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…
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). Source: Drug Industry Daily
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Source: Drug Industry Daily
The FDA blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility. Source: Drug Industry…
Generic drug price competition may come at the cost of relaxed manufacturing standards, according to a study published in the Journal of Operations Management. Source: Drug Industry Daily
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qualify for PDUFA fee waivers or refunds if the fee would be a significant barrier to development, according to new FDA draft guidance aimed at…
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…
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…
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. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb urged internet stakeholders to help the agency crack down on illicit online opioid sales Tuesday as the FDA posted warnings sent to nine online operators of…