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New Drug Designations - November 2023

New Drug Designations – November 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices  Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…

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Insights+ Key Biosimilars Events of January 2020

Insights+ Key Biosimilars Events of January 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilar is expanding its footprints worldwide with multiple collaborations. In Jan 2020, Pfizer launched its two biosimilars [Ruxience (biosimilar, rituximab) & Trazimera (biosimilar, trastuzumab)] at lowest WAC in the US Our team at PharmaShots has summarized key…

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Insights+ Key Biosimilars Events of August 2019

Insights+ Key Biosimilars Events of August 2019

Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space…

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