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Merck Names Neoclease Winner of 2025 Biotech Grant

The Pharma Data

By combining Neoclease’s AI-designed gene-editing platform with our technologies, regulatory expertise, and process support, we aim to help accelerate new treatments that minimize side effects and maximize effectiveness for patients.”

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Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care

Drug Target Review

Dr Aaron Haubner, Senior Manager of North America Medical Affairs and Market Access at Terumo Blood and Cell Technologies , reveals that while promising new treatments emerge, urgent partnerships are needed to ensure this essential blood therapy reaches the patients who need it most.

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Alnylam Promotes Pushkal Garg to Chief R&D Officer

The Pharma Data

This leadership transition arrives at a pivotal moment in Alnylam’s evolution, as the company builds upon the recent commercial success of AMVUTTRA® (vutrisiran) —a landmark treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

RNA
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Gepirone

New Drug Approvals

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4]

FDA
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

FDA
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Contezolid

New Drug Approvals

3] In 2021, it was approved by the National Medical Products Administration of China for the treatment of complicated skin and soft tissue infections (cSSTI). [3] It is advancing into further clinical studies including step-down therapy with in-hospital intravenous CZA administration followed by outpatient oral CZD treatment.

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Vamorolone

New Drug Approvals

Vamorolone , sold under the brand name Agamree , is a synthetic corticosteroid , which is used for the treatment of Duchenne muscular dystrophy. [4] In December 2023, it was approved in the EU for the treatment of patients ≥4 years of age. Treatment of crude 9.3 4] [5] [6] [7] [8] It is taken by mouth. [1] with peracetic acid 9.4

FDA