes as necessary
Late Radiation Toxicities
-- The overall incidence
of late radiation toxicities (any grade) was
higher with ERBITUX in ... ERBITUX
and radiation versus radiation alone arms, respectively
- The incidence
of grade 3 or 4 late radiation toxicities were similar
between the ...
Indevus and FDA Agree on Path Forward for NEBIDO(R)
... appear to provide an adequate
size database to determine the precise incidence
of serious post-injection,
Indevus and FDA also ... of testosterone undecanoate intramuscular
injection, namely, to reduce the incidence
and/or severity of the serious
oil- based reactions. Further, Indevus and ...