Payors often sue companies in the wake of government agency enforcement actions, but one group is not waiting for the US Federal Trade Commission’s response to companies defying its request to delist Orange Book patent listings.
Payors Take Lead From FTC In Suing BI Over Its Orange Book Patent Listings For Inhalers
Class action complaint alleges Boehringer Ingelheim engaged in a ‘Respimat Orange Book scheme’ to thwart generic competition for Combivent Respimat and Spiriva Respimat that cost payors millions, if not billions, in overcharges.
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Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.
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Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?
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An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.
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The Health and Human Services Department's decision to eliminate the Richardson Waiver may be a blow for transparency, but will not completely eliminate scrutiny of regulations, experts said.
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President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
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Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
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A lengthy notice-and-comment rulemaking process is not congruent with the congressional mandate to keep an up-to-date list of drugs in short supply, US judge said, denying compounders' request to stay removal of the GLP-1 tirzepatide from the shortage list.