Legal & IP
FDA law experts do not buy the outsourcers’ argument that the agency must go through notice-and-comment rulemaking to remove a drug from the shortage list.
Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.
Pharmacy benefit manager sues Federal Trade Commission, claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.
Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion, as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned.
An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.
Disputes over orphan and new clinical investigation exclusivity are among the early drug and biologic cases where legal filings cite the Loper Bright decision, which overturned the Chevron doctrine of deference to agency actions.
Determining what falls within the statutory definition of ‘biological product’ is an interpretative question that courts, rather than the agency, must resolve, Lilly said in a lawsuit repeatedly citing the US Supreme Court’s June decision in Loper Bright.
Eli Lilly will provide a know-how manufacturing guide to EVA Pharma, as it prepares to manufacture and sell baricitinib by 2026.
Glenmark Pharmaceuticals agreed to pay $25m in the US to resolve its alleged liability under the False Claims Act linked to price-fixing allegations.
Medicines regulators in the EU have “much to gain” from using AI models in their processes, but this technology must be used in a “safe and responsible” way, says the European Medicines Agency.
Despite its legal stay of execution, lack of confirmatory data means the European Commission’s decision for market removal is likely to stand.
Hikma has asked the US Court of Appeals for the Federal Circuit for a full court rehearing of a panel decision that reopened a dispute with Amarin over a skinny-label generic version of Vascepa.
Days after Sandoz received US FDA approval for its Enzeevu aflibercept biosimilar, Regeneron sued alleging that Sandoz failed to follow the “patent dance” set out in the BPCIA framework and claiming infringement of multiple patents on its Eylea.
With concern over the mpox health emergency continuing to build, the Medicines Patent Pool has offered its services to play a part in the global response.
India prohibits the manufacture and sale of over 150 fixed-dose combinations (FDCs) that lack therapeutic justification and pose potential health risks, though all eyes are on how effectively the regulatory apparatus enforces the ban, not the first in the area, amid legal action. One firm has secured an ad interim ruling for its combination drug.
AI has the potential to save vast amounts of time and money by optimizing pharma supply chain processes, but companies must think about legal risk and liability from all angles, Ewan Townsend, partner at law firm Arnold & Porter, tells the Pink Sheet.
MSN Laboratories will be unable to move forward with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US for now after the originator won a stay of the firm’s ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit.
Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.
Letter to US FDA by a bipartisan group of House members cites clinical trials sponsored by Eli Lilly and Pfizer as examples of a widespread industry practice. But any legislation to curtail such practices is not expected to be part of the BIOSECURE Act.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.