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The FDA has invited applicants for certain products containing bendamustine to share how broad of a scope they believe Eagle Pharmaceuticals’ seven-year orphan drug exclusivity for Bendeka (bendamustine) should be, and if it should apply to Treanda. Read More
“At this point, we don’t see a clinical need for outsourcing facilities to compound from these bulk substances,” said FDA Commissioner Scott Gottlieb. Read More
The petition cites materials from Janssen that say consumers “may be asked to switch to a biosimilar that works in a similar way” to its drug Remicade, phrasing that wrongly implies a biosimilar would have a different mechanism of action. Read More
Hospira moved for a judgment that producing biosimilar batches is protected under safe harbor—and that it didn’t owe damages greater than $1.5 million per batch of drugs later sold. Read More
Under the new benefits, short-term opioid prescriptions for acute pain will be provided for no longer than a week, and telepsychiatry care provided by both a prescriber and therapist will become a covered benefit. Read More
New Jersey’s Supreme Court threw out more than 500 claims alleging Roche failed to adequately warn patients that its acne drug Accutane “caused” ulcerative colitis rather than “was associated with it.” Read More
Congress in a rare bipartisan effort approved a wide-ranging bill designed to address the opioid crisis. President Trump has vowed to sign the sprawling legislation, which was overwhelmingly approved Wednesday by the Senate and last month by the House. Read More
Proposed doses should be “discussed and justified within the totality of evidence, including the context of known exposure-response relationships and the level of confidence in the PBPK model for its intended uses,” the guidance states. Read More
GlaxoSmithKline Tuesday announced it will begin paying doctors again to promote its products as part of changes to its policy for working with healthcare professionals (HCPs). The move reverses a 2013 decision to stop financially rewarding physicians to talk about its treatments. Read More