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Insights+: EMA Marketing Authorization of New Drugs in August 2024

Insights+: EMA Marketing Authorization of New Drugs in August 2024

Shots:    The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry   The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)  PharmaShots has compiled a list…

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Viewpoints_Manojkumar Bupathy

Advancing Cancer Therapy Delivery: Manojkumar Bupathy from Rocky Mountain Cancer Centers in Conversation with PharmaShots

Shots:  Addressing a high unmet medical need, PharmaShots had a riveting dialogue exchange with Manojkumar Bupathy from Rocky Mountain Cancer Centers  Manojkumar shared insights from the real-world study that analysed the treatment pattern and clinical outcomes in patients with locally advanced/metastatic urothelial carcinoma   The study reveals that four out of the ten patients received only…

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Johnson& Johnson

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC) 

Shots:  The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor  The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs…

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