Manufacturing
The new plant will give Novartis end-to-end capabilities centered on North Carolina, where it plans to have five facilities across three sites.
Sun Pharmaceutical is bringing Merck spinoff Organon into the fold, paying $11.75 billion in hopes of becoming a top global biosimilar player.
FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.
The takeover will give Amneal control of four facilities to manufacture biosimilars for a planned wave of launches in the coming years.
The Durham plant will manufacture immunology, neuroscience and oncology drugs once AbbVie finishes construction in 2028.
New Life told FDA inspectors that they lacked the authority to enter parts of a facility where it made the GLP-1 receptor agonists semaglutide and tirzepatide.
Viatris, which Pfizer created in 2020, voluntarily withdrew extended-release products made at a plant in Ireland after an analysis revealed an issue that could affect bioavailability.
With Health Secretary Robert F. Kennedy Jr. declaring himself “a big fan of peptides,” the FDA has arranged an advisory committee to discuss allowing compounders to make molecules despite earlier safety concerns.
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With many overseas patients preferring orals to injectables, Eli Lilly has filed for approval of orforglipron in more than 40 countries and is building manufacturing capacity to support the obesity drug.
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