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Latest From Heidelberg Pharma AG

NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.

Drug Approval Standards Research & Development

How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs

For the Pepaxto appeal to be wrapped up on a faster timeline than Genentech’s dispute with the US FDA drugs center over Avastin’s breast cancer claim, CBER Director Peter Marks, the commissioner’s designee, would have to render a final decision before January 2024.

Review Pathway Post Market Regulation & Studies

Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September

Since the Center for Drug Evaluation and Research is conducting the single-day hearing on the type 2 diabetes treatment ITCA 650 under its usual process for advisory committee meetings, it denied Intarcia’s requests for input on adding ad hoc members and extended presentation time.

Advisory Committees Drug Review

FDA’s Pepaxto Decider: Peter Marks To Handle Oncopeptides’ Appeal Of Accelerated Approval Withdrawal

CBER director will decide whether the multiple myeloma drug should be withdrawn under new expedited withdrawal procedures; it's the third time FDA leaders have asked senior officials in the biologics center to help decide the fate of a CDER-regulated accelerated approval drug.

Review Pathway Post Market Regulation & Studies
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Company Information

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  • Pharmaceuticals
    • Radiopharmaceuticals, Contrast Agents
  • Biotechnology
    • Large Molecule
  • Other Names / Subsidiaries
    • Heidelberg Pharma Research GmbH
    • Wilex AG