Now ViroPharma has 60 days to submit its full submission to Health Canada and once submitted, review by the Canadian regulator must be completed before the end of the second half of 2012.
Priority Review status was granted for all three requested indications for Cinryze: treatment of angioedema attacks in adults, adolescents and children six years of age and above with hereditary angioedema (HAE); pre-procedure prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE; and routine prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE.
Fosun Pharma agrees XH-S004 overseas licensing deal
Itepekimab meets primary endpoint in one of two Phase 3 COPD trials
Inogen secures FDA clearance for SIMEOX 200 Airway Clearance Device
Infex Therapeutics begins Phase IIa trial for RESP-X in NCFB patients
Destiny Pharma launches research on XF-73 for cystic fibrosis MRSA infections
Polarean Imaging enters into trade-in agreement with University of Kansas Medical Center
Sionna Therapeutics doses first healthy subject in SION-109 phase one clinical trial
Arcturus Therapeutics granted FDA Orphan Drug Designation for ARCT-032 to treat cystic fibrosis
SpliSense completes SPL84 first-in-human, Phase one clinical trial for cystic fibrosis treatment
Positive Phase 2, Proof-of-Concept Results for VX-548 Published in New England Journal of Medicine
Inogen acquires Physio-Assist, expanding respiratory product portfolio and global presence