Cypros Merger With RiboGene Brings Phase III Anti-Emetic Emitasol
Executive Summary
Cypros' acquisition of RiboGene adds a late stage anti-emetic product Emitasol to the pipeline of the Carlsbad, Calif. company. Submission of an NDA for Emitasol is anticipated within 12 to 18 months.
You may also be interested in...
Roberts
Ribogene grants Roberts exclusive marketing rights in North America and Mexico for Ribogene's Emitasol, a Phase III intranasal delivery formulation of metoclopramide used to treat emesis, especially among chemotherapy patients. Ribogene will provide up to $7 mil. for development through Phase III and submission of an NDA. The NDA submission target is the second half of 1999, Roberts says. In a separate transaction, Roberts will purchase $10 mil. of Ribogene convertible preferred stock
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials