FDA Concerns About Baraclude Cancer Risk Tempered By Hepatitis B Virus Oncogenicity
This article was originally published in The Pink Sheet Daily
After Carcinogenicity Assessment Committee establishes a potential risk in humans, Bristol proposes 12,500-patient, long-term, postmarketing safety study. Implications and design of the study are a primary focus of reviewers' discussion of hepatitis B agent's safety.
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Entecavir clears FDA after a six-month priority review. Baraclude labeling includes data showing superior efficacy versus GlaxoSmithKline’s Epivir-HBV. Bristol will detail the product to the 3,500 physicians who treat most U.S. cases of hepatitis B using a Baraclude-specific sales force.
Bristol-Myers Squibb’s Baraclude (entecavir) recommended for first-line treatment of chronic hepatitis B virus at meeting of FDA’s Antiviral Drugs Advisory Committee. The committee unanimously agrees entecavir has favorable risk/benefit profile despite potential carcinogenicity risks.
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