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As part of its ongoing campaign against opioid-related fraud, the Justice Department unsealed a superseding indictment Thursday against a CEO and four doctors in connection with a conspiracy to write unnecessary prescriptions. Read More
Two major drug store chains sued Johnson & Johnson this week alleging the company strong-armed insurers out of covering biosimilars of its immunosuppressant drug Remicade (infliximab). Read More
Innovative antiretroviral HIV drugs may qualify for PDUFA fee waivers or refunds if the fee would be a significant barrier to development, according to new FDA draft guidance aimed at implementing the President’s Emergency Plan for AIDS Relief. Read More
The FDA estimates that its generic drug approval pathway — which led to a record-setting year of generic drug approvals in 2017 — helped consumers save $11.8 billion in drug costs through February 2018. Read More
The Trump administration has formally delayed implementing an Obama-era rule that would have set a ceiling on drug prices for 340B hospital discount programs and fine those drug makers who violate the rules. Read More
A Florida doctor is the latest to plead guilty in connection with an Insys scheme to pay kickbacks in exchange for prescribing its opioid drug Subsys. Read More