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BioWorld - Sunday, December 14, 2025
Home » Topics » Regulatory » Courts

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Jury convicts biotech execs in fraud scheme

Dec. 11, 2024
By Mari Serebrov
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.
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No preliminary injunction delaying Entresto generic

Dec. 4, 2024
By Mari Serebrov
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.
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US lawmakers call out PBM role in opioid epidemic

Dec. 3, 2024
By Mari Serebrov
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.
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Kiromic’s nondisclosure of clinical hold leads to SEC settlements

Dec. 3, 2024
By Mari Serebrov
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.
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Counterfeiter ordered to pay Gilead millions in restitution

Nov. 27, 2024
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.
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Astellas patent survives ‘natural law’ decision

Sep. 24, 2024
By Mari Serebrov
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.
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Drug manufacturers next on US FTC’s rebate hit list

Sep. 23, 2024
By Mari Serebrov
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.
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Pills, bottle atop $100 bill

PhRMA challenge to US price negotiations lives again

Sep. 23, 2024
By Mari Serebrov
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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Astellas patent survives ‘natural law’ decision

Sep. 19, 2024
By Mari Serebrov
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.
Read More

Glenmark settles US civil price-fixing allegations

Sep. 10, 2024
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol.
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