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In another blow to the Catalent site in Indiana, Incyte received a complete response letter in its bid to expand the label for Zynyz. Regeneron and Scholar Rock were also handed CRLs due to issues at the facility, now owned by Novo Nordisk. Read more below. |
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Reynald Castaneda |
Deputy Editor, Endpoints News
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by Nicole DeFeudis
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Lonza agreed to sell its capsules and health ingredients business to a UK-based investment firm for $2.2 billion upfront. The separation has been a long time coming for Lonza, which first divulged plans to divest the unit in December 2024. At the time, CEO Wolfgang Wienand was about six months into his role and said the Swiss manufacturer is “not the best owner anymore" for CHI. In a news release Friday, Lonza called the deal the “last and most significant step” to complete its transformation into a
“pure-play CDMO.” The deal with Lone Star Funds is expected to close in this year's second half. | |
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by Anna Brown
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The FDA has handed Incyte a complete response letter for a label expansion of the company's monoclonal antibody Zynyz over issues at a third-party manufacturing site in Indiana that was formerly owned by Catalent. Incyte’s supplemental BLA for Zynyz as a treatment for metastatic non-small cell lung cancer was rejected
due to problems with the factory’s “regulatory compliance,” according to an SEC filing. There were no issues directly related to Zynyz, including with the drug's efficacy, safety and third-party drug substance manufacturer, the filing states. The application was supported with data from Incyte’s Phase 3 POD1UM-304 study. Incyte is now the third company to receive a CRL due to ongoing issues at the troubled facility in Bloomington, IN. Last year, Regeneron and Scholar Rock were also hit with CRLs for drugs made at the
factory, which is now owned by Novo Nordisk. | |
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by Anna Brown
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Eli Lilly is making moves in East Asia. The Indianapolis drugmaker said Wednesday it is earmarking $3 billion over the next decade to increase its manufacturing footprint in
China. Earlier this week, Lilly said it is investing $500 million in South Korea over the next five years through a memorandum of understanding with the government. Lilly’s China budget will be used to boost local production of its GLP-1 pill orforglipron and other oral drugs. Orforglipron is under review by Chinese regulators for obesity and type 2 diabetes. There are currently no GLP-1 weight loss pills available in China, meaning Lilly could be the first to market there, with no reports of Novo Nordisk filing for approval in the country. Novo’s Rybelsus, which is an oral version of semaglutide, is approved in China for type 2 diabetes. | |
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by Nicole DeFeudis
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Evotec plans to close another four sites and cut about a sixth of its staff amid a broader, multi-year shake-up. It’s the latest round of layoffs for the German biotech and manufacturer, which has cut hundreds of employees over the last two years. The company also changed CEOs, shuttered its gene therapy unit, and closed five sites between 2024 and 2025. Evotec said Tuesday it will reduce its footprint to 10 facilities. As a result, the company expects to eliminate up to 800 positions.
Last month, Evotec said it had roughly 4,800 global employees. Evotec’s CEO Christian Wojczewski said in a news release that the next phase of its reorganization will “position the company for sustainable,
high-quality growth.” The company expects its plans will be “substantially implemented by the end of 2027.” | |
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by Nicole DeFeudis
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Ipsen is pulling its cancer drug Tazverik from the market after an independent data monitoring committee found safety concerns in a confirmatory trial. The committee reported cases of secondary cancers that begin in blood-forming tissue, also known as hematologic malignancies, in a follicular lymphoma
study dubbed SYMPHONY-1. The trial pitted Tazverik plus the immunotherapies lenalidomide and rituximab as a second-line treatment against the latter two standard-of-care medicines alone. Ipsen said it’s withdrawing Tazverik immediately for all of its approved uses, including follicular lymphoma and epithelioid sarcoma. A spokesperson declined to comment on the number of
hematologic malignancies observed in the trial, and said that more research is necessary. | |
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