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Latest From Sue Sutter
Ixifi (infliximab-qbtx), which references Janssen's Remicade, marks first US approval of a biosimilar developed entirely by Pfizer; big pharma says it is not currently planning to launch Ixifi because it remains "committed" to marketing Celltrion's Inflectra.
Celgene's ASH briefing notes 'unprecedented' MRD-negative data in Phase I study in multiple myeloma development program for CAR-T therapy bb2121; firm sees potential opportunity for the marker to pave way for approval in earlier-line settings of the disease.
Measures that would increase financial transparency and empower federal government to negotiate drug prices highlighted by National Academies representative who discussed recent report on drug affordability, but former Congressional Budget Office Director Holtz-Eakin warns Senate HELP Committee against taking measures that merely shift costs from one party to another.
FDA is considering whether a breach of duty to act or correct violations under the FDCA must occur before criminal charges are brought, Chief Counsel Rebecca Wood says. Clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.
Short-acting insulin approved under 505(b)(2) pathway appears poised to receive three years of Hatch-Waxman exclusivity but would lose nine months of this protection under FDA's current interpretation of the 'transition provisions' for certain protein products that take effect in March 2020.
Patients with the conditions experience the same symptoms, US FDA advisory committee concludes. Industry sponsors had advocated for combined trials, but panel did not agree with firms' recommendations on study duration and outcome measures.