Robert Califf Stabilized US FDA, His Departure May Signal A Coming Storm

The two-time FDA commissioner resigned on 20 January as part of the administration change. Califf is credited with righting an agency demoralized from the COVID-19 pandemic, but worries about its future are high.

Robert Califf at CERSI
Two-time FDA Commissioner Robert Califf received high marks, but agency stakeholders worry about what is next. • Source: Screenshot

When Robert Califf returned to White Oak as US Food and Drug Commissioner for the second time in February 2022, the highly lethal wave of the COVID-19 omicron variant was raging and much of the agency was downtrodden after more than two years of nonstop pandemic work and public backlash from controversial decisions and political meddling by the first Trump Administration.

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Precision Underlines US FDA’s 2025 Cancer, Neuroscience Candidates

 

Top areas for potential 2025 approvals were shaped by R&D focused on increasingly tightly targeted therapies, including the eight new candidates to join the still-burgeoning kinase inhibitor class and RNA interference, as well as many varieties of antibodies.

Novel Agents Up For US FDA Approval In 2025

 

CBER has at least 14 and CDER another 10 novel biologics among the more than 60 candidates with a user fee goal in 2025.

Balancing Competitiveness and Sustainability In EU Regulations, What’s Next For Pharma

 

Restrictions on commonly used chemicals, increased reporting requirements and enhanced environmental risk assessments are just some of the new EU sustainability and environmental rules pharmaceutical companies are potentially facing. While some measures are multi-sectoral, others are pharma specific. The Pink Sheet takes a look at some of the developments in 2024 and expectations for 2025 and beyond.

More Heart, Less Skin: US FDA’s 2025 Novel Approvals Should Reflect Pipeline Shifts

 

Only one-third of novel agents with 2025 goal dates come from the traditional oncology, hematology and neuroscience strongholds. Immunodermatology also is cooling, while cardiovascular drugs return to the front burner.

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EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.

Recent And Upcoming FDA Advisory Committee Meetings

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