Drug Delivery
The new plant will give Novartis end-to-end capabilities centered on North Carolina, where it plans to have five facilities across three sites.
FEATURED STORIES
Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?
If the U.S. can help Japan reform its drug pricing controls, both countries stand to benefit.
Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.
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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.
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.