Acura and King plan to submit an NDA for a version of their oxycodone formulation Acurox that contains impediments to abuse by snorting or injection but does not contain the niacin FDA says is ineffective at preventing oral abuse.
The U.S. Patent and Trademark Office has set up a task force to implement the Supreme Court's forthcoming ruling in the Bilski case as to what is patentable subject matter. PTO official Arti Rai tells a meeting of the Biotechnology Industry Organization about the agency's efforts to push through patent reform leegislaiton and reduce the pendency of patent applications by 40 percent.
Sen. Byron Dorgan of North Dakota and Gov. Brian Schweitzer of Montana seek permission from HHS to conduct a demonstration project allowing residents of their states to buy drugs imported from Canada.
Genzyme is making progress in structuring a consent decree with FDA, the company reported during its first quarter earnings call April 21. A draft the agency sent to Genzyme would impose an upfront payment of $175 million based on past profits from products made at the troubled Allston Landing, Mass., manufacturing facility. Genzyme, which reported sales declines for the two drugs most affected by the Allston situation – Cerezyme and Fabrazyme – also could face royalties of 18.5 percent on products made and distributed from the facility if certain deadlines are not met.
Abbott expects U.S. health care reform legislation to negatively impact 2010 sales by about $230 million, which led the pharma to lower its full year earnings per share guidance, execs told investors during an April 21 first quarter earnings call.