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EU CHMP To Review July Rejection Of Drugs For Schizophrenia, Metastatic Breast Cancer

 
• By Ian Schofield

The EMA’s CHMP is this week hearing oral evidence on two products it turned down in July – for schizophrenia and metastatic breast cancer – as well as on other drugs for multiple myeloma and multiple sclerosis.

Review
The CHMP is reviewing its initial rejections of two new drugs.

During its meeting this week, the European Medicines Agency’s scientific committee, the CHMP, is due to re-examine approval applications for two products that it rejected earlier this year: Vanda Pharmaceuticals Inc.’s Fanaptum (iloperidone) for schizophrenia and Nektar Therapeutics’ Onzeald (etirinotecan pegol) for breast cancer with brain metastases.

In rejecting Fanaptum at its meeting in July, the CHMP said the product’s effectiveness was “modest” and that it started to exert its effects after two to three weeks of treatment, which was “a concern when treating sudden (acute) episodes of schizophrenia.” The committee was also

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

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Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.