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The Latest in Life Science

Rewriting Approval: The FDA's Emerging Framework for Faster Access to Therapies
This year, as the nation celebrates the 250th anniversary of the American Revolution, the U.S. Food and Drug Administration (“FDA”) is engaged in a revolution of its own: a broad-based effort to forge an alternative pathway for new medical products to reach the public in an expedited fashion.

Injectable Peptides: Out of the Back Alley and Into the Light?
Spanish explorer Ponce de Leon’s “fountain of youth” is legendary. In St. Augustine, Florida, visitors still flock to a tourist attraction named for that mystical spring, hoping that a drink from the city’s natural waters might turn back their biological clocks.
At least the only consequence of indulging in the Ponce de Leon fantasy is a mouthful of sulfur‑smelling water. Today’s pursuit of the “fountain of youth” carries greater risk. Increasing numbers of consumers are injecting themselves with unapproved peptides based on unsubstantiated claims that these compounds bestow regenerative properties. Many of these products are purchased from online sellers operating outside traditional regulatory oversight, where they have not been tested for either efficacy or safety.

Pharmaceuticals Turn to “Niche‑Busters” for Sustained Growth
The pharmaceutical industry is in the middle of a meaningful shift in research strategy. For many years, research teams pursued blockbuster drugs—compounds designed to treat common conditions shared by large segments of the population. Novel treatments for high blood pressure, diabetes, elevated cholesterol, and other widespread ailments were the gold standard.