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InKine Pharmaceutical has submitted an electronic new drug application (NDA)
for U.S. marketing approval of its next generation sodium phosphate tablet,
INKP-102.
Bayer Pharmaceuticals and Onyx Pharmaceuticals have announced that sorafenib
(formerly BAY 43-9006) has been accepted into the FDA's Pilot 1 Program for
continuous marketing applications.
Immtech International has announced the results of the safety trial comparing
three different formulations of DB289, the company's first oral drug candidate.
Predix Pharmaceuticals has begun Phase I studies with PRX-08066, its highly
selective, proprietary 5-HT2B receptor antagonist for the treatment of pulmonary
hypertension (PH) and hypoxia-induced PH syndromes caused by chronic obstructive
pulmonary disease and mountain sickness.
Ariad Pharmaceuticals has initiated enrollment of patients with prostate cancer
who have become refractory to standard hormone therapy in a multicenter Phase
II clinical trial of its novel mTOR inhibitor, AP23573, as a single agent.
Renovis has announced that a first analysis of data from the Phase III SAINT
I trial involving more than 1,700 patients conducted by its licensee, AstraZeneca,
shows a statistically significant reduction versus placebo on the primary outcome
of disability after an acute ischemic stroke, as measured by the Modified Rankin
Scale.
Tercica has announced that the FDA has accepted for filing and granted priority
review of the company's New Drug Application (NDA) for Increlex, or recombinant
human insulin-like growth factor-1 (rhIGF-1).
Baxter Healthcare Corporation announced recently that the U. S. Food and Drug
Administration (FDA) has approved Gammagard Liquid [Immune Globulin Intravenous
(Human)] (IGIV) 10 percent Solution for the treatment of primary immunodeficiency
disorders associated with defects in humoral immunity.
Serono and Genmab A/S have signed an agreement under which Genmab grants Serono
exclusive worldwide rights to develop and commercialize Genmab's HuMax-TAC.