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Merck & Co. and Vertex Pharmaceuticals have begun a Phase I clinical study
for VX-680, a small molecule inhibitor of Aurora kinases, in patients with solid
tumor cancers.
Spectrum Pharmaceuticals has completed enrollment in the Phase II trial of EOquin
as a single agent in patients with recurrent superficial bladder cancer refractory
to at least one prior treatment regimen.
Join FDAnews Jan. 20 for the 90-minute audio alert, "Clinical Trials:
Planning for a Lean, Mean Development Machine." Learn how to speed drug
approvals and cut costs from Dr. William Sietsema, one of the world's
top authorities on how to streamline the clinical development process. On Jan.
25, learn about "Off-Label Drug Promotion: Identify and Eliminate Risky
Practices." Hear one of the nation's top legal advisors, Keith Korenchuk,
present a proven approach that mitigates off-label risks throughout your operations.
Valeant Pharmaceuticals International has recently submitted a complete response
to an approvable letter from the FDA for Zelapar following the successful completion
of two safety studies required for its approval.
Bristol-Myers Squibb and Otsuka Pharmaceutical have received approval from the
FDA for an oral solution formulation of Abilify, a treatment for schizophrenia
and acute manic and mixed episodes associated with bipolar disorder.
Senetek has announced uniformly positive results from its initial multifaceted
study of the effects of its patented adenine derivative, Zeatin, and two other
new compounds representing new cytokinin classifications, AK801 and PRK124.
ImClone Systems has begun patient treatment in a Phase I clinical trial of its
fully human monoclonal antibody targeting the vascular endothelial growth factor
receptor-2 (VEGFR-2), IMC-1121B, in patients with solid tumors.