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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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Top Performing Drug – Dupixent (April Edition)
INSIGHTS+

Top Performing Drug – Dupixent (April Edition)

Shots: In continuation of our previous series on the top-performing drug of the month, based on 2021 revenue, this month we have selected Dupixent and prepared a curated analysis report for our readers Dupixent is an interleukin-4 receptor alpha antagonist used for the treatment of multiple indications including atopic dermatitis, asthma, eosinophilic esophagitis, etc. PharmaShots…
April 26, 2023

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Viewpoints_Dr. Volker Knappertz
VIEWPOINTS

Dr. Volker Knappertz, EVP R&D, Aurinia Shares Insights on LUPKYNIS MAA from EMA

Shots: Volker spoke about the granting of marketing authorization by EC to treat adults with active lupus nephritis.The approval was based on the results of the P-III AURORA study  Volker also talked about the collaboration between Aurinia and Otsuka Pharmaceutical for the development and commercialization of LUPKYNIS The interview gives an understanding of how Aurinia…
December 7, 2022

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Insights+ Key Biosimilars Events of July 2020
INSIGHTS+

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar) Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020 1. Samsung…
August 7, 2020

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