All 10 pharmaceutical companies whose products were selected for the first round of Medicare drug price negotiations have agreed to participate in the talks, the Department of Health and Human Services announced Tuesday.
The Biden administration on Tuesday released its list of 10 prescription medicines that will be subject to the first-ever price negotiations by the U.S. Medicare health program that covers 66 million people, with big-selling blood thinner Eliquis from Bristol Myers Squibb and Pfizer among them.
The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities detected in the company’s approved Helicobacter pylori drug products, the company announced Thursday.
Merck’s exceptional revenue growth in 2021 and the first half of 2022 came thanks to three big brands, one of which is not even approved by the FDA yet.
On Friday, Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.
The FDA will still allow continued distribution of sitagliptin containing NTTP with an acceptable intake limit of 37 ng per day and up to 246.7 ng per day.