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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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Takeda

Takeda Reports the EC’s Approval of Adzynma to Treat Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 

Shots:    The EC has approved Adzynma (recombinant ADAMTS13) to treat ADAMTS13 deficiency in cTTP adults & children. Adzynma is also being assessed under P-IIb study for immune-mediated thrombotic thrombocytopenic purpura (iTTP)  Approval was based on the P-III study assessing Adzynma to treat cTTP, published in the NEJM, with patients receiving Adzynma (40IU/kg, IV, weekly) or…

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Immunology Top 20 2024

Top 20 Immunology Companies of 2024

Shots: Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…

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Takeda

Takeda’s ADAMTS13 Receives the CHMP’s Positive Opinion for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 

Shots:  The CHMP has granted a positive opinion to ADAMTS13 (rADAMTS13) for treating ADAMTS13 deficiency in cTTP children and adults   The positive opinion was based on the P-III study assessing the efficacy, PK, safety, and tolerability for the same. Data was published in The New England Journal of Medicine in May 2024  rADAMTS13 is a…

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VIEWPOINTS_Salomé Juethner_2024

Takeda at AAAAI 2024: Salomé Juethner highlights P-IV Results from ENABLE and EMPOWER Studies

Shots:  At the American Academy of Allergy, Asthma, & Immunology (AAAAI), Takeda presented 9 abstracts focusing on health equity and real-world data from P-IV (ENABLE) & (EMPOWER) studies evaluating HAE patients  Salomé Juethner, Senior Medical Director-Head of Rare Genetics at Takeda, in a stimulating conversation with PharmaShots, talks about shares insights from the real-world P-IV…

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Takeda

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 

Shots:  The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights  The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…

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