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Five drugs that are likely to make the Inflation Reduction Act (IRA) price negotiation list accounted for 13 percent ($29 billion) of 2021 Medicare Part D spending, but were less than one percent of all covered drugs according to a Kaiser Family Foundation (KFF) analysis of the latest available sales data from CMS. Read More
Two more drugmakers — Johnson & Johnson’s Janssen Pharmaceuticals and Astellas Pharma — filed lawsuits this week against CMS seeking relief from the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA), claiming the program is unconstitutional and bringing the number of lawsuits filed to six. Read More
Following a fiery social media post, Johnson & Johnson has agreed to grant licenses to Stop TB Partnership’s global drug facilities to middle and low income countries to produce generic versions of its Sirturo (bedaquiline), the first new drug to treat multi-drug resistant tuberculosis (MDR-TB) in 50 years. Read More
The U.S. Chamber of Commerce and three other chambers have filed a motion for a preliminary injunction preventing implementation of the Drug Price Negotiation Program in the Inflation Reduction Act (IRA) because it violates the Fifth Amendment Due Process Clause. Read More
Merck has asked a federal judge to issue an order granting a summary judgment in its case against HHS over the Inflation Reduction Act (IRA) on the grounds that “no genuine issue as to any material fact exists.” Read More
The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Read More
The Association of Accessible Medicines (AAM) has filed a lawsuit against a new Minnesota law that controls pharmaceutical pricing, calling the law unconstitutional and discriminatory. Read More
AAM recommends a drug stockpile and reserve capacity program and targeted federal grants for generic manufacturers with excess manufacturing capacity to reduce drug shortages. Read More
The Association for Accessible Medicines (AAM) says that the “looming” Nov. 27 Drug Supply Chain Security Act deadline requiring interoperable exchange, verification and tracing for all drug products, could cause a spike in drug shortages. Read More
The FTC’s lawsuit to block the merger of Amgen and Horizon violates the companies’ right to due process as, with the case relegated to an administrative law judge (ALJ) and not a jury, the commission will be “playing the roles of ‘investigator, prosecutor, and judge,’” the companies said in their June 29 counterclaim filing. Read More
This is Lilly’s second biopharma acquisition in June having announced a planned purchase of Dice Therapeutics for approximately $2.4 billion. Read More