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AstraZeneca has sued to block an Arkansas law that requires the company to ship its drugs to any pharmacy — for-profit or otherwise — working with hospitals participating in the controversial 340B federal discount program. Read More
The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed. Read More
AstraZeneca has strengthened its oncology and rare disease portfolios with two buy-outs totaling close to $3.5 billion, the company has reported. Read More
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments. Read More
Manufacturing and distributing adulterated drugs for nearly a decade — some of which originated in a foreign country without FDA authorization — has brought $3.5 million in penalties to a Pennsylvania generic pharmaceutical company. Read More
President Biden wants to extend the cost-capping Inflation Reduction Act (IRA) far beyond Medicare recipients and their prescriptions, and allow Medicare to negotiate the prices of 500 drugs over the next 10 years, he said during his State of the Union (SotU) address on Thursday night. Read More
President Biden announced on Monday that manufacturers for all ten drugs have agreed to participate in the Inflation Reduction Act (IRA) drug price negotiations — but that negotiations continue as all drugmakers have submitted counter offers. Read More
The U.S. government should have to prove that the claims in False Claims Act (FCA) kickback cases would not have been submitted “but for” kickbacks, says Teva Pharmaceuticals in response its latest to a years-long back-and-forth with the Department of Justice (DOJ). Read More
This week, critics complain that the Biden administration just doesn’t get Bayh-Dole, the DOJ hands BioMarin a subpoena, another Humira biosimilar snags FDA OK, and Novo Nordisk sticks a deal for molecular glue. Read More