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Antibiotic Development Question: Should A Phage Library Equal One Application?

 
• By Derrick Gingery

FDA may have to take a personalized medicine approach when deciding how to classify a phage bank used to create the treatments.

3d render Bacteriophage viruses infecting bacterial cell
3-D rendering of Bacteriophage viruses infecting bacterial cell

Adaptive Phage Therapeutics is moving toward commercialization of a potentially non-traditional antimicrobial treatment, but has yet to answer a simple, yet very important question.

"That was probably one of my biggest questions when I started Adapted Phage Therapeutics: What's the drug?" company CEO Greg Merril said June 14 during a Duke-Margolis Center workshop on...

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US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
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Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

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