Kaléo, Inc.
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Latest From Kaléo, Inc.
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.
FTC’s Salvos Against Biopharma To Reverberate Through 2024
The Federal Trade Commission broke new ground last year in its opposition to M&A transactions and challenge of Orange Book patent listings. The biopharma community is waiting to see if deals will face similar hurdles in 2024 and whether there will be legal battles if manufacturers of drug-device combination products decline to delist their patents. Researchers advocate that the FTC extend its inquiry to device patents on GLP-1 receptor agonists, including Wegovy and Ozempic.
Opioid Labeling Instructions On Naloxone Are Compromise In Co-Prescribing Debate
US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.
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