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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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PharmaShots Interview Janssen’s Mark Wildgust Shares Insights on Imbruvica for Chronic Lymphocytic Leukemia and Darzalex for Multiple Myeloma

PharmaShots Interview: Janssen’s Mark Wildgust Shares Insights on Imbruvica for Chronic Lymphocytic Leukemia and Darzalex for Multiple Myeloma

In an interview with PharmaShots, Mark Wildgust, Vice President, Global Medical Affairs, Oncology at Janssen shared his views on the data of Imbruvica in P-III (GLOW) and P-II (CAPTIVATE) studies for the treatment of CLL or SLL and also highlighted the results of Darzalex in the P-II (GRIFFIN) & P-III (MAIA) study for multiple myelomaThe P-III (GLOW) and P-II (CAPTIVATE) studies evaluating Imbruvica + venetoclax (I+V) as a…

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