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FDA/IoM “Uncertainty” Conference Adds Uncertainty to Biogen Growth Plans For Tysabri

 
• By Michael McCaughan

An FDA/Institute of Medicine workshop on characterizing and communicating the uncertainty inherent in risk/benefit decisions touched on an important topic for every sponsor. But two “case studies” included points a very particular interest to Biogen Idec, and to sponsors in the COPD class.

Uncertainty is fact of life for regulators. FDA officials make drug approval decisions based on inherently incomplete data. Even the largest clinical study can’t answer every question about how a medicine will perform in the real world—and, indeed, the larger the trial the more new questions are likely to arise if you dig deeply into the data.

As Center for Drug Evaluation & Research Director Janet Woodcock put it in her opening remarks to a Feb. 12...

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• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
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Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

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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.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.