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MannKind Gears Up To Make Commercial Case For Inhaled Insulin Afrezza

 
• By Emily Hayes

With two new positive Phase III studies, MannKind is getting back on regulatory track, with plans for a new FDA filing of Afrezza in the fourth quarter. Still, the firm is planning more Phase IIIb/Phase IV studies to differentiate the inhaled insulin on the market.

With two positive Phase III studies for inhaled insulinAfrezzaunder its belt, MannKind Corp. thinks it finally has what it takes to win FDA approval – but the company is already turning its attention to planning Phase IIIb/IV trials that will provide evidence to make a case for the new concept in the highly competitive diabetes market.

Described as an “ultra-rapid acting mealtime insulin” by its maker, Afrezza has traveled a long regulatory road. The drug has been subject to two FDA “complete response” letters, one in...

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Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.