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Johnson & Johnson (J&J) disclosed that it has pursued arbitration against beleaguered vaccine manufacturer Emergent BioSolutions for alleged breach of contract. Read More
More than 100 West Virginia cities and counties have reached a $400 million settlement with drug distributors McKesson, AmerisourceBergen and Cardinal Health, resolving allegations that the companies recklessly oversupplied West Virginia residents with opioids. Read More
Gilead Sciences’ Biktarvy, a three-component antiviral, suppressed HIV infections in 99 percent of patients who took it as part of two phase 3 studies. There were no treatment failures, the company reported at the 24th International AIDS Conference in Montreal. Read More
Sanofi has failed to convince a federal appeals court that Viatris monopolized the market for injected epinephrine through anticompetitive pricing for its EpiPen. Read More
Swiss biotech ObsEva has announced a corporate restructuring and layoffs following a notice from the FDA that the company’s new drug application (NDA) for its lead candidate linzagolix for uterine fibroids has deficiencies that are keeping the agency from advancing its review. Read More
After less than stellar interim results from a phase 3 trial focused on head and neck cancer, AstraZeneca is calling it quits in the indication for the checkpoint inhibitor it netted following its now four-year-old partnership with Innate Pharma. Read More
This second part of Drug Industry Daily’s two-part report on user fee reauthorization focuses on prospects for the Biosimilar User Fee Act and the Generic Drug User Fee Act.Read More
The agency said all changes to disposable manufacturing materials for approved drug products should be communicated to the FDA through postapproval submissions. Read More