Calling it “incredible news,” Massachusetts Attorney General Andrea Joy Campbell reported June 16 that U.S. District Judge William Young ordered the Trump administration to restore funding for NIH research grants focusing on gender and diversity, equity and inclusion (DEI).
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
A court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies.
The U.S. Department of Justice arrested two men in connection with fraudulently billing the Medicare program for COVID-19 tests, some of which were billed for deceased beneficiaries. The case is notable for its use of foreign nationals recruited to set up non-existent labs to file the claims, seeming to signal a new front in efforts to corral Medicare fraud in the U.S.
A former board member of Chinook Therapeutics Inc. and four others were charged May 22 in a 19-count indictment stemming from an alleged insider trading scheme that produced more than $600,000 in profits after the June 2023 announcement that Novartis AG was acquiring the Seattle-based Chinook in a $3.5 billion deal.
Innovative Health LLC, of Scottsdale, Ariz., obtained a jury verdict of $147 million against Johnson & Johnson’s Biosense Webster unit for practices that thwarted the use of less costly reprocessed medical devices.
The U.S. Department of Justice said the CEO of Spinefrontier Inc., Kingsley Chin, entered a guilty plea in connection with allegations that he made false statements about payments made to surgeons for consulting work the physicians did not perform.
Device makers may find it difficult to avoid running afoul of the Anti-Kickback Statute, but a recent case in the U.S. Court of Appeals for the Seventh Circuit suggests that the statutory definition of a referral is not set in stone.
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts.
RSS
