USpolicy

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Eli Lilly, Regeneron, and five other drugmakers will take part in an FDA pilot designed to make it quicker and easier to set up manufacturing plants.

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Pharma trade body EFPIA says access to new medicines is worsening across Europe, as it makes the socioeconomic case for spending more on novel drugs.

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The US launches a concerted effort to "restore American leadership in clinical trials" as it deals with the emergence of China as a global R&D hub.

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A Section 301 probe by the US Trade Representative into Germany's medicine pricing and reimbursement policies raises the threat of punitive tariffs.

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The FDA has laid out a framework to use 'prior knowledge' on manufacturing, non-clinical, and clinical data to support cell and gene therapy filings.

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The US Supreme Court has refused to consider lawsuits from pharma groups challenging Medicare's drug pricing negotiation powers.