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Astellas Pharma announced a $21.3 million research collaboration with PeptiDream to discover novel protein degraders — enzymes that disassemble and break down unneeded proteins — used in cancer treatments. Read More
Despite the catastrophic damage a tornado caused to Pfizer’s colossal sterile injectable drug manufacturing plant and warehouse in Rocky Mount, N.C., last week, FDA Commissioner Robert Califf says he doesn’t expect “immediate significant impacts” on the supply chain. Read More
A tornado with winds of 150 mph slammed into Pfizer’s enormous drug manufacturing plant in Nash County, N.C., on July 19, knocking out the facility that makes 25 percent of the company’s injectable medications. Read More
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