Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.YM BioSciences has announced that the clinical hold imposed by the FDA on the development of the company's AeroLEF has been lifted. The lifting of this hold permits YM to resume the expansion into the US of the Phase II clinical development of AeroLEF.
Subscribe to our email newsletter
AeroLEF is being developed as a novel and effective approach to the management of acute pain by delivering a proprietary formulation of inhaled, nebulized, free-and-liposome-encapsulated fentanyl. The free fentanyl results in rapid onset of analgesia while the liposome-encapsulated fentanyl produces the unique extended duration of pain relief, the company said.
YM has also appointed Ali Raza as president of the AeroLEF division to lead the product’s further development. Dr Raza has held a number of leadership roles in established and development-stage pharmaceutical companies. He led the global development of Crestor, a product approved in more than 60 countries and which is competing for market leadership with Lipitor.
David Allan, chairman and CEO of YM, said: “We welcome Dr Raza and have high confidence that his breadth of experience in global drug development will significantly reinforce our team’s ability to realize the substantial value of AeroLEF’s unique approach to the treatment of pain.”