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Provention Bio, Inc.

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Latest From Provention Bio, Inc.

A Year's Struggle: How Japan Is Recovering Damaged Generic Supplies After Quality Violations

Japan struggles to recover its ever-expanding supply chain for generic drugs after several key players had their production stopped because of a series of GMP violations. As the share of generics grows under government policy, some in the industry argue the problems are deeply rooted in a decades-old pricing system.

Japan Generic Drugs

US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters

COVID does not appear to be a driving factor, and letters are split almost equally between clinical and quality concerns.

Complete Response Letters Drug Approval Standards

Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Approvals Drug Approval Standards

Provention Maps Possible Regulatory Path For Troubled Teplizumab

Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.

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