FDA issues complete response letter to Leo Pharma's tralokinumab
Leo Pharma's plans to soon launch dermatitis drug tralokinumab in the US were halted on Thursday, since the FDA has rejected the firm's application for marketing authorization and asks for more data on the injection pen that the drug is packaged in.
BY ELIZABETH MØNSTED JOHANSEN, TRANSLATED BY NIELSINE NIELSEN
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The number of endoscopes sold is significantly higher than what the market had predicted in Ambu's second quarter. However, this has not brought about the kind of revenue that analysts had expected. The full-year outlook is maintained.
Ambu is intensifying its efforts to create the next generation of its duodenoscopes. A number of competitors are circling, and an upcoming tender is a good opportunity for income. CEO Juan Jose Gonzalez calls the new duodenoscope the biggest earner of the future.
US electronics company Bose's announced launch of a new, cheap self-tuning hearing aid won't cause sales to plummet for established hearing aid manufacturers, analysts believe. Demant welcomes the competition and WSA plans to test Bose's new solution to understanding its technology.