Drug Delivery

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With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.
Major pharmaceutical companies are committing billions to US manufacturing in an effort to avoid steep tariffs threatened by President Donald Trump.
As the industry awaits official word from the administration on how the tariffs will hit, analysts go over the possibilities with one certainty: there will be increased costs for medicines.
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CVS Caremark’s recent decision to take AbbVie’s Humira off its major formularies has caused the blockbuster to lose more market share to biosimilars, according to the latest report from Samsung Bioepis.
The Senate on Thursday unanimously passed a bill aimed at limiting the number of patents drugmakers can introduce and making it easier for generic and biosimilar competitors to enter the market.
The Federal Trade Commission plans to file lawsuits against the three largest pharmacy benefit managers over allegedly steering patients away from less expensive drugs, according to The Wall Street Journal.
As Novo Nordisk’s weight loss drug enters the Chinese market, its patent is expiring in two years and biosimilar competition is rising.
House Speaker Mike Johnson (R-La.) on Monday said he intends to have a “significant package of China-related legislation” signed into law by the end of this year, including the BIOSECURE Act which intends to stop federal contracts with Chinese “companies of concern.”

A federal judge ruled last week that the U.S. government can use its economic standing as a bulk purchaser to negotiate for better deals, handing Boehringer Ingelheim a loss in its legal challenge to the Inflation Reduction Act.
Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act.
President Joe Biden and Sen. Bernie Sanders in a Tuesday op-ed in USA Today called on Novo Nordisk and Eli Lilly to “stop ripping off Americans” with “unconscionably high prices” for their GLP-1 medicines.
Samsung Biologics announced Tuesday it has signed its largest contract ever—a $1.06 billion manufacturing deal with an unnamed pharmaceutical company headquartered in the U.S.
FDA
AbbVie and Merck/Daiichi Sankyo were hit this week with Complete Response Letters from the FDA, which rejected their respective drugs due to manufacturing issues.