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The State of Biologics Testing 2026

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The State of Biologics Testing 2026

The success of modern biologics depends not only on groundbreaking science but on the robustness, speed, and credibility of the testing programs that support them. Across the industry, long established testing paradigms are being re-examined as new modalities emerge, regulatory agencies promote innovation and animal reduction, and development timelines continue to compress.

Charles River publishes The State of Biologics Testing 2026 to help document and interpret this moment of change. Based on Charles River’s deep involvement in biologics testing worldwide, and informed by interviews with leaders across biopharma, quality, and regulatory functions, the report captures how organizations are navigating the transition—from traditional compendial methods to advanced technologies, digital tools, and risk-based approaches.

This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry adapting to new scientific and regulatory realities.

The post The State of Biologics Testing 2026 appeared first on GEN – Genetic Engineering and Biotechnology News.

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An obesity drug deep-dive, and peptides move mainstream

Can any of the new obesity medications in development stand out from the pack? Which company just broke records with its IPO? And will the Food and Drug Administration allow greater access to experimental peptides?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

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Can any of the new obesity medications in development stand out from the pack? Which company just broke records with its IPO? And will the Food and Drug Administration allow greater access to experimental peptides?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

Read the rest…

Read More

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RFK Jr. claims his calendar is publicly available. We’ve been trying to get it for a year

WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.

But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.

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WASHINGTON — Health secretary Robert F. Kennedy Jr. on Wednesday pointed to his “publicly available calendar” as an example of his commitment to transparency and to beat back unfavorable reporting.

But no such calendar, detailing who Kennedy meets with or how he spends his time, has been released by the administration. STAT has been asking the Department of Health and Human Services for Kennedy’s calendar for more than a year, via Freedom of Information Act requests and emails to the press office.

Read the rest…

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Nonprofit buys experimental cancer drug to maintain patient access

In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug.

As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, will also acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.

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In a rare move, nonprofit organization Blood Cancer United announced Thursday it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug.

As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, will also acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last.

Read the rest…

Read More

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