A roundup of manufacturing news from Bavarian Nordic & Regeneron Pharmaceuticals. Highlights below. 

* Bavarian Nordic To Supply 10 M Mpox Vaccine Doses to Africa by 2025
* FDA Issues Complete Response Letter to Regeneron’s Cancer Drug 

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Bavarian Nordic To Supply 10 M Mpox Vaccine Doses to Africa by 2025 
Bavarian Nordic, a Hellerup (near Copenhagen), Denmark-based vaccine company, has outlined plans for providing vaccines for the mpox outbreak in Africa. The Africa Centers for Disease Control and Prevention (Africa CDC) declared the mpox outbreak a public health emergency of continental security on August 13, 2024, followed by the World Health Organization declaring mpox as a public health emergency of international concern on August 14, 2024. 

The company has informed the Africa CDC that it has the capacity to manufacture 10 million doses by the end of 2025, in addition to current orders, and could supply up to 2 million doses this year (2024). 

Source: Bavarian Nordic 

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FDA Issues Complete Response Letter to Regeneron’s Cancer Drug 
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) over manufacturing issues to Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, for the company’s biologics license application (BLA) for linvoseltamab for treating relapsed/refractory multiple myeloma that has progressed after at least three prior therapies.  

The CRL stems from a pre-approval inspection at a third-party fill–finish manufacturer for another company’s product candidate. The third-party fill–finish manufacturer has since informed Regeneron that it believes the findings have been resolved, that its facility is awaiting re-inspection by the FDA, which is expected to take place in the coming months (as reported on August 20, 2024). 

Regulatory review of linvoseltamab remains ongoing by the European Medicines Agency in the same indication.  

Source: Regeneron Pharmaceuticals