Drug Delivery

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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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Merck, Eli Lilly and AstraZeneca have similarly suspended or outright canceled investments in the U.K. in the past week after a sizeable increase in a mandatory levy in the region.
The patient-specific nature of autologous cell therapies presents unique challenges that can best be addressed by a middle path between on-site and centralized manufacturing.
Some observers see risks to becoming over-reliant on local facilities, noting the potential need for trade partners if domestic production is disrupted.
AstraZeneca in January also stopped its $610 million plans to construct a vaccine R&D and manufacturing site in the U.K.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.
FDA
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term.
As the political winds shift on a whim and public distrust of the pharma industry reaches fever pitch over drug pricing, executives are being asked to navigate an impassible path.
Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.