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The Department of Justice filed suit against Mallinckrodt in a Massachusetts federal court yesterday for allegedly evading more than $250 million worth of Medicaid rebates for its H.P. Acthar Gel (repository corticotropin). Read More
FDA Commissioner Stephen Hahn told Congress yesterday that India is restricting exports of 13 active pharmaceutical ingredients (API) and the drug formulations made from them to protect its internal supply chain. Read More
The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level serial numbers. Read More
A blockchain-based drug tracking network is capable of meeting future supply chain regulatory requirements, according to pharma companies that took part in a pilot program run by the FDA. Read More
Former FDA Commissioner Scott Gottlieb warned of the potential for “unprecedented supply chain disruptions” as the COVID-19 outbreak threatens China’s production of starting materials. The agency reported the first coronavirus-related shortage on February 27 but did not name the product. Read More
Sandoz has agreed to pay $195 million to settle charges related to the Department of Justice’s three-year antitrust investigation into the generic drug industry, the company announced yesterday. Read More
The latest decision ends the drugmakers’ Truvada patent challenges before the board. The matter is now in the hands of the U.S. District Court for the District of Delaware, where HHS has sued the drugmaker for patent infringement. Read More
Opioid makers and 37 Attorneys General told an Ohio federal court that proposed attorney fees could derail a global settlement in the opioid multidistrict litigation. Read More
The FDA unveiled a pilot program last week that will use plain language and podcasts to explain its guidance documents in snapshots posted to its website. Read More