| |||
Eisai Provides Preliminary Efficacy Update On EORTC Phase III ... 02/07/2008 21:00. Eisai Corporation of North America is a wholly-owned subsidiary of
Eisai Co., Ltd., a research-based human health care (hhc) company
that discovers, develops and markets products throughout the world.
Eisai focuses its efforts in three therapeutic areas: neurology,
gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities;... // RedOrbit Total: 10 news articles First News Article: PR Newswire, 27/06/2008 01:06 02/07/2008 07:03 Eisai Provides Preliminary Efficacy Update On EORTC Phase III ... PR Newswire
Submission of Five-Day Dosing Regimen sNDA Targeted for Fiscal WOODCLIFF LAKE, N.J., July 1, 2008 /PRNewswire/ -- Eisai North America today announced the preliminary efficacy data from a initiated in 2002 comparing Dacogen(R) (decitabine) to Best (BSC) in elderly patients with myelodysplastic syndromes (MDS). The did not demonstrate a statistically significant advantage of treatment on median overall survival. However, response rates were to those observed in other clinical trials of Dacogen in patients with MDS. In the trial, conducted by the European Organisation for the Treatment of Cancer (EORTC), Dacogen was administered on a schedule. In this study, the number of treatment cycles was a potentially life-threatening group of bone marrow diseases that production... // PR Newswire 02/07/2008 03:29 FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term ... FOXBusiness
WOODCLIFF LAKE, N.J., June 30, 2008 /PRNewswire via COMTEX/
----Eisai Corporation of North America, a wholly-owned subsidiary
of Tokyo-based Eisai Co., Ltd., announced today that the Food and
Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium)
20 mg for the short-term (up to eight weeks) treatment of
gastroesophageal reflux disease (GERD) in adolescents ages 12 and
above. Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9... // FOXBusiness 01/07/2008 19:13 FDA Approves ACIPHEX(R) (rabeprazole Sodium) 20 Mg For Short-Term ... Medical News Today
Eisai Corporation of North America, a wholly-owned subsidiary of
Tokyo-based Eisai Co., Ltd., announced that the Food and Drug
Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks)
treatment of gastroesophageal reflux disease (GERD) in adolescents
ages 12 and above. Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6... // Medical News Today 01/07/2008 09:14 FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term ... PR Newswire
WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ -- Eisai Corporation
of
North America, a wholly-owned subsidiary of Tokyo-based Eisai Co.,
Ltd.,
announced today that the Food and Drug Administration (FDA) has
approved
ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight
weeks)
treatment of gastroesophageal reflux disease (GERD) in adolescents
ages 12
and above. Included in the submission was a 12-week, multi-center,
open-label,
randomized, parallel-group study of 111 adolescent GERD patients.
In this
study, ACIPHEX was well tolerated in adolescent subjects, with a
safety
profile similar to that of adults. The adverse events reported
without
regard to relationship to ACIPHEX that occurred in greater than or
equal to
2 percent of 111 patients were headache (9.9 percent),... // PR Newswire 01/07/2008 09:08 FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term ... Biloxi Sun Herald
01/07/2008 09:03 FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term ... PR Newswire
Included in the submission was a 12-week, multi-center, open-label,
randomized, parallel-group study of 111 adolescent GERD patients.
In this study, ACIPHEX was well tolerated in adolescent subjects,
with a safety profile similar to that of adults. The adverse events
reported without regard to relationship to ACIPHEX that occurred in
greater than or equal to 2 percent of 111 patients were headache
(9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent),
vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy
results demonstrated that once-daily treatment with ACIPHEX 20 mg
for eight weeks reduced the severity and frequency of GERD symptoms
compared to symptoms prior to treatment. ACIPHEX was discovered and developed by Eisai and is copromoted in the United States with... // PR Newswire 01/07/2008 08:58 FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term ... Earthtimes
WOODCLIFF LAKE, N.J., June 30 NJ-Eisai-FDA-Approved WOODCLIFF LAKE, N.J. , June 30 /PRNewswire/ -- Eisai Corporation of North America , a wholly-owned subsidiary of Tokyo -based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above. Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, ACIPHEX was well tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to ACIPHEX that occurred in greater than or equal to 2... // Earthtimes 27/06/2008 20:09 FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) To ... Medical News Today
Eisai Corporation of North America announced that the U.S. Food and
Drug Administration (FDA) has accepted for priority review a
supplemental biologics license application (sBLA) for ONTAK(R). The
sBLA seeks to convert an accelerated approval indication into full
approval. It is based on a placebo-controlled Phase III clinical
trial to confirm the clinical effectiveness of ONTAK in certain
patients with cutaneous T-cell lymphoma (CTCL). ONTAK is indicated for the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the IL-2 receptor. The safety and efficacy of ONTAK in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined. ONTAK was granted accelerated approval under... // Medical News Today 27/06/2008 01:06 FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to ... PR Newswire
ONTAK is indicated for the treatment of patients with persistent or
recurrent CTCL whose malignant cells express the CD25 component of
the IL-2 receptor. The safety and efficacy of ONTAK in patients
with CTCL whose malignant cells do not express the CD25 component
of the IL-2 receptor have not been examined. ONTAK was granted
accelerated approval under Subpart E in February 1999. CTCL is a rare form of cancer in which T-cells, cells that the body uses to fight infections, become cancerous and affect the skin. CTCL can also spread to other organs in a small number of patients. Subpart E is an FDA regulation that allows the accelerated approval of a biologic agent based on a surrogate endpoint or an effect on a clinical endpoint other than survival and is most common in serious diseases... // PR Newswire |