May 2023 Global Innovative Drug Report

This May 2023 Global Innovative Drug Report offers a comprehensive overview of the latest advancements in the pharmaceutical industry and an analysis of each selected drug. Within the report, we delve into various aspects of each drug, including its snapshot, R&D status, active patents, mechanisms of action, clinical trials, competitive landscape, and other crucial factors.

Download it now to learn about:

• The first approved drugs in May 

• New drug analysis 

• Global drugs under expedited review pathway in May 

• Analysis of selected ERP drugs 

May 2023 Global Innovative Drug Report Overview

1.) Drugs Approved in May

In May 2023, a total of 18 drugs received global approval, representing a diverse range of therapeutic categories. These include:

• 4 Small molecule drugs (SMD)
• 4 Monoclonal antibodies (mAb)
• 2 Prophylactic vaccines
• 2 Allergen extracts
• 1 Blood component
• 1 Gene therapy
• 1 Bispecific antibody
• 1 Enzyme
• 1 Fusion protein
• 1 Synthetic peptide

2.) Comprehensive Analysis of Newly Introduced Medications 

This report also offers a comprehensive analysis of five recently approved drugs, providing valuable insights into their profiles and impact. Let’s delve into the in-depth analysis of Benegrastim, one of the featured drugs, which encompasses the following comprehensive details:

3.) Global Drugs Under Expedited Review Pathway in May 

In May 2023, there were 57 drugs worldwide undergoing Expedited Review pathways. These included:

• 32 Orphan Drug designations
• 12 Fast Track designations
• 5 Priority reviews
• 4 Breakthrough Therapy designations
• 2 Regenerative Medicine Advanced Therapy designations
• 1 Innovative Licensing and Access Pathway (ILAP)
• 1 Accelerated Approval

These designations and pathways aim to accelerate the evaluation and approval process, ensuring timely access to innovative treatments for patients in need.

4.) Analysis of Selected ERP Drugs 

Within this report, we selected five drugs under Expedited Review pathways for detailed analysis. Now, let’s explore the report content focused on Spesolimab, which provides an in-depth examination of the following key details:

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