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FDA declines to approve novel infusion for uncontrolled gout over manufacturing concerns
The FDA has declined to approve Sobi’s investigational infusion of nanoencapsulated sirolimus plus pegadricase for adults with uncontrolled gout, according to a press release from the manufacturer.The FDA issued a complete response letter to Sobi requiring additional information regarding manufacturing control strategy of the biological component of the drug, as well as to address contract
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endpoints.news
Sobi receives CRL for gout combination drug over manufacturing
The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment over production concerns and issues with its…
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fiercepharma.com
FDA rejects Sobi’s gout drug over manufacturing issues, sparing Amgen blockbuster
Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA. | Sobi’s plan to introduce a challenger to Amgen’s blockbuster…
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healio.com
FDA declines to approve novel infusion for uncontrolled gout over manufacturing concerns
The FDA has declined to approve Sobi’s investigational infusion of nanoencapsulated sirolimus plus pegadricase for adults with uncontrolled gout, according to a press release from…