(CLSN): Top-line results from the phase III trial of
Thermodox in liver cancer expected before the end of the year. The "HEAT" study compares Thermodox plus radiofrequency thermal ablation (RFA) versus RFA alone in patients with primary liver cancer. The primary endpoint of the study is improvement in progression-free survival.
(CLVS): Top-line results from a phase III study of
CO-011 in pancreatic cancer expected before year's end. The "LEAP" study compares CO-011 versus gemcitabine in metastatic, chemo-naive pancreatic cancer patients whose tumors express low levels of hENT1, a protein which gemcitabine requires to enter cells. Survival is the study's primary endpoint.
(DVAX) brings its hepatitis B vaccine Heplisav in front of an FDA advisory panel on Nov. 14.
FDA will announce an approval decision for
(EXEL - Get Report) medullary thyroid cancer drug cabozantinib on or before Nov. 29.
presents important new data on its all-oral hepatitis C combination regimens at the
American Association for the Study of Liver Disease annual meeting
beginning Saturday, Nov. 10.
An FDA advisory panel convenes Dec. 20 to review
(HEB - Get Report)
Ampligen as a treatment for chronic fatigue syndrome
will release results from a
phase III studies of NKTR-118
in opioid-induced constipation before the end of the year. The "KODIAC" trials, consisting of two phase III placebo-controlled efficacy and an open-label, placebo-controlled long-term safety study, are designed to determine the efficacy and safety of NKTR-118, a once-daily tablet, for the treatment of constipation in patients taking prescription opioid medications.
is expecting an FDA approval decision for Gattex on Friday, Dec. 28. Gattex treats patients with short-bowel syndrome. An
FDA advisory panel voted
last month to recommend the drug's approval.
awaits an FDA decision on Nov. 21 for tofacitinib, the first rheumatoid arthritis pill.
: Top-line results before the end of the year for the phase III melanoma study of Allovectin (injected directly into melanoma lesions) versus dacarbazine or temozolomide in patients with recurrent metastatic melanoma. The primary endpoint of the study is durable response rate at 24 weeks but the more important and necessary (for approval) secondary endpoint is overall survival.
(VVUS - Get Report)
reports third-quarter financial results on Tuesday, Nov. 6, including the
first reported sales for its weight-los pill Qsymia
(ZIOP - Get Report)
set to announced results from the phase III study of
palifosfamide in sarcoma
. The "PICASSO III" study compares palifosfamide plus doxorubicin to doxorubicin alone in patients with front-line metastatic soft-tissue sarcoma. The study's primary endpoint is improvement in progression-free survival (for accelerated approval) and overall survival (for full approval.)
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