Transkaryotic Therapies gene-activated erythropoietin product does not literally fall within the scope of Amgen's process Patent No. 5,618,698 or No. 5,621,080, which claims certain EPO glycoproteins, Boston federal court Judge William Young ruled June 9. However, if TKT's EPO is equivalent to the product claimed by the '080 patent, it may be found to infringe the patent, Amgen said. Young also denied TKT and partner Aventis' motion for noninfringement of Patent No. 5,547,933. The trial will resume June 12 (1"The Pink Sheet" May 22, p. 28)

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 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