The plant received an approval from the European Medicines Agency (EMA) last week.
The FDA approval for the Framingham site allows Genzyme to begin the process of returning patients to full dosing (1 mg/kg) levels. The EMA approval also allows Genzyme to start the process of moving the most severely affected patients in Europe to full dose of Fabrazyme in the first three months of 2012. All patients in the US will be returned to full dosing starting in March, while the global return to normal supply levels will begin in the second quarter.
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