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Eli Lilly’s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia
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The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory…
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Fujian Cosunter’s Oral COVID-19 Therapy Receives Conditional Approval in China
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Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436), a Chinese pharmaceutical company, has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has received conditional marketing approval in China. GST-HG171 is a 3CL protease (3CLpro) inhibitor, characterized as having broad-spectrum anti-COVID-19 activity. 3CL protease is an essential protease for…
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Bayer Withdraws Aliqopa FDA Filing Following Missed Phase III Endpoint
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Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
