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Bronchitol AdComm Shows Difficulty Of Following In Kalydeco’s Shadow

 
• By Sue Sutter

Comparisons between the robustness of the efficacy data for dry powder mannitol and Vertex’s ivacaftor were difficult for FDA to avoid during the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 review of Pharmaxis’ cystic fibrosis drug.

The FDA advisory committee review of Pharmaxis Ltd.’s cystic fibrosis drug Bronchitol (mannitol inhalation powder) shows the difficulty faced by a new drug moving through the regulatory process shortly after a breakthrough treatment’s approval in the same disease.

The Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 review of dry powder mannitol (DPM) came almost one year to the day...

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• By Bridget Silverman

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US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 
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Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 
• By Sarah Karlin-Smith

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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

More from North America