Shares of Voyager Therapeutics Inc. and its partner, Neurocrine Biosciences Inc., fell in early trading Dec. 23 after Voyager announced an FDA clinical hold on the phase II Restore-1 trial of VY-AADC, an adeno-associated virus-based gene therapy Neurocrine is developing as NBIb-1817 for the treatment of Parkinson's disease. The trial had been paused since at least November as its data safety monitoring board reviewed MRI abnormalities in some study participants.
In an exclusive interview with BioWorld on the challenges facing a deeply divided Congress and some of the highlights of his years in the U.S. House, retiring Congressman Greg Walden (R-Ore.) said that once the COVID- 19 pandemic is over, federal policymakers should hold a summit with officials from states and major cities to look at a new preparedness partnership that would ensure the availability of strategic medical supplies.
TORONTO – An airway clearance device that uses acoustic sound waves to treat lung disorders and respiratory infections like cystic fibrosis (CF) is now being used to clear the lungs of patients suffering very badly from COVID-19. Developed by Montreal-based Dymedso Inc., more than 675 Frequencer acoustic devices currently being utilized across the world are assisting COVID-19 patients by removing mucous and secretions from their lungs and smaller airways.
Miach Orthopaedics Inc. got a leg up on competitors with the U.S. FDA's de novo approval of its Bridge-Enhanced ACL Repair (BEAR) implant. The company achieved a long-term goal in orthopedics, developing a graft-free system that enables the anterior cruciate ligament (ACL) to repair itself. The device represents the first new treatment for ACL tears in three decades.