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Navigating Regulatory Hurdles in Drug Development

DrugBank

In 2020, the FDA halted Johnson & Johnson’s COVID-19 vaccine production at a contract manufacturing facility after discovering quality control issues. One notable success story is Moderna’s mRNA vaccine development for COVID-19, which benefited from early regulatory engagement and streamlined approval pathways.

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ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs

Alta Sciences

ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs pmjackson Mon, 07/07/2025 - 21:31 New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS).

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mRNA Tech Transfer Phase 2.0 Discussed at G20 Summit

The Pharma Data

This meant putting the fundamentals of mRNA production directly into the hands of local innovators — a dramatic departure from previous models that kept much of vaccine production within a small number of firms in high-income settings. mRNA Technology Transfer Programme Moves Into Phase 2.0, 2026–2030).

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FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

BioPharma Drive: Drug Pricing

Ibtrozi has also shown the ability to help people whose cancer has spread to the brain, a leading cause of disease progression, the company said. You can unsubscribe at anytime. In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million.

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Vor, with new CEO, changes course to target autoimmune disease

BioPharma Drive: Drug Pricing

Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Now, Vor is reestablishing itself as an autoimmune disease company. You can unsubscribe at anytime. Europe and South America, according to the companies.

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Edwin Cohn and the Harvard Blood Factory

Codon

The same team also invented several other products that proved useful for treating battlefield injuries, including gamma globulins to inoculate soldiers against diseases and fibrin film to minimize bleeding during brain surgeries. Still, Cohn’s work ought to be iconic amongst those interested in scientific progress and metascience.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

The Strategy must address appropriately restructuring the Federal Governments response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease.

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