Manufacturing
Vitruvias Therapeutics has “ceased operations” after voluntarily recalling a batch recall of generic thyroid tablets due to possible superpotency that could cause a range of adverse events.
Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist.
The talent pool not keeping pace with increased outsourcing demand is just one reason CDMOs have trouble filling roles, according to a search expert. He also told BioSpace who is most in demand and how candidates can stand out from the competition.
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
After committing $2 billion to a new North Carolina facility to boost capacity for its next-gen obesity candidates, Roche’s Genentech is putting down more cash to expand a device fill-finish site in Oregon.
The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
With demand for pharma services historically lagging behind changes in biotech funding, analysts expect CDMOs to experience an uptick in activity in late 2026 or early 2027.
Companies that manufacture MDMA and psilocybin for patients in other countries are looking to use their experience to access the potential U.S. market.
ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns.
Despite earlier claims of improvement at the fill-finish plant, the FDA has classified the facility as Official Action Indicated based on inspection findings.
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