Even though pharmacy benefit manager (PBM) reforms were dropped from the continuing resolution that was signed into law Dec. 21 to keep the U.S. government fully functional through March 14, the incoming administration and Congress likely will continue to try to rein in the PBMs, which serve as middlemen in the nation’s drug supply chain.
As if the uncertainties surrounding an incoming administration weren’t enough, a landmark U.S. Supreme Court decision and a potential new avenue of liability for drug and device manufacturers could bring an added level of unpredictability to the sector for 2025.
Nearly three years after being terminated as president and CEO of Cytodyn Inc., Nader Pourhassan was convicted June 9 by a U.S. federal jury for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab. The jury also convicted Kazem Kazempour, the CEO of Amarex Clinical Research LLC, a contract research organization hired by Cytodyn, for his part in the scheme.
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
The congressional finger-pointing at pharmacy benefit managers (PBMs) continues. The latest singling out is in a bipartisan letter from four House members calling on the U.S. Department of Justice to investigate and hold PBMs accountable for the role they played in the nationwide opioid crisis.
Kiromic Biopharma Inc. and two former senior officials have settled with the U.S. SEC to resolve charges involving nondisclosure of U.S. FDA clinical holds on two cancer candidates before and after a July 2021 follow-on public offering that raised $40 million the company desperately needed.
The U.S. District Court for the Northern District of California ordered Lorik Papyan, who pleaded guilty three years ago to one count of unlicensed wholesale distribution of prescription drugs, to pay Gilead Sciences Inc. nearly $32 million in restitution to cover lost profits due to a counterfeit HIV drug scheme he was involved in.
The U.S. Court of Appeals for the Federal Circuit reined in a district court that invalidated three claims in an Astellas Pharma Inc. patent protecting bladder drug Myrbetriq (mirabegron) based on a issue that was never argued.
When the U.S. FTC filed suit Sept. 20 against the country’s three largest pharmacy benefit managers over their alleged use of rebates to artificially inflate U.S. insulin prices, it also put the three big insulin makers, and other drug manufacturers, on notice that they could be next.
The U.S. Court of Appeals for the Fifth Circuit revived the Pharmaceutical Research and Manufacturers of America’s (PhRMA) constitutional challenge to the Medicare price negotiations, sending it back to a federal court in Texas for a do-over.
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