Novo-Nordisk Norditropin launched Feb. 20; patent litigation with Genentech is ongoing.
Executive Summary
NOVO NORDITROPIN LAUNCH FEB. 20 FOR HUMAN GROWTH HORMONE INSUFFICIENCY brings the Novo Nordisk somatropin product to market without having settled underlying patent infringement issues. Norditropin was cleared by FDA in May 1995, but the launch has been delayed by patent litigation between Novo Nordisk and Genentech. The path to market was cleared for Novo when a D.C. appeals court granted a stay of a lower court's preliminary injunction against the Norditropin launch ("The Pink Sheet" Dec. 23, 1996, In Brief). Bio-Technology General's Bio-Tropin somatropin human growth hormone product is still held up by a preliminary injunction dating from April 1996 ("The Pink Sheet" April 15, 1996, T&G-3).
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth