Legal Issues

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.

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.

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

In the space of a few days, all four generics manufacturers that had successfully petitioned for a re-examination of a key patent shielding Novo Nordisk’s mega blockbuster Ozempic have reached settlement agreements terminating their challenges.

The payout will bring GSK closer to resolving lawsuits which have occupied it for years – though investors are now likely to focus on new product growth concerns at the UK firm.

Fresenius Kabi is facing up to a patent-litigation suit over its proposed biosimilars to Amgen’s Prolia/Xgeva brands – although a prior lawsuit involving biosimilar sponsor Sandoz concluded with a settlement agreement.

The US FTC and FDA both received letters from the Senate but with different messaging. One commends for achieved findings and requests a new investigation and another scalds for not doing the assigned job.

The world’s best-selling diabetes medicine, with sales last year across the globe of around $14bn, is now in the crosshairs in the US for Viatris’ Mylan and its partner Natco, after the firms announced an agreement settling litigation that was pending before the US Patent and Trademark Office’s Patent Trial and Appeal Board.

The US International Trade Commission looks set to ban the importation of Ascletis's THRβ agonist into the US for use in clinical trials due to an initial legal determination on potential infringement of trade secrets related to Viking's same-class candidate VK2809.

A public interest group has accused the pharma major of using excessive pricing to bolster sales of blockbuster Humira, consequently damaging the health of Dutch patients.