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Latest From AmerisourceBergen Corporation.

Humanigen Aims For New EUA Request After FDA Turns Down Lenzilumab

The company plans to make a new EUA request prior to filing a BLA, but does not yet have a specific timeline. Meanwhile, it has been preparing for the drug’s distribution as a COVID-19 treatment.

Coronavirus COVID-19 Regulation

J&J, Distributors May Be Free Of Opioid Litigation If Enough States Sign On To $26bn Settlement

NY AG has ‘no comment’ on whether criminal charges will be pursued against company executives; NC AG predicts ‘north of 40 states’ expected to accept settlement and would then need to convince municipalities to come on board. States with ongoing litigation against manufacturers may opt for jury trial instead. 

Legal Issues Advertising, Marketing & Sales

US FDA Takes Star Turn In Recent Drug Ingredient Liability Lawsuits

Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year; 16 cases in multidistrict litigation listed in chart showing status of settlements and upcoming bellwether trials.

Legal Issues Ingredients

US FDA Takes Star Turn In Recent Product Liability Lawsuits

Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year. Chart of 16 cases in multidistrict litigation shows status of settlements and upcoming bellwether trials.

FDA Legal Issues
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