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Innovent’s IBI343 Secures the NMPA’s Breakthrough Therapy Designation for Advanced Pancreatic Cancer

Shots: The NMPA has granted BTD to IBI343 alone for treating CLDN18.2+ advanced pancreatic ductal adenocarcinoma (PDAC) progressed post 1L of systematic therapy Designation was based on the ongoing P-I trial of IBI343 (6mg/kg, Q3W) in CLDN18.2+ advanced PDAC patients (n=43) treated with at least 1L of therapy (5% received 2L+ of therapy) across…
January 16, 2025

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New Drug Designations - October 2024
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New Drug Designations – October 2024

Shots:   PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, NMPA, and EMA   The October 2024 report covers designations granted to 33 drugs and 2 devices, encompassing 14 small molecules, 4 biologics, 8 cell and gene therapies, and 2 medical devices.  Significant trends this month…
November 26, 2024

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New Drug Designations - September 2024
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New Drug Designations – September 2024

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA, Health Canada and EMA.  The September 2024 report covers regulatory designations for 42 drugs and 1 device, including 16 small molecules, 6 biologics, 12 cell and gene therapies, and 1 device, among others.  Significant trends this month…
October 29, 2024

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New Drug Designations - April 2024
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New Drug Designations – April 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices   Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…
May 30, 2024

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New Drug Designations - March 2024
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New Drug Designations – March 2024

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices    Trellis Bioscience's…
April 30, 2024

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New Drug Designations - July 2023
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New Drug Designations – July 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test  MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…
August 21, 2023

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New Drug Designations - June 2023
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New Drug Designations – June 2023

Shots:  PharmaShots' designation report provides a condensed overview of several drugs and their designations by the US FDA, the EU, China, and the UK. This month’s report includes 7 biological drugs, 13 small molecules and 9 cell and gene therapies  CellCentric’s Inobrodib, for multiple myeloma and Rocket Pharmaceuticals’ RP-A601, for PKP2-arrhythmogenic cardiomyopathy were the two…
July 17, 2023

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Insights+ Key Biosimilars Events of May 2019
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Insights+ Key Biosimilars Events of May 2019

Biosimilars are going in market with vast emerging needs of people for multiple diseases. The biologics that are too costly to be used in the markets. Hence physicians are developing biosimilars a reference product to biologics which are biologically similar to biologics. Our team at PharmaShots have summarized some of the news regarding biosimilars in…
June 4, 2019

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