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Ahead of a large suit that’s pending with state and local governments across the U.S., Ohio has reached a settlement with Cardinal Health, AmerisourceBergen and McKesson — the three largest opioid distributors — for $808 million, resolving claims that the companies played a role in fueling the opioid epidemic. Read More
The FDA has finalized its Q&A guidance on biosimilars and interchangeable biosimilars, addressing hot topics for developers, including submitting supplements for approved biosimilar applications and for manufacturing changes. Read More
A federal court in Florida issued a consent decree last week to Premier Pharmacy Labs, a compounding pharmacy in Weeki Wachi, prohibiting the company from producing or distributing any drugs until it corrects unsanitary conditions and serious violations of good manufacturing practice. Read More
The alliance outlines numerous concerns with FDA’s plan to construct a national drug packaging identification and tracing system that would link all distributors and allow authorized parties to track any shipment. Read More
The Department of Justice (DOJ) has appealed Purdue Pharma’s $10 billion bankruptcy settlement that resolved thousands of lawsuits and granted the company’s owners, the Sackler family, immunity from future opioid-related legal proceedings. Read More
Under the Biden administration, the FDA has been able to become “boring” again, while the administration looks toward rebuilding the agency’s reputation and its authority after it took a beating under President Trump. Read More
Bamlanivimab and etesevimab are FDA authorized for treating mild-to-moderate COVID-19 in people 12 years and older who are at high risk of progressing to severe disease. Read More
REGEN-COV is currently authorized to prevent COVID-19 infection in people 12 years and older who have been exposed to the coronavirus and are at high risk of progressing to severe disease. Read More
The House Ways and Means Committee voted 24-19 yesterday to advance the Build Back Better Act with drug pricing reform provisions, shortly after the same reforms failed to make it into the House Energy & Commerce Committee’s version. Read More
The FDA’s vision of an enhanced drug distribution security program that would allow electronic tracing of every shipment is an impossibly complicated project that would take years to build, expose confidential company information and might even run afoul of federal law, said the Healthcare Distribution Alliance (HDA), the national organization that represents pharmaceutical distributors. Read More