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Sandoz
NEWS

Sandoz Introduces Tyruko (Biosimilar, Tysabri) for Multiple Sclerosis in Germany 

Shots :  Sandoz has introduced Tyruko (natalizumab), biosimilar of Tysabri for the treatment of r/r multiple sclerosis (RRMS), in Germany which will be available from Feb 1   Polpharma Biologics is responsible for the development, manufacturing and supply of Tyruko while Sandoz holds its commercialization rights in all markets as per a global commercialization agreement signed…
January 31, 2024

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Astellas
NEWS

Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advance Bladder Cancer

Shots The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety The results depicted that the study met its…
January 29, 2024

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Takeda
NEWS

Takeda Reports EC’s Approval of Hyqvia as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Shots Takeda’s Hyqvia has been approved as maintenance therapy for treating chronic inflammatory demyelinating polyneuropathy (CIDP) on stable IVIG therapy valid throughout the EU plus Iceland, Liechtenstein, Norway & Northern Ireland The approval is based on the results from the P-III (ADVANCE-CIDP 1) study assessing Hyqvia’s safety and efficacy as a maintenance therapy to…
January 29, 2024

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NEWS

Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia

Shots: The CHMP has granted a positive opinion to Ryzeneuta (20mg, IV) based on its safety and efficacy evaluation results as compared to PBO The recommendation was made by CHMP for EC’s approval as medicinal product for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with…
January 26, 2024

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Insights+: EMA Marketing Authorization of New Drugs in December 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots:  The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis   PharmaShots has compiled a list of a…
January 23, 2024

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New Drug Designations - November 2023
INSIGHTS+

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…
December 27, 2023

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