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Michael Cipriano

Washington, DC
Michael Cipriano is a writer based in Washington, D.C. who covers FDA regulatory policy. He has primarily written about advisory committees, FDA public meetings and drug regulation. He is also part of the Pink Sheet’s efforts to expand coverage into Latin America. Previously, Michael has covered generic drug and biosimilar regulation, as well as issues impacting clinical trials.
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Latest From Michael Cipriano

US FDA First's RMAT Designation: Humacyte Got A 'Quick Response'

Humacyte's bioengineered blood vessel, Humacyl, demonstrated long-term potency in Phase II studies; the product, which will regulated as a biologic, can now benefit from increased interactions with FDA under the the Regenerative Medicine Advanced Therapy program.

Regenerative Medicine Biologics

Pfizer's Avelumab Makes Its Debut, In Rare Form Of Skin Cancer

Pfizer got Bavencio to market by focusing on an unmet need, but the PD-L1 inhibitor is still a few years behind, competing with other checkpoint inhibitors over more valuable indications.

Approvals ImmunoOncology

US Generic 'Breakthrough' Pathway Could Have Unintended Consequences

CDER Director Woodcock warns that incentivizing ANDA development with breakthrough-style approach could have unintended consequences, such as more citizen petitions designed to delay generic availability.

Generic Drugs Legislation

Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.

Combination Products Policy

Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

Jeffrey Shuren and Janet Woodcock tell Senate committee that agency is more concerned with implementing combination product provisions of the 21st Century Cures Act.

Combination Products Review Pathway

Zika Vaccines Might Be Approved By 2020

Nothing's even in Phase II yet, but sponsors and US government researchers remain optimistic.

Vaccines Research & Development
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