Avonex (interferon beta-1a) marketer Biogen expects to meet with FDA in the second quarter regarding the agency's proposal for an interferon class black box warning. "Alpha interferon is used at different dosing ranges and is used to treat patients with different diseases than multiple sclerosis, so it is conceivable that the safety profile will differentiate from that of the beta interferon," VP-Medical Research Burt Adelman, MD, said April 12. FDA notified alpha and beta interferon manufacturers that the warning should be similar to that found in labeling for Schering-Plough's Peg-Intron (1"The Pink Sheet" March 5, In Brief)
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Manufacturers of alpha and beta interferon products are requested to submit revised labeling with a black box warning in a Feb. 26 letter from the Center for Biologics Evaluation & Research. The revised labeling should indicate the potential for life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders, CBER says. The black box will be similar to the warning found in labeling for Schering-Plough's PEG-Intron (1"The Pink Sheet" Jan. 29, p. 16)
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