The Trump administration dashed hopes that it would temper the Medicare price negotiations mandated by the Inflation Reduction Act when it filed the government’s brief in response to Novartis AG’s appeal to the U.S. Court of Appeals for the Third Circuit.
Novartis AG lost its bid, at least for now, to delay generic competition to its blockbuster heart drug, Entresto (sacubitril, valsartan), on the basis of patent infringement.
The U.S. FDA issued a revised draft guidance, “Promotional labeling and advertising considerations for prescription biological reference and biosimilar products,” to help ensure promotional communications involving reference biologics or their follow-ons are accurate, truthful and not misleading.
In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
The queue of lawsuits challenging the constitutionality of the U.S. Inflation Reduction Act’s (IRA) prescription drug price negotiations continues to grow. Novartis AG is the latest drug company, but probably not the last, to join the line. It filed its challenge in federal court in New Jersey Sept. 1, a few days after the Centers for Medicare & Medicaid Services included the company’s heart failure drug, Entresto (sacubitril and valsartan), on its list of the 10 drugs subject to the first round of IRA negotiations.
The list of 10 part D Medicare drugs listed by the Centers for Medicare & Medicaid Services (CMS) as eligible for negotiation raised some eyebrows on Wall Street, but proved mostly in accord with what the industry expected. Under the Inflation Reduction Act, Medicare can for the first time bargain with drug companies. The back-and-forth begins this year, carrying into next year, and the agreed-upon prices will take effect in 2026.
Claiming it would be impossible to carve out a so-called skinny label that would comply with generic drug “same labeling” rules, Novartis AG is petitioning the U.S. FDA, for the second time, not to approve generic versions of its blockbuster heart drug, Entresto (sacubitril + valsartan), that attempt to carve around a cardiovascular indication that has exclusivity until Feb. 16, 2024.
