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Exclusive_Moitreyee Chatterjee-Kishore_2024
EXCLUSIVE

Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Shots:  Recently EC granted Marketing Authorization to Astellas’ VYLOY (zolbetuximab) in combination with chemotherapy for the treatment of patients with advanced gastric and GEJ cancers  Zolbetuximab, a monoclonal antibody designed to target gastric tumor cells that express CLDN18.2 biomarker  Today, at PharmaShots we have Dr. Moitreyee Chatterjee-Kishore the Head of Development, Immuno-Oncology and Cancer Cell…
September 26, 2024

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NEWS

The EC Approves Biogen’s Tofidence (Biosimilar, Roactemra) for Treating Arthritis and COVID-19 

   Shots:  The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19  The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III…
June 24, 2024

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Samsung Bioepis
NEWS

Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders

Shots:  The EC has granted marketing authorization for Pyzchiva (Biosimilar, Stelara) to treat autoimmune disorders in gastroenterology, dermatology, and rheumatology  The approval was based on P-I & P-III studies of Pyzchiva vs Stelara. P-I trial assessing the PK, safety, tolerability & immunogenicity in healthy volunteers, and  P-III trial assessing the efficacy, safety & PK profile…
April 22, 2024

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New Drug Designations - February 2024
INSIGHTS+

New Drug Designations – February 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, and EC. This month’s report includes designations allotted to 13 small molecules, 20 biologics, and 2 devices  SN Bioscience’s SNB-101 received ODD from the US FDA for the treatment of pancreatic cancer based on preclinical results. It…
March 28, 2024

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New Drug Designations - January 2024
INSIGHTS+

New Drug Designations – January 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine   NRx Pharmaceuticals’ NRX-101 small molecule, focused…
February 20, 2024

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New Drug Designations - December 2023
INSIGHTS+

New Drug Designations – December 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 6 biological drugs, 10 small molecules, 5 cell and gene therapies, 1 recombinant fusion protein, 1 peptide and 2 devices   Neurocrine Biosciences’ Crinecerfont, focused on the treatment of Congenital Adrenal Hyperplasia…
January 25, 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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Insights+ Key Biosimilars Events of September 2023
INSIGHTS+

Insights+ Key Biosimilars Events of September 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During the month of September, Sandoz entered into a development and commercialization agreement…
October 4, 2023

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Top Performing Drug – Enbrel (June Edition)
INSIGHTS+

Top Performing Drug – Enbrel (June Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have covered Enbrel as the top-performing drug of the month Enbrel is a biologic drug classified as a TNF inhibitor used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other autoimmune diseases PharmaShots…
June 28, 2023

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