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Keeping Track: Novartis, Calardius Pick Up Speed; ADMA Stumbles

 
• By Michael Cipriano

The latest drug development news and highlights from our FDA Performance Tracker.

FDA shows no signs of going on summer vacation, with another active week of approvals and helpful suggestions. And the agency delivered a bit of bad news in an area that could signal growing concern for manufacturers: ADMA Biologics Inc. has become the third drugmaker in as many weeks to land a quality-related complete response letter, with FDA rejecting its primary humoral immunodeficiency disease candidate RI-002.

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More from Approvals

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• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

 
• By Neena Brizmohun

Israel has introduced a new framework to expedite the marketing approval of medicines, make the country a more attractive destination for drug registration and help reduce drug prices through market competition.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

More from Product Reviews

US FDA Advisory Committee Meetings In Jeopardy After Layoffs, But Some Employees Called Back

 
• By Sue Sutter

Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.