If there had been any lingering market concerns following the temporary partial clinical hold earlier this year for Arcellx Inc.’s multiple myeloma CAR T-cell therapy, CART-ddBCMA, they were likely put to rest as partner Gilead Sciences Inc.’s Kite unit expanded the scope of the firms’ late 2022 collaboration to include lymphomas. At the same time, Kite exercised an option to negotiate a license for Arcellx’s ARC-Sparx program, ACLX-001, in multiple myeloma.
Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
Arcellx Inc. signed a deal that could be worth almost $4 billion with Gilead Sciences Inc.’s unit Kite Pharma Inc. to push forward Arcellx's lead late-stage candidate CART-ddBCMA for relapsed or refractory multiple myeloma. The arrangement brings $225 million up front plus an equity investment of $100 million, along with as much as $3.9 billion in milestone payments. Arcellx CEO Rami Elghandour said the firm sorted through a number of suitors interested in the program. Data at the American Society of Clinical Oncology meeting “catalyzed a number of discussions and a broad set of interests. We felt of the possibilities out there, [Kite/Gilead is] the partner of choice in this space.”
It’s taken eight years of jury trials, court reversals and appeals for Amgen Inc. to get the nod to argue its case before the U.S. Supreme Court on what is needed to meet the enablement standard for functional patent claims that envelop a genus.
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.
Gilead Sciences Inc. said it is increasing manufacturing capacity to match an anticipated increase in demand for its CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), which gained FDA approval for a wider group of lymphoma patients late last week.
Kite Pharma Inc. is no longer on the hook for $1.2 billion in damages and royalties a jury awarded to Juno Therapeutics Inc. and the Sloan Kettering Institute for Cancer Research in a patent infringement suit involving Kite’s CAR T therapy Yescarta (axicabtagene ciloleucel).
Barely a week after cutting a deal with Beigene Ltd. that included an up-front of $45 million cash, Shoreline Biosciences Inc. and Gilead Sciences Inc.-owned Kite are collaborating to develop allogeneic cell therapies in a deal that could bring Shoreline more than $2.3 billion plus royalties.