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Everest Medicines Announces Approval of Clinical Trial Application by China National Medical Products Administration for Phase 3 Registration Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer

On January 6, 2021, Everest Medicines (HKEX 1952.HK) announced that the National Medical Products Administration (NMPA) of the People’s Republic of China approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic urothelial cancer (mUC).  With this CTA, Everest Medicines plans to enroll patients in China…

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Commission Issues Exclusion Order in Botox Trade Secret Case

In July we reported that the presiding Administrative Law Judge recommended issuing an exclusion order blocking the importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  Since that time, the parties have submitted lengthy Petitions for Review and answered questions raised by the Commissioners.  Now, the Commission has ruled….

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Federal Circuit Affirms PTAB Finding that Rituxan® Biogen Patent is Invalid

As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…

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