08:00 , Jan 5, 2015 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

Japan approved Vimizim elosulfase alfa from BioMarin to treat mucopolysaccharidosis IVA (MPS IVA, Morquio’s syndrome), a rare inherited lysosomal storage disease. BioMarin said the recombinant human N-acetylgalactosamine-6-sulfatase is the first drug approved in Japan for...
08:00 , Dec 15, 2014 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

BioMarin said Brazil and Australia approved Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS IVA, Morquio’s syndrome), a rare inherited lysosomal storage disease. The recombinant human N-acetylgalactosamine-6-sulfatase is also approved in Canada and the U.S....
07:00 , Jul 28, 2014 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

BioMarin said Health Canada approved an NDS for Vimizim elosulfase alfa as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis IVA (MPS IVA, Morquio’s syndrome), a rare inherited lysosomal storage...
07:00 , May 5, 2014 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

BioMarin said the European Commission approved Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome), a rare inherited lysosomal storage disease. The company has begun supplying the drug in the EU and said it...
08:00 , Feb 24, 2014 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

BioMarin said EMA's CHMP issued a positive opinion recommending approval of the company's Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome), a rare inherited lysosomal storage disease. FDA approved the recombinant human N-acetylgalactosamine-6-sulfatase...
08:00 , Feb 17, 2014 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

FDA approved a BLA from BioMarin for Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). In November, FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of Vimizim (see BioCentury, Nov. 25, 2013)....
08:00 , Dec 9, 2013 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

BioMarin submitted an NDS for Priority Review to Health Canada for Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). Priority Review allows for a shortened review target of 180 days. A BLA for...
08:00 , Nov 25, 2013 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of Vimizim elosulfase alfa from BioMarin to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). The panel voted 18-1 in favor of approving Vimizim for all patients, with...
08:00 , Nov 18, 2013 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

The French National Agency for Medicines and Health Products Safety (ANSM) granted an Authorization of Temporary Use (ATU) for BioMarin's Vimizim elosulfase alfa to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). The authorization allows patients in...
07:00 , Oct 28, 2013 |  BC Week In Review  |  Clinical News

Vimizim elosulfase alfa regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Nov. 19 to discuss a BLA for Vimizim elosulfase alfa from BioMarin to treat mucopolysaccharidosis IVA (MPS-IVA, Morquio's syndrome). Vimizim, a recombinant human N-acetylgalactosamine-6-sulfatase, has...